Product Classification

• Device: condom, synthetic
• Regulation Description: Condom.
• Regulation Medical Specialty: Obstetrics/Gynecology
• Review Panel: Obstetrics/Gynecology
• Product Code: MOL
• Premarket Review: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices (OHT3); Reproductive, Gynecology and Urology Devices (DHT3B)
• Submission Type: 510(k)
• Regulation Number: 884.5300
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Recognized Consensus Standards

• 5-62 ASQ ANSI Z1.4-2003 (R2018)
  Sampling Procedures and Tables for Inspection by Attributes
• 9-68 ISO 23409 First edition 2011-02-15
  Male Condoms - Requirements and test methods for condoms made from synthetic materials
• 9-145 ASTM D7661-18
  Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• center for measurement standards of industrial
• global quality and regulatory services
• regulatory technology services, llc
• third party review group, llc