Nitrile Examination Gloves— 510(k) K211515

Substantially Equivalent

Beijing Reagent Latex Products Co., Ltd.

FDA 510(k) clearance K211515 for Nitrile Examination Gloves, Substantially Equivalent on 2021-08-24. Applicant: Beijing Reagent Latex Products Co., Ltd..

Clearance details

Applicant
Beijing Reagent Latex Products Co., Ltd.
Product code
Code LZA
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Abbreviated
Location
Beijing, CN
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.