Cleared Traditional

mCare? Powder Free Nitrile Black Examination Glove

K192444 · Mercator Medical (Thailand), Ltd. · General Hospital
Dec 2019
Decision
116d
Days
Class 1
Risk

About This 510(k) Submission

K192444 is an FDA 510(k) clearance for the mCare? Powder Free Nitrile Black Examination Glove, 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 December 31, 2019, 116 days after receiving the submission on September 6, 2019. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6250.

Submission Details

510(k) Number K192444 FDA.gov
FDA Decision Cleared SESE
Date Received September 06, 2019
Decision Date December 31, 2019
Days to Decision 116 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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