Cleared Special

Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

K232039 · Grand Work Plastic Products Co., Ltd. · General Hospital
Aug 2023
Decision
30d
Days
Class 1
Risk

About This 510(k) Submission

K232039 is an FDA 510(k) clearance for the Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, a Polymer Patient Examination Glove (Class I — General Controls, product code LZA), submitted by Grand Work Plastic Products Co., Ltd. (Zanhuang County, CN). The FDA issued a Cleared decision on August 9, 2023, 30 days after receiving the submission on July 10, 2023. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6250.

Submission Details

510(k) Number K232039 FDA.gov
FDA Decision Cleared SESE
Date Received July 10, 2023
Decision Date August 09, 2023
Days to Decision 30 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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