Maxitex Duplex Sterile Latex Powdered Surgeon Gloves with Protein Labeling Claim (100 Micrograms or Less)

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

510(k) Number

K010439 ↗

FDA Product Code

KGO

Device Class

Class I

Regulation

21 CFR Part 878.4460

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Nugard Black Powder Free Latex Examination Glove, Polymer Coated, Contains 50 Micrograms or less of water extractable protein

  Class I

  FDA 510(k) K170779 Active Cleared 24 May 2017

• Maxitex Latex Neuro Pf Surgical Glove Powderfree

  Class I

  FDA 510(k) K041437 Active Cleared 16 Sep 2004

• Sur-G Glov and Maxitex

  Class I

  FDA 510(k) K102119 Active Cleared 27 Aug 2010

• Powder Free Polychloroprene Examination Glove Blue, Powder Free Polychloroprene Examination Glove Pink

  Class I

  FDA 510(k) K161932 Active Cleared 28 Nov 2016

• Nuzone Nitrile Surgical Gloves Powder Free

  Class I

  FDA 510(k) K000179 Active Cleared 15 May 2000

• Synthetic Surgical Glove-Powderfree Nuzone X2

  Class I

  FDA 510(k) K041436 Active Cleared 20 Aug 2004

See all devices from Terang Nusa Sdn Bhd →