Identity
- Trade Name
- PremierPro Surgeons Glove FDA UDI
- Generic Name
- Hevea-latex surgical glove, non-powdered, non-antimicrobial FDA UDI
- Device Name
- Latex Ortho, PF, Size 6.0, Pair Color Brown 50pair/box, 4bxs/case FDA UDI
- Model / Reference
- 44660 FDA UDI
- Description
- Latex Ortho, PF, Size 6.0, Pair Color Brown 50pair/box, 4bxs/case FDA UDI
Identifiers
- Catalog Number
- 44660 FDA UDI
- Primary DI / UDI-DI
- 00811220031213 FDA UDI
- FDA Product Code
- KGO FDA UDI
- GMDN Term
- Hevea-latex surgical glove, non-powdered, non-antimicrobial FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4460 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
Yes
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
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 12 Inch FDA UDI
Category: Hevea-latex surgical glove, non-powdered, non-antimicrobial
PremierPro Surgeons Glove by Svs Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Hevea-latex surgical glove, non-powdered, non-antimicrobial.
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- MocareHealth — Motex Healthcare(Anhui)Co., Ltd. · Class I
- HALYARD — Ansell Healthcare Product · Class I
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 56fa6467-7f3d-4666-8743-a3f335393c5f 36 fields · synced May 31, 2026