ZEHUI GLOVE CO., LTD.

⚠️ High Risk

FEI: 3015775872 • Jiujiang, Jiangxi • CHINA

FEI

FEI Number

3015775872

📍

Location

Jiujiang, Jiangxi

🇨🇳

Country

CHINA

🏢

Address

Jiangshan Village, Hukou County, , Jiujiang, Jiangxi, China

High Risk

FDA Import Risk Assessment

64.3

LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

Total Refusals

Unique Violations

2/14/2024

Latest Refusal

10/30/2023

Earliest Refusal

Score Breakdown

Violation Severity

61.3×40%

Refusal Volume

58.1×30%

Recency

61.9×20%

Frequency

100.0×10%

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

Violation Summary

47736×

HOLES

The quality of the article falls below that which it purports or is represented to possess, in that the devices contain defects/holes.

34110×

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).

Refusal History

Date	Product	Violations	Division
2/14/2024	80LZAGLOVE, PATIENT EXAMINATION, POLY	477HOLES	Division of Northeast Imports (DNEI)
2/14/2024	80LZAGLOVE, PATIENT EXAMINATION, POLY	477HOLES	Division of Northeast Imports (DNEI)
2/14/2024	80LZAGLOVE, PATIENT EXAMINATION, POLY	477HOLES	Division of Northeast Imports (DNEI)
12/14/2023	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	Division of West Coast Imports (DWCI)
12/14/2023	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	Division of West Coast Imports (DWCI)
12/14/2023	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	Division of West Coast Imports (DWCI)
12/14/2023	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	Division of West Coast Imports (DWCI)
12/14/2023	80LYZGLOVE, PATIENT EXAMINATION, VINYL	341REGISTERED 477HOLES	Division of West Coast Imports (DWCI)
12/14/2023	80LYZGLOVE, PATIENT EXAMINATION, VINYL	341REGISTERED 477HOLES	Division of West Coast Imports (DWCI)
12/14/2023	80LYZGLOVE, PATIENT EXAMINATION, VINYL	341REGISTERED 477HOLES	Division of West Coast Imports (DWCI)
12/8/2023	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	Division of Northern Border Imports (DNBI)
12/8/2023	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	Division of Northern Border Imports (DNBI)
12/8/2023	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	Division of Northern Border Imports (DNBI)
12/8/2023	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	Division of West Coast Imports (DWCI)
12/8/2023	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	Division of West Coast Imports (DWCI)
12/8/2023	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	Division of West Coast Imports (DWCI)
12/8/2023	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	Division of West Coast Imports (DWCI)
12/8/2023	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	Division of West Coast Imports (DWCI)
12/8/2023	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	Division of West Coast Imports (DWCI)
12/8/2023	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	Division of West Coast Imports (DWCI)
12/7/2023	80LYZGLOVE, PATIENT EXAMINATION, VINYL	341REGISTERED 477HOLES	Division of West Coast Imports (DWCI)
12/7/2023	80LYZGLOVE, PATIENT EXAMINATION, VINYL	341REGISTERED 477HOLES	Division of West Coast Imports (DWCI)
12/7/2023	80LYZGLOVE, PATIENT EXAMINATION, VINYL	341REGISTERED 477HOLES	Division of West Coast Imports (DWCI)
12/7/2023	80LYZGLOVE, PATIENT EXAMINATION, VINYL	341REGISTERED 477HOLES	Division of West Coast Imports (DWCI)
12/7/2023	80LYZGLOVE, PATIENT EXAMINATION, VINYL	341REGISTERED 477HOLES	Division of West Coast Imports (DWCI)
12/7/2023	80LYZGLOVE, PATIENT EXAMINATION, VINYL	341REGISTERED 477HOLES	Division of West Coast Imports (DWCI)
12/7/2023	80LYZGLOVE, PATIENT EXAMINATION, VINYL	341REGISTERED 477HOLES	Division of West Coast Imports (DWCI)
11/29/2023	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	Division of Northern Border Imports (DNBI)
11/29/2023	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	Division of Northern Border Imports (DNBI)
11/29/2023	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	Division of Northern Border Imports (DNBI)
11/21/2023	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	Division of Northern Border Imports (DNBI)
11/21/2023	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	Division of Northern Border Imports (DNBI)
11/21/2023	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	Division of Northern Border Imports (DNBI)
10/31/2023	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	Division of Northern Border Imports (DNBI)
10/30/2023	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	Division of Northern Border Imports (DNBI)
10/30/2023	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	Division of Northern Border Imports (DNBI)

Frequently Asked Questions

What is ZEHUI GLOVE CO., LTD.'s FDA import refusal history?

ZEHUI GLOVE CO., LTD. (FEI: 3015775872) has 36 FDA import refusal record(s) in our database, spanning from 10/30/2023 to 2/14/2024.

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. ZEHUI GLOVE CO., LTD.'s FEI number is 3015775872.

What types of violations has ZEHUI GLOVE CO., LTD. received?

ZEHUI GLOVE CO., LTD. has been cited for 2 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 ZEHUI GLOVE CO., LTD. come from?

All FDA import refusal data for ZEHUI GLOVE 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.