Mal Latex Examination Gloves

510(k) Number

K896604 ↗

FDA Product Code

LYY

Device Class

Class I

Regulation

21 CFR Part 880.6250

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Powder Free Latex Examination Gloves, Non-Sterile

  Class I

  FDA 510(k) K081488 Active Cleared 28 Aug 2008

• Powder Free Nitrile Examination Gloves, Black

  Class I

  FDA 510(k) K161099 Active Cleared 23 Feb 2017

• Latex Powderfree Sterile Examination Gloves, Models-Extra Small, Small, Medium, Large, Extra Large

  Class I

  FDA 510(k) K013996 Active Cleared 26 Feb 2002

• Surgeon's Gloves Pre-Powdered, Models 6.5, 7, 7.5, 8, 8.5

  Class I

  FDA 510(k) K992752 Active Cleared 5 Nov 1999

• Powder Free Latex Examination Gloves, Black

  Class I

  FDA 510(k) K062709 Active Cleared 6 Dec 2006

• Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs Use and Simulated Gastric Acid)

  Class I

  FDA 510(k) K212408 Active Cleared 18 May 2022

See all devices from Pt. Maja Agung Latexindo →