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Curaplex CUR5604

by Bound Tree Medical, LLC

Curaplex CUR5604 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 00812277034776), 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

510(k) K102444

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00812277034776 UDI-DI Date15 Feb 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK102444 Date22 Nov 2010DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K102444 decided 22 Nov 2010 Active
  • FDA GUDID UDI-DI 00812277034776 listed 15 Feb 2019 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K102444
  2. Listed FDA GUDID 00812277034776

Coverage

1 jurisdiction

United States of America
  • 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  • Withdrawn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
CUR5604
Primary DI / UDI-DI
00812277034776
510(k) Number
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

Related devices

Category: Vinyl examination/treatment glove, non-powdered

Cleared under the same submission (K102444)

and 8 more cleared under K102444

Similar devices

Other devices filed under FDA product code LYZ (Vinyl patient examination glove).

Other devices from Bound Tree Medical, LLC

See all devices from Bound Tree Medical, LLC →

Properties

  • Single use
  • Lot / batch number
  • Manufacturing date
Other properties (12, all answered No)