# K214108: Medline Orbis Chemo Surgical Gown

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industries, LP
- Decided: May 6, 2022 after 128 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
Longest line of descent: 3 generations back to K880382 (1988). 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)
- K193327: Cardinal Health ChemoPlus Full Coverage Gown, Closed Back, Cardinal Health ChemoPlus Full Coverage Gown, Open Back, Cardinal Health ChemoPlus Full Coverage Sleeve, Cardinal Health200, LLC (2020) Summary page 5.

## Indications for use
The Medline Orbis Chemo Surgical Gown is intended to be worn by operating room personnel during surgical procedures to protect operating room personnel from transfer of microorganisms, body fluids, and particulate material. Additionally the gown is intended to protect healthcare personnel from exposure to chemotherapy drugs during their preparation, handling, and administration. 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. The Medline Orbis Chemo Surgical Gown meets the level 3 barrier protection requirements in accordance with ANSI/AAMI Standard PB70:2012 "Liquid Barrier Performance and Classification of Protective Apparel and Drapes intended for use in Health Care Facilities" The Medline Orbis Chemo Surgical 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." 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 Etopside [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 Gown selection should be specifically chosen for the type of chemotherapy agent used. Users are recommended to review Material Safety Data Sheets for Chemotherapy Drugs being used to determine the required level of protection.

Source page: https://510kreport.com/device/K214108
Methodology: https://510kreport.com/methodology