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510(k) K821043

STERILE PATIENT EXAM. GLOVES by Phoenix Glove Co. — Product Code FMC

K821043 is an FDA 510(k) premarket notification submitted by Phoenix Glove Co. for the device "STERILE PATIENT EXAM. GLOVES". The FDA issued a decision of Substantially Equivalent on May 21, 1982. The device falls under product code FMC (Patient Examination Glove), a Class I device regulated under 21 CFR 880.6250. Phoenix Glove Co. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 1982
Date Received
April 14, 1982
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 Phoenix Glove Co.

  • K830660 — STERILE SURGICAL DRAPES (March 17, 1983)
  • K821044 — PATIENT PREP KITS/TRAYS-STERILE (June 23, 1982)
  • K821666 — STERILE SURGICAL DRAPES (June 21, 1982)
  • K801846 — ELECTROCARDIOGRAPH ELECTRODE (September 9, 1980)
  • K781820 — GLOVES, VINYL EXAMINATION (December 7, 1978)

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)
  • 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