Absogel Sterile Powder-Free Surgical Gloves

510(k) Number

K945948 ↗

FDA Product Code

KGO

Device Class

Class I

Regulation

21 CFR Part 878.4460

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Absogel Non-Sterile Examination Gloves (Powder-Free)

  Class I

  FDA 510(k) K946056 Active Cleared 20 Jul 1995

• Ampri

  Class I

  FDA 510(k) K954002 Active Cleared 29 Jan 1996

• Correct Touch Surgeons Gloves

  Class I

  FDA 510(k) K892176 Active Cleared 6 Sep 1989

• Powder-Free Latex Examination Glove with Protein Labeling Claim (Contains 50 Micrograms or Less of Total Water Extracta

  Class I

  FDA 510(k) K990812 Active Cleared 4 May 1999

• Correct Touch Examination Gloves (Latex)

  Class I

  FDA 510(k) K892175 Active Cleared 25 Aug 1989

• Absogel Chemotheraphy Gloves

  Class I

  FDA 510(k) K990677 Active Cleared 1 Nov 1999

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