Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004168786

FEI Number

3004168786

Entity Name

GRAND WORK PLASTIC PRODUCTS CO., LTD.

City/State/Country

ZANHUANG Hebei, CN

Establishment Address

DONGGAO INDUSTRIAL ZONE, ZANHUANG Hebei 050000, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

GRAND WORK PLASTIC PRODUCTS CO., LTD. (Owner Number: 9058864)

Owner / Operator Contact Address

DONGGAO INDUSTRIAL ZONE, --, ZANHUANG, CN-HE 050000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LYZ	Vinyl Patient Examination Glove	General Hospital	Class 1	880.6250	2011-02-08
LYZ	Vinyl Patient Examination Glove	General Hospital	Class 1	880.6250	2007-12-27
QDO	Fentanyl And Other Opioid Protection Glove	General Hospital	Class 1	880.6250	2023-09-09
OPJ	Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs	General Hospital	Class 1	880.6250	2023-09-09
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2023-09-09
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2023-09-09
LYZ	Vinyl Patient Examination Glove	General Hospital	Class 1	880.6250	2020-02-06
LYZ	Vinyl Patient Examination Glove	General Hospital	Class 1	880.6250	2010-11-17
LYZ	Vinyl Patient Examination Glove	General Hospital	Class 1	880.6250	2016-07-25
LYZ	Vinyl Patient Examination Glove	General Hospital	Class 1	880.6250	2015-01-26
LYZ	Vinyl Patient Examination Glove	General Hospital	Class 1	880.6250	2007-12-27
LYZ	Vinyl Patient Examination Glove	General Hospital	Class 1	880.6250	2007-12-27
LYZ	Vinyl Patient Examination Glove	General Hospital	Class 1	880.6250	2007-12-27
OPJ	Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs	General Hospital	Class 1	880.6250	2020-11-21
LYZ	Vinyl Patient Examination Glove	General Hospital	Class 1	880.6250	2020-11-21

Official Correspondent

Yuli Wu

US Agent Details

Kathy Liu Email: registration@csrepresent.com Phone: (909) 5901611

Related Public Records

Same Entity

GRAND WORK PLASTIC PRODUCTS 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
K052612	Shanghai Antares Industries, Inc.	DISPOSABLE POWDER FREE VINYL EXAM GLOVES WITH VITAMIN COMPLEX, NOPAL AND LANOLIN BLUE COLOR	2005-11-22
K120584	Wealth on (Jiangsu) Co., Ltd.	POWER FREE STRETCH VINYL PATIENT EXAMINATION GLOVES	2012-07-10
K220992	Ever Global (Vietnam) Enterprise Corporation	Disposable Powder Free Vinyl Exam Glove, Black/Blue/Purple	2022-10-19
K112610	Inpro Technology Device Factory	SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE (AND MULTIPLE LABELS)	2011-12-05
K131340	Made Plastic Co., Ltd.	POWDER FREE YELLOW SYNTHETIC VINYL PATIENT EXAMINATION GLOVES	2014-09-09

Similar Registrations

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3012317628	ZIBO LING YUN MEDICAL PRODUCTS CO., LTD.	Zibo Shandong, CN
3015477649	SHANDONG SHANGWEI MEDICAL PRODUCTS CO.,LTD	HEZE CITY Shandong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004168786. Last updated year: 2026. Please use registration number 3004168786 when referencing this establishment in official correspondence.