Beijing Reagent Latex Products Co., Ltd.

⚠️ Moderate Risk

FEI: 3000980306 • Beijing, Beijing • CHINA

FEI

FEI Number

3000980306

📍

Location

Beijing, Beijing

🇨🇳

Country

CHINA

🏢

Address

NO 30 Nansanlitun, , Beijing, Beijing, China

Moderate Risk

FDA Import Risk Assessment

48.1

LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

Total Refusals

Unique Violations

1/7/2008

Latest Refusal

12/5/2001

Earliest Refusal

Score Breakdown

Violation Severity

50.3×40%

Refusal Volume

64.2×30%

Recency

0.0×20%

Frequency

87.0×10%

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

50850×

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.

34148×

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).

11818×

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).

Refusal History

Date	Product	Violations	Division
1/7/2008	79KGOSURGEON'S GLOVES	341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
11/28/2007	79KGOSURGEON'S GLOVES	341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
11/19/2007	79KGOSURGEON'S GLOVES	341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
9/21/2007	79KGOSURGEON'S GLOVES	118NOT LISTED 508NO 510(K)	Florida District Office (FLA-DO)
7/13/2007	79KGOSURGEON'S GLOVES	341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
2/22/2007	79KGOSURGEON'S GLOVES	341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
10/31/2006	80LYYGLOVE, PATIENT EXAMINATION, LATEX	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
10/30/2006	80LYYGLOVE, PATIENT EXAMINATION, LATEX	341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
9/21/2006	79KGOSURGEON'S GLOVES	118NOT LISTED	Florida District Office (FLA-DO)
9/12/2006	79KGOSURGEON'S GLOVES	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
7/17/2006	79KGOSURGEON'S GLOVES	341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
7/5/2006	79KGOSURGEON'S GLOVES	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
6/12/2006	79KGOSURGEON'S GLOVES	118NOT LISTED 508NO 510(K)	Florida District Office (FLA-DO)
11/3/2005	79KGOSURGEON'S GLOVES	341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
9/7/2005	80LYYGLOVE, PATIENT EXAMINATION, LATEX	341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
8/25/2005	79KGOSURGEON'S GLOVES	341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
8/17/2005	79KGOSURGEON'S GLOVES	341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
6/14/2005	79KGOSURGEON'S GLOVES	341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
6/14/2005	79KGOSURGEON'S GLOVES	341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
6/9/2005	79KGOSURGEON'S GLOVES	341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
4/12/2005	79KGOSURGEON'S GLOVES	341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
4/8/2005	79KGOSURGEON'S GLOVES	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
3/14/2005	79KGOSURGEON'S GLOVES	341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
2/17/2005	79KGOSURGEON'S GLOVES	341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
1/12/2005	79KGOSURGEON'S GLOVES	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
12/9/2004	79KGOSURGEON'S GLOVES	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
12/6/2004	79KGOSURGEON'S GLOVES	341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
11/10/2004	79KGOSURGEON'S GLOVES	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
11/3/2004	79KGOSURGEON'S GLOVES	118NOT LISTED 341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
11/3/2004	79KGOSURGEON'S GLOVES	118NOT LISTED 341REGISTERED	Division of Southeast Imports (DSEI)
11/1/2004	79KGOSURGEON'S GLOVES	118NOT LISTED 341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
11/1/2004	79KGOSURGEON'S GLOVES	118NOT LISTED 341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
10/18/2004	79KGOSURGEON'S GLOVES	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
3/22/2004	79KGOSURGEON'S GLOVES	118NOT LISTED 341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
2/19/2004	79KGOSURGEON'S GLOVES	118NOT LISTED 341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
1/23/2004	79KGOSURGEON'S GLOVES	118NOT LISTED 341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
10/17/2003	79KGOSURGEON'S GLOVES	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
10/9/2003	79KGOSURGEON'S GLOVES	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
7/25/2003	79KGOSURGEON'S GLOVES	118NOT LISTED 341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
7/25/2003	79KGOSURGEON'S GLOVES	118NOT LISTED 341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
5/27/2003	79KGOSURGEON'S GLOVES	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
5/27/2003	79KGOSURGEON'S GLOVES	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
4/2/2003	79KGOSURGEON'S GLOVES	118NOT LISTED 341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
3/6/2003	79KGOSURGEON'S GLOVES	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
3/6/2003	79KGOSURGEON'S GLOVES	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
2/6/2003	79KGOSURGEON'S GLOVES	508NO 510(K)	Florida District Office (FLA-DO)
11/6/2002	79KGOSURGEON'S GLOVES	118NOT LISTED 341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
8/7/2002	79KGOSURGEON'S GLOVES	118NOT LISTED	Florida District Office (FLA-DO)
8/5/2002	79KGOSURGEON'S GLOVES	118NOT LISTED 341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
7/10/2002	79KGOSURGEON'S GLOVES	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
3/25/2002	78FLAMONITOR, TEMPERATURE, DIALYSIS	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
2/11/2002	79KGOSURGEON'S GLOVES	118NOT LISTED 341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
12/5/2001	78FLAMONITOR, TEMPERATURE, DIALYSIS	118NOT LISTED 341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)

Frequently Asked Questions

What is Beijing Reagent Latex Products Co., Ltd.'s FDA import refusal history?

Beijing Reagent Latex Products Co., Ltd. (FEI: 3000980306) has 53 FDA import refusal record(s) in our database, spanning from 12/5/2001 to 1/7/2008.

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. Beijing Reagent Latex Products Co., Ltd.'s FEI number is 3000980306.

What types of violations has Beijing Reagent Latex Products Co., Ltd. received?

Beijing Reagent Latex Products Co., Ltd. has been cited for 3 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 Beijing Reagent Latex Products Co., Ltd. come from?

All FDA import refusal data for Beijing Reagent Latex Products 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.