Cleared Traditional

Copioumed Chemotherapy Isolation Gown

K230135 · Copioumed International, Inc. · General Hospital

Oct 2023

Decision

259d

Days

Class 2

Risk

About This 510(k) Submission

K230135 is an FDA 510(k) clearance for the Copioumed Chemotherapy Isolation Gown, a Gown, Isolation, Surgical (Class II — Special Controls, product code FYC), submitted by Copioumed International, Inc. (Taipei City, TW). The FDA issued a Cleared decision on October 4, 2023, 259 days after receiving the submission on January 18, 2023. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number	K230135 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 18, 2023
Decision Date	October 04, 2023
Days to Decision	259 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF