Smart Glove Corporation Sdn. Bhd.
⚠️ Moderate Risk
FEI: 3001856884 • Klang, Selangor Darul Ehsan • MALAYSIA
FEI Number
3001856884
Location
Klang, Selangor Darul Ehsan
Country
MALAYSIAAddress
Lot 6487, Batu 5 3/4 Sementa, Jalan Kapar, Klang, Selangor Darul Ehsan, 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.
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 |
|---|---|---|---|
| 9/18/2017 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | Division of Northern Border Imports (DNBI) | |
| 9/18/2017 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | Division of Northern Border Imports (DNBI) | |
| 9/18/2017 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | Division of Northern Border Imports (DNBI) | |
| 9/18/2017 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | Division of Northern Border Imports (DNBI) | |
| 9/18/2017 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | Division of Northern Border Imports (DNBI) | |
| 6/22/2010 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Southwest Import District Office (SWI-DO) |
| 6/22/2010 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Southwest Import District Office (SWI-DO) |
| 5/19/2009 | 80NPCGLOVE, PATIENT EXAMINATION, POWDER FREE, | 477HOLES | Los Angeles District Office (LOS-DO) |
| 5/19/2009 | 80NPCGLOVE, PATIENT EXAMINATION, POWDER FREE, | 477HOLES | Los Angeles District Office (LOS-DO) |
| 5/19/2009 | 80NPCGLOVE, PATIENT EXAMINATION, POWDER FREE, | 477HOLES | Los Angeles District Office (LOS-DO) |
| 5/19/2009 | 80NPCGLOVE, PATIENT EXAMINATION, POWDER FREE, | 477HOLES | Los Angeles District Office (LOS-DO) |
| 5/19/2009 | 80NPCGLOVE, PATIENT EXAMINATION, POWDER FREE, | 477HOLES | Los Angeles District Office (LOS-DO) |
| 5/19/2009 | 80NPCGLOVE, PATIENT EXAMINATION, POWDER FREE, | 477HOLES | Los Angeles District Office (LOS-DO) |
| 6/14/2005 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 118NOT LISTED | New York District Office (NYK-DO) |
| 12/30/2003 | 80LZCGLOVE, PATIENT EXAMINATION, SPECIALTY | 477HOLES | Los Angeles District Office (LOS-DO) |
| 4/25/2003 | 80LZCGLOVE, PATIENT EXAMINATION, SPECIALTY | 477HOLES | Baltimore District Office (BLT-DO) |
| 4/25/2003 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Baltimore District Office (BLT-DO) |
Frequently Asked Questions
What is Smart Glove Corporation Sdn. Bhd.'s FDA import refusal history?
Smart Glove Corporation Sdn. Bhd. (FEI: 3001856884) has 17 FDA import refusal record(s) in our database, spanning from 4/25/2003 to 9/18/2017.
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. Smart Glove Corporation Sdn. Bhd.'s FEI number is 3001856884.
What types of violations has Smart Glove Corporation Sdn. Bhd. received?
Smart Glove Corporation Sdn. Bhd. 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 Smart Glove Corporation Sdn. Bhd. come from?
All FDA import refusal data for Smart Glove Corporation 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.