Cleared Abbreviated

Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs and Fentanyl Citrate

K221626 · Jr Engineering & Medical Technologies (M) Sdn. Bhd. · General Hospital
Dec 2022
Decision
184d
Days
Class 1
Risk

About This 510(k) Submission

K221626 is an FDA 510(k) clearance for the Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs and Fentanyl Citrate, 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 December 7, 2022, 184 days after receiving the submission on June 6, 2022. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6250.

Submission Details

510(k) Number K221626 FDA.gov
FDA Decision Cleared SESE
Date Received June 06, 2022
Decision Date December 07, 2022
Days to Decision 184 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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