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510(k) K920649

COMPASEP by Wilde-USA, Inc. — Product Code FMC

K920649 is an FDA 510(k) premarket notification submitted by Wilde-USA, Inc. for the device "COMPASEP". The FDA issued a decision of Substantially Equivalent on July 23, 1992. The device falls under product code FMC (Patient Examination Glove), a Class I device regulated under 21 CFR 880.6250. Wilde-USA, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 23, 1992
Date Received
February 12, 1992
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 Wilde-USA, Inc.

  • K913582 — COMPATIT R (June 24, 1993)
  • K915653 — KERAMAIL (April 8, 1993)
  • K913581 — WILDE ADHESIVE BONDING SYSTEM (February 26, 1993)
  • K923472 — COMPACOLOR (October 13, 1992)
  • K913089 — WILDE LIGHT CURING COMPOSITE RESTORATIVE RESINS (April 21, 1992)
  • K915250 — WIL-PDS & WIL-PDI CASTING ALLOYS (April 21, 1992)
  • K912990 — CONVERBASE (March 25, 1992)
  • K920557 — WIL-O-DONT ORTHODONTIC MATERIAL/WIL-O-LUX (March 20, 1992)
  • K915654 — KERALLOY-D CAPS (March 2, 1992)
  • K912993 — WILDE DENTURE RESINS (February 3, 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)
  • 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)
  • 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