# K261811: PRIMED Chemotherapy Drug Tested Gowns (PM4-99450: PRIMED Chemotherapy Drug Tested Isolation Gown, Purple, AAMI Level 2; PM4-99460: PRIMED Chemotherapy Drug Tested Isolation Gown, Blue, AAMI Level 3)

- Pathway: 510(k) (Traditional)
- Applicant: PRIMED Medical Products, Inc.
- Decided: Sep 1, 2026 after 92 days
- Product code: QSO (Medical Gowns With Chemotherapy Labeling Claims - Tested For Use With Chemotherapy Drugs)
- 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: 2 generations back to K080795 (2008). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101468: 3M Basic Disposable Surgical Gown, 3M HP Disposable Surgical Gown, 3M Reinforced Disposable Surgical Gown, 3M Disposable, 3M Company Corp (2011) Summary page 5.

## Indications for use
PRIMED Chemotherapy Drug Tested Gowns are non-sterile, single-use isolation gowns intended to be worn by healthcare personnel to protect both the patient and the wearer from the transfer of microorganisms, body fluids, and particulate material. In addition, these gowns provide protection against chemotherapy drugs. The listed chemotherapy drugs showed no breakthrough within 480 minutes at a standardized breakthrough rate of 0.1 pg/cm?minute when tested in accordance with ASTM F739:2020 standard. Chemotherapy Drug Name Carmustine (BiCNU). 3.3 mg/ml, Cisplatin, 1 mg/ml, Cyclophosphamide (Cytoxan), 20 mg/ml, Dacarbazine, 10 mg/ml, Doxorubicin Hydrochloride, 2 mg/mi, Etoposide (Toposar), 20.0 mg/ml, Fluorouracil, 50 mg/ml, Mitomycin C, 0.5 mg/ml, Paclitaxel (Taxol), 6 mg/ml, Thio-Tepa (THT), 10 mg/ml, Vincristine, 1 mg/ml

Source page: https://510kreport.com/device/K261811
Methodology: https://510kreport.com/methodology