Identity
- Trade Name
- Curaplex FDA UDI
- Generic Name
- Nitrile examination/treatment glove, non-powdered, antimicrobial FDA UDI
- Device Name
- PERSONAL PROTECTION KIT WITH 6XL TYCHEM COVERALL 12/CS FDA UDI
- Model / Reference
- 2909006XL FDA UDI
- Description
- PERSONAL PROTECTION KIT WITH 6XL TYCHEM COVERALL 12/CS FDA UDI
Identifiers
- Catalog Number
- 2909006XL FDA UDI
- Primary DI / UDI-DI
- 00815277027496 FDA UDI
- FDA Product Code
- OKH FDA UDI
- GMDN Term
- Nitrile examination/treatment glove, non-powdered, antimicrobial FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4040 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
Yes
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Surgical/medical respirator, non-antimicrobial, single-useShoe coverEye splash shield, single-useVisitor hygiene coverall
Curaplex by Bound Tree Medical, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Nitrile examination/treatment glove, non-powdered, antimicrobial.
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- Cerulean — J & A Global Inc.
- AG GLOVE — ASIA GATE INTERNATIONAL SDN. BHD. · Class I
- PALMCARE — Hi-Care Thai Gloves Co. , Ltd. · Class I
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 II | Pending data |
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Manufacturer
- Manufacturer
- Bound Tree Medical, Llc
Sources (1)
- FDA UDI cb05b681-c383-457d-9415-4f77e59430da 34 fields · synced May 31, 2026