Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3025771437

FEI Number

3025771437

Entity Name

NAM DUONG PERSONAL PROTECTIVE EQUIPMENT MANUFACTURING JOINT STOCK COMPANY

City/State/Country

Duy Tien Township Ha Nam, VN

Establishment Address

Thai Hoa Group, Hoa Mac Ward, Duy Tien Township Ha Nam 18000, VN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

NAM DUONG PERSONAL PROTECTIVE EQUIPMENT MANUFACTURING JOINT (Owner Number: 10087062)

Owner / Operator Contact Address

239 Ly Nhan Tong street, Thai Hoa Hamlet,, Duy Tien Ward,, VN-18 18000, VN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

NAM DUONG PPE.,JSC NAM DUONG PPE.,JSC NAM DUONG PPE.,JSC Medline Level 3 Surgical Gown (Aurora Non Reinforced & Aurora Fabric Reinforced) Medline Level 3 Surgical Gown (Sirus Fabric Reinforced) Medline Level 3 Surgical Gown (Sirus Non-Reinforced) Medline Level 2 Surgical Gown (Eclipse Non-Reinforced) Medline Level 3 Surgical Gown (Eclipse Fabric Reinforced)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2024-12-22
FYF	Cap, Surgical	General, Plastic Surgery	Class 1	878.4040	2024-01-26
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2023-06-27
KPY	Shield, Protective, Personnel	Radiology	Class 1	892.6500	2023-01-07
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2023-01-07

Official Correspondent

No official correspondent registered.

US Agent Details

Rosanna Lee Business: Simcon International LLC Email: rlee@simconintl.com Phone: (847) 9492290

Related Public Records

Same Entity

NAM DUONG PERSONAL PROTECTIVE EQUIPMENT MANUFACTURING JOINT

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K892118	Paramount Products, Inc.	NON-STERILE MASKS AND CAPS	1989-04-20

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3025771437. Last updated year: 2026. Please use registration number 3025771437 when referencing this establishment in official correspondence.