Product Classification

• Device: condom
• Regulation Description: Condom.
• Regulation Medical Specialty: Obstetrics/Gynecology
• Review Panel: Obstetrics/Gynecology
• Product Code: HIS
• 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

• ISO 4074:2002 TECHNICAL CORRIGENDUM 2 Natural latex rubber condoms - Requirements and test methods, Technical Corrigendum 2
• 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
• ASTM D6499-12 Standard Test Method for the Immunological Measurement of Antigenic Protein in Natural Rubber and Its Products
• 4074 First edition 2002-02-15/ ISO 4074:2002 TECHNICAL CORRIGENDUM 1 Natural latex rubber condoms - Requirements and test methods, Technical Corrigendum 1
• ISO 16038 First edition 2005-11-01 Rubber condoms -- Guidance on the use of ISO 4074 in the quality management of natural rubber latex condoms
• ASTM D3492-08 Standard Specification for Rubber Contraceptives (Male Condoms)
• ASTM D6355-07 Standard Test Method for Human Repeat Insult Patch Testing of Medical Gloves

Guidance Documents

• Latex Condoms for Men - Information for 510(k) Premarket Notifications: Use of Consensus Standards for Abbreviated Submissions  
• Labeling for Male Condoms Made of Natural Rubber Latex - Class II Special Controls Guidance Document - Draft Guidance for Industry and FDA Staff

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.