POWER-FREE NITRILE EXAMINATION GLOVES, PEPPERMINT SCENTED, BLUE COLOR— 510(k) K121528

Substantially Equivalent

Shen Wei (Usa), Inc.

FDA 510(k) clearance K121528 for POWER-FREE NITRILE EXAMINATION GLOVES, PEPPERMINT SCENTED, BLUE COLOR, Substantially Equivalent on 2012-09-11. Applicant: Shen Wei (Usa), Inc..

Clearance details

Applicant: Shen Wei (Usa), Inc.
Product code: Code LZA
Advisory panel: General Hospital
Date received: 2012-05-23
Decision date: 2012-09-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Union City, CA, US

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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.