Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3031180726

FEI Number

3031180726

Entity Name

SHANDONG HYSURE SAFETY TECH CO., LTD

City/State/Country

Weifang City Shandong, CN

Establishment Address

Room 1201, Building 1, Heping Square, No. 3555 Heping Road, Weifang City Shandong 261021, CN

Establishment Type(s)

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

Owner / Operator

Shandong Hysure Safety Tech Co., Ltd (Owner Number: 10090339)

Owner / Operator Contact Address

Room 1201, Building 1, Heping Square, No. 3555 Heping Road, Weifang City, CN-SD 261021, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K212578

PMA Number

N/A

All Registered Proprietary Names

polymer patient examination glove Nitrile Disposable Examination Gloves, Tested forUse with Chemotherapy Drugs and Fentanyl polymer patient examination glove

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	2024-03-14
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2024-03-14
QDO	Fentanyl And Other Opioid Protection Glove	General Hospital	Class 1	880.6250	2026-01-21
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2026-01-21
OPJ	Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs	General Hospital	Class 1	880.6250	2026-01-21
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2026-01-21
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2024-03-14

Official Correspondent

Carrie Li

US Agent Details

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

Related Public Records

Same Entity

Shandong Hysure Safety 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

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
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 3031180726. Last updated year: 2026. Please use registration number 3031180726 when referencing this establishment in official correspondence.