ComfortPro Blue Nitrile Examination Gloves Powder Free— 510(k) K212850

Substantially Equivalent

Thai Rubber Industry Company Limited

FDA 510(k) clearance K212850 for ComfortPro Blue Nitrile Examination Gloves Powder Free, Substantially Equivalent on 2021-12-10. Applicant: Thai Rubber Industry Company Limited. Device class: 1.

Clearance details

Applicant
Thai Rubber Industry Company Limited
Product code
Code LZA
Device class
Class 1
Regulation
21 CFR 880.6250
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Abbreviated
Location
Pluakdaeng, TH
Download summary PDFView on FDA.gov ↗

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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.