Identity
- Trade Name
- Primeros FDA UDI
- Generic Name
- Basic male condom, Hevea-latex FDA UDI
- Device Name
- Natural latex male condom. Transparent, cylindrical shaped, ultra thin, nominal width 53 mm, smooth with reservoir. Lubricated with silicone oil. 100% electronically tested. FDA UDI
- Model / Reference
- Softglide 3's FDA UDI
- Description
- Natural latex male condom. Transparent, cylindrical shaped, ultra thin, nominal width 53 mm, smooth with reservoir. Lubricated with silicone oil. 100% electronically tested. FDA UDI
Identifiers
- Catalog Number
- QA-224 FDA UDI
- Primary DI / UDI-DI
- 19556807313839 FDA UDI
- 510(k) Number
- K070511 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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Basic male condom, Hevea-latex
Primeros by Richter Rubber Technology Sdn. Bhd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Basic male condom, Hevea-latex.
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Cleared under the same submission
K070511 also covers:
- Inspire — RICHTER RUBBER TECHNOLOGY SDN. BHD.
- Inspire — RICHTER RUBBER TECHNOLOGY SDN. BHD.
- Primeros — RICHTER RUBBER TECHNOLOGY SDN. BHD.
- Primeros — RICHTER RUBBER TECHNOLOGY SDN. BHD.
- Primeros — RICHTER RUBBER TECHNOLOGY SDN. BHD.
- Primeros — RICHTER RUBBER TECHNOLOGY SDN. BHD.
- Primeros — RICHTER RUBBER TECHNOLOGY SDN. BHD.
- Primeros — RICHTER RUBBER TECHNOLOGY SDN. BHD.
- Primeros — RICHTER RUBBER TECHNOLOGY SDN. BHD.
- Primeros — RICHTER RUBBER TECHNOLOGY SDN. BHD.
- Primeros — RICHTER RUBBER TECHNOLOGY SDN. BHD.
- Primeros — RICHTER RUBBER TECHNOLOGY SDN. BHD.
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
- Richter Rubber Technology Sdn. Bhd.
Sources (1)
- FDA UDI 390b344c-b5dd-44e7-8330-709349b68a53 36 fields · synced May 30, 2026