510(k) K261811

Device

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)

Applicant

PRIMED Medical Products, Inc.

510(k) number

K261811

Product code

QSO

Decision

Substantially Equivalent (SESE)

Decision date

2026-09-01

Date received

2026-06-01

Regulation

878.4040

Classification name

Medical Gowns With Chemotherapy Labeling Claims - Tested For Use With Chemotherapy Drugs

Medical specialty

General, Plastic Surgery

Review panel

General, Plastic Surgery

Device class

2

Clearance type

Traditional

Statement or summary

Summary

Third party reviewed

N