Identity
- Trade Name
- PremierPro FDA UDI
- Generic Name
- Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial FDA UDI
- Device Name
- PremierPro Powder Free Textured Latex Exam Glove Medium 100count FDA UDI
- Model / Reference
- 4603 FDA UDI
- Description
- PremierPro Powder Free Textured Latex Exam Glove Medium 100count FDA UDI
Identifiers
- Catalog Number
- 4603 FDA UDI
- Primary DI / UDI-DI
- 00818566010643 FDA UDI
- 510(k) Number
- K051404 FDA UDI
- FDA Product Code
- LYY FDA UDI
- GMDN Term
- Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6250 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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial
PremierPro by Svs Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K051404 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 I | Pending data |
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Manufacturer
- Manufacturer
- Svs Llc
Sources (1)
- FDA UDI 8b095b9d-2ec0-4401-9420-b02b4be9f220 36 fields · synced May 30, 2026