Microporous Hypoallergenic

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K840946 ↗

FDA Product Code

KGW

Device Class

Class II

Regulation

21 CFR Part 878.4370

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Blood Lancet

  Class II

  FDA 510(k) K850100 Active Cleared 29 Jan 1987

• Clear Plastic-Hypoallergenic

  Class I

  FDA 510(k) K840949 Active Cleared 17 Aug 1984

• Gainor Medical Syringe

  Class II

  FDA 510(k) K844306 Active Cleared 30 Nov 1984

• First Aid Bandage

  Class I

  FDA 510(k) K840951 Active Cleared 31 Oct 1984

• Skin Closure

  Class I

  FDA 510(k) K840945 Active Cleared 31 Oct 1984

• Clear Porous Plastic-Hypoallergenic

  Class II

  FDA 510(k) K840948 Active Cleared 14 Aug 1984

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