Polymer Coated, Powder Free, Latex Examination Gloves with Protein Content Labeling Claim (50 Micrograms or Less)

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

510(k) Number

K994354 ↗

FDA Product Code

LYY

Device Class

Class I

Regulation

21 CFR Part 880.6250

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Polymer Coated Powder Free Nitrile Examination Gloves, Blue

  Class I

  FDA 510(k) K994416 Active Cleared 3 Feb 2000

• Powder Free Nitrile Examination Gloves

  Class I

  FDA 510(k) K990495 Active Cleared 2 Apr 1999

• Prepowdered Nitrile Examination Gloves

  Class I

  FDA 510(k) K990499 Active Cleared 2 Apr 1999

• Powder Free Latex Examination Gloves, W/ Protein Labeling Claim

  Class I

  FDA 510(k) K990501 Active Cleared 2 Apr 1999

• Prepowdered Latex Examination Gloves with Protein Content Labeling Claim (100 Micrograms or Less)

  Class I

  FDA 510(k) K990502 Active Cleared 2 Apr 1999