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SKORE (Colors)

FDA UDI

Class II (US FDA UDI)

by Ttk Healthcare Limited

Identity

Trade Name
SKORE (Colors) FDA UDI
Generic Name
Basic male condom, Hevea-latex FDA UDI
Device Name
The SKORE (Colors) is made of natural rubber latex. It is smooth, straight walled, teat ended, yellow colored 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(Colors) 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 Yellow FDA UDI
Description
The SKORE (Colors) is made of natural rubber latex. It is smooth, straight walled, teat ended, yellow colored 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(Colors) 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
08906007134750 FDA UDI
510(k) Number
K202403 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 (Colors) by Ttk Healthcare Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Basic male condom, Hevea-latex.

Cleared under the same submission

K202403 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ttk Healthcare Limited

Sources (1)

  • FDA UDI 3f97f605-1899-4810-8b93-131c4515f5f3 35 fields · synced Jun 8, 2026