FDA cleared the 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) from PRIMED Medical Products, Inc. on Sep 1, 2026 under K261811, a traditional 510(k). The device falls under product code QSO, Medical Gowns With Chemotherapy Labeling Claims - Tested For Use With Chemotherapy Drugs, regulated at 21 CFR 878.4040 as a Class 2 device. The review panel was General, Plastic Surgery.
FDA logged the submission as received on Jun 1, 2026. The decision came 92 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.
PRIMED Medical Products, Inc. has one other decision in the tracker over the last 12 months: K252964 (PRIMED Surgical and Procedure Masks).
Questions & Answers
What did FDA clear under K261811?
K261811 is the FDA 510(k) for 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), submitted by PRIMED Medical Products, Inc.. FDA's decision date was Sep 1, 2026, under product code QSO (Medical Gowns With Chemotherapy Labeling Claims - Tested For Use With Chemotherapy Drugs).
Who makes the 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)?
PRIMED Medical Products, Inc., based in Edmonton, is the applicant of record for K261811.
How long did the K261811 review take?
FDA received the submission on Jun 1, 2026 and issued its decision on Sep 1, 2026, 92 days later.