Identity
- Trade Name
- HEPRO.US Disposable Nitrile Gloves Class 450 XL FDA UDI
- Generic Name
- Nitrile examination/treatment glove, non-powdered, non-antimicrobial FDA UDI
- Device Name
- Hepro.us Nitrile Disposable Gloves Deluxe Class 450, Color Blue, Non-Powdered, Textured, Size X-Large, 1Case of 10 Boxes = 1,000 pcs FDA UDI
- Model / Reference
- CT - 450 Nitrile XL FDA UDI
- Description
- Hepro.us Nitrile Disposable Gloves Deluxe Class 450, Color Blue, Non-Powdered, Textured, Size X-Large, 1Case of 10 Boxes = 1,000 pcs FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850578007921 FDA UDI
- FDA Product Code
- LZA FDA UDI
- GMDN Term
- Nitrile 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
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: Nitrile examination/treatment glove, non-powdered, non-antimicrobial
HEPRO.US Disposable Nitrile Gloves Class 450 XL 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 8b60e050-33cf-4311-a2f2-c384fac1a144 33 fields · synced Jun 6, 2026