mCare(R) Powder Free Nitrile Orange Examination Gloves— 510(k) K200967

Substantially Equivalent

Mercator Medical (Thailand), Ltd.

FDA 510(k) clearance K200967 for mCare(R) Powder Free Nitrile Orange Examination Gloves, Substantially Equivalent on 2020-06-06. Applicant: Mercator Medical (Thailand), Ltd..

Clearance details

Applicant
Mercator Medical (Thailand), Ltd.
Product code
Code LZA
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Amphur Rattaphum, TH
Download summary PDFView on FDA.gov ↗

Adverse events under product code LZA

product code LZA
Other
1
Total
1

Source: openFDA MAUDE database, through . 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.