Home / 510(k) Clearances / K905109

510(k) K905109

PATIENT EXAMINATION GLOVE/HYPOALLERGENIC by Tactyl Technologies, Inc. — Product Code FMC

K905109 is an FDA 510(k) premarket notification submitted by Tactyl Technologies, Inc. for the device "PATIENT EXAMINATION GLOVE/HYPOALLERGENIC". The FDA issued a decision of Substantially Equivalent on November 21, 1990. The device falls under product code FMC (Patient Examination Glove), a Class I device regulated under 21 CFR 880.6250. Tactyl Technologies, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 1990
Date Received
November 13, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Patient Examination Glove
Device Class
Class I
Regulation Number
880.6250
Review Panel
HO
Submission Type

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)
  • K950185 — TACTYLON(TM) POWDER FREE SURGEONS GLOVE (April 13, 1995)
  • K911431 — TACTYLON(TM) CONDOM (December 27, 1994)
  • K902831 — TACTYLON TM SURGICAL GLOVE (July 10, 1990)

Other clearances for product code FMC

  • K042618 — LAGLOVE BRAND DOUBLE POLYMER COATED NITRILE EXAMINATION GLOVES (POWDER FREE - BL (November 26, 2004)
  • K014134 — POWDER-FREE LATEX EXAM GLOVES WITH PROTEIN LABELING (<50UG/G) (January 22, 2002)
  • K992337 — BLOSSOM POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (August 17, 1999)
  • K932404 — NITRILE RUBBER POWDER-FREE EXAMINATION GLOVE (May 18, 1994)
  • K932405 — NITRILE RUBBER EXAMINATION GLOVES (POWERED) (May 18, 1994)
  • K923175 — SURGICAL INSTRUMENT KIT, DISPOSABLE (June 17, 1993)
  • K920649 — COMPASEP (July 23, 1992)
  • K915376 — GLASION VARNISH (January 22, 1992)
  • K905127 — LATEX GLOVE APPLICATION AND REMOVAL SYSTEM (January 30, 1991)
  • K903746 — COMFIT, PATIENT EXAMINATION GLOVES (September 5, 1990)

FDA data resources