Nitrile Examination Gloves, Green/ Blue/ Black Color— 510(k) K211778

Substantially Equivalent

Zhenjiang Suhui Latex Products Co., Ltd.

FDA 510(k) clearance K211778 for Nitrile Examination Gloves, Green/ Blue/ Black Color, Substantially Equivalent on 2021-09-02. Applicant: Zhenjiang Suhui Latex Products Co., Ltd..

Clearance details

Applicant: Zhenjiang Suhui Latex Products Co., Ltd.
Product code: Code LZA
Advisory panel: General Hospital
Date received: 2021-06-09
Decision date: 2021-09-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yangzhong, 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.