Cleared Traditional

mCare®Powder-free Nitrile Blue Examination Gloves with Chemotherapy Drugs Labeling Claimed (K190876) - FDA 510(k) Clearance

Class I General Hospital device.

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

K190876 is an FDA 510(k) clearance for the mCare®Powder-free Nitrile Blue Examination Gloves with Chemotherapy Drugs Lab.... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Mercator Medical (Thailand), Ltd. (Amphur Rattaphum, TH). The FDA issued a Cleared decision on December 2, 2019 after a review of 242 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6250 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Mercator Medical (Thailand), Ltd. devices

Submission Details

510(k) Number K190876 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
113d slower than avg
Panel avg: 129d · This submission: 242d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LZA Polymer Patient Examination Glove
Device Class Class 1 - 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.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Consultant

Regulatory Insight, Inc.
Kevin Walls

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LZA Polymer Patient Examination Glove

All 489
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K190876.
Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, White color, Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, Orange color
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K190725 · Riverstone Resources Sdn Bhd · Dec 2019
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K192232 · Hartalega NGC Sdn. Bhd. · Nov 2019
Powder-free Nitrile Patient Examination Glove, Green Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs
K183441 · Semperit Investments Asia Pte , Ltd. · Oct 2019
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K190454 · Hartalega NGC Sdn. Bhd. · Sep 2019