Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007707004

FEI Number

3007707004

Entity Name

SHANDONG HUAYUE GLOVE CO., LTD.

City/State/Country

Zibo Shandong, CN

Establishment Address

East of Yifan Rd. and North of Naqi Rd., Science and Technology Based Ind. Zone, Zibo Shandong 255400, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Shandong Huayue Glove Co., Ltd. (Owner Number: 10029444)

Owner / Operator Contact Address

East of Yifan Rd. and North of Naqi Rd., Science and Technology Based Ind. Zone, Zibo, CN-SD 255400, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K090520

PMA Number

N/A

All Registered Proprietary Names

Huayue

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	2019-07-11
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2023-12-09
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2023-12-09
LYZ	Vinyl Patient Examination Glove	General Hospital	Class 1	880.6250	2009-05-14
LYZ	Vinyl Patient Examination Glove	General Hospital	Class 1	880.6250	2009-05-21

Official Correspondent

Jinyou Lin

US Agent Details

Ken Li Business: Omni International Corp Email: like@bluesail.cn Phone: (603) 4711499

Related Public Records

Same Entity

Shandong Huayue Glove 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 3007707004. Last updated year: 2026. Please use registration number 3007707004 when referencing this establishment in official correspondence.