DISPOSABLE POWDER FREE NITRILE EXAM GLOVES, WHITE COLOR— 510(k) K000226

Substantially Equivalent

Sheen More Ent. Co., Ltd.

FDA 510(k) clearance K000226 for DISPOSABLE POWDER FREE NITRILE EXAM GLOVES, WHITE COLOR, Substantially Equivalent on 2000-03-02. Applicant: Sheen More Ent. Co., Ltd..

Clearance details

Applicant: Sheen More Ent. Co., Ltd.
Product code: Code LZA
Advisory panel: General Hospital
Date received: 2000-01-27
Decision date: 2000-03-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tou-Liu, Yun-Lin, TW

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.