Curaplex CUR5603

by Bound Tree Medical, LLC

Curaplex CUR5603 is a Class I device made by Bound Tree Medical, LLC, cleared under FDA 510(k) K102444 on 22 Nov 2010 and listed in FDA GUDID since 15 Feb 2019 (UDI-DI 00812277034769), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

FDA submission, from GUDID

Trust

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00812277034769 UDI-DI	Date15 Feb 2019Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK102444	Date22 Nov 2010Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00812277034769
FDA 510(k) database 510(k) number K102444

Across registries

2 registries list this device

FDA 510(k) K102444 decided 22 Nov 2010 Active
FDA GUDID UDI-DI 00812277034769 listed 15 Feb 2019 Listed

Timeline

2 dated events

22 Nov 2010 Cleared FDA 510(k) K102444
15 Feb 2019 Listed FDA GUDID 00812277034769

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Curaplex
Generic name: Vinyl examination/treatment glove, non-powdered
Model / Ref / Catalog: CUR5603

Primary DI / UDI-DI: 00812277034769
510(k) Number: K102444
FDA product code: LYZ
GMDN term: Vinyl examination/treatment glove, non-powdered

Device class: Class I
Regulation number: 880.6250
GUDID distribution status: In Commercial Distribution

Similar devices in this category

Other devices filed under Vinyl examination/treatment glove, non-powdered.

Other devices from Bound Tree Medical, LLC

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Properties

Single use
Lot / batch number
Manufacturing date

Other properties (12, all answered No)