Ophthalmic Eye Shield Suppliers
Limit companies to: Worldwide USA
Dupaco, Inc. | Address: 4144 Avenida de la Plata, Oceanside, California 92056-3512, USA 
www.dupacoinc.com | Send Inquiry | Phone: +1-(800)-546-4550
FDA Registration: 2021969 Year Established: 1975 Annual Revenues: USD 1-5 Million Employee Count: ~20 Quality: FDA , ISO 13485 Certified
Products: IV Tubing Warmers, General Medical Supplies, IV Tubing Warmers,Fluid Warmer, Reservoir Bag (FDA Code: BTC), Protective Helmet System, Protective Helmet System, Table Platform, ...
Dupaco, Inc. is a medical device manufacturing company. Our product line includes protective helmet system, patient eye protectors, and airway support device. With our ProneView® protective helmet more...
www.dupacoinc.com | Send Inquiry | Phone: +1-(800)-546-4550
FDA Registration: 2021969 Year Established: 1975 Annual Revenues: USD 1-5 Million Employee Count: ~20 Quality: FDA , ISO 13485 Certified
Products: IV Tubing Warmers, General Medical Supplies, IV Tubing Warmers,Fluid Warmer, Reservoir Bag (FDA Code: BTC), Protective Helmet System, Protective Helmet System, Table Platform, ...
Dupaco, Inc. is a medical device manufacturing company. Our product line includes protective helmet system, patient eye protectors, and airway support device. With our ProneView® protective helmet more...
Ultracell Medical Technologies, Inc. | Address: 183 Providence New London Turnpike,PO Box 326, North Stonington, Connecticut 06359, USA
ultracell.com | Send Inquiry | Phone: +1-(860)-599-4883
Year Established: 1991 Annual Revenues: USD 1-5 Million Employee Count: ~20 Quality: ISO 9001, CE Certified
Products: Absorbing Supplies, Cotton & Rayon Dressings, Cotton, Instrument Wipes, Retractor Holder, Automatic Retractor Holder, Disposable Irrigating Syringe, ...
Ultracell Medical Technologies provides a complete range of ENT, ophthalmic and specialty disposable sponge products. We are an ISO 9001, CE MARK certified company. We offer products like patient & st more...
ultracell.com | Send Inquiry | Phone: +1-(860)-599-4883
Year Established: 1991 Annual Revenues: USD 1-5 Million Employee Count: ~20 Quality: ISO 9001, CE Certified
Products: Absorbing Supplies, Cotton & Rayon Dressings, Cotton, Instrument Wipes, Retractor Holder, Automatic Retractor Holder, Disposable Irrigating Syringe, ...
Ultracell Medical Technologies provides a complete range of ENT, ophthalmic and specialty disposable sponge products. We are an ISO 9001, CE MARK certified company. We offer products like patient & st more...
Hurricane Medical | Address: 2331K 63rd Avenue East, Bradenton, Florida 34203, USA
www.hurricanemedical.com | Send Inquiry | Phone: +1-(941)-751-0588
FDA Registration: 1064005
Products: Manipulators, Rotators, Spatulas and Picks, Disposables, Irrigating Cannulas, Cystotome Needles, Intraocular Lens Manipulators, Punctal Irrigation Cannulas, ...
Hurricane Medical manufactures surgical products. We offer services to ophthalmic professionals. Our lasik irrigators are designed to irrigate the corneal interface & stronial bed. We are accredited w more...
www.hurricanemedical.com | Send Inquiry | Phone: +1-(941)-751-0588
FDA Registration: 1064005
Products: Manipulators, Rotators, Spatulas and Picks, Disposables, Irrigating Cannulas, Cystotome Needles, Intraocular Lens Manipulators, Punctal Irrigation Cannulas, ...
Hurricane Medical manufactures surgical products. We offer services to ophthalmic professionals. Our lasik irrigators are designed to irrigate the corneal interface & stronial bed. We are accredited w more...
