Zibo Blue Sail Innovation Co., Ltd

FDA Device Registration & Listing · Zibo Shandong, CN · Registration 3009243435

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
3009243435
FEI Number
3009243435
Entity Name
Zibo Blue Sail Innovation Co., Ltd
City/State/Country
Zibo Shandong, CN
Establishment Address
No. 21 Qingtian Road, Qilu Chemical Industrial Park,, Zibo Shandong 255414, CN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Zibo Blue Sail Innovation Co., Ltd (Owner Number: 10027479)
Owner / Operator Contact Address
No. 21 Qingtian Road, Qilu Chemcial Industrial Park, Zibo, CN-SD 255414, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K171782
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
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2017-02-23
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2017-10-23
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2017-10-23

Official Correspondent

Robin Liu

US Agent Details

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

Related Public Records

Same Entity

Zibo 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
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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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009243435. Last updated year: 2026. Please use registration number 3009243435 when referencing this establishment in official correspondence.
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