Sunmax Enterprise Shanghai Co. Powder Free Blue Nitrile Patient Examination Glove Tested with Chemotherapy Drugs

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

510(k) Number

K090336 ↗

FDA Product Code

LZA

FDA applicant

Sunmax Enterprise Shanghai Co. , Ltd.

Device Class

Class I

Regulation

21 CFR Part 880.6250

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Sunmax Enterprise Shanghai Vinyl Powdered Patient Exam. Gloves

  Class I

  FDA 510(k) K960746 Active Cleared 27 Jun 1996

• Powder-Free Vinyl Patient Examination Gloves

  Class I

  FDA 510(k) K964964 Active Cleared 7 Feb 1997

• Sunmax Blue Nitrile Powdered Examination Gloves

  Class I

  FDA 510(k) K011717 Active Cleared 14 Aug 2001

• Sunmax Blue Nitrile Powder-Free Examination Glove

  Class I

  FDA 510(k) K011765 Active Cleared 16 Aug 2001