Sterile and Non-Sterile Powder-Free Latex Patient Examination Glove, with Extractable Protein Content Labeling Claim (50

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

510(k) Number

K062917 ↗

FDA Product Code

LYY

FDA applicant

Wear Safe Malaysia Sdn. Bhd.

Device Class

Class I

Regulation

21 CFR Part 880.6250

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Powder Free Nitrile Examination Gloves, White (Non-Colored) or Blue (Colored), Non-Sterile

  Class I

  FDA 510(k) K093500 Active Cleared 19 Jan 2010

• Powder Free Latex Examination Gloves Blue (Colored), Non-Sterile, with Protein Labeling Claim of 50UG per DM2 of Glove

  Class I

  FDA 510(k) K101799 Active Cleared 3 Sep 2010

• Powder Free Polymer Coated Latex Examination Gloves, Sterile, with Protein Labeling Claim of 50 Ug per DM2 of Glove

  Class I

  FDA 510(k) K090327 Active Cleared 3 Apr 2009

• Sterile Powder Free Nitrile Surgical Glove, White Colored. Tested for Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim

  Class I

  FDA 510(k) K172420 Active Cleared 29 Sep 2017

• Powder Free Polymer Coated Latex Examination Gloves, Non-Sterile, with Protein Labeling Claim of 50 Micrograms per DM2 O

  Class I

  FDA 510(k) K092492 Active Cleared 21 Oct 2009

• Patient Nitrile Examination Gloves Powder Free Chlorinated

  Class I

  FDA 510(k) K992678 Active Cleared 17 Nov 1999

See all devices from Wear Safe (Malaysia) Sdn. Bhd. →