SHANDONG XINGYU GLOVES CO., LTD

FDA Device Registration & Listing · Gaomi Shandong, CN · Registration 3013451367

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
3013451367
FEI Number
3013451367
Entity Name
SHANDONG XINGYU GLOVES CO., LTD
City/State/Country
Gaomi Shandong, CN
Establishment Address
No.2158,Yaoqian Road,Economic Development Zone, Gaomi Shandong 261502, CN
Establishment Type(s)
Manufacture Medical Device,Export Device to the United States But Perform No Other Operation on Device
Owner / Operator
Shandong Xingyu gloves Co., Ltd (Owner Number: 10064146)
Owner / Operator Contact Address
No.2158,Yaoqian Road,Economic Development Zone, Gaomi, CN-SD 261502, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K233990
PMA Number
N/A

All Registered Proprietary Names

Xingyu Powder Free Nitrile Patient Examination Gloves, Blue Color Nitrile Disposable Examination Gloves

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 2020-03-25
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2024-04-18
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2024-04-18
OPJ Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs General Hospital Class 1 880.6250 2024-04-18
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2024-04-18

Official Correspondent

GAOYONG HONG

US Agent Details

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

Related Public Records

Same Entity

Shandong Xingyu gloves 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 3013451367. Last updated year: 2026. Please use registration number 3013451367 when referencing this establishment in official correspondence.
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