FDA 510(k)
FDA class 2
Substantially Equivalent
🇲🇾 Malaysia
MALE LATEX CONDOM
K Number: K132107
·
Decision Mar 7, 2014
Classifications
1
FEI Numbers
77
Registration Numbers
77
Same Product Code
400
Applicant Total
3
Review Days
242
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
- MALE LATEX CONDOM
- K Number
- K132107
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 884.5300
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Nulatex Sdn. Bhd.
- Date Received
- July 8, 2013
- Decision Date
- March 7, 2014
- Product Code
- HIS
- 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 |
|---|---|---|---|
| HIS | Condom | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HIS), ordered by most recent decision date.
Male Latex Condom HA
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
LifeStyles® HydraFeel Natural Rubber Latex Condom
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Natural rubber latex male condom
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Lelo Hex Lubricated Natural Rubber Latex Condom
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Trojan Ultra Ribbed Ecstasy latex condom with lubricant (Trojan Ultra Ribbed Ecstasy)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
0.04 ZERO ZERO FOUR Male Latex Condom
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology