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510(k) K992337

BLOSSOM POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM 50 MCGM OR LESS OF TOTAL WATER EXTRACTA by Mexpo Intl., Inc. — Product Code FMC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 17, 1999
Date Received
July 13, 1999
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 Mexpo Intl., Inc.

  • K990210 — POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100 MICRO (March 29, 1999)
  • K984040 — BLOSSOM POWDERED LATEX EXAMINATION GLOVES (January 13, 1999)
  • K974782 — LOW PROTEIN POWDER FREE LATEX EXAMINATION GLOVES (February 24, 1998)

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)
  • 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)