Thermoplastic Elastomer (TPE) Hybrid Examination Glove— 510(k) K210463

Substantially Equivalent

Xuzhou Full Sun Medical Products , Ltd.

FDA 510(k) clearance K210463 for Thermoplastic Elastomer (TPE) Hybrid Examination Glove, Substantially Equivalent on 2022-01-23. Applicant: Xuzhou Full Sun Medical Products , Ltd..

Clearance details

Applicant: Xuzhou Full Sun Medical Products , Ltd.
Product code: Code LZA
Advisory panel: General Hospital
Date received: 2021-02-16
Decision date: 2022-01-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pizhou, 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.