Identity
- Trade Name
- Pulse® CR Aqua FDA UDI
- Generic Name
- Polychloroprene examination/treatment glove, non-powdered FDA UDI
- Device Name
- Gloves, Exam, Chloroprene, Non-Sterile, Powder-Free, Textured, Aqua, XL FDA UDI
- Model / Reference
- 194352 FDA UDI
- Description
- Gloves, Exam, Chloroprene, Non-Sterile, Powder-Free, Textured, Aqua, XL FDA UDI
Identifiers
- Primary DI / UDI-DI
- 50813172023181 FDA UDI
- FDA Product Code
- OPC FDA UDILZC FDA UDI
- GMDN Term
- Polychloroprene 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Polychloroprene examination/treatment glove, non-powdered
Pulse® CR Aqua by Innovative Healthcare Corporation — 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
- Innovative Healthcare Corporation
Sources (1)
- FDA UDI a3fafcf8-bcdb-4f38-a5a2-8c26cb6bfc14 33 fields · synced May 30, 2026