Identity
- Trade Name
- Trojan Ultra Thin Armor FDA UDI
- Generic Name
- Medicated male condom, Hevea-latex FDA UDI
- Device Name
- For Contraception Plus STI Protection FDA UDI
- Model / Reference
- 00022600999539 FDA UDI
- Description
- For Contraception Plus STI Protection FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00022600999539 FDA UDI
- 510(k) Number
- K912901 FDA UDI
- FDA Product Code
- HIS FDA UDI
- GMDN Term
- Medicated 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: Medicated male condom, Hevea-latex
Trojan Ultra Thin Armor by Church & Dwight Co., Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Medicated male condom, Hevea-latex.
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- Trojan™ Premium Latex Condoms ENZ™ Armor Spermicidal Lubricant — Church & Dwight Co., Inc. · Class II
Cleared under the same submission
K912901 also covers:
- TROJAN 100CT BULK MIX — Church & Dwight Co., Inc.
- TROJAN™ Premium Latex Condoms Platinum Pack — Church & Dwight Co., Inc.
- TROJAN™ Premium Latex Condoms Platinum Pack — Church & Dwight Co., Inc.
- Trojan Her Pleasure Condom — Church & Dwight Co., Inc.
- Trojan Pleasure Pack — Church & Dwight Co., Inc.
- Trojan Pleasure Pack — Church & Dwight Co., Inc.
- Trojan Pleasure Pack Condoms — Church & Dwight Co., Inc.
- Trojan The Edge — Church & Dwight Co., Inc.
- Trojan ULTRA FIT Freedom Feel Condom — Church & Dwight Co., Inc.
- Trojan Ultra Thin w/ Spermicide — Church & Dwight Co., Inc.
- Trojan UltraFit Sensitive Tip Feel — Church & Dwight Co., Inc.
- Trojan Variety 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Church & Dwight Co., Inc.
Sources (1)
- FDA UDI a43647b2-8621-4b47-9634-afd76326d44a 35 fields · synced Jun 9, 2026