FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Sagami Original 002 Polyurethane Male Condom
K Number: K252158
·
Decision Mar 30, 2026
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
22
Applicant Total
17
Review Days
264
Basic Information
- Device Name
- Sagami Original 002 Polyurethane Male Condom
- K Number
- K252158
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.5300
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mayer Laboratories
- Date Received
- July 9, 2025
- Decision Date
- March 30, 2026
- Product Code
- MOL
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MOL | Condom, Synthetic | FDA class 2 | Obstetrics/Gynecology |
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Other Clearances by Mayer Laboratories
| K Number | Device Name | ||
|---|---|---|---|
| K001974 | EZ-ON CONDOM | Oct 24, 2001 | Substantially Equivalent |
| K946374 | KIMONO MICROTHIN | Nov 8, 1995 | Substantially Equivalent |
| K946376 | MAXX | Sep 22, 1995 | Substantially Equivalent |
| K943064 | KIMONO (CONDOMS) | Sep 22, 1995 | Substantially Equivalent |
| K925869 | SHEATHES, STERILE SHEATHES | Jan 6, 1994 | Substantially Equivalent |
| K926049 | DIGITEX, DIGITEX HYPOALLERGENIC | Jul 22, 1993 | Substantially Equivalent |
| K904375 | KIMONO PLUS | Nov 26, 1990 | Substantially Equivalent |
| K904453 | LABELLING MODIFICATION TO MAXX PLUS | Nov 23, 1990 | Substantially Equivalent |
| K904840 | ORION PLUS/MODIFICATION | Nov 20, 1990 | Substantially Equivalent |
| K895530 | STANDARD CONDOM | Nov 28, 1989 | Substantially Equivalent |