510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K261811Substantially Equivalent

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., Edmonton, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

Clearance record

Decision date
Received
(92 days to decision)
Product code
QSO Medical Gowns With Chemotherapy Labeling Claims - Tested For Use With Chemotherapy Drugs
Regulation
21 CFR 878.4040
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
PRIMED Medical Products, Inc. 200, 2003-91 St. SW, Edmonton, CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QSO

Trailing 12 months
1 clearance under product code QSO in the twelve months to October 2026, September 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code QSO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20261
October 20260