Home / 510(k) Clearances / K842301

510(k) K842301

DISPOSABLE LATEX BANDAGE by Inmed Corp. — Product Code KGX

K842301 is an FDA 510(k) premarket notification submitted by Inmed Corp. for the device "DISPOSABLE LATEX BANDAGE". The FDA issued a decision of Substantially Equivalent on November 5, 1984. The device falls under product code KGX (Tape And Bandage, Adhesive), a Class I device regulated under 21 CFR 880.5240. Inmed Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 5, 1984
Date Received
June 11, 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 Inmed Corp.

  • K862672 — ESOPHAGEAL STETHOSCOPE WITH THERMISTOR (October 27, 1986)
  • K853162 — STERILE NASOPHARYNGEAL AIRWAY (August 6, 1985)
  • K850152 — PRECONNECTED URETHRAL CATHETER TRAY (March 12, 1985)
  • K850335 — URETEROSCOPY CATHETER (March 12, 1985)
  • K850248 — DISPOSABLE GUEDEL AIRWAY (March 12, 1985)
  • K844801 — ULTRA EXTERNAL CATHETER (January 15, 1985)
  • K842866 — URETHRAL CATHETERIZATION TRAY (September 10, 1984)
  • K841040 — FOX POST NASAL BALLOON CATHETER (August 17, 1984)
  • K842865 — ESOPHAGEAL STETHOSCOPE (August 15, 1984)
  • K841037 — PENROSE DRAINS (April 25, 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