Encore Microptic Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (50 Micrograms or Less)

• • Terminated Z-0621-2011 FDA Unclassified (pre-2012) ·initiated 3 Sep 2010

  open package seams on sterile gloves

510(k) Number

K000295 ↗

FDA Product Code

KGO

Device Class

Class I

Regulation

21 CFR Part 878.4460

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

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