Identity
- Trade Name
- Trojan™ Premium Latex Condoms ENZ™ Armor™ FDA UDI
- Generic Name
- Medicated male condom, Hevea-latex FDA UDI
- Model / Reference
- 00022600932529 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00022600932529 FDA UDI
- 510(k) Number
- K901199 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
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
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™ Premium Latex Condoms ENZ™ Armor™ by Church & Dwight Co., Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Medicated male condom, Hevea-latex.
- Lifestyles — LUNAMAX LLC · Class II
- Lifestyles — LUNAMAX LLC · Class II
- Trojan™ Premium Latex Condoms Her Pleasure™ Sensations Armor™ — Church & Dwight Co., Inc. · Class II
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- Trojan Ultra Thin Armor — Church & Dwight Co., Inc. · Class II
- Trojan™ Premium Latex Condoms ENZ™ Armor™ Value Pack — Church & Dwight Co., Inc. · Class II
- Trojan™ Premium Latex Condoms Sensitivity Ultra Thin Armor™ — Church & Dwight Co., Inc. · Class II
- Trojan™ Premium Latex Condoms ENZ™ Armor Spermicidal Lubricant — Church & Dwight Co., Inc. · Class II
Cleared under the same submission
K901199 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Church & Dwight Co., Inc.
Sources (1)
- FDA UDI 5382b25f-11ef-4e39-92d4-8992359f0a5d 34 fields · synced Jun 9, 2026