Powder Free White, Blue Sterilized Nitrile Copolymer Surgical Gloves Tested for Use with Chemotherapy Drugs

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

510(k) Number

K181047 ↗

FDA Product Code

KGO

Device Class

Class I

Regulation

21 CFR Part 878.4460

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Sterile Latex Surgical Gloves (Powdered) with Protein Content Labeling Claim (100 Micrograms or Less)

  Class I

  FDA 510(k) K011066 Active Cleared 11 Sep 2001

• Powder Free Nitrile Examination Glove with Tested for Use with Chemotherapy Drugs Labeling Claim (Blue)

  Class I

  FDA 510(k) K050598 Active Cleared 7 Apr 2005

• Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs (Blue)

  Class I

  FDA 510(k) K063627 Active Cleared 20 Mar 2007

• Polymer Coat, Powder Free, Latex Examination Gloves

  Class I

  FDA 510(k) K991624 Active Cleared 9 Jul 1999

• Powder Free Nitrile Examination Glove (Black and Gray)

  Class I

  FDA 510(k) K060724 Active Cleared 17 May 2006

• Smarttex

  Class I

  FDA 510(k) K974557 Active Cleared 13 Mar 1998

See all devices from Smart Glove Corporation Sdn. Bhd. →