Powder Free Synthetic Examination Gloves

510(k) Number

K971356 ↗

FDA Product Code

LZA

Device Class

Class I

Regulation

21 CFR Part 880.6250

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Vinyl Examination Gloves, Pre-Powdered with Vitamin E

  Class I

  FDA 510(k) K023753 Active Cleared 25 Mar 2003

• Blue Latex Examination Gloves, Powder Free

  Class I

  FDA 510(k) K013320 Active Cleared 19 Dec 2001

• Vinyl Examination Gloves, Powder Free, Violet Color

  Class I

  FDA 510(k) K031913 Active Cleared 9 Jul 2003

• Non-Sterile Latex Examination Gloves(Pre-Powdered)

  Class I

  FDA 510(k) K925683 Active Cleared 4 Jun 1993

• Vinyl Examination Gloves (Non Sterile)

  Class I

  FDA 510(k) K934536 Active Cleared 23 Jun 1994

• Powder Free Nitrile Examination Gloves, Purple Color

  Class I

  FDA 510(k) K023072 Active Cleared 13 Feb 2003

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