Medtronic Xomed Surgical Products, Inc | Address: 6743 Southpoint Drive North, Jacksonville, Florida 32216-0980, USA
www.xomed.com | Phone: +1-(904)-296-9600, 800-874-5797
FDA Registration: 1045254 Year Established: 1999 Annual Revenues: USD 500 Million to 1 Billion Employee Count: ~650 Quality: ISO 9001, CE Certified
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), Sinus Trochars and Cannulae, Gastroenterologic Needle Holder (FDA Code: FHQ), Surgical Navigation Interface/Display, ...
Medtronic Xomed Surgical Products, Inc develops products that treat people with ear, nose and throat (ENT) diseases. our products include MeroPack®, Bioresorbable Nasal Dressing and Sinus Stent, I more...
www.xomed.com | Phone: +1-(904)-296-9600, 800-874-5797
FDA Registration: 1045254 Year Established: 1999 Annual Revenues: USD 500 Million to 1 Billion Employee Count: ~650 Quality: ISO 9001, CE Certified
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), Sinus Trochars and Cannulae, Gastroenterologic Needle Holder (FDA Code: FHQ), Surgical Navigation Interface/Display, ...
Medtronic Xomed Surgical Products, Inc develops products that treat people with ear, nose and throat (ENT) diseases. our products include MeroPack®, Bioresorbable Nasal Dressing and Sinus Stent, I more...
KLS Martin, L.P. | Address: 11239-1 St.Johns Industrial Parkway S, Jacksonville, Florida 32246-7652, USA
www.klsmartinusa.com | Send Inquiry | Phone: +1-(904)-641-7746, 800-625-1557
FDA Registration: 1057946 Year Established: 1993 Annual Revenues: USD 10-25 Million Employee Count: ~100 Quality: ISO 9001 Certified
Products: Vaginal Retractors (FDA Code: HDL), Elevators, Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), Freer Periosteal Elevators, ...
KLS Martin, L.P. focuses on surgical fields. Our mario® instrument management software manages & controls sterile supplies according to economic, technical & process-oriented criteria. Our C-plate more...
www.klsmartinusa.com | Send Inquiry | Phone: +1-(904)-641-7746, 800-625-1557
FDA Registration: 1057946 Year Established: 1993 Annual Revenues: USD 10-25 Million Employee Count: ~100 Quality: ISO 9001 Certified
Products: Vaginal Retractors (FDA Code: HDL), Elevators, Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), Freer Periosteal Elevators, ...
KLS Martin, L.P. focuses on surgical fields. Our mario® instrument management software manages & controls sterile supplies according to economic, technical & process-oriented criteria. Our C-plate more...
Protech Medical | Address: 4087 Burns Road, Palm Beach Gardens, Florida 33410, USA
www.protecheyewear.com | Send Inquiry | Phone: +1-(561)-627-9769
FDA Registration: 1063300 Quality: ISO 9001, CE Certified
Products: Radiation Protection - Lead-Free Gowns, Radiation Protective Eyewear, Maternity Apron, Buckle Apron, Back Relief Apron, Surgical Drop Shoulder Apron, ...
Protech Medical manufactures radiation protective eyewear, garments and equipment that are ideal for physicians, nurses & medical technicians. We are an ISO 9001, CE MARK certified company. We offer p more...
www.protecheyewear.com | Send Inquiry | Phone: +1-(561)-627-9769
FDA Registration: 1063300 Quality: ISO 9001, CE Certified
Products: Radiation Protection - Lead-Free Gowns, Radiation Protective Eyewear, Maternity Apron, Buckle Apron, Back Relief Apron, Surgical Drop Shoulder Apron, ...
Protech Medical manufactures radiation protective eyewear, garments and equipment that are ideal for physicians, nurses & medical technicians. We are an ISO 9001, CE MARK certified company. We offer p more...
Medone Surgical, Inc. | Address: 670 Tallevast Road, Sarasota, Florida 34243, USA
www.medone.com | Send Inquiry | Phone: +1-(941)-359-3129, 866-633-6631
FDA Registration: 3014197664
Products: Retinal Brushes, Retinal Instruments, Curved Microscissors, Vertical Microscissors, Curved Scissors, Angled Micro Capsulorhexis Forceps, ...
