Comfit (Powder Free Examination Gloves (Hypoallergenic, Low Protein, Beaded)

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K953213 ↗

FDA Product Code

LYY

Device Class

Class I

Regulation

21 CFR Part 880.6250

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Scinitrex (Powder Free Nitrile Examination Gloves)

  Class I

  FDA 510(k) K952051 Active Cleared 15 Dec 1995

• Scipotex

  Class I

  FDA 510(k) K945785 Active Cleared 28 Apr 1995

• Comfit Powered Examination Gloves(Beaded, Hypoallerg)

  Class I

  FDA 510(k) K935866 Active Cleared 18 May 1994

• Comfit Blue Powder Free Examination Gloves

  Class I

  FDA 510(k) K943563 Active Cleared 7 Mar 1995

• Comfit, Patient Examination Gloves

  Class I

  FDA 510(k) K903746 Active Cleared 5 Sep 1990

• Scinitrex (Green Powdered Nitrile Examination Gloves)

  Class I

  FDA 510(k) K951921 Active Cleared 30 Oct 1995

See all devices from Wembley Rubber Products (M) Sdn Bhd →