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510(k) K950185

TACTYLON(TM) POWDER FREE SURGEONS GLOVE by Tactyl Technologies, Inc. — Product Code KGO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 13, 1995
Date Received
January 17, 1995
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 Tactyl Technologies, Inc.

  • K955464 — TACTYLON POWDER FREE EXAMINATION GLOVE (April 25, 1996)
  • K955419 — POWDER FREE TACTYLON SURGEONS GLOVE (April 15, 1996)
  • K953583 — LUBRICATED CONDOM (January 26, 1996)
  • K911431 — TACTYLON(TM) CONDOM (December 27, 1994)
  • K905109 — PATIENT EXAMINATION GLOVE/HYPOALLERGENIC (November 21, 1990)
  • K902831 — TACTYLON TM SURGICAL GLOVE (July 10, 1990)

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  • K230079 — Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Derm (August 23, 2023)
  • K222993 — Flexylon Surgical Powder Free Gloves with Low Dermatitis Potential Claim, Green (August 18, 2023)