Product Classification

• Device: condom, synthetic
• Regulation Description: Condom.
• Regulation Medical Specialty: Obstetrics/Gynecology
• Review Panel: Obstetrics/Gynecology
• Product Code: MOL
• Submission Type: 510(k)
• Regulation Number: 884.5300
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standards

• ANSI/ASQ Z1.4-2008 Sampling Procedures and Tables for Inspection by Attributes
• ASTM D7661-10 Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms
• ISO 23409 First edition 2011-02-15 Male Condoms - Requirements and test methods for condoms made from synthetic materials

Guidance Document

• Testing guidance for Male Condoms Made from New Material (Non-Latex)

Third Party Review

• Eligible for Accredited Persons Program

Accredited Persons

• bsi healthcare
• center for measurement standards of industrial
• dekra certification b.v.
• intertek testing services
• pharmalink technical group, llc
• regulatory technology services, llc
• tuv sud america inc.
• underwriters laboratories, inc.