Powder Free Latex Surgeons Gloves Polymer Coated Sterile with Optional Labeling Claim of E.P. Less Than 50 Ug/DM2

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

510(k) Number

K033564 ↗

FDA Product Code

KGO

FDA applicant

Kanam Latex Industries Pvt. , Ltd.

Device Class

Class I

Regulation

21 CFR Part 878.4460

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Latex Patient Examination Gloves

  Class I

  FDA 510(k) K897139 Active Cleared 23 Jan 1990

• Powderfree Latex Surgeon's Gloves

  Class I

  FDA 510(k) K013914 Active Cleared 6 Feb 2002

• Pre-Powdered Sterile Exam Gloves

  Class I

  FDA 510(k) K052214 Active Cleared 13 Sep 2005

• Powder Free Latex Sterile Patient Examination Gloves

  Class I

  FDA 510(k) K052728 Active Cleared 5 Dec 2005

• Surgicare Sterile Surgical Gloves

  Class I

  FDA 510(k) K904972 Active Cleared 31 Jan 1991