Shandong Feiyang Professional Gloves Co., Ltd.

⚠️ High Risk

FEI: 3012646089 • Qinzhou, Shandong • CHINA

FEI

FEI Number

3012646089

📍

Location

Qinzhou, Shandong

🇨🇳

Country

CHINA

🏢

Address

338 Huaqing Drive, Qixin Chemical Industry Zone, Qinzhou, Shandong, China

High Risk

FDA Import Risk Assessment

63.7

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

6/16/2025

Latest Refusal

3/26/2024

Earliest Refusal

Score Breakdown

Violation Severity

55.2×40%

Refusal Volume

46.5×30%

Recency

88.2×20%

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

50816×

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.

11810×

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).

32805×

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.

3415×

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).

2233×

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.

39052×

3905

162×

DIRECTIONS

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.

4771×

HOLES

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

Refusal History

Date	Product	Violations	Division
6/16/2025	80LZAGLOVE, PATIENT EXAMINATION, POLY	477HOLES	Division of Northeast Imports (DNEI)
11/13/2024	80LZAGLOVE, PATIENT EXAMINATION, POLY	118NOT LISTED 3280FRNMFGREG 341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
11/13/2024	80LZAGLOVE, PATIENT EXAMINATION, POLY	118NOT LISTED 3280FRNMFGREG 341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
11/13/2024	80LZAGLOVE, PATIENT EXAMINATION, POLY	118NOT LISTED 3280FRNMFGREG 341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
11/13/2024	80LZAGLOVE, PATIENT EXAMINATION, POLY	118NOT LISTED 3280FRNMFGREG 341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
11/13/2024	80LZAGLOVE, PATIENT EXAMINATION, POLY	118NOT LISTED 3280FRNMFGREG 341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
10/16/2024	80LZAGLOVE, PATIENT EXAMINATION, POLY	118NOT LISTED 16DIRECTIONS 39053905 508NO 510(K)	Division of Southeast Imports (DSEI)
10/16/2024	80LZAGLOVE, PATIENT EXAMINATION, POLY	118NOT LISTED 16DIRECTIONS 39053905 508NO 510(K)	Division of Southeast Imports (DSEI)
7/24/2024	80LZAGLOVE, PATIENT EXAMINATION, POLY	508NO 510(K)	Division of Northeast Imports (DNEI)
6/21/2024	80LZAGLOVE, PATIENT EXAMINATION, POLY	508NO 510(K)	Division of Northern Border Imports (DNBI)
6/21/2024	80LZAGLOVE, PATIENT EXAMINATION, POLY	508NO 510(K)	Division of Northern Border Imports (DNBI)
6/21/2024	80LZAGLOVE, PATIENT EXAMINATION, POLY	508NO 510(K)	Division of Northern Border Imports (DNBI)
4/29/2024	80LZAGLOVE, PATIENT EXAMINATION, POLY	118NOT LISTED 223FALSE 508NO 510(K)	Division of West Coast Imports (DWCI)
4/29/2024	80LZAGLOVE, PATIENT EXAMINATION, POLY	118NOT LISTED 223FALSE 508NO 510(K)	Division of West Coast Imports (DWCI)
4/29/2024	80LZAGLOVE, PATIENT EXAMINATION, POLY	118NOT LISTED 223FALSE 508NO 510(K)	Division of West Coast Imports (DWCI)
3/26/2024	80LZAGLOVE, PATIENT EXAMINATION, POLY	508NO 510(K)	Division of West Coast Imports (DWCI)
3/26/2024	80LZAGLOVE, PATIENT EXAMINATION, POLY	508NO 510(K)	Division of West Coast Imports (DWCI)

Frequently Asked Questions

What is Shandong Feiyang Professional Gloves Co., Ltd.'s FDA import refusal history?

Shandong Feiyang Professional Gloves Co., Ltd. (FEI: 3012646089) has 17 FDA import refusal record(s) in our database, spanning from 3/26/2024 to 6/16/2025.

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. Shandong Feiyang Professional Gloves Co., Ltd.'s FEI number is 3012646089.

What types of violations has Shandong Feiyang Professional Gloves Co., Ltd. received?

Shandong Feiyang Professional Gloves Co., Ltd. has been cited for 8 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 Shandong Feiyang Professional Gloves Co., Ltd. come from?

All FDA import refusal data for Shandong Feiyang Professional 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.