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Data / Medical devices / Hong Kong / Medcare Industry Co., Limited

Medcare Industry Co., Limited: FDA-registered device maker in Kowloon, Hong Kong, 1 510(k) clearance

Medcare Industry Co., Limited is registered with the FDA (registration 3038704522) in Kowloon, Hong Kong. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated May 14, 2021. Registered through 2027. FDA data exported November 3, 2026.

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FDA registration number
3038704522
Address
Wong King Industrial Building No 2 Tai Yau Street, Kowloon, Hong Kong, 999077
Owner or operator
MEDCARE INDUSTRY CO., LIMITED (10096140)
Roles
Exporter to the US
First device listed
July 7, 2026
Registered through
2027

Devices it lists

DeviceProduct codeClassRoleSource
Vinyl Patient Examination GloveLYZ1Exporter to the USaccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
May 14, 2021K210780Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)LYZSubstantially EquivalentShandong Shangwei Medical Products Co., Ltd.accessdata.fda.gov

Compare with other makers

Updated May 14, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.