Home / 510(k) Clearances / K140477

510(k) K140477

BIOGEL PS SURGICAL GLOVE SERIES, BIOGEL SKINSENSE SURGICAL GLOVE SERIES by Molnlycke Health Care Us, LLC — Product Code KGO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 23, 2015
Date Received
February 26, 2014
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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