Trojan™ XOXO Ultra Thin Condoms

FDA UDI

Class II (US FDA UDI)

by Church & Dwight Co., Inc.

Identity

Trade Name: Trojan™ XOXO Ultra Thin Condoms FDA UDI
Generic Name: Basic male condom, Hevea-latex FDA UDI
Model / Reference: 00022600998488 FDA UDI

Identifiers

Primary DI / UDI-DI: 00022600998488 FDA UDI
510(k) Number: K161915 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

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

Yes

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Basic male condom, Hevea-latex

Trojan™ XOXO Ultra Thin Condoms by Church & Dwight Co., Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K161915 also covers:

Trojan XOXO Ultra Thin Mini Travel Pack — Church & Dwight Co., Inc.

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: Church & Dwight Co., Inc.

Sources (1)

FDA UDI ba28c71e-21d4-46b1-8c00-10b4d1bef912 34 fields · synced Jun 9, 2026