Great Glove Sdn Bhd
⚠️ Moderate Risk
FEI: 3005099002 • Petaling Jaya, Selangor • MALAYSIA
FEI Number
3005099002
Location
Petaling Jaya, Selangor
Country
MALAYSIAAddress
3rd Floor, Damansara Utama, Petaling Jay, Jalan 79, Petaling Jaya, Selangor, Malaysia
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/5/2012 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | New Orleans District Office (NOL-DO) |
| 9/5/2012 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | New Orleans District Office (NOL-DO) |
| 6/5/2012 | 80OPEPOWDERED LATEX PATIENT EXAMINATION GLOVE | 477HOLES | Florida District Office (FLA-DO) |
| 2/28/2011 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Great Glove Sdn Bhd's FDA import refusal history?
Great Glove Sdn Bhd (FEI: 3005099002) has 4 FDA import refusal record(s) in our database, spanning from 2/28/2011 to 9/5/2012.
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. Great Glove Sdn Bhd's FEI number is 3005099002.
What types of violations has Great Glove Sdn Bhd received?
Great Glove Sdn Bhd has been cited for 1 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 Great Glove Sdn Bhd come from?
All FDA import refusal data for Great Glove Sdn Bhd 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.