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510(k) K840947

CLOTH-HYPOALLERGENIC by Gainor Medical — Product Code KGX

K840947 is an FDA 510(k) premarket notification submitted by Gainor Medical for the device "CLOTH-HYPOALLERGENIC". The FDA issued a decision of Substantially Equivalent on August 17, 1984. The device falls under product code KGX (Tape And Bandage, Adhesive), a Class I device regulated under 21 CFR 880.5240. Gainor Medical has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 17, 1984
Date Received
March 5, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tape And Bandage, Adhesive
Device Class
Class I
Regulation Number
880.5240
Review Panel
SU
Submission Type

Other clearances by Gainor Medical

  • K850100 — BLOOD LANCET (January 29, 1987)
  • K850150 — ULSTER SCIENTIFIC, INC. AUTOLET LANCETS/GAINOR MED (February 21, 1985)
  • K844305 — GAINOR MEDICAL FLOWMAX NEEDLES (November 30, 1984)
  • K844306 — GAINOR MEDICAL SYRINGE (November 30, 1984)
  • K840945 — SKIN CLOSURE (October 31, 1984)
  • K840950 — ZINC OXIDE TAPE (October 31, 1984)
  • K840951 — FIRST AID BANDAGE (October 31, 1984)
  • K840946 — MICROPOROUS HYPOALLERGENIC (August 17, 1984)
  • K840949 — CLEAR PLASTIC-HYPOALLERGENIC (August 17, 1984)
  • K840948 — CLEAR POROUS PLASTIC-HYPOALLERGENIC (August 14, 1984)

Other clearances for product code KGX

  • K001240 — SERAGARD INJECTION PATCH (June 21, 2000)
  • K983368 — CARE BAND ANTIBACTERIAL BANDAGES (February 17, 1999)
  • K972914 — SYVEK PATCH (December 22, 1997)
  • K943314 — ADHESIVE BANDAGES WITH OTC DRUG (January 17, 1996)
  • K952606 — TARGETT PATCH (December 21, 1995)
  • K954007 — PARALLEL (November 22, 1995)
  • K944587 — DERMIVIEW HYPOALLERGENIC CLEAR TAPE (October 30, 1995)
  • K944588 — STERILE PLASTIC DRESSING (November 7, 1994)
  • K941788 — BAND-AID BRAND ADHESIVE BANDAGES, SPORT STRIP (October 3, 1994)
  • K940536 — BAND-AID(TM) BRAND ADHESIVE BANDAGE (October 3, 1994)

FDA data resources