Latex Polymer Coated Powder Free Surgical Glove with Protein Labeling Claim of 50 microgram or Less per Gram of Glove (Natural), Latex Polymer Coated Powder Free Surgical Glove with Protein Labeling Claim of 50 microgram or Less per Gram of Glove (Green)

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K160928 ↗

FDA Product Code

KGO

Device Class

Class I

Regulation

21 CFR Part 878.4460

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant Drug- Dark Violet Blue (DVBU)

  Class I

  FDA 510(k) K142805 Active Cleared 18 Dec 2014

• Latex Powdered Examination Gloves with Protein Labeling Claim of 200 Microgram or Less per Gram of Glove

  Class I

  FDA 510(k) K142270 Active Cleared 25 Nov 2014

• Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (White); Dark Violet Blue (DVBU); Dark Blue (DKBU)

  Class I

  FDA 510(k) K162924 Active Cleared 24 Jan 2017