Nitrile Examination Gloves— 510(k) K212922

Substantially Equivalent

Hsk Medical Apparatus Foshan China Co., Ltd.

FDA 510(k) clearance K212922 for Nitrile Examination Gloves, Substantially Equivalent on 2021-12-10. Applicant: Hsk Medical Apparatus Foshan China Co., Ltd..

Clearance details

Applicant: Hsk Medical Apparatus Foshan China Co., Ltd.
Product code: Code LZA
Advisory panel: General Hospital
Date received: 2021-09-14
Decision date: 2021-12-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Foshan, CN

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.