Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014819517

FEI Number

3014819517

Entity Name

WELLMIEN HEALTHCARE TECH.(SUZHOU) CO., LTD.

City/State/Country

Suzhou Jiangsu, CN

Establishment Address

1-3603, Global 188, NO.88 Suhui Road, Suzhou Industrial Park, Suzhou Jiangsu 215000, CN

Establishment Type(s)

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

Owner / Operator

Wellmien Healthcare Tech.(Suzhou) Co., Ltd. (Owner Number: 10080621)

Owner / Operator Contact Address

1-3603, Global 188, NO.88 Suhui Road, Suzhou Industrial Park, Suzhou, CN-JS 215000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Face Mask Eye Pad Examination Gowns Apron Nursing Pad Medical Bedding and Blanket Disposable pillow, Reusable pillow, Non-woven pillow, Disposable Bed pillow, Disposable hygienic pillows Face Shield Powder Free Nitrile Patient Examination Glove, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs Non woven ball(without x-ray detectable) absorbent pads OR Towel, Operation Towel Non woven swab/Non woven pad (without x-ray detectable) Surgical operation towel(without x-ray detectable) Gauze / sponge Oversleeves Nitrile Powder Free Patient Examination Gloves, Blue Color Surgical Mask Pad, Alcohol, Device Disinfectant Tape and bandage, adhesive

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
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	2021-02-15
HMP	Pad, Eye	General, Plastic Surgery	Class 1	878.4440	2021-02-15
FME	Gown, Examination	General Hospital	Class 1	880.6265	2021-02-15
IWO	Apron, Protective	Radiology	Class 1	892.6500	2021-02-15
NTX	Nursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (F-68)	General Hospital	Class 1	880.5630	2021-02-15
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2021-02-15
KPY	Shield, Protective, Personnel	Radiology	Class 1	892.6500	2021-02-15
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2023-02-15
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2023-02-15
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2021-06-19
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2021-02-15
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2021-02-15
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2023-02-15
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2021-02-15
LRJ	Disinfectant, Medical Devices	General Hospital	Class 1	880.6890	2021-02-15
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2021-02-15

Official Correspondent

Charles Shen

US Agent Details

Charles Shen Business: Manton Business and Technology Services Email: cyshen@aol.com Phone: (608) 2179358

Related Public Records

Same Entity

Wellmien Healthcare Tech.(Suzhou) 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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014819517. Last updated year: 2026. Please use registration number 3014819517 when referencing this establishment in official correspondence.