Product Classification

• Device: respirator,surgical
• Regulation Description: Surgical apparel.
• Regulation Medical Specialty: General & Plastic Surgery
• Review Panel: General Hospital
• Product Code: MSH
• Submission Type: 510(k)
• Regulation Number: 878.4040
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standards

• AAMI/ANSI EC53:1995/(R) 2008 ECG cables and leadwires
• ASTM F2100-11 Standard Specification for Performance of Materials Used in Medical Face Masks
• ASTM F2101-07 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus
• ASTM F1862-07 Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)

Guidance Document

• Surgical Masks - Premarket Notification [510(k)] Submissions; Guidance for Industry and FDA

Third Party Review

• Eligible for Accredited Persons Program

Accredited Persons

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