Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3018779144

FEI Number

3018779144

Entity Name

XINGYU MEDICAL TECH CO.,LTD

City/State/Country

Weifang City Shandong, CN

Establishment Address

No.2189 Yaoqian Road, Gaomi Economic Development Zone,, Weifang City Shandong 261500, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Xingyu Medical Tech Co.,Ltd (Owner Number: 10081106)

Owner / Operator Contact Address

No.2189 Yaoqian Road, Gaomi Economic Development Zone,, Weifang City, CN-SD 261500, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K212735

PMA Number

N/A

All Registered Proprietary Names

Xingyu Powder Free Nitrile Patient Examination Gloves, Blue Color Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl Nitrile Disposable Examination Gloves-510K Xingyu Nitrile Powder Free Patient Examination Gloves, White Color Nitrile Disposable Examination Gloves Nitrile Disposable Examination Gloves (Tested For Use With Chemotherapy Drugs)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2021-03-17
OPJ	Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs	General Hospital	Class 1	880.6250	2024-08-14
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2024-08-14
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2024-08-14
QDO	Fentanyl And Other Opioid Protection Glove	General Hospital	Class 1	880.6250	2024-08-14
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2021-12-22
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2021-03-17
QDO	Fentanyl And Other Opioid Protection Glove	General Hospital	Class 1	880.6250	2024-04-16
OPJ	Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs	General Hospital	Class 1	880.6250	2024-04-16
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2024-04-16
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2024-04-16
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2022-01-19
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2022-01-19

Official Correspondent

Chongyu Xu

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

Xingyu Medical Tech 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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3026062711	RMKH GLOVE (CAMBODIA) CO., LTD.	Bavet City Svay Rieng, KH
3043739177	US Paper Mill LLC	Chillicothe, OH, US
3042765418	VITAL EDGE INSTRUMENTS LLC	Leesburg, VA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3018779144. Last updated year: 2026. Please use registration number 3018779144 when referencing this establishment in official correspondence.