Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004150701

FEI Number

3004150701

Entity Name

SHANDONG BLUE SAIL INNOVATION CO LTD

City/State/Country

WEIFANG Shandong, CN

Establishment Address

East Side of Xingan Road,, Dongcheng Street Office, Linqu County, WEIFANG Shandong 262600, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SHANDONG BLUE SAIL INNOVATION CO LTD (Owner Number: 10034242)

Owner / Operator Contact Address

East Side of Xing'an Road,, Dongcheng Street Office, Linqu County, WEIFANG, CN-SD 262600, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K103619

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	2010-11-16
LYZ	Vinyl Patient Examination Glove	General Hospital	Class 1	880.6250	2010-11-16
LYZ	Vinyl Patient Examination Glove	General Hospital	Class 1	880.6250	2011-12-17

Official Correspondent

Senlin Hou

US Agent Details

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

Related Public Records

Same Entity

SHANDONG BLUE SAIL INNOVATION 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

Registration Number	Establishment Name	Location
3020106122	BINH AN MEDICAL CO., LTD	Dong Trieu Township, Quang Ninh, VN
3017940518	STAR INVESTMENT AND TRADE JOINT STOCK COMPANY	Bac Ninh, VN
3012304513	JIANGSU HUAYUAN MEDICAL TECHNOLOGY CO., LTD.	Dongtai Jiangsu, CN
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 3004150701. Last updated year: 2026. Please use registration number 3004150701 when referencing this establishment in official correspondence.