Biodegradable Powder Free Flock-Lined Nitrile Examination Glove, Black and Gray Colors, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate Simulated Gastric Acid Solution

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K213142 ↗

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

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  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

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  FDA 510(k) K013795 Active Cleared 22 Jan 2002

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

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  FDA 510(k) K013793 Active Cleared 22 Jan 2002

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

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  FDA 510(k) K060073 Active Cleared 1 May 2006

• Powder- Free Nitrile Examination Gloves, Black Color

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  FDA 510(k) K090194 Active Cleared 7 Jul 2009

• Powder-Free Nitrile Examination Gloves

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  FDA 510(k) K032024 Active Cleared 29 Oct 2003

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