Laglove Sdn Bhd (M) aka LA Glove
⚠️ Moderate Risk
FEI: 1000153953 • Kajang • MALAYSIA
FEI Number
1000153953
Location
Kajang
Country
MALAYSIAAddress
Lot 478 Jalan Simpang Balak, Off Batu 13, Jalan Cheras, Kajang, , 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.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/20/2015 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Los Angeles District Office (LOS-DO) |
| 1/17/2013 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Florida District Office (FLA-DO) |
| 11/19/2012 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Florida District Office (FLA-DO) |
| 11/19/2012 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Florida District Office (FLA-DO) |
| 10/1/2012 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Los Angeles District Office (LOS-DO) |
| 10/1/2012 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Los Angeles District Office (LOS-DO) |
| 10/1/2012 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Los Angeles District Office (LOS-DO) |
| 10/1/2012 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Los Angeles District Office (LOS-DO) |
| 9/14/2012 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Los Angeles District Office (LOS-DO) |
| 5/31/2012 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Cincinnati District Office (CIN-DO) |
| 12/15/2011 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Los Angeles District Office (LOS-DO) |
| 4/21/2011 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | Los Angeles District Office (LOS-DO) | |
| 3/17/2010 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Los Angeles District Office (LOS-DO) |
| 1/12/2010 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 1/12/2010 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 6/5/2009 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Laglove Sdn Bhd (M) aka LA Glove's FDA import refusal history?
Laglove Sdn Bhd (M) aka LA Glove (FEI: 1000153953) has 16 FDA import refusal record(s) in our database, spanning from 6/5/2009 to 7/20/2015.
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. Laglove Sdn Bhd (M) aka LA Glove's FEI number is 1000153953.
What types of violations has Laglove Sdn Bhd (M) aka LA Glove received?
Laglove Sdn Bhd (M) aka LA Glove 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 Laglove Sdn Bhd (M) aka LA Glove come from?
All FDA import refusal data for Laglove Sdn Bhd (M) aka LA Glove 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.