Polyisoprene Powder Free Surgical Underglove for Use with Chemotherapy Drugs (Blue), Polyisoprene Powder Free Surgical Glove for Use with Chemotherapy Drugs (Natural)

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

510(k) Number

K200897 ↗

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 and Tested for Use With Chemotherapy Drugs (Dawn Blue)

  Class I

  FDA 510(k) K171874 Active Cleared 12 Oct 2017

• Nitrile Powder Free Examination Gloves with Colloidal Oatmeal - Lemon Green

  Class I

  FDA 510(k) K180644 Active Cleared 10 Aug 2018

• Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for Use with Chemotherapy Drugs

  Class I

  FDA 510(k) K162819 Active Cleared 9 Jan 2017

• Latex Powder Free Examination Gloves with Colloidal Oatmeal Usp Skin Protectant Drug with Protein Labeling Claim of 50 M

  Class I

  FDA 510(k) K133953 Active Cleared 28 May 2014

• Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP with Low-Dermatitis Potential Claim and Tested For Use with Chemotherapy Drugs (White)

  Class I

  FDA 510(k) K180505 Active Cleared 14 Jun 2018

• Powder Free Examination Gloves with Colloidal Oatmeal USP and Tested for Use with Chemotherapy Drugs - (Lemon Green)

  Class I

  FDA 510(k) K180645 Active Cleared 16 Nov 2018

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