FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SAXON GOLD ULTRA SPERMICIDAL RAINBOW CONDOM
K Number: K943883
·
Decision Apr 14, 1995
Classifications
1
FEI Numbers
77
Registration Numbers
77
Same Product Code
400
Applicant Total
18
Review Days
248
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
- SAXON GOLD ULTRA SPERMICIDAL RAINBOW CONDOM
- K Number
- K943883
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.5300
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Aladan Corp.
- Date Received
- August 9, 1994
- Decision Date
- April 14, 1995
- 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
Other Clearances by Aladan Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K960590 | TRI-CLEAN 110/TRI-CLEAN PLUS GLOVE | Oct 31, 1996 | Substantially Equivalent |
| K952404 | SAFETEX SUPER HYPERALLERGENIC POWDERFREE LATEX MEDICAL GLOVE | Jul 20, 1995 | Substantially Equivalent |
| K952556 | SAFETEX SUPER HYPOALLERGENIC POWDERED LATEX EXAMINATION GLOVE | Jun 26, 1995 | Substantially Equivalent |
| K943933 | SAXON GOLD ULTRA SPERMICIDAL RAINBOW CONDOM | Jun 22, 1995 | Substantially Equivalent |
| K951839 | ALADAN HYPOALLERGENIC LATEX MEDICAL EXAMINATION GLOVES | Jun 15, 1995 | Substantially Equivalent |
| K942758 | HYPOALLERGEN NON-STER POWDERFREE LATEX PAT EXAM GLOVE | Jul 8, 1994 | Substantially Equivalent |
| K940873 | SAFETEX HYPOALLERGENIC POWDERFREE LATEX EXAMINATION GLOVE | Apr 22, 1994 | Substantially Equivalent |
| K911774 | ALADAN LATEX MEDICAL GLOVE | May 3, 1991 | Substantially Equivalent |
| K911447 | LATEX EXAMINATION GLOVES (HYPOALLERGENIC) | Apr 16, 1991 | Substantially Equivalent |
| K905279 | CONDOM (RUBBER) CONTRACEPTIVE | Feb 19, 1991 | Substantially Equivalent |