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510(k) K905127

LATEX GLOVE APPLICATION AND REMOVAL SYSTEM by Success Builders Intl., Inc. — Product Code FMC

K905127 is an FDA 510(k) premarket notification submitted by Success Builders Intl., Inc. for the device "LATEX GLOVE APPLICATION AND REMOVAL SYSTEM". The FDA issued a decision of Substantially Equivalent on January 30, 1991. The device falls under product code FMC (Patient Examination Glove), a Class I device regulated under 21 CFR 880.6250. Success Builders Intl., Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 1991
Date Received
November 14, 1990
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 Success Builders Intl., Inc.

  • K905177 — STAT(TM) GLOVE (January 30, 1991)

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)
  • K905109 — PATIENT EXAMINATION GLOVE/HYPOALLERGENIC (November 21, 1990)
  • K903746 — COMFIT, PATIENT EXAMINATION GLOVES (September 5, 1990)

FDA data resources