Medone Surgical, Inc. manufactures & markets surgical products. We are an ISO certified company. We offer products for retina surgery, cannulas related accessory products, including FlexTip™Cann more...
www.medone.com | Send Inquiry | Phone: +1-(941)-359-3129, 866-633-6631
FDA Registration: 3014197664
Products: Retinal Brushes, Retinal Instruments, Curved Microscissors, Vertical Microscissors, Curved Scissors, Angled Micro Capsulorhexis Forceps, ...
Medone Surgical, Inc. manufactures & markets surgical products. We are an ISO certified company. We offer products for retina surgery, cannulas related accessory products, including FlexTip™Cann more...
Bovie Medical Corporation | Address: 7100 30th Ave. N., St. Petersburg, Florida 33710-2902, USA
www.aaronmed.com | Send Inquiry | Phone: +1-(727)-384-2323, 800-537-2790
FDA Registration: 3007593903 Annual Revenues: USD 25-50 Million Employee Count: ~110 Quality: ISO 9001, CE Certified
Products: Forceps (FDA Code: HTD), Ophthalmic Burrs, Monopolar Aids, Cutting Loops, Monopolar Generators, Dopplers, ...
Bovie Aaron Medical produces a wide range of electrosurgery equipment & accessories, as well as other medical devices. Our Aaron 900™ high frequency desiccator removes the need to go through a t more...
www.aaronmed.com | Send Inquiry | Phone: +1-(727)-384-2323, 800-537-2790
FDA Registration: 3007593903 Annual Revenues: USD 25-50 Million Employee Count: ~110 Quality: ISO 9001, CE Certified
Products: Forceps (FDA Code: HTD), Ophthalmic Burrs, Monopolar Aids, Cutting Loops, Monopolar Generators, Dopplers, ...
Bovie Aaron Medical produces a wide range of electrosurgery equipment & accessories, as well as other medical devices. Our Aaron 900™ high frequency desiccator removes the need to go through a t more...
Marina Medical Instruments Inc. | Address: 955 Shotgun Rd, Sunrise, Florida 33326, USA
www.marinamedical.com | Send Inquiry | Phone: +1-(954)-924-4418, 800-697-1119
FDA Registration: 2084346 Year Established: 1998 Annual Revenues: USD 1-5 Million Employee Count: ~30 Quality: ISO Certified
Products: Vaginal Retractors (FDA Code: HDL), Curettes, Forceps (FDA Code: HTD), Retractors, Hemostatic Mosquito Forceps, Bone Cutters, ...
Marina Medical Instruments Inc. supplies medical instruments. Our product range comprises of vaginal agenesis, fan retractors, pelvic surgery, surgical caps, scopes, electrosurgical, cystoscopy & bari more...
www.marinamedical.com | Send Inquiry | Phone: +1-(954)-924-4418, 800-697-1119
FDA Registration: 2084346 Year Established: 1998 Annual Revenues: USD 1-5 Million Employee Count: ~30 Quality: ISO Certified
Products: Vaginal Retractors (FDA Code: HDL), Curettes, Forceps (FDA Code: HTD), Retractors, Hemostatic Mosquito Forceps, Bone Cutters, ...
Marina Medical Instruments Inc. supplies medical instruments. Our product range comprises of vaginal agenesis, fan retractors, pelvic surgery, surgical caps, scopes, electrosurgical, cystoscopy & bari more...
Halyard Health, Inc. | Address: 5405 Windward Parkway, Alpharetta, Georgia 30004, USA
https://www.halyardhealth.com | Phone: 844-HALYARD (425-9273)
FDA Registration: 3011270181 Year Established: 1903 Annual Revenues: > USD 1 Billion Employee Count: ~30 Quality: CE Certified
Products: Stethoscopes, Splints, Autoclaves, Forceps (FDA Code: HTD), Face Masks, Scrubs, ...
Halyard Health, Inc. is a consumer & medical products company. Its global tissue, personal care and health care brands include Huggies, Pull-Ups, Kotex, Depend, Kleenex, Scott, Kimwipes and WypAll. Ou more...
https://www.halyardhealth.com | Phone: 844-HALYARD (425-9273)
FDA Registration: 3011270181 Year Established: 1903 Annual Revenues: > USD 1 Billion Employee Count: ~30 Quality: CE Certified
Products: Stethoscopes, Splints, Autoclaves, Forceps (FDA Code: HTD), Face Masks, Scrubs, ...
