FDA 510(k)
FDA class 2
Substantially Equivalent
🇲🇾 Malaysia
DOTTED CONDOM, MALE NATURAL RUBBER LATEX CONDOM
K Number: K012962
·
Decision Nov 9, 2001
Classifications
1
FEI Numbers
77
Registration Numbers
77
Same Product Code
400
Applicant Total
9
Review Days
66
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Basic Information
- Device Name
- DOTTED CONDOM, MALE NATURAL RUBBER LATEX CONDOM
- K Number
- K012962
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 884.5300
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Innolatex Sdn. Bhd
- Date Received
- September 4, 2001
- Decision Date
- November 9, 2001
- 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 |
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Other Clearances by Innolatex Sdn. Bhd
| K Number | Device Name | ||
|---|---|---|---|
| K053367 | MALE NATURAL RUBBER LATEX CONDOM | Feb 21, 2006 | Substantially Equivalent |
| K041837 | INNOLATEX MALE LATEX CONDOMS COLORED AND SCENTED | Sep 24, 2004 | Substantially Equivalent |
| K012665 | ULTRA THIN MALE LATEX CONDOM WITH SILICONE LUBRICANT | Nov 9, 2001 | Substantially Equivalent |
| K012964 | 56MM CONDOM,MALE NATURAL RUBBER LATEX CONDOM | Nov 9, 2001 | Substantially Equivalent |
| K012664 | ULTRA THICK MALE LATEX CONDOM WITH SILICONE LUBRICANT | Nov 9, 2001 | Substantially Equivalent |
| K010919 | MALE NATURAL RUBBER LATEX CONDOM | Jun 15, 2001 | Substantially Equivalent |
| K010178 | SPERMICIDAL LUBRICATED MALE LATEX CONDOM | Apr 27, 2001 | Substantially Equivalent |
| K002393 | NON-SPERMICIDAL LUBRICATED MALE LATEX CONDOM | Dec 19, 2000 | Substantially Equivalent |