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U.S. Department of Health and Human Services

Product Classification

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Device medical gowns with chemotherapy labeling claims - tested for use with chemotherapy drugs
Regulation Description Surgical apparel.
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.
Physical State Woven or non-woven fabric
Technical Method Medical gowns that are worn by healthcare personnel have been tested for permeation and breakthrough resistance against various concentrations and types of chemotherapy drugs using an appropriate test method.
Target Area Body
Regulation Medical Specialty General & Plastic Surgery
Review Panel General Hospital
Product CodeQSO
Premarket Review Office of Surgical and Infection Control Devices (OHT4)
Infection Control Devices (DHT4C)
Submission Type 510(k)
Regulation Number 878.4040
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Recognized Consensus Standards
Third Party Review Not Third Party Eligible
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