DISPOSABLE POWDERED NITRILE EXAM GLOVE, WHITE COLOR— 510(k) K001155

Substantially Equivalent

Sheen More Ent. Co., Ltd.

FDA 510(k) clearance K001155 for DISPOSABLE POWDERED NITRILE EXAM GLOVE, WHITE COLOR, Substantially Equivalent on 2000-05-23. Applicant: Sheen More Ent. Co., Ltd..

Clearance details

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