FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EZ-ON CONDOM
K Number: K001974
·
Decision Oct 24, 2001
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
22
Applicant Total
17
Review Days
482
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- EZ-ON CONDOM
- K Number
- K001974
- 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
- June 29, 2000
- Decision Date
- October 24, 2001
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MOL), ordered by most recent decision date.
Sagami Original 002 Polyurethane Male Condom
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ONE Nitrile Condom
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Durex Polyisoprene Condom
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
TROJAN SIS Synthetic Latex Condom with Silicone Lubricant
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ONE Nitrile Condom
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Polyisoprene Extra Large Condom
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Other Clearances by Mayer Laboratories
| K Number | Device Name | ||
|---|---|---|---|
| K252158 | Sagami Original 002 Polyurethane Male Condom | Mar 30, 2026 | 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 |