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Views: 22 Author: Site Editor Publish Time: 2023-01-16 Origin: Site
Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), many medical gloves are required to undergo premarket notification in accordance with section 510(k). Further details on this can be found in the Premarket Notification 510(k) document. The FDA's regulations apply to various types of medical gloves, as listed in the table below.
Glove Type | Product Code |
Patient Examination Glove | FMC |
Latex Patient Examination Glove | LYY |
Vinyl Patient Examination Glove | LYZ |
Powder-Free Guayle Rubber Examination Glove | OIG |
Powder-Free Polychloroprene Patient Examination Glove | OPC |
Radiation Attenuating Medical Glove | OPH |
Specialty Patient Examination Glove(such as chemotherapy, etc.) | LZC |
Surgeon’s Gloves | KGO |
Powder-Free Non-Natural Rubber Latex Surgeon’s Gloves | OPA |
Medical Gloves With Chemotherapy Labeling Claims | OPJ |
The FDA's regulations prohibit the distribution of certain devices, including powdered surgeon's gloves, powdered patient examination gloves, and absorbable powder for lubricating surgeon's gloves. These banned products are not covered by the FDA's policy.
If you are searching for FDA-cleared medical gloves, you can search the 510(k) Premarket Notification database and use the product codes specified in the table above for medical gloves.
FITONE offers 510-clears disposable latex and nitrile gloves. If you require further assistance, please do not hesitate to contact our team for support.
