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HEPRO.US Sterile Latex Surgical Gloves 1 Box 50 pairs-Size Large 8"
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- HEPRO.US Sterile Latex Surgical Gloves 1 Box 50 pairs-Size Large 8" FDA UDI
- Generic Name
- Hevea-latex surgical glove, non-powdered, non-antimicrobial FDA UDI
- Device Name
- HEPRO.US Sterile Latex Surgical Gloves 1 Box 50 pairs-Size Large 8" Surgical Gloves-Non-powder Sterilized by Gamma Radiation, Sterile Until package is opened 8" FDA UDI
- Model / Reference
- BX Surgical Latex Glove FDA UDI
- Description
- HEPRO.US Sterile Latex Surgical Gloves 1 Box 50 pairs-Size Large 8" Surgical Gloves-Non-powder Sterilized by Gamma Radiation, Sterile Until package is opened 8" FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00854427007193 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
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
Category: Hevea-latex surgical glove, non-powdered, non-antimicrobial
HEPRO.US Sterile Latex Surgical Gloves 1 Box 50 pairs-Size Large 8" by Hepro.us Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Hepro.us Inc.
Sources (1)
- FDA UDI daa11bf9-ef11-47a6-87d8-16b16c6a526f 33 fields · synced May 30, 2026