DISPOSABLE POWDER FREE NITRILE EXAM GLOVE, BLUE COLOR— 510(k) K992686

Substantially Equivalent

Sheen More Ent. Co., Ltd.

FDA 510(k) clearance K992686 for DISPOSABLE POWDER FREE NITRILE EXAM GLOVE, BLUE COLOR, Substantially Equivalent on 1999-09-24. Applicant: Sheen More Ent. Co., Ltd..

Clearance details

Applicant: Sheen More Ent. Co., Ltd.
Product code: Code LZA
Advisory panel: General Hospital
Date received: 1999-08-10
Decision date: 1999-09-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tou-Liu, Yun-Lin, TW

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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.