Halyard Health, Inc. is a consumer & medical products company. Its global tissue, personal care and health care brands include Huggies, Pull-Ups, Kotex, Depend, Kleenex, Scott, Kimwipes and WypAll. Ou more...
Vyaire Medical, Inc. | Address: 26125 North Riverwoods Blvd, Mettawa, Illinois 60045, USA
www.vyaire.com | Send Inquiry | Phone: +1-(610)-862-0800
FDA Registration: 2050001 Year Established: 2001 Annual Revenues: USD 50-100 Million Employee Count: ~230 Quality: ISO 9001, CE Certified
Products: Oxygen Masks (FDA Code: BYG), Fetal Monitors, Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Hematology Analyzers, ...
Vyaire Medical, Inc. develops & distributes technology medical devices that are used in respiratory care, neurology, vascular medicine and critical care. Our Infant Flow® SiPAP™ renders bi-l more...
www.vyaire.com | Send Inquiry | Phone: +1-(610)-862-0800
FDA Registration: 2050001 Year Established: 2001 Annual Revenues: USD 50-100 Million Employee Count: ~230 Quality: ISO 9001, CE Certified
Products: Oxygen Masks (FDA Code: BYG), Fetal Monitors, Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Hematology Analyzers, ...
Vyaire Medical, Inc. develops & distributes technology medical devices that are used in respiratory care, neurology, vascular medicine and critical care. Our Infant Flow® SiPAP™ renders bi-l more...
Luxtec | Address: 99 Hartwell Street, West Boylston, Maryland 01583, USA
www.luxtec.com | Send Inquiry | Phone: +1-(508)-835-9700
Year Established: 1981 Annual Revenues: USD 10-25 Million Employee Count: ~140 Quality: ISO 9001, CE Certified
Products: Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Light Sources, Visual Acuity Charts (FDA Code: HOX), Surgical Headlights, ...
Luxtec produces medical illumination systems. We develop lighting and visualization systems for the operating room. Our products include headlights, ultralite, halogen, camera, surgical loupes, monito more...
www.luxtec.com | Send Inquiry | Phone: +1-(508)-835-9700
Year Established: 1981 Annual Revenues: USD 10-25 Million Employee Count: ~140 Quality: ISO 9001, CE Certified
Products: Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Light Sources, Visual Acuity Charts (FDA Code: HOX), Surgical Headlights, ...
Luxtec produces medical illumination systems. We develop lighting and visualization systems for the operating room. Our products include headlights, ultralite, halogen, camera, surgical loupes, monito more...
Alimed, Inc. | Address: 297 High Street, Dedham, Massachusetts 02026, USA
www.alimed.com | Send Inquiry | Phone: +001-(800)-225-2610
FDA Registration: 1218386 Employee Count: ~180 Quality: ISO, CE Certified
Products: Masks & Breathing Bags, Hypodermic Syringes, Bodyfat Analyzers, Spirometers, Disposable Examination Gloves, Furniture & Storage, ...
Alimed, Inc. is a manufacturer and supplier of pre-formed orthoses, alarms for fall management, cushions, diagnostic imaging & operating room accessories, orthopedic rehabilitation equipment, and ergo more...
www.alimed.com | Send Inquiry | Phone: +001-(800)-225-2610
FDA Registration: 1218386 Employee Count: ~180 Quality: ISO, CE Certified
Products: Masks & Breathing Bags, Hypodermic Syringes, Bodyfat Analyzers, Spirometers, Disposable Examination Gloves, Furniture & Storage, ...
Alimed, Inc. is a manufacturer and supplier of pre-formed orthoses, alarms for fall management, cushions, diagnostic imaging & operating room accessories, orthopedic rehabilitation equipment, and ergo more...
3M Medical Specialties | Address: 3M Center, St. Paul, Minnesota 55144-1000, USA
www.3m.com/us/healthcare/medicalspecialties | Send Inquiry | Phone: +1-(888)-364-3577
FDA Registration: 1717046
Products: Stethoscopes, Splints, Autoclaves, Surgical Sealants, Electronic Stethoscopes (FDA Code: DQD), Endo Staplers, ...
