HI-CARE THAI GLOVES CO LTD
⚠️ Moderate Risk
FEI: 3020764656 • Hatyai, SONGKHLA • THAILAND
FEI Number
3020764656
Location
Hatyai, SONGKHLA
Country
THAILANDAddress
89/1, Moo 4, Tambon Chalung, Amphoe Hatyai, Hatyai, 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
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).
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.
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).
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.
DEVICEGMPS
The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of Section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or a condition prescribed by an order under section 520(f)(2) of the FD&C Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/21/2025 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 2780DEVICEGMPS | Division of Northern Border Imports (DNBI) |
| 1/7/2025 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Division of Northeast Imports (DNEI) |
| 8/31/2022 | 80OIGRUBBER EXAMINATION GLOVES, POWDER-FREE | Division of Northeast Imports (DNEI) | |
| 8/31/2022 | 80OIGRUBBER EXAMINATION GLOVES, POWDER-FREE | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is HI-CARE THAI GLOVES CO LTD's FDA import refusal history?
HI-CARE THAI GLOVES CO LTD (FEI: 3020764656) has 4 FDA import refusal record(s) in our database, spanning from 8/31/2022 to 5/21/2025.
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. HI-CARE THAI GLOVES CO LTD's FEI number is 3020764656.
What types of violations has HI-CARE THAI GLOVES CO LTD received?
HI-CARE THAI GLOVES CO LTD has been cited for 6 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 HI-CARE THAI GLOVES CO LTD come from?
All FDA import refusal data for HI-CARE THAI GLOVES CO LTD 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.