Powder-Free Latex Examination Glove Sterile with Optional Protein Labeling Claim (50 Micrograms or Less)

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

510(k) Number

K001216 ↗

FDA Product Code

LYY

Device Class

Class I

Regulation

21 CFR Part 880.6250

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Non-Sterile Powder-Free Latex Examination Gloves with Protein Labeling Claim 50 Micrograms or Less

  Class I

  FDA 510(k) K001232 Active Cleared 15 May 2000

• Sterile Latex Powdered Patient Examination Gloves

  Class I

  FDA 510(k) K000891 Active Cleared 28 Apr 2000

• Latex Surgical Gloves, Pre-Powdered

  Class I

  FDA 510(k) K993450 Active Cleared 29 Dec 1999

• Powderfree Latex Surgeon's Gloves with Protien Labeling Claim (50 Mocrograms or Less

  Class I

  FDA 510(k) K000896 Active Cleared 3 May 2000

• Powdered Patient Examination Gloves, Latex

  Class I

  FDA 510(k) K001715 Active Cleared 5 Jul 2000