Cleared Abbreviated

JR MEDIC Nitrile Examination Gloves Powder Free- Black

K221169 · Jr Engineering & Medical Technologies (M) Sdn. Bhd. · General Hospital
Oct 2022
Decision
186d
Days
Class 1
Risk

About This 510(k) Submission

K221169 is an FDA 510(k) clearance for the JR MEDIC Nitrile Examination Gloves Powder Free- Black, a Polymer Patient Examination Glove (Class I — General Controls, product code LZA), submitted by Jr Engineering & Medical Technologies (M) Sdn. Bhd. (Hulu Selangor, MY). The FDA issued a Cleared decision on October 25, 2022, 186 days after receiving the submission on April 22, 2022. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6250.

Submission Details

510(k) Number K221169 FDA.gov
FDA Decision Cleared SESE
Date Received April 22, 2022
Decision Date October 25, 2022
Days to Decision 186 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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