Guthrie Prime Powdered Latex Examination Gloves with Protein Content Labeling Claim (200 Micrograms or Less)

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

510(k) Number

K003872 ↗

FDA Product Code

LYY

Device Class

Class I

Regulation

21 CFR Part 880.6250

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Patient Examination Latex Gloves (Non-Sterile)

  Class I

  FDA 510(k) K911694 Active Cleared 25 Apr 1991

• Guthrie Prime Powder-Free

  Class I

  FDA 510(k) K990228 Active Cleared 19 Feb 1999

• Guthrie Prime Pre-Powdered Patient Latex Examination Glove

  Class I

  FDA 510(k) K993793 Active Cleared 12 Jan 2000

• Nitrile Examination Gloves (Powered)

  Class I

  FDA 510(k) K003922 Active Cleared 15 Feb 2001

• Guthrie Shield Plus Blue Latex Examination Gloves (Powder-Free)

  Class I

  FDA 510(k) K010078 Active Cleared 29 Jan 2001

• Guthrie Latex Surgical Glove (Pre-Powdered)

  Class I

  FDA 510(k) K001047 Active Cleared 28 Apr 2000

See all devices from Guthrie Medicare Products (Melaka) Sdn Bhd →