Cleared Special

Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, Xylazine, Gastric acid, Fentanyl in Gastric acid and Xylazine in Gastric acid

K252244 · Ever Global (Vietnam) Enterprise Corporation · General Hospital
Aug 2025
Decision
34d
Days
Class 1
Risk

About This 510(k) Submission

K252244 is an FDA 510(k) clearance for the Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, Xylazine, Gastric acid, Fentanyl in Gastric acid and Xylazine in Gastric acid, a Polymer Patient Examination Glove (Class I — General Controls, product code LZA), submitted by Ever Global (Vietnam) Enterprise Corporation (Taman Village, VN). The FDA issued a Cleared decision on August 21, 2025, 34 days after receiving the submission on July 18, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6250.

Submission Details

510(k) Number K252244 FDA.gov
FDA Decision Cleared SESE
Date Received July 18, 2025
Decision Date August 21, 2025
Days to Decision 34 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code LZA — Polymer Patient Examination Glove
Device Class Class I — General Controls
CFR Regulation 21 CFR 880.6250
Definition A Nitrile (or Polymer) Patient Examination Glove Is A Disposable Device Made Of Nitrile Rubber Or Synthetic Polymers That May Or May Not Bear A Trace Amount Of Residual Powder, And Is Intended To Be Worn On The Hand For Medical Purposes To Provide A Barrier Against Potentially Infectious Materials And Other Contaminants.

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