Identity
- Trade Name
- SKORE Thin Condoms with Flavors FDA UDI
- Generic Name
- Basic male condom, Hevea-latex FDA UDI
- Device Name
- The SKORE Thin Condoms with flavors - SKORE NOTHING Strawberry condom is made of natural rubber latex. It is straight walled, smooth, teat ended, transparent strawberry flavored male condoms. It meets the requirements as specified in ISO 4074:2015 – Natural rubber latex male condoms – Requirements and test methods and ASTM D3492:2016– Standard Specification for Rubber Contraceptives (Male Condoms). The SKORE Thin Condoms with flavors- SKORE NOTHING Strawberry natural rubber latex condoms are used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases). FDA UDI
- Model / Reference
- SKORE NOTHING Strawberry FDA UDI
- Description
- The SKORE Thin Condoms with flavors - SKORE NOTHING Strawberry condom is made of natural rubber latex. It is straight walled, smooth, teat ended, transparent strawberry flavored male condoms. It meets the requirements as specified in ISO 4074:2015 – Natural rubber latex male condoms – Requirements and test methods and ASTM D3492:2016– Standard Specification for Rubber Contraceptives (Male Condoms). The SKORE Thin Condoms with flavors- SKORE NOTHING Strawberry natural rubber latex condoms are used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases). FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08906007135436 FDA UDI
- 510(k) Number
- K230049 FDA UDI
- FDA Product Code
- HIS FDA UDI
- GMDN Term
- Basic male condom, Hevea-latex FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.5300 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
Yes
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Basic male condom, Hevea-latex
SKORE Thin Condoms with Flavors by Ttk Healthcare Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K230049 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Ttk Healthcare Limited
Sources (1)
- FDA UDI c5fcba17-e1bd-4ea0-9b8a-830562a69f72 35 fields · synced May 30, 2026