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510(k) K896165

STERILE HYPOALLERGENIC SURGEONS' GLOVES by Isratech Marketing Corp. — Product Code KGO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 1989
Date Received
October 25, 1989
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.

Other clearances by Isratech Marketing Corp.

  • K871483 — TISSUE CULTURE/BACTERIOLOGICAL PETRI DISHES (April 29, 1987)

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