Hwa & Silktex Powdered Latex Examination Gloves, with Protein Content Labeling Claim (140 Micrograms or Less)

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

510(k) Number

K994432 ↗

FDA Product Code

LYY

Device Class

Class I

Regulation

21 CFR Part 880.6250

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Hwa (and) Silktex Powder-Free Latex Examination Glove

  Class I

  FDA 510(k) K992810 Active Cleared 27 Sep 1999

• Hwa (and) Silktex Powder-Free Latex Examination Glove with Protein Labeling Claim (50 Microgram or Less)

  Class I

  FDA 510(k) K000725 Active Cleared 5 Apr 2000

• Powder-Free Latex Examination Gloves-Blue Color

  Class I

  FDA 510(k) K010803 Active Cleared 11 May 2001

• Hwa Teh Examination Gloves

  Class I

  FDA 510(k) K896251 Active Cleared 21 Nov 1989

• Hwa (and) Silktex Pre-Powdered Latex Examination Glove

  Class I

  FDA 510(k) K992730 Active Cleared 14 Sep 1999