Medi Glove Co.,Ltd.
⚠️ High Risk
FEI: 3014645046 • Tianjin, Tianjin • CHINA
FEI Number
3014645046
Location
Tianjin, Tianjin
Country
CHINAAddress
No. 4 Taiyuan Road, Xuguan Tun Industrial Zone,Wuqing District, Tianjin, Tianjin, 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
HOLES
The quality of the article falls below that which it purports or is represented to possess, in that the devices contain defects/holes.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
DE IMP GMP
The article is subject to refusal of admission pursuant to section 801(a)(1) in that it appears that the methods used in, or the facilities or controls used for, the manufacture of the device do not conform to the applicable requirements of section 520(f).
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/7/2025 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | Division of West Coast Imports (DWCI) | |
| 4/16/2025 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Division of Northeast Imports (DNEI) |
| 4/10/2025 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 290DE IMP GMP | Division of Northeast Imports (DNEI) |
| 3/13/2025 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Division of West Coast Imports (DWCI) |
| 2/18/2025 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Division of Southwest Imports (DSWI) |
| 2/18/2025 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Division of Southwest Imports (DSWI) |
| 2/18/2025 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Division of Southwest Imports (DSWI) |
| 2/18/2025 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Division of Southwest Imports (DSWI) |
| 1/22/2025 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | Division of West Coast Imports (DWCI) | |
| 1/22/2025 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | Division of West Coast Imports (DWCI) | |
| 1/10/2025 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Division of West Coast Imports (DWCI) |
| 12/18/2024 | 80LZCGLOVE, PATIENT EXAMINATION, SPECIALTY | 477HOLES | Division of Northern Border Imports (DNBI) |
| 12/18/2024 | 80LZCGLOVE, PATIENT EXAMINATION, SPECIALTY | 477HOLES | Division of Northern Border Imports (DNBI) |
| 12/18/2024 | 80LZCGLOVE, PATIENT EXAMINATION, SPECIALTY | 477HOLES | Division of Northern Border Imports (DNBI) |
| 12/18/2024 | 80LZCGLOVE, PATIENT EXAMINATION, SPECIALTY | 477HOLES | Division of Northern Border Imports (DNBI) |
| 12/18/2024 | 80LZCGLOVE, PATIENT EXAMINATION, SPECIALTY | 477HOLES | Division of Northern Border Imports (DNBI) |
| 12/4/2024 | 80LZCGLOVE, PATIENT EXAMINATION, SPECIALTY | 477HOLES | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is Medi Glove Co.,Ltd.'s FDA import refusal history?
Medi Glove Co.,Ltd. (FEI: 3014645046) has 17 FDA import refusal record(s) in our database, spanning from 12/4/2024 to 5/7/2025.
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. Medi Glove Co.,Ltd.'s FEI number is 3014645046.
What types of violations has Medi Glove Co.,Ltd. received?
Medi Glove Co.,Ltd. has been cited for 4 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 Medi Glove Co.,Ltd. come from?
All FDA import refusal data for Medi Glove 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.