FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CONDOM
K Number: K940045
·
Decision Jan 30, 1995
Classifications
1
FEI Numbers
77
Registration Numbers
77
Same Product Code
400
Applicant Total
30
Review Days
390
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Basic Information
- Device Name
- CONDOM
- K Number
- K940045
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.5300
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Ansell, Inc.
- Date Received
- January 5, 1994
- Decision Date
- January 30, 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 |
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Other Clearances by Ansell, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K984392 | ANSELL CONDOMS | Jul 21, 1999 | Substantially Equivalent |
| K983518 | LIFESTYLES XTRA PLEASURE | Jul 6, 1999 | Substantially Equivalent |
| K940047 | SPERMICIDALLY LUBRICATED CONDOM | Dec 19, 1995 | Substantially Equivalent |
| K953379 | HYPOALLERGENIC POWDERED AMBIDEXTROUS COAGULATN DIPPED LATEX EXAMINATION GLOVE | Sep 27, 1995 | Substantially Equivalent |
| K945766 | HYPOALLERGENIC POWDERED AMBIDEXTROUS PATIENT EXAMINATION GLOVES | Aug 7, 1995 | Substantially Equivalent |
| K945767 | POWDER FREE, HYPOALLERGENIC AMBIDEXTROUS PATIENT EXAMINATION GLOVES | Mar 2, 1995 | Substantially Equivalent |
| K940046 | NON-LUBRICATED CONDOM | Jan 30, 1995 | Substantially Equivalent |
| K913766 | ANSELL NO POWDER AMBI PATIENT EXAMINATION GLOVES | Mar 11, 1993 | Substantially Equivalent |
| K914760 | LATEX EXAMINATION GLOVES | Jan 17, 1992 | Substantially Equivalent |
| K903107 | PATIENT EXAM GLOVES (DUSTED W/USP STARCH POWDER) | Aug 29, 1990 | Substantially Equivalent |