3M Medical Specialties and OEM Products offers solutions, technologies and services for health care product development. We produce a wide range of medical tapes, diagnostic components and optical sup more...
www.3m.com/us/healthcare/medicalspecialties | Send Inquiry | Phone: +1-(888)-364-3577
FDA Registration: 1717046
Products: Stethoscopes, Splints, Autoclaves, Surgical Sealants, Electronic Stethoscopes (FDA Code: DQD), Endo Staplers, ...
3M Medical Specialties and OEM Products offers solutions, technologies and services for health care product development. We produce a wide range of medical tapes, diagnostic components and optical sup more...
Jedmed Instrument Company | Address: 5416 JEDMED Court, St. Louis, Missouri 63129-2221, USA
www.jedmed.com | Send Inquiry | Phone: +1-(314)-845-3770
FDA Registration: 1926681 Annual Revenues: < USD 1 Million Employee Count: ~40 Quality: ISO Certified
Products: Otoscopes, Dry Heat Sterilizers (FDA Code: KMH), Laboratory Sterilizers, Laryngoscopes, Lacrimal Dilators and Cannulas, Dressing Forceps, ...
Jedmed Instrument Company manufactures instruments in the areas of ENT, opthalmology and dentistry. Our endonasal DCR technique uses a fiberoptic probe inserted in the punctum for guidance. Our kaps t more...
www.jedmed.com | Send Inquiry | Phone: +1-(314)-845-3770
FDA Registration: 1926681 Annual Revenues: < USD 1 Million Employee Count: ~40 Quality: ISO Certified
Products: Otoscopes, Dry Heat Sterilizers (FDA Code: KMH), Laboratory Sterilizers, Laryngoscopes, Lacrimal Dilators and Cannulas, Dressing Forceps, ...
Jedmed Instrument Company manufactures instruments in the areas of ENT, opthalmology and dentistry. Our endonasal DCR technique uses a fiberoptic probe inserted in the punctum for guidance. Our kaps t more...
Richmond Products, Inc. | Address: 4400 Silver Avenue SE, Albuquerque, New Mexico 87108, USA
www.richmondproducts.com | Send Inquiry | Phone: +1-(505)-275-2406
Products: Hand Held Rotary Prisms, Press-On Prisms, Individual Prisms, Occluders, Prism Bars, Maddox Rods, ...
Richmond Products, Inc. produces screening tests & accessories for ophthalmologists and optometrists. Our product includes aniseikonia, phoropter, chin rest, occluders, prisms, novelty, trial frames, more...
www.richmondproducts.com | Send Inquiry | Phone: +1-(505)-275-2406
Products: Hand Held Rotary Prisms, Press-On Prisms, Individual Prisms, Occluders, Prism Bars, Maddox Rods, ...
Richmond Products, Inc. produces screening tests & accessories for ophthalmologists and optometrists. Our product includes aniseikonia, phoropter, chin rest, occluders, prisms, novelty, trial frames, more...
George Tiemann & Co. | Address: 25 Plant Avenue, Hauppauge, New York 11788, USA
www.atozsurgical.com | Send Inquiry | Phone: +1-(631)-273-0005
FDA Registration: 2424531 Annual Revenues: USD 1-5 Million Employee Count: ~20
Products: Vaginal Retractors (FDA Code: HDL), Blades, Curettes, Forceps (FDA Code: HTD), Scissors, Uterine Sound Instruments, ...
George Tiemann & Co. manufactures surgical instruments. Our products include single patient kit, transplant supplies, ergonomic chair, hair clips, magni-focuser, plastic cups, slot punch, back lightin more...
www.atozsurgical.com | Send Inquiry | Phone: +1-(631)-273-0005
FDA Registration: 2424531 Annual Revenues: USD 1-5 Million Employee Count: ~20
Products: Vaginal Retractors (FDA Code: HDL), Blades, Curettes, Forceps (FDA Code: HTD), Scissors, Uterine Sound Instruments, ...
George Tiemann & Co. manufactures surgical instruments. Our products include single patient kit, transplant supplies, ergonomic chair, hair clips, magni-focuser, plastic cups, slot punch, back lightin more...
