VIETGLOVE CORPORATION
⚠️ Moderate Risk
FEI: 3012446547 • Binh Duong, BINH DUONG • VIETNAM
FEI Number
3012446547
Location
Binh Duong, BINH DUONG
Country
VIETNAMAddress
Cau Sat Hamlet, Lai Hung Commune, , Binh Duong, BINH DUONG, Vietnam
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
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.
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).
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/8/2022 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Division of West Coast Imports (DWCI) |
| 1/8/2022 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Division of West Coast Imports (DWCI) |
| 8/24/2021 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Division of Southwest Imports (DSWI) |
| 8/5/2021 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Division of West Coast Imports (DWCI) |
| 6/28/2021 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | Division of West Coast Imports (DWCI) | |
| 6/4/2021 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | Division of West Coast Imports (DWCI) | |
| 5/28/2021 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Division of West Coast Imports (DWCI) |
| 1/29/2020 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Division of Northeast Imports (DNEI) |
| 1/29/2020 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Division of Northeast Imports (DNEI) |
| 1/29/2020 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Division of Northeast Imports (DNEI) |
| 5/18/2017 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 333LACKS FIRM | Division of Southwest Imports (DSWI) |
Frequently Asked Questions
What is VIETGLOVE CORPORATION's FDA import refusal history?
VIETGLOVE CORPORATION (FEI: 3012446547) has 11 FDA import refusal record(s) in our database, spanning from 5/18/2017 to 1/8/2022.
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. VIETGLOVE CORPORATION's FEI number is 3012446547.
What types of violations has VIETGLOVE CORPORATION received?
VIETGLOVE CORPORATION 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 VIETGLOVE CORPORATION come from?
All FDA import refusal data for VIETGLOVE CORPORATION 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.