CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown CoverU Disposable Gown with Tape - Chemo Gown— 510(k) K210414

Substantially Equivalent

Medtecs (Taiwan) Corp.

FDA 510(k) clearance K210414 for CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown CoverU Disposable Gown with Tape - Chemo Gown, Substantially Equivalent on 2022-10-21. Applicant: Medtecs (Taiwan) Corp..

Clearance details

Applicant: Medtecs (Taiwan) Corp.
Product code: Code FYC
Advisory panel: General, Plastic Surgery
Date received: 2021-02-11
Decision date: 2022-10-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taipei City, TW

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.