mCare® Powder Free Nitrile Black Examination Glove— 510(k) K192444

Substantially Equivalent

Mercator Medical (Thailand), Ltd.

FDA 510(k) clearance K192444 for mCare® Powder Free Nitrile Black Examination Glove, Substantially Equivalent on 2019-12-31. Applicant: Mercator Medical (Thailand), Ltd..

Clearance details

Applicant: Mercator Medical (Thailand), Ltd.
Product code: Code LZA
Advisory panel: General Hospital
Date received: 2019-09-06
Decision date: 2019-12-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Amphur Rattaphum, TH

Download summary PDF View on FDA.gov ↗

Adverse events under product code LZA

product code LZA

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.