Product Classification

• 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 Code: QSO
• 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

• 6-487 AAMI ANSI PB70:2022
  Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities
• 6-488 ASTM F1671/F1671M-22
  Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System
• 6-496 ASTM F739-20
  Standard Test Method for Permeation of Liquids and Gases Through Protective Clothing Materials Under Conditions of Continuous Contact

Third Party Review

Not Third Party Eligible