Pre-Powdered Latex Orthopedic Surgeon's Gloves

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

510(k) Number

K030444 ↗

FDA Product Code

KGO

FDA applicant

Primus Gloves Private , Ltd.

Device Class

Class I

Regulation

21 CFR Part 878.4460

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Powder Free Latex Microsurgery Gloves with Brown Color and Protein Labeling Claim of 50 Micrograms or Less Protein Gram

  Class I

  FDA 510(k) K030445 Active Cleared 5 Jun 2003

• Vinyl Examination Gloves Sterile Powedered

  Class I

  FDA 510(k) K020044 Active Cleared 26 Feb 2002

• Pre-Powdered Sterile Surgeon's Gloves (with a 50 Microgram/Gm Protein Claim

  Class I

  FDA 510(k) K021065 Active Cleared 8 May 2002