Product Classification

• Device: surgical apparel with material claims
• Regulation Description: Surgical apparel.
• Definition: Surgical apparel with material claims are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Surgical apparel with material claims contain components that have been constructed, treated, modified, and/or coated with substances that are intended or known to create or enhance a functional element of the device. Examples include fluid repellency, soil retention, or antimicrobial activity.
• Physical State: The device consists of surgical apparel consisting of textiles that are constructed, treated, modified, and/or coated with substances that are intended or known to create or enhance a functional element of the device.
• Technical Method: The device contains specific materials that are intended to enhance inhibition of microorganism transfer, reduce soil retention, or kill microorganisms on the device surface or within the device material under specified contact conditions.
• Target Area: The devices are worn by the operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.
• Regulation Medical Specialty: General & Plastic Surgery
• Review Panel: General Hospital
• Product Code: QBW
• Premarket Review: Office of Surgical and Infection Control Devices (OHT4); Infection Control and Plastic and Reconstructive Surgery Devices (DHT4B)
• 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

Third Party Review

Not Third Party Eligible