Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested For Use With the Opioid Fentanyl Citrate, Simulated Gastric Acid, and Fentanyl In Gastric Acid

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

510(k) Number

K221773 ↗

FDA Product Code

LZA

FDA applicant

Onetexx Sdn Bhd

Device Class

Class I

Regulation

21 CFR Part 880.6250

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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