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FDA UDIEUDAMEDClass I (US FDA UDI)
by Uniseal
Identity
- Trade Name
- Retrieving data. Wait a few seconds and try to cut or copy again. FDA UDI
- Generic Name
- Nitrile examination/treatment glove, non-powdered, non-antimicrobial FDA UDI
- Device Name
- Nitrile Powder Free Textured Blue Exam Gloves, Non- Sterile, Chemo and Fentanyl Tested, NFPA Certified, Low Derma, Extended length, size XXL FDA UDI
- Model / Reference
- 1210-0 FDA UDI
- Description
- Nitrile Powder Free Textured Blue Exam Gloves, Non- Sterile, Chemo and Fentanyl Tested, NFPA Certified, Low Derma, Extended length, size XXL FDA UDI
Identifiers
- Primary DI / UDI-DI
- 20744514121007 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Retrieving data. Wait a few seconds and try to cut or copy again. by Uniseal — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED
Similar devices
Also classified as Nitrile examination/treatment glove, non-powdered, non-antimicrobial.
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- Medicom AssureTouch — AMD Medicom Inc · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
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 |
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Manufacturer
- Manufacturer
- Uniseal
Sources (2)
- FDA UDI 53043fb1-5476-4162-b6fd-8abdfa716211 33 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 3, 2026