Protexis
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- PROTEXIS FDA UDI
- Generic Name
- Polyisoprene surgical glove, non-powdered, non-antimicrobial FDA UDI
- Device Name
- Sterile Polyisoprene Powder-Free Surgical Gloves with Neu-Thera Coating EUDAMEDSterile Polyisoprene Powder-Free Surgical Gloves with Emollient Coating FDA UDI
- Model / Reference
- 2D73EB75 EUDAMEDFDA UDISterile Polyisoprene Powder-Free Surgical Gloves with Neu-Thera Coating EUDAMED
- Description
- Sterile Polyisoprene Powder-Free Surgical Gloves with Emollient Coating FDA UDI
Identifiers
- Catalog Number
- 2D73EB75 FDA UDI
- Primary DI / UDI-DI
- 10885380027406 EUDAMEDFDA UDI
- Basic UDI-DI
- 063014000000000000005156S EUDAMED
- FDA Product Code
- KGO FDA UDILZC FDA UDI
- EMDN Code
- T01010203 POLYISOPREN SURGICAL GLOVES EUDAMED
- GMDN Term
- Polyisoprene surgical glove, non-powdered, non-antimicrobial FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4460 FDA UDI880.6250 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
Yes
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Polyisoprene surgical glove, non-powdered, non-antimicrobial
Protexis by Cardinal Health 200, LLC — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Polyisoprene surgical glove, non-powdered, non-antimicrobial.
- Biogel® PI Micro Indicator® Underglove — Mölnlycke Health Care AB · Class I
- Sempermed Syntegra UV Polyisoprene Surgical Glove — SEMPERMED USA, INC.
- Sempermed Syntegra IR Polyisoprene Surgical Glove — SEMPERMED USA, INC.
- GAMMEX — Ansell Healthcare Product · Class I
- GAMMEX — Ansell Healthcare Product · Class I
- GAMMEX — Ansell Healthcare Product · Class I
- Gammex — Bosma Enterprises · Class I
- GAMMEX — Ansell Healthcare Product · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Cardinal Health 200, LLC
Sources (2)
- FDA UDI 45cd4353-9591-45c8-a350-36421a608ffe 34 fields · synced Oct 10, 2026
- EUDAMED 38fec3a5-5391-4316-88ed-a14357afeafd 61 fields · synced Oct 9, 2026