Cleared Traditional

mCare(R) Powder Free Nitrile Orange Examination Gloves

K200967 · Mercator Medical (Thailand), Ltd. · General Hospital
Jun 2020
Decision
57d
Days
Class 1
Risk

About This 510(k) Submission

K200967 is an FDA 510(k) clearance for the mCare(R) Powder Free Nitrile Orange Examination Gloves, 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 June 6, 2020, 57 days after receiving the submission on April 10, 2020. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6250.

Submission Details

510(k) Number K200967 FDA.gov
FDA Decision Cleared SESE
Date Received April 10, 2020
Decision Date June 06, 2020
Days to Decision 57 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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