Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012341425

FEI Number

3012341425

Entity Name

Cardinal Health K.K.

City/State/Country

FUKUROI Shizuoka, JP

Establishment Address

3033 MOROI, FUKUROI Shizuoka 437-1121, JP

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Cardinal Health 200, LLC (Owner Number: 9028292)

Owner / Operator Contact Address

3651 Birchwood Drive, --, Waukegan, IL 60085, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2016-05-23
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2016-05-23
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	1977-12-31
KGZ	Accessories, Catheter	General, Plastic Surgery	Class 1	878.4200	1999-08-04
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2010-10-18
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2009-11-02
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2010-10-25
GAB	Needle, Suturing, Disposable	General, Plastic Surgery	Class 1	878.4800	2009-07-08
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2011-10-06
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2012-05-07
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2011-05-11
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2011-10-06
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2009-09-17
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2016-03-24
ITG	Bandage, Cast	Physical Medicine	Class 1	890.3025	1999-08-04

Official Correspondent

No official correspondent registered.

US Agent Details

Stacey Henning Email: stacey.henning@cardinalhealth.com Phone: (312) 2702081

Related Public Records

Same Entity

Cardinal Health 200, LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3004839227	Cardinal Health Malta 212 Ltd	Marsa, MT
3015541720	Cardinal Health Germany Manufacturing GmbH	Halberstadt Saxony-Anhalt, DE
1033903	Cardinal Health	Greenwood, SC, US
9611018	Cardinal Health Ireland Manufacturing Limited	TULLAMORE Offaly, IE
8040459	Kendall-Gammatron Limited	SAMPRAN Nakhon Pathom, TH

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K002933	Maxxim Medical	STERILE SENSICARE SYNTHETIC POLYISOPRENE POWDER-FREE SURGICAL GLOVES	2000-10-19
K913402	Smith & Nephew Perry	PERRY(R) DERMAGUARD(R) PLUS GLOVES	1991-10-02
K170216	Tactile Systems Technology, Inc. (Dba Tactile Medical)	Flexitouch System	2017-05-26
K100306	Covidien	KENDALL SCD SEQUENTIAL COMPRESSION COMFORT SLEEVES	2010-05-04

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3012551999	ST.MARYS RUBBERS PVT LTD	Kottayam Kerala, IN
3025413681	GUILIN HUADA BIOTECHNOLOGY CO., LTD.	Guilin City Guangxi, CN
8041005	WRP ASIA PACIFIC SDN. BHD.	SALAK TINGGI, SEPANG Selangor, MY
3004122598	PRODUCTOS MEDLINE S.A. DE C.V.	NUEVO LAREDO Tamaulipas, MX

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012341425. Last updated year: 2026. Please use registration number 3012341425 when referencing this establishment in official correspondence.