# K230135: Copioumed Chemotherapy Isolation Gown

- Pathway: 510(k) (Traditional)
- Applicant: Copioumed International, Inc.
- Decided: Oct 4, 2023 after 259 days
- Product code: FYC (Gown, Isolation, Surgical)
- Device class: 2
- Regulation: 21 CFR 878.4040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K952116 (1995). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190306: AMD Ritmed AssureWear VersaGown, Amd Medicom, Inc. (2020) Summary page 7.

## Indications for use
Copioumed Chemotherapy Isolation Gown is intended to be worn by healthcare personnel to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate. Copioumed Chemotherapy Isolation Gown is non-sterile and for single use only. Copioumed Chemotherapy Isolation Gown meets the requirements of an AAMI Level 3 barrier protection for an isolation gown per ANSI/AAMI PB70:2012 Liquid Barrier Performance Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities (ANSI/AAMI PB70). C pioumed Chemotherapy Isolation Gown is a disposable device intended to protect health care personal from exposure to chemotherapy drugs during preparation, handling, and administration. The Copioumed Chemotherapy Isolation Gown has been evaluated for resistance to permeation of various chemotherapy drugs per ASTM F739-20 "Standard Test Method for Permeation of Liquids and Gases Through Protective Clothing Materials Under Conditions of Continuous Contact." Chemotherapy drug permeation resistance, average standardized breakthrough time in minutes.*: Carmustine [3.3 mg/ml] >480 Cisplatin [1.0 mg/ml] >480 Cyclophosphamide [20 mg/ml] >480 Cytarabine Hydrochloride [100 mg/ml] >480 Dacarbazine [10 mg/ml] >480 Daunorubicin Hydrochloride [5 mg/ml] >480 Doxorubicin Hydrochloride [2 mg/ml] > 480 Etoposide [20 mg/ml] >480 Fluorouracil [50 mg/ml] >480 Ifosfamide [50 mg/ml] > 480 Methotrexate [25 mg/ml] >480 Mitomycin C [0.5 mg/ml] >480 Mitoxantrone [2.0 mg/ml] >480 Paclitaxel [6 mg/ml] >480 Thiotepa [10 mg/ml] >480 Vincristine Sulfate [1 mg/ml] >480 *No permeation was detected at either the minimum detectable permeation or 0.1 μg/cm2/min

Source page: https://510kreport.com/device/K230135
Methodology: https://510kreport.com/methodology