FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇭 Thailand
Playboy 3 Contour Condom
K Number: K211450
·
Decision Sep 30, 2021
Classifications
1
FEI Numbers
83
Registration Numbers
83
Same Product Code
398
Applicant Total
4
Review Days
143
Basic Information
- Device Name
- Playboy 3 Contour Condom
- K Number
- K211450
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.5300
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Thai Nippon Rubber Industry Public Company Limited
- Date Received
- May 10, 2021
- Decision Date
- September 30, 2021
- 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.
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
LifeStyles NRL Textured Condom
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
SKORE Smooth, Dotted, Thin Condoms - SKORE Blues, SKORE Belgian Chocolate, SKORE Dots, SKORE NOTHING Strawberry, SKORE NOTHING Chocolate, SKORE SKIN THIN Ultra fine; SKORE Bulbous Condoms - SKORE WARM, SKORE COOL; SKORE Benzocaine Condoms - SKORE NOTHING Climax Delay, SKORE DUO MAX, SKORE NOT OUT
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology