DONGTAI CITY HUAYI GLOVES CO., LTD.
⚠️ High Risk
FEI: 3017252891 • Dongtai, Jiangsu • CHINA
FEI Number
3017252891
Location
Dongtai, Jiangsu
Country
CHINAAddress
No. 36 Nanzhuang Road, High-Tech Industrial Development Zone Of, Dongtai, Jiangsu, 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.
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.
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 |
|---|---|---|---|
| 12/19/2024 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 12/19/2024 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 12/19/2024 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 12/19/2024 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | Division of Northern Border Imports (DNBI) | |
| 12/19/2024 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | Division of Northern Border Imports (DNBI) | |
| 12/19/2024 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | Division of Northern Border Imports (DNBI) | |
| 12/19/2024 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | Division of Northern Border Imports (DNBI) | |
| 6/11/2024 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Division of Northern Border Imports (DNBI) |
| 3/20/2024 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | Division of West Coast Imports (DWCI) | |
| 3/14/2024 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Division of West Coast Imports (DWCI) |
| 3/8/2024 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is DONGTAI CITY HUAYI GLOVES CO., LTD.'s FDA import refusal history?
DONGTAI CITY HUAYI GLOVES CO., LTD. (FEI: 3017252891) has 11 FDA import refusal record(s) in our database, spanning from 3/8/2024 to 12/19/2024.
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. DONGTAI CITY HUAYI GLOVES CO., LTD.'s FEI number is 3017252891.
What types of violations has DONGTAI CITY HUAYI GLOVES CO., LTD. received?
DONGTAI CITY HUAYI GLOVES 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 DONGTAI CITY HUAYI GLOVES CO., LTD. come from?
All FDA import refusal data for DONGTAI CITY HUAYI GLOVES 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.