Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008076203

FEI Number

3008076203

Entity Name

SUNDEX CORPORATION

City/State/Country

Taipei, TW

Establishment Address

7F-3, No. 186, SEC. 4, Nanjing E. Rd, Taipei 10595, TW

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

Sundex Corporation (Owner Number: 10041552)

Owner / Operator Contact Address

5F-9, No. 79, Sec.1, Hsin Tai Wu Road, Hsi-Chih District, Taipei, TW-NOTA 22101, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Nitrile Gloves, Scissors Nitrile Gloves Cotton applicators PAD, EYE Dressing, wound, occlusive Gauze / sponge,nonresorbable for external use pick, massaging BANDAGE, ELASTIC

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HTS	Knife, Orthopedic	Orthopedic	Class 1	888.4540	2023-09-20
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2024-11-04
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2024-11-04
KXG	Applicator, Absorbent Tipped, Sterile	General Hospital	Class 1	880.6025	2023-09-27
HMP	Pad, Eye	General, Plastic Surgery	Class 1	878.4440	2024-11-04
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2024-11-04
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2024-11-04
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2012-08-13
EFW	Toothbrush, Manual	Dental	Class 1	872.6855	2012-11-05
JET	Pick, Massaging	Dental	Class 1	872.6650	2024-11-04
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2024-11-04
QKR	Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua	Unknown	Class N	N/A	2020-04-16

Official Correspondent

Sophia Chang

US Agent Details

Ingrid Liao Business: Fleet Link, Inc Email: ingrid@fleetlinkinc.us Phone: (508) 2791500

Related Public Records

Same Entity

Sundex Corporation

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K212801	Hong Seng Gloves Sdn Bhd	Powder free nitrile examination glove- black, non sterile	2022-01-09
K260806	Vista Industries,, LLC	Nitrile Disposable Examination Gloves	2026-06-03
K011593	Ansell Healthcare Products, Inc.	MICRO-TOUCH NITRILE POWDER FREE SYNTHETIC MEDICAL EXAMINATION GLOVES, COLOR BLUE NON-STERILE	2001-06-21
K981039	Sri Johani Sdn. Bhd.	POWDERFREE GREEN NITRILE EXAMINATION GLOVES (POLYMER COATED)	1998-04-21
K101595	Better Care Plastic Technology Cp., Ltd.	POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE	2010-08-06

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-2019	COVIDIEN LLC	1	Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the dressing.
Z-0014-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m), REF 6715 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0015-2019	COVIDIEN LLC	1	Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, REF 7880 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0016-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100 Cotton, 8 Ply, Large 4-1/2 x 9.3 (11.4 cm x 2.8 m), REF 6716 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0017-2019	COVIDIEN LLC	1	Dermacea Gauze Fluff Roll, 6 Ply, 4-1/2 x 4-1/8 yd (11.4 cm x 3.7 m), REF 441103 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.

Similar Registrations

Registration Number	Establishment Name	Location
3027262786	SOLENDOS., INC.	GURO-GU Seoul, KR
3021519357	CnS MEDICAL CO., LTD.	Pocheon-si Gyeonggi, KR
8010733	PRO-MED INSTRUMENTE GMBH	TUTTLINGEN Baden-Wurttemberg, DE
9613910	NARANG MEDICAL, LTD.	New Delhi, IN
8010155	A.HANDTE MEDIZINTECHNIK GMBH & CO. KG	TUTTLINGEN Baden-Wurttemberg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008076203. Last updated year: 2026. Please use registration number 3008076203 when referencing this establishment in official correspondence.