Identity
- Trade Name
- KIMTECH FDA UDI
- Generic Name
- Nitrile examination/treatment glove, non-powdered, non-antimicrobial FDA UDI
- Device Name
- KIMTECH PURPLE NITRILE-XTRA (XL) POWDER-FREE EXAM GLOVES FDA UDI
- Model / Reference
- 55090 FDA UDI
- Description
- KIMTECH PURPLE NITRILE-XTRA (XL) POWDER-FREE EXAM GLOVES FDA UDI
Identifiers
- Catalog Number
- 55090 FDA UDI
- Primary DI / UDI-DI
- 10076490735903 FDA UDI
- FDA Product Code
- LZC FDA UDILZA FDA UDIQDO 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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Kimtech by Ansell Healthcare Product — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Nitrile examination/treatment glove, non-powdered, non-antimicrobial.
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Cleared under the same submission
K113423 also covers:
- KIMTECH — Ansell Healthcare Product
- KIMTECH — Ansell Healthcare Product
- KIMTECH — Ansell Healthcare Product
- KIMTECH — Ansell Healthcare Product
- Halyard — O&M HALYARD, INC.
- Halyard — O&M HALYARD, INC.
- Halyard — O&M HALYARD, INC.
- Halyard — O&M HALYARD, INC.
- Halyard — O&M HALYARD, INC.
- Halyard — O&M HALYARD, INC.
- Halyard — O&M HALYARD, INC.
- Halyard — O&M HALYARD, INC.
K200633 also covers:
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ansell Healthcare Product
Sources (1)
- FDA UDI 28e7a846-6328-4023-96ee-2fbbbeac98cc 37 fields · synced May 30, 2026