Cleared Traditional

Powder Free Black Nitrile Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistant

K210330 · Wrp Asia Pacific Sdn. Bhd. · General Hospital
Mar 2022
Decision
393d
Days
Class 1
Risk

About This 510(k) Submission

K210330 is an FDA 510(k) clearance for the Powder Free Black Nitrile Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistant, a Polymer Patient Examination Glove (Class I — General Controls, product code LZA), submitted by Wrp Asia Pacific Sdn. Bhd. (Sepang, MY). The FDA issued a Cleared decision on March 4, 2022, 393 days after receiving the submission on February 4, 2021. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6250.

Submission Details

510(k) Number K210330 FDA.gov
FDA Decision Cleared SESE
Date Received February 04, 2021
Decision Date March 04, 2022
Days to Decision 393 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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