Cleared Traditional

CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown CoverU Disposable Gown with Tape - Chemo Gown

K210414 · Medtecs (Taiwan) Corp. · General Hospital

Oct 2022

Decision

617d

Days

Class 2

Risk

About This 510(k) Submission

K210414 is an FDA 510(k) clearance for the CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown CoverU Disposable Gown with Tape - Chemo Gown, a Gown, Isolation, Surgical (Class II — Special Controls, product code FYC), submitted by Medtecs (Taiwan) Corp. (Taipei City, TW). The FDA issued a Cleared decision on October 21, 2022, 617 days after receiving the submission on February 11, 2021. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number	K210414 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 11, 2021
Decision Date	October 21, 2022
Days to Decision	617 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF