Sri Trang Gloves (Thailand) Public Company Limited
⚠️ Moderate Risk
FEI: 1000266564 • Hat Yai, Songkhla • THAILAND
FEI Number
1000266564
Location
Hat Yai, Songkhla
Country
THAILANDAddress
Thanon Phetkasem Soi 10, , Hat Yai, Songkhla, Thailand
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
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).
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
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).
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.
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 |
|---|---|---|---|
| 7/30/2021 | 80FMCGLOVE, PATIENT EXAMINATION | 341REGISTERED | Division of West Coast Imports (DWCI) |
| 7/23/2021 | 80QDOFENTANYL AND OTHER OPIOID PROTECTION GLOVE | 118NOT LISTED | Division of West Coast Imports (DWCI) |
| 5/25/2021 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | Division of West Coast Imports (DWCI) | |
| 8/9/2012 | 80LZCGLOVE, PATIENT EXAMINATION, SPECIALTY | 223FALSE | New Orleans District Office (NOL-DO) |
| 8/9/2012 | 80LZCGLOVE, PATIENT EXAMINATION, SPECIALTY | 223FALSE | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Sri Trang Gloves (Thailand) Public Company Limited's FDA import refusal history?
Sri Trang Gloves (Thailand) Public Company Limited (FEI: 1000266564) has 5 FDA import refusal record(s) in our database, spanning from 8/9/2012 to 7/30/2021.
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. Sri Trang Gloves (Thailand) Public Company Limited's FEI number is 1000266564.
What types of violations has Sri Trang Gloves (Thailand) Public Company Limited received?
Sri Trang Gloves (Thailand) Public Company Limited 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 Sri Trang Gloves (Thailand) Public Company Limited come from?
All FDA import refusal data for Sri Trang Gloves (Thailand) Public Company Limited 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.