Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011238790

FEI Number

3011238790

Entity Name

ZHONGJIN IRRADIATION WUHAN CO., LTD.

City/State/Country

Wuhan Hubei, CN

Establishment Address

No.55,,Jinyang Road, Yangluo Economic Development Zone., Wuhan Hubei 430415, CN

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

Zhongjin Irradiation Wuhan Co., Ltd. (Owner Number: 10047541)

Owner / Operator Contact Address

No.55 Jinyang Road, Yangluo Economic Development Zone., Wuhan, CN-HB 430415, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

hydrocolloid dressing Synthetic Glove Medical Exam Glove Hydrocoll Classic,5X5 cm,P10 ;Hydrocoll Classic,10X10 cm,P10;Hydrocoll Classic,15X15 cm,P5; Iodoform packing strip;Plain packing strip Non-stick Pad XEROFORM petrolatum dressing;Oil Emulsion dressing;petrolatum dressing Iodoform packing strip;Plain packing strip Iodoform packing strip

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2025-03-11
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2025-03-11
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2021-05-26
LYZ	Vinyl Patient Examination Glove	General Hospital	Class 1	880.6250	2014-11-12
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2025-03-11
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2024-06-19
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2025-03-11
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2014-10-04
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2024-06-19
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2024-06-19
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2024-06-19

Official Correspondent

Xue Lin

US Agent Details

James H. Liao Email: jamess@sino2us.com Phone: (310) 3758169

Related Public Records

Same Entity

Zhongjin Irradiation Wuhan Co., Ltd.

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
3030671502	GUANGDONG VYIMED CO., LTD.	Qingyuan Guangdong, CN
9610406	ANSELL (THAILAND) LTD.	THAILAND Krung Thep Maha Nakhon, TH
3026062711	RMKH GLOVE (CAMBODIA) CO., LTD.	Bavet City Svay Rieng, KH
3043739177	US Paper Mill LLC	Chillicothe, OH, US
3013681444	ANREL DISTRIBUTION LLC	Jackson, NJ, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011238790. Last updated year: 2026. Please use registration number 3011238790 when referencing this establishment in official correspondence.