Colored Powder Free and Polymer Coated Examination Glove (Blue, Black and Pink) with a Protein Claim of Less Than

• • Terminated Z-0712-2012 FDA Unclassified (pre-2012) ·initiated 22 Dec 2011

  The recall was initiated because Adenna Inc. distributed latex gloves that have been FDA refused.

510(k) Number

K100694 ↗

FDA Product Code

LYY

Device Class

Class I

Regulation

21 CFR Part 880.6250

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Tekmedic Powder-Free Latex Examination Gloves with Protein Content Labeling Claim (50 Micrograms or Less)

  Class I

  FDA 510(k) K994250 Active Cleared 7 Feb 2000

• Powder-Free Patient Examination Gloves

  Class I

  FDA 510(k) K971949 Active Cleared 28 Jul 1997

• Tekmedic Powder-Free with Protein Labeling Claim (50 Micrograms or Less)

  Class I

  FDA 510(k) K013317 Active Cleared 17 Dec 2001

• Patient Examination Gloves (Latex)

  Class I

  FDA 510(k) K892094 Active Cleared 31 May 1989

• Tekmedic Powdered Single-Use Latex Patient Examination Gloves with Protein & Powder Label Claim Contains 70MGM or Less O

  Class I

  FDA 510(k) K000555 Active Cleared 12 Apr 2000

• Colored Powder Free Latex Examination Glove (White and Blue)

  Class I

  FDA 510(k) K121594 Active Cleared 25 Oct 2012

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