Cleared Abbreviated

Disposable Powder Free Nitrile Examination Glove, White, Tested for Use With Chemotherapy Drugs, Disposable Powder Free Nitrile Examination Glove, Blue, Tested for Use With Chemotherapy Drugs

K190403 · Ever Global (Vietnam) Enterprise Corporation · General Hospital
Sep 2019
Decision
199d
Days
Class 1
Risk

About This 510(k) Submission

K190403 is an FDA 510(k) clearance for the Disposable Powder Free Nitrile Examination Glove, White, Tested for Use With Chemotherapy Drugs, Disposable Powder Free Nitrile Examination Glove, Blue, Tested for Use With Chemotherapy Drugs, a Polymer Patient Examination Glove (Class I — General Controls, product code LZA), submitted by Ever Global (Vietnam) Enterprise Corporation (Long Tanh District, VN). The FDA issued a Cleared decision on September 6, 2019, 199 days after receiving the submission on February 19, 2019. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6250.

Submission Details

510(k) Number K190403 FDA.gov
FDA Decision Cleared SESE
Date Received February 19, 2019
Decision Date September 06, 2019
Days to Decision 199 days
Submission Type Abbreviated
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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