Ellman International, Inc. | Address: 3333 Royal Ave, Oceanside, New York 11572, USA
www.ellman.com | Send Inquiry | Phone: +1-(516)-594-3333, 800-835-5355
FDA Registration: 2428235 Annual Revenues: USD 5-10 Million Employee Count: ~80 Quality: ISO 9001, CE Certified
Products: Eyewash Solutions, Standard, Eye Shields, Arthroscopes (FDA Code: HRX), Integrated Anesthesia Machines, Anesthesia, ...
Ellman International, Inc. designs & manufactures radiosurgical device, electrodes, smoke evacuation unit, gynecology, dermatology, plastic surgery, and podiatry. The radiosirgical device includes neu more...
www.ellman.com | Send Inquiry | Phone: +1-(516)-594-3333, 800-835-5355
FDA Registration: 2428235 Annual Revenues: USD 5-10 Million Employee Count: ~80 Quality: ISO 9001, CE Certified
Products: Eyewash Solutions, Standard, Eye Shields, Arthroscopes (FDA Code: HRX), Integrated Anesthesia Machines, Anesthesia, ...
Ellman International, Inc. designs & manufactures radiosurgical device, electrodes, smoke evacuation unit, gynecology, dermatology, plastic surgery, and podiatry. The radiosirgical device includes neu more...
Bausch & Lomb | Address: 1400 N. Goodman St., Rochester, New York 14609, USA
www.bausch.com | Send Inquiry | Phone: +1-(585)-338-6000, 800-553-5340
FDA Registration: 1920664 Annual Revenues: USD 100-500 Million Employee Count: ~1000 Quality: ISO 9000, ISO 9001, ISO 9002, CE Certified
Products: Lacrimal Dilators and Cannulas, Intraocular Lens Manipulators, Phacoemulsification Systems, Dressing Forceps, Tissue Forceps, Intraocular Lens Forceps, ...
Bausch & Lomb is the eye health company dedicated to perfecting vision and enhancing life. We offer a comprehensive portfolio of eye health products. Our three broad categories of products are vision more...
www.bausch.com | Send Inquiry | Phone: +1-(585)-338-6000, 800-553-5340
FDA Registration: 1920664 Annual Revenues: USD 100-500 Million Employee Count: ~1000 Quality: ISO 9000, ISO 9001, ISO 9002, CE Certified
Products: Lacrimal Dilators and Cannulas, Intraocular Lens Manipulators, Phacoemulsification Systems, Dressing Forceps, Tissue Forceps, Intraocular Lens Forceps, ...
Bausch & Lomb is the eye health company dedicated to perfecting vision and enhancing life. We offer a comprehensive portfolio of eye health products. Our three broad categories of products are vision more...
Mohawk Medical Mall | Address: 335 Columbia Street, Utica, New York 13502, USA
www.mohawkmedicalmall.com | Send Inquiry | Phone: +1-(315)-797-0570, 800-962-5660
Annual Revenues: < USD 1 Million Quality: CE Certified
Products: Defibrillators, Colposcopes, Electrocardiographs (ECGs), Spirometers, Otoscopes, Stethoscopes, ...
Mohawk Medical Mall specializes in offering healthcare supplies and equipment. We offer various medical equipment including anoscopes, blood drawing chairs, cabinets, centrifuges, colposcopes, defibri more...
www.mohawkmedicalmall.com | Send Inquiry | Phone: +1-(315)-797-0570, 800-962-5660
Annual Revenues: < USD 1 Million Quality: CE Certified
Products: Defibrillators, Colposcopes, Electrocardiographs (ECGs), Spirometers, Otoscopes, Stethoscopes, ...
Mohawk Medical Mall specializes in offering healthcare supplies and equipment. We offer various medical equipment including anoscopes, blood drawing chairs, cabinets, centrifuges, colposcopes, defibri more...
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FDA Code / Regulation: HOY / 886.4750
An ophthalmic eye shield is a device that consists of a plastic or aluminum eye covering intended to protect the eye or retain dressing materials in place.
Classification. Class I (general controls). When made only of plastic or aluminum, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 886.9. When made only of plastic or aluminum, the devices are exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180 of this chapter, with respect to general requirements concerning records, and 820.198 of this chapter, with respect to complaint files.
