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Sempermed Syntegra IR Polyisoprene Surgical Glove
FDA UDIIdentity
- Trade Name
- Sempermed Syntegra IR Polyisoprene Surgical Glove FDA UDI
- Generic Name
- Polyisoprene surgical glove, non-powdered, non-antimicrobial FDA UDI
- Device Name
- Sempermed Syntegra IR Polyisoprene Surgical Glove, size 8.5 FDA UDI
- Model / Reference
- SIR850 FDA UDI
- Description
- Sempermed Syntegra IR Polyisoprene Surgical Glove, size 8.5 FDA UDI
Identifiers
- Catalog Number
- SIR850 FDA UDI
- Primary DI / UDI-DI
- 00841277106718 FDA UDI
- FDA Product Code
- OPA FDA UDIKGO FDA UDI
- GMDN Term
- Polyisoprene surgical glove, non-powdered, non-antimicrobial FDA UDI
Classification
- 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
No
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Polyisoprene surgical glove, non-powdered, non-antimicrobialPolychloroprene surgical glove, non-powdered
Sempermed Syntegra IR Polyisoprene Surgical Glove by Sempermed Usa, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Polychloroprene surgical glove, non-powdered.
- Gammex — Bosma Enterprises · Class I
- GAMMEX — Ansell Healthcare Product · Class I
- PremierPro Surgeons Glove — SVS LLC · Class I
- HALYARD — Ansell Healthcare Product · Class I
- Criterion CR Surgeons Glove — HENRY SCHEIN, INC. · Class I
- Biogel® Neoderm® — Mölnlycke Health Care AB · Class I
- Biogel® Neoderm® — Mölnlycke Health Care AB · 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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Sempermed Usa, Inc.
Sources (1)
- FDA UDI c6aaefc9-2e5c-4763-80e1-3a9c3e0f2195 35 fields · synced May 30, 2026