Cleared Traditional

Powder Free Polyurethane Examination Gloves, Blue color, Tested for use with Chemotherapy Drugs

K222892 · Grand Work Plastic Products Co., Ltd. · General Hospital
Dec 2022
Decision
83d
Days
Class 1
Risk

About This 510(k) Submission

K222892 is an FDA 510(k) clearance for the Powder Free Polyurethane Examination Gloves, Blue color, Tested for use with Chemotherapy Drugs, a Polymer Patient Examination Glove (Class I — General Controls, product code LZA), submitted by Grand Work Plastic Products Co., Ltd. (Shijiazhuang, CN). The FDA issued a Cleared decision on December 15, 2022, 83 days after receiving the submission on September 23, 2022. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6250.

Submission Details

510(k) Number K222892 FDA.gov
FDA Decision Cleared SESE
Date Received September 23, 2022
Decision Date December 15, 2022
Days to Decision 83 days
Submission Type Traditional
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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