Product Classification

• Device: cover, barrier, protective
• Regulation Description: Surgical drape and drape accessories.
• Regulation Medical Specialty: General & Plastic Surgery
• Review Panel: General Hospital
• Product Code: MMP
• Submission Type: 510(k)
• Regulation Number: 878.4370
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standards

• AAMI/ANSI PB70:2003/(R)2009 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities
• ISO 11810-1 First edition 2005-02-15 Lasers and laser-related equipment - Test method and classification for the laser-resistance of surgical drapes and/or patient-protective covers - Part 1: Primary ignition and penetration
• ISO 11810-2 First edition 2007-05-01 Lasers and laser-related equipment - Test method and classification for the laser-resistance of surgical drapes and/or patient-protective covers - Part 2: Secondary ignition

Third Party Review

• Eligible for Accredited Persons Expansion Pilot Program

Accredited Persons

• dekra certification b.v.
• intertek testing services
• regulatory technology services, llc
• tuv sud america inc.
• underwriters laboratories, inc.