Sagami Original 002 Polyurethane Male Condom— 510(k) K252158
Substantially EquivalentMayer Laboratories
FDA 510(k) clearance K252158 for Sagami Original 002 Polyurethane Male Condom, Substantially Equivalent on 2026-03-30. Applicant: Mayer Laboratories. Device class: 2.
Summary
Mayer Laboratories' Sagami Original 002 Polyurethane Male Condom is filed under MOL, synthetic condoms. The record doesn't list sizes.
Class II, 21 CFR 884.5300. Obstetrics/Gynecology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Mayer Laboratories filed from Berkeley, California. Review took 264 calendar days (July 9, 2025 to March 30, 2026).
Clearance details
- Applicant
- Mayer Laboratories
- Product code
- Product code MOL
- Device class
- Class 2
- Regulation
- 21 CFR 884.5300
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Berkeley, CA, US
Recent devices under product code MOL
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