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FDA’s policy on medical gloves for US market

Views: 22     Author: Site Editor     Publish Time: 2023-01-16      Origin: Site


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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


Latex Patient Examination Glove


Vinyl Patient Examination Glove


Powder-Free Guayle Rubber Examination Glove


Powder-Free Polychloroprene Patient Examination Glove


Radiation Attenuating Medical Glove


Specialty Patient Examination Glove(such as chemotherapy, etc.)


Surgeon’s Gloves


Powder-Free Non-Natural Rubber Latex Surgeon’s Gloves


Medical Gloves With Chemotherapy Labeling Claims


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.

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