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510(k) K014134

POWDER-FREE LATEX EXAM GLOVES WITH PROTEIN LABELING (<50UG/G) by Supergrade Healthcare Products Sdn. Bhd. — Product Code FMC

K014134 is an FDA 510(k) premarket notification submitted by Supergrade Healthcare Products Sdn. Bhd. for the device "POWDER-FREE LATEX EXAM GLOVES WITH PROTEIN LABELING (<50UG/G)". The FDA issued a decision of Substantially Equivalent on January 22, 2002. The device falls under product code FMC (Patient Examination Glove), a Class I device regulated under 21 CFR 880.6250. Supergrade Healthcare Products Sdn. Bhd. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 2002
Date Received
December 17, 2001
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 Supergrade Healthcare Products Sdn. Bhd.

  • K934133 — PATIENT EXAMINATION GLOVES (POWDER FREE GLOVES) (January 7, 1994)
  • K891232 — PATIENT EXAMINATION GLOVES (March 22, 1989)

Other clearances for product code FMC

  • K042618 — LAGLOVE BRAND DOUBLE POLYMER COATED NITRILE EXAMINATION GLOVES (POWDER FREE - BL (November 26, 2004)
  • K992337 — BLOSSOM POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (August 17, 1999)
  • K932405 — NITRILE RUBBER EXAMINATION GLOVES (POWERED) (May 18, 1994)
  • K932404 — NITRILE RUBBER POWDER-FREE EXAMINATION GLOVE (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)
  • K903746 — COMFIT, PATIENT EXAMINATION GLOVES (September 5, 1990)

FDA data resources