Medical Gowns With Chemotherapy Labeling Claims - Tested For Use With Chemotherapy Drugs
Medical Gowns with Chemotherapy Labeling Claims are protective garments worn by healthcare personnel to shield both the patient and wearer from the transfer of microorganisms, body fluids, and particulate material, with the additional distinction that these gowns have been specifically tested for permeation and breakthrough resistance against various chemotherapy drugs. They provide a higher level of protection than standard medical gowns when handling hazardous oncology drugs. Classified as FDA Class 2 under regulation 878.4040, they require 510(k) clearance in the General and Plastic Surgery specialty. They are not implants and not life-sustaining.
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Basic Information
- Product Code
- QSO
- Device Class
- FDA class 2
- Regulation Number
- 878.4040
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- HO
- Submission Type
- 1
Device Characteristics
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.
FEI Numbers
This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.