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510(k) K903746

COMFIT, PATIENT EXAMINATION GLOVES by Wembley Rubber Products (M) Sdn Bhd — Product Code FMC

K903746 is an FDA 510(k) premarket notification submitted by Wembley Rubber Products (M) Sdn Bhd for the device "COMFIT, PATIENT EXAMINATION GLOVES". The FDA issued a decision of Substantially Equivalent on September 5, 1990. The device falls under product code FMC (Patient Examination Glove), a Class I device regulated under 21 CFR 880.6250. Wembley Rubber Products (M) Sdn Bhd has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 5, 1990
Date Received
August 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 Wembley Rubber Products (M) Sdn Bhd

  • K982600 — PROFEEL SYNTHETIC COPOLYMER SURGICAL GLOVES (POWDERED) (March 12, 1999)
  • K972616 — ONCOLOGY PLUS POWDER FREE LATEX EXAMINATION GLOVES (PROTEIN CONTENT LABELING) (January 27, 1999)
  • K972615 — CHEMO PLUS POWDER FREE BLUE LATEX EXAMINATION GLOVES (PROTEIN CONTENT LABELING) (January 26, 1999)
  • K972621 — PROFEEL POWDER FREE SURGICAL GLOVES (PROTEIN CONTENT LABELING) (October 24, 1997)
  • K953213 — COMFIT (POWDER FREE EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN, BEADED) (October 11, 1996)
  • K962189 — COMFIT POWDER FREE GREEN EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN) (July 26, 1996)
  • K962188 — COMFIT POWDER FREE BLUE EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN) (July 26, 1996)
  • K953590 — COMFIT (June 27, 1996)
  • K960178 — COMFIT BROWN, BEADED SURGEON'S GLOVES (POWDERED, HYPOALLERGENIC) (May 6, 1996)
  • K960407 — COMFIT ORTHOPEDIC (April 26, 1996)

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)
  • K905109 — PATIENT EXAMINATION GLOVE/HYPOALLERGENIC (November 21, 1990)

FDA data resources