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510(k) K932405

NITRILE RUBBER EXAMINATION GLOVES (POWERED) by Safeskin Corp. — Product Code FMC

K932405 is an FDA 510(k) premarket notification submitted by Safeskin Corp. for the device "NITRILE RUBBER EXAMINATION GLOVES (POWERED)". The FDA issued a decision of Substantially Equivalent on May 18, 1994. The device falls under product code FMC (Patient Examination Glove), a Class I device regulated under 21 CFR 880.6250. Safeskin Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 18, 1994
Date Received
May 13, 1993
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 Safeskin Corp.

  • K993117 — SAFESKIN PFE-XTRA POWDER-FREE LATEX EXAMINATION GLOVES, PROTEIN CONTENT 50 MCG O (March 2, 2000)
  • K994081 — SAFESKIN TACTYLON PF POWDER-FREE SURGEON'S GLOVES (January 18, 2000)
  • K992830 — SAFESKIN POLYMER-COATED NITRILE EXAMINATION GLOVES, POWDER-FREE SHIELDMASTER NIT (October 27, 1999)
  • K992210 — SHIELDMASTER POWDERED PURPLE NITRILE EXAMINATION GLOVES (September 10, 1999)
  • K992162 — SAFESKIN PURPLE POWDER-FREE NITRILE EXAMINATION GLOVES FOR USE WITH CHEMOTHERAPE (August 30, 1999)
  • K992062 — SAFESKIN STERILE PURPLE NITRILE EXAMINATION GLOVES (August 25, 1999)
  • K991951 — SAFESKIN SYNTHETIC BINYO POWDER-FREE POLYMER COATED EXAMINATION GLOVES (GREEN, W (July 26, 1999)
  • K991317 — POWDER-FREE LATEX SURGEON'S GLOVE SAFESKIN PFS PLUS CONTAINS 50MLGM OR LESS OF T (May 21, 1999)
  • K970899 — SAFESKIN POWDERED EXAMINATION GLOVE (May 6, 1997)
  • K962139 — SAFESKIN (December 19, 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)
  • 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