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510(k) K955419

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

K955419 is an FDA 510(k) premarket notification submitted by Tactyl Technologies, Inc. for the device "POWDER FREE TACTYLON SURGEONS GLOVE". The FDA issued a decision of Substantially Equivalent on April 15, 1996. The device falls under product code KGO (Surgeon'S Gloves), a Class I device regulated under 21 CFR 878.4460. Tactyl Technologies, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 15, 1996
Date Received
November 27, 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)
  • K953583 — LUBRICATED CONDOM (January 26, 1996)
  • K950185 — TACTYLON(TM) POWDER FREE SURGEONS GLOVE (April 13, 1995)
  • K911431 — TACTYLON(TM) CONDOM (December 27, 1994)
  • K905109 — PATIENT EXAMINATION GLOVE/HYPOALLERGENIC (November 21, 1990)
  • K902831 — TACTYLON TM SURGICAL GLOVE (July 10, 1990)

Other clearances for product code KGO

  • K253060 — Sterile Latex Powder Free Surgical Gloves (May 22, 2026)
  • K250313 — Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested For U (August 19, 2025)
  • K240790 — Polyisoprene Surgical gloves (August 23, 2024)
  • K232079 — Natural Rubber Latex Surgical Glove, Powder Free, Sterile, Tested for Use with C (March 28, 2024)
  • K232444 — Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drug (December 20, 2023)
  • K231902 — GAMMEX PI Hybrid Micro (340002055); GAMMEX PI Hybrid Micro (340002060); GAMMEX P (October 20, 2023)
  • K231973 — PolyIsoprene Powder Free Black Colour Radiation Attenuating Surgical Glove (September 29, 2023)
  • K231446 — Single-Use Latex Sterile Surgical Gloves (SG100) (September 22, 2023)
  • K230578 — Polyisoprene Surgical Glove (Unified Double Layer), Sterile, Tested for Use with (August 31, 2023)
  • K230079 — Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Derm (August 23, 2023)

FDA data resources