Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016704566

FEI Number

3016704566

Entity Name

DONGGUAN LUDA INDUSTRIAL CO., LTD

City/State/Country

Dongguan Guangdong, CN

Establishment Address

Room 201, Building 1, No. 70 Xihuwenquan South Road, Shilong Town, Dongguan Guangdong 523325, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

DONGGUAN LUDA INDUSTRIAL CO., LTD (Owner Number: 10064188)

Owner / Operator Contact Address

Room 201, Building 1, No. 70 Xihuwenquan South Road, Shilong Town, Dongguan, CN-GD 523325, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Industrially compostable Food Container PP Face Masks,N95 Masks,Surgical Masks Nitrile Medical Examination Gloves, Latex Medical Examination/Surgical Gloves TPE Gloves, PE Gloves, PLA Gloves, Vinyl Medical Examination Gloves, PE Apron, PEVA Apron, POE Apron, TPU Apron, Vinyl Apron

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HSP	Splint, Traction	Orthopedic	Class 1	888.5890	2025-12-03
MSH	Respirator, Surgical	General, Plastic Surgery	Class 2	878.4040	2021-01-19
PXC	Personal Protection Kit	General Hospital	Class 1	880.6250	2025-12-03
IWO	Apron, Protective	Radiology	Class 1	892.6500	2021-05-26

Official Correspondent

Lu Wanchun

US Agent Details

Peter Yang Business: JIAMEI CONSULTING INC. Email: info@jiameiconsulting.com Phone: (310) 2168437

Related Public Records

Same Entity

DONGGUAN LUDA INDUSTRIAL CO., LTD

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
K102092	Prestige Ameritech	PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK, REGULAR SIZE MODEL RP CERIES	2010-10-06

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016704566. Last updated year: 2026. Please use registration number 3016704566 when referencing this establishment in official correspondence.