Nitrile Powdered Examination Gloves (Blue)

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K051778 ↗

FDA Product Code

LZA

Device Class

Class I

Regulation

21 CFR Part 880.6250

Advisory Committee

General Hospital

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

See all devices from Hartalega Sdn Bhd →