Cleared Traditional

Nitrylex Classic Powder Free Nitrile Blue Examination Gloves Tested for Use with Chemotherapy

K213548 · Mercator Medical (Thailand), Ltd. · General Hospital
Feb 2022
Decision
105d
Days
Class 1
Risk

About This 510(k) Submission

K213548 is an FDA 510(k) clearance for the Nitrylex Classic Powder Free Nitrile Blue Examination Gloves Tested for Use with Chemotherapy, a Polymer Patient Examination Glove (Class I — General Controls, product code LZA), submitted by Mercator Medical (Thailand), Ltd. (Amphur Rattaphum, TH). The FDA issued a Cleared decision on February 21, 2022, 105 days after receiving the submission on November 8, 2021. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6250.

Submission Details

510(k) Number K213548 FDA.gov
FDA Decision Cleared SESE
Date Received November 08, 2021
Decision Date February 21, 2022
Days to Decision 105 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

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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