Absogel Non-Sterile Examination Gloves (Powder-Free)

510(k) Number

K946056 ↗

FDA Product Code

LYY

Device Class

Class I

Regulation

21 CFR Part 880.6250

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Ampri

  Class I

  FDA 510(k) K954002 Active Cleared 29 Jan 1996

• Absogel Sterile Powder-Free Surgical Gloves

  Class I

  FDA 510(k) K945948 Active Cleared 31 Jul 1995

• 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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