SHANDONG BAISHENG MEDICAL PRODUCTS CO., LTD
⚠️ High Risk
FEI: 3009711549 • LINQU, Shandong • CHINA
FEI Number
3009711549
Location
LINQU, Shandong
Country
CHINAAddress
6728 YONGQING ST, , LINQU, Shandong, China
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
HOLES
The quality of the article falls below that which it purports or is represented to possess, in that the devices contain defects/holes.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/16/2025 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 508NO 510(K) | Division of Northeast Imports (DNEI) |
| 5/16/2025 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 508NO 510(K) | Division of Northeast Imports (DNEI) |
| 12/31/2024 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 508NO 510(K) | Division of West Coast Imports (DWCI) |
| 11/20/2024 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 508NO 510(K) | Division of West Coast Imports (DWCI) |
| 11/19/2024 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 508NO 510(K) | Division of West Coast Imports (DWCI) |
| 10/22/2024 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 508NO 510(K) | Division of West Coast Imports (DWCI) |
| 7/24/2024 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 7/24/2024 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 6/11/2024 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 5/8/2024 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | Division of West Coast Imports (DWCI) | |
| 5/8/2024 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | Division of West Coast Imports (DWCI) | |
| 5/8/2024 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | Division of West Coast Imports (DWCI) | |
| 2/27/2024 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | Division of West Coast Imports (DWCI) | |
| 1/11/2024 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | Division of West Coast Imports (DWCI) | |
| 1/11/2024 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | Division of West Coast Imports (DWCI) | |
| 1/11/2024 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | Division of West Coast Imports (DWCI) | |
| 1/11/2024 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 118NOT LISTED | Division of West Coast Imports (DWCI) |
| 1/10/2024 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | Division of West Coast Imports (DWCI) | |
| 1/10/2024 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | Division of West Coast Imports (DWCI) | |
| 1/10/2024 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | Division of West Coast Imports (DWCI) | |
| 1/10/2024 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | Division of West Coast Imports (DWCI) | |
| 1/10/2024 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | Division of West Coast Imports (DWCI) | |
| 1/10/2024 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | Division of West Coast Imports (DWCI) | |
| 12/20/2023 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | Division of West Coast Imports (DWCI) | |
| 12/20/2023 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | Division of West Coast Imports (DWCI) | |
| 11/14/2023 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Division of West Coast Imports (DWCI) |
| 11/14/2023 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Division of West Coast Imports (DWCI) |
| 10/2/2023 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is SHANDONG BAISHENG MEDICAL PRODUCTS CO., LTD's FDA import refusal history?
SHANDONG BAISHENG MEDICAL PRODUCTS CO., LTD (FEI: 3009711549) has 28 FDA import refusal record(s) in our database, spanning from 10/2/2023 to 5/16/2025.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. SHANDONG BAISHENG MEDICAL PRODUCTS CO., LTD's FEI number is 3009711549.
What types of violations has SHANDONG BAISHENG MEDICAL PRODUCTS CO., LTD received?
SHANDONG BAISHENG MEDICAL PRODUCTS CO., LTD has been cited for 3 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about SHANDONG BAISHENG MEDICAL PRODUCTS CO., LTD come from?
All FDA import refusal data for SHANDONG BAISHENG MEDICAL PRODUCTS CO., LTD is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.