# K211036: Plus Medical Chemotherapy Gown

- Pathway: 510(k) (Traditional)
- Applicant: Foshan Nanhai Plus Medical Co, Ltd.
- Decided: May 4, 2022 after 392 days
- Product code: FYA (Gown, 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Plus Medical Chemotherapy Gowns are intended to protect healthcare personnel from exposure to chemotherapy drugs during preparation, handling and administration. The gowns are a closed back design, single use, disposable medical device provided sterile and non-sterile. Non-sterile gowns are to be sold in bulk to re-packager/re-labeler establishments for ethylene oxide (EtO) sterilization according to ISO 11135-1 prior to marketing to the end users and Sterile surgical gowns are to be sold directly to users after EtO sterilization validation to ISO 11135-1. Plus Medical Chemotherapy Gown meets the barrier protection requirements of AAMI Level 4 per ANSI/AAMI PB70:2012. Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities. Plus Medical Chemotherapy Gown has been evaluated for resistance to permeation of various chemotherapy drugs per ASTM F739-12 Standard Test Method for Permeation of Liquids and Gases through Protective Clothing Materials under Conditions of Continuous Contact. Testing data is provided per test procedure ASTM F739-12, the following 12 chemotherapy drugs has no breakthrough at the Standardized Breakthrough Rate of 0.1ug/cm2/minute, up to 480 minutes. Test Chemotherapy Drugs Average Standardized Breakthrough Time Carmustine (BCNU) [3.3mg/ml] >480mins Cisplatin [1.0mg/ml] >480mins Cyclophosphamide (Cytoxan) [20.0mg/ml] >480mins Dacarbazine [10.0mg/ml] >480mins Doxorubicin HCI [2.0mg/ml] >480mins Etoposide [20.0mg/ml] >480mins Fluorouracil [SO0mg/ml] >480mins Methotrexate [25mg/ml] >480mins Mitomycin C [0.5mg/ml] >480mins Paclitaxel [6.0mg/ml] >480mins Thio Tepa [10mg/ml] >480mins Vincristine Sulfate [1.0mg/ml] >480mins *No permeation was detected at either the minimum detectable permeation or 0.1ug/cm2/minute. When chemotherapy drugs are present, gown selection should be based on the specific type(s) of chemicals used. Users are recommended to review drug labeling or material safety data sheets for the chemicals being used to determine an adequate level of protection.

Source page: https://510kreport.com/device/K211036
Methodology: https://510kreport.com/methodology