510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QSOClass II

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

21 CFR 878.4040 / General, Plastic Surgery
FDA source (opens on fda.gov)

QSO is the FDA product code for Medical Gowns With Chemotherapy Labeling Claims - Tested For Use With Chemotherapy Drugs, a class II device type, regulated under 21 CFR 878.4040. FDA's definition for this code reads: "Medical gowns that are worn by healthcare personnel to protect both the patient and the wearer from transfer of microorganisms, body fluids, and particulate material. In addition, these gowns have been tested for permeation and breakthrough resistance against various concentrations and types of chemotherapy drugs". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
QSO
Device name
Medical Gowns With Chemotherapy Labeling Claims - Tested For Use With Chemotherapy Drugs
FDA definition
Medical gowns that are worn by healthcare personnel to protect both the patient and the wearer from transfer of microorganisms, body fluids, and particulate material. In addition, these gowns have been tested for permeation and breakthrough resistance against various concentrations and types of chemotherapy drugs.
Regulation
21 CFR 878.4040
Device class
Class II
Review panel
General, Plastic Surgery
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code QSO

By decision year
1 clearance under product code QSO with a decision year between 2026 and 2026, 2026 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QSO by decision year
YearClearances
20261

Applicants with the most clearances

Product code QSO
Applicants holding the most 510(k) clearances under product code QSO
ApplicantClearances
PRIMED Medical Products, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code