Powder-Free Latex Surgeon's Glove Safeskin Pfs Plus Contains 50MLGM or Less of Total Water Extractable Protein per Gram

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

510(k) Number

K991317 ↗

FDA Product Code

KGO

Device Class

Class I

Regulation

21 CFR Part 878.4460

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Nitrile Rubber Examination Gloves (Powered)

  Class I

  FDA 510(k) K932405 Active Cleared 18 May 1994

• Nitrile Rubber Powder-Free Examination Glove

  Class I

  FDA 510(k) K932404 Active Cleared 18 May 1994

• Patient Examination Gloves (Latex)

  Class I

  FDA 510(k) K891435 Active Cleared 12 May 1989

• Safeskin Pfe-Xtra Powder-Free Latex Examination Gloves, Protein Content 50 Mcg or Less, for Use with Chemotherapeutic AG

  Class I

  FDA 510(k) K993117 Active Cleared 2 Mar 2000

• Modified Patient Examination Gloves

  Class I

  FDA 510(k) K894311 Active Cleared 10 Aug 1989

• Safeskin Powdred Hypoallergenic Steril Surg Gloves

  Class I

  FDA 510(k) K894354 Active Cleared 23 Aug 1989

See all devices from Safeskin Corp. →