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510(k) K171375

Gammex PI Breach Detect Powder Free Surgical Glove by Ansell Healthcare Products, LLC — Product Code KGO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 6, 2018
Date Received
May 10, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Surgeon'S Gloves
Device Class
Class I
Regulation Number
878.4460
Review Panel
HO
Submission Type

A surgeon's glove is a disposable device made of natural rubber latex or synthetic polymers that may or may not bear powder to facilitate donning, and it is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.

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