Orange and Orange-White Colors

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K211455 ↗

FDA Product Code

LZA

FDA applicant

Shen Wei USA, Inc.

Device Class

Class I

Regulation

21 CFR Part 880.6250

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Powder-Free Nitrile Examination Gloves with Aloe Vera

  Class I

  FDA 510(k) K993876 Active Cleared 7 Feb 2000

• Powder-Free Latex Examination Gloves with Aloe and Protein Claim, Tested for Use with Chemotherapy Drugs, Green Color

  Class I

  FDA 510(k) K013795 Active Cleared 22 Jan 2002

• Powder Free Latex Examination Gloves with Aloe Vera @ph 5.5 and Protein Labeling Claims

  Class I

  FDA 510(k) K013793 Active Cleared 22 Jan 2002

• Textured Powder Free Nitrile Exam Gloves (Black Color), Chemo Labeling

  Class I

  FDA 510(k) K060073 Active Cleared 1 May 2006

• Powder- Free Nitrile Examination Gloves, Black Color

  Class I

  FDA 510(k) K090194 Active Cleared 7 Jul 2009

• Powder-Free Nitrile Examination Gloves

  Class I

  FDA 510(k) K032024 Active Cleared 29 Oct 2003

See all devices from Shen Wei (Usa), Inc. →