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Curaplex

FDA UDI

Class II (US FDA UDI)

by Bound Tree Medical, Llc

Identity

Trade Name
Curaplex FDA UDI
Generic Name
Nitrile examination/treatment glove, non-powdered, antimicrobial FDA UDI
Device Name
Curaplex Infection Kit Special (Min Order Of 50) FDA UDI
Model / Reference
5814-25SIK FDA UDI
Description
Curaplex Infection Kit Special (Min Order Of 50) FDA UDI

Identifiers

Catalog Number
5814-25SIK FDA UDI
Primary DI / UDI-DI
00815277028790 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

No

FDA UDI

Prescription Use

No

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Nitrile examination/treatment glove, non-powdered, antimicrobialSkin cleaning wipeAntiseptic skin toweletteInfectious waste absorbent

Curaplex by Bound Tree Medical, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Infectious waste absorbent.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bound Tree Medical, Llc

Sources (1)

  • FDA UDI 2f7e463f-85d7-4730-9e73-f0a0a23e72eb 34 fields · synced Jun 1, 2026