TG Medical Sdn Bhd (Factory 3)
⚠️ High Risk
FEI: 3002808366 • Klang, Selangor • MALAYSIA
FEI Number
3002808366
Location
Klang, Selangor
Country
MALAYSIAAddress
Lot 5091, 5th Mile, 5 Jalan Teratai, Klang, Selangor, Malaysia
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.
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).
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.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/7/2024 | 80KGOSURGEON'S GLOVES | Division of Southeast Imports (DSEI) | |
| 9/18/2017 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | Division of Northern Border Imports (DNBI) | |
| 5/16/2012 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | New York District Office (NYK-DO) |
| 11/9/2010 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 341REGISTERED | New York District Office (NYK-DO) |
| 11/9/2010 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 341REGISTERED | New York District Office (NYK-DO) |
| 11/9/2010 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 341REGISTERED | New York District Office (NYK-DO) |
| 11/9/2010 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 341REGISTERED | New York District Office (NYK-DO) |
| 4/16/2010 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Los Angeles District Office (LOS-DO) |
| 3/2/2010 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Los Angeles District Office (LOS-DO) |
| 7/14/2006 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | New York District Office (NYK-DO) |
| 6/24/2006 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Los Angeles District Office (LOS-DO) |
| 6/6/2006 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Cincinnati District Office (CIN-DO) |
| 5/9/2006 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Southwest Import District Office (SWI-DO) |
| 5/9/2006 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Southwest Import District Office (SWI-DO) |
| 5/2/2006 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | San Francisco District Office (SAN-DO) |
| 5/2/2006 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Philadelphia District Office (PHI-DO) |
| 1/18/2005 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | New York District Office (NYK-DO) |
| 1/25/2002 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | San Juan District Office (SJN-DO) |
Frequently Asked Questions
What is TG Medical Sdn Bhd (Factory 3)'s FDA import refusal history?
TG Medical Sdn Bhd (Factory 3) (FEI: 3002808366) has 18 FDA import refusal record(s) in our database, spanning from 1/25/2002 to 6/7/2024.
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. TG Medical Sdn Bhd (Factory 3)'s FEI number is 3002808366.
What types of violations has TG Medical Sdn Bhd (Factory 3) received?
TG Medical Sdn Bhd (Factory 3) has been cited for 5 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 TG Medical Sdn Bhd (Factory 3) come from?
All FDA import refusal data for TG Medical Sdn Bhd (Factory 3) 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.