Patient Examination Gloves (Latex)

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K892611 ↗

FDA Product Code

LYY

Device Class

Class I

Regulation

21 CFR Part 880.6250

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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  Class I

  FDA 510(k) K133123 Active Cleared 30 May 2014

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  FDA 510(k) K061553 Active Cleared 17 Jul 2006

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  FDA 510(k) K202536 Active Cleared 11 Aug 2021

• Evergreen and Multiple Private Labels Non-Sterile Powdered Latex Patient Examination Gloves, with Protein Labeling (200

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  FDA 510(k) K011376 Active Cleared 25 May 2001

• Non-Sterile, Powder Free, Polymer Coated Latex Examination Gloves with Water Extractable Protein Claim of 50 Microgram O

  Class I

  FDA 510(k) K991742 Active Cleared 21 Jun 1999

• Non-sterile, Powder Free, ambidextrous, textured, beaded cuff, single use, Doffy® Nitrile Examination Glove, Tested for use with Chemotherapy Drugs

  Class I

  FDA 510(k) K220644 Active Cleared 25 Mar 2023

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