WUHAN ZONSEN MEDICAL PRODUCTS CO., LTD

FDA Device Registration & Listing · Wuhan Hubei, CN · Registration 3015140351

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3015140351
FEI Number
3015140351
Entity Name
WUHAN ZONSEN MEDICAL PRODUCTS CO., LTD
City/State/Country
Wuhan Hubei, CN
Establishment Address
No. 8 Jinchao Road, Zhucheng Street, Xinzhou District, Wuhan Hubei 431000, CN
Establishment Type(s)
Manufacture Medical Device,Export Device to the United States But Perform No Other Operation on Device
Owner / Operator
Wuhan Zonsen Medical Products Co., Ltd (Owner Number: 10059207)
Owner / Operator Contact Address
No. 8 Jinchao Road, Zhucheng Street, Xinzhou District, Wuhan, CN-HB 431000, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

CSR Wrap ACCESSORY, SURGICAL APPAREL Mask, Surgical Nitrile Examination Gloves (Model: ZMG1351) MASK, SCAVENGING Medline Surgical Masks Plaster of Paris bandage CSR Wrap BEDDING, DISPOSABLE, MEDICAL Underpad CSR Wrap GOWN, EXAMINATION Surgical Mask CSR Wrap COVER, SHOE, OPERATING-ROOM Surgical gown, model ZSG1005 Reinforced surgical gown, model ZSG1006 CSR Wrap Surgical Isolation Gown CSR Wrap First Aid Kit High elastic bandage, Elastic tubular bandage, Crepe bandage CSR Wrap Mask, Surgical Elastic adhesive bandage, Cohesive bandage SUIT, SURGICAL Operating Room Towels ZONSEN1 Non-surgical isolation gown trousers shoe cover nonwoven hood lab coat beard cover boot cover Cotton roll, Dental cotton Face Mask Sterilization Wrap ALCOHOL PREP PAD; BZK PAD; CLEANSING WIPE; NONWOVEN PAD; OB TOWOLETTE Gauze roll, Gauze sponge, Gauze Bandage, Gauze lap sponge, Gauze ball, Non-woven sponge, Eye pad

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FRG Wrap, Sterilization General Hospital Class 2 880.6850 2024-02-04
LYU Accessory, Surgical Apparel General, Plastic Surgery Class 1 878.4040 2018-12-12
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2020-02-24
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2022-03-24
KHA Mask, Scavenging Anesthesiology Class 1 868.5590 2019-09-11
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2024-01-08
LGF Component, Cast Orthopedic Class 1 888.5940 2021-07-12
FRG Wrap, Sterilization General Hospital Class 2 880.6850 2024-02-04
KME Bedding, Disposable, Medical General Hospital Class 1 880.6060 2018-12-12
FRG Wrap, Sterilization General Hospital Class 2 880.6850 2024-02-04
FME Gown, Examination General Hospital Class 1 880.6265 2018-12-11
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2022-12-20
FRG Wrap, Sterilization General Hospital Class 2 880.6850 2024-02-04
FXP Cover, Shoe, Operating-Room General, Plastic Surgery Class 1 878.4040 2018-12-12
FYA Gown, Surgical General, Plastic Surgery Class 2 878.4040 2021-12-20
FRG Wrap, Sterilization General Hospital Class 2 880.6850 2024-02-04
FYC Gown, Isolation, Surgical General, Plastic Surgery Class 2 878.4040 2022-01-21
FRG Wrap, Sterilization General Hospital Class 2 880.6850 2024-04-02
LRR First Aid Kit With Drug Unknown Class N N/A 2023-08-15
FQM Bandage, Elastic General Hospital Class 1 880.5075 2021-07-12
FRG Wrap, Sterilization General Hospital Class 2 880.6850 2024-02-04
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2020-02-24
KGX Tape And Bandage, Adhesive General Hospital Class 1 880.5240 2021-07-12
FXO Suit, Surgical General, Plastic Surgery Class 1 878.4040 2018-12-12
GEC Brush, Scrub, Operating-Room General, Plastic Surgery Class 1 878.4800 2021-01-18
FYF Cap, Surgical General, Plastic Surgery Class 1 878.4040 2021-01-18
OEA Non-Surgical Gown General, Plastic Surgery Class 1 878.4040 2018-12-12
EFN Cotton, Roll Dental Class 1 872.6050 2021-07-12
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 2021-07-21
FRG Wrap, Sterilization General Hospital Class 2 880.6850 2023-10-20
LRJ Disinfectant, Medical Devices General Hospital Class 1 880.6890 2019-02-17
NAB Gauze / Sponge,Nonresorbable For External Use General, Plastic Surgery Class 1 878.4014 2021-07-12

Official Correspondent

Xudong Li

US Agent Details

Mark Gordon Email: Mark.W.Gordon@outlook.com Phone: (571) 4072862

Related Public Records

Same Entity

Wuhan Zonsen Medical Products Co., Ltd
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3042285072 WUHAN ZONSEN MEDICAL PRODUCTS CO., LTD Wuhan Hubei, CN

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K201622 Guangdong Kingfa Sci. & Tech.Co., Ltd. Medical surgical mask 2020-11-24
K881618 3M Company ASEPTEX 1809 FLUID-RESISTANT MOLDED SURGICAL MASK 1988-05-09
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015140351. Last updated year: 2026. Please use registration number 3015140351 when referencing this establishment in official correspondence.
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