Identity
- Trade Name
- microdot® Pro Gloves FDA UDI
- Generic Name
- Vinyl examination/treatment glove, non-powdered FDA UDI
- Device Name
- Microdot® Pro Nitrile Medium Gloves FDA UDI
- Model / Reference
- 1402-10 FDA UDI
- Description
- Microdot® Pro Nitrile Medium Gloves FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00847713000947 FDA UDI
- 510(k) Number
- K201530 FDA UDI
- FDA Product Code
- LZA FDA UDILZC FDA UDIQDO FDA UDI
- GMDN Term
- Vinyl examination/treatment glove, non-powdered 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Vinyl examination/treatment glove, non-powdered
microdot® Pro Gloves by Cambridge Sensors USA, LLC. — 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
- Cambridge Sensors USA, LLC.
Sources (1)
- FDA UDI 50bd91d4-f618-4c76-ade9-98eeaf767d8b 34 fields · synced May 30, 2026