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510(k) K831564

ORTHOPEDIC SURGICAL GLOVE by Ansell, Inc. — Product Code FMC

K831564 is an FDA 510(k) premarket notification submitted by Ansell, Inc. for the device "ORTHOPEDIC SURGICAL GLOVE". The FDA issued a decision of Substantially Equivalent on July 12, 1983. The device falls under product code FMC (Patient Examination Glove), a Class I device regulated under 21 CFR 880.6250. Ansell, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 12, 1983
Date Received
May 16, 1983
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 Ansell, Inc.

  • K984392 — ANSELL CONDOMS (July 21, 1999)
  • K983518 — LIFESTYLES XTRA PLEASURE (July 6, 1999)
  • K940047 — SPERMICIDALLY LUBRICATED CONDOM (December 19, 1995)
  • K953379 — HYPOALLERGENIC POWDERED AMBIDEXTROUS COAGULATN DIPPED LATEX EXAMINATION GLOVE (September 27, 1995)
  • K945766 — HYPOALLERGENIC POWDERED AMBIDEXTROUS PATIENT EXAMINATION GLOVES (August 7, 1995)
  • K945767 — POWDER FREE, HYPOALLERGENIC AMBIDEXTROUS PATIENT EXAMINATION GLOVES (March 2, 1995)
  • K940045 — CONDOM (January 30, 1995)
  • K940046 — NON-LUBRICATED CONDOM (January 30, 1995)
  • K913766 — ANSELL NO POWDER AMBI PATIENT EXAMINATION GLOVES (March 11, 1993)
  • K914760 — LATEX EXAMINATION GLOVES (January 17, 1992)

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