Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3033848619

FEI Number

3033848619

Entity Name

Hilo Healthcare China Co.,ltd

City/State/Country

Lu'An Anhui, CN

Establishment Address

YuAn Industrial Park, Lu'An Anhui 237100, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Hilo Industries LLC (Owner Number: 10073187)

Owner / Operator Contact Address

7035 E Pecos Rd, STE 1001 Bldg 1, Mesa, AZ 85212, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Shoe Cover Surgical Gown Standard Surgical Gown Surgical Cap, Single Layer Surgical Cap, Tri-Layer

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FXP	Cover, Shoe, Operating-Room	General, Plastic Surgery	Class 1	878.4040	2022-06-16
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2021-11-11
FYF	Cap, Surgical	General, Plastic Surgery	Class 1	878.4040	2022-06-16

Official Correspondent

Daniel Marquardt

US Agent Details

Daniel Marquardt Business: HILO INDUSTRIES LLC Email: daniel@hiloindustries.com Phone: (703) 3484613

Related Public Records

Same Entity

Hilo Industries LLC

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3034226814	Hilo Industries LLC	Mesa, AZ, US

Related 510(k) Records

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

Similar Registrations

Registration Number	Establishment Name	Location
3014314985	ANHUI MEDPUREST MEDICAL TECHNOLOGY CO.,LTD	Anqing Anhui, CN
3013429557	HEYUAN HONG DE MEDICAL PRODUCTS CO., LTD.	Heyuan City Guangdong, CN
3038718579	OKETZ LOGISTICS LLC	Coral Gables, FL, US
3008808082	PLANET(SHANGHAI) INTERNATIONAL CO.,LTD	shanghai, CN
3013823570	GUANGZHOU BAOLI HARDWