PRIMED Chemotherapy Drug Tested Gowns (PM4-99450: PRIMED Chemotherapy Drug Tested Isolation Gown, Purple, AAMI Level 2 +1 more— 510(k) K261811

Name: FDA 510(k) clearance K261811
Creator: U.S. Food and Drug Administration
Published: 2026-09-01

Substantially Equivalent

PRIMED Medical Products, Inc.

FDA 510(k) clearance K261811 for PRIMED Chemotherapy Drug Tested Gowns (PM4-99450: PRIMED Chemotherapy Drug Tested Isolation Gown, Purple, AAMI Level 2 +1 more, Substantially Equivalent on 2026-09-01. Applicant: PRIMED Medical Products, Inc.. Device class: 2.

Clearance details

Device name as filed: 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.
Product code: Code QSO
Device class: Class 2
Regulation: 21 CFR 878.4040
Advisory panel: General, Plastic Surgery
Date received: 2026-06-01
Decision date: 2026-09-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Edmonton, CA

Download summary PDF View on FDA.gov ↗

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