Cleared Traditional

mCare?Powder-free Nitrile Blue Examination Gloves with Chemotherapy Drugs Labeling Claimed

K190876 · Mercator Medical (Thailand), Ltd. · General Hospital
Dec 2019
Decision
242d
Days
Class 1
Risk

About This 510(k) Submission

K190876 is an FDA 510(k) clearance for the mCare?Powder-free Nitrile Blue Examination Gloves with Chemotherapy Drugs Labeling Claimed, 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 2, 2019, 242 days after receiving the submission on April 4, 2019. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6250.

Submission Details

510(k) Number K190876 FDA.gov
FDA Decision Cleared SESE
Date Received April 04, 2019
Decision Date December 02, 2019
Days to Decision 242 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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