Home / 510(k) Clearances / K840620

510(k) K840620

TPN/CVP DRESSING CHANGE KIT by Marwood Medical, Inc. — Product Code FMC

K840620 is an FDA 510(k) premarket notification submitted by Marwood Medical, Inc. for the device "TPN/CVP DRESSING CHANGE KIT". The FDA issued a decision of Substantially Equivalent on May 30, 1984. The device falls under product code FMC (Patient Examination Glove), a Class I device regulated under 21 CFR 880.6250. Marwood Medical, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 30, 1984
Date Received
February 14, 1984
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 Marwood Medical, Inc.

  • K850340 — EYE PROCEDURE PACK (May 22, 1985)
  • K850338 — EMERGENCY ROOM PACK (March 25, 1985)
  • K850339 — SPECIAL PROCEDURES PACK (March 12, 1985)
  • K850341 — CARDIOVASCULAR SET UP (February 25, 1985)
  • K850337 — CARDIAC CATHETERIZATION PACK (February 25, 1985)
  • K840619 — I.V. START KIT (March 27, 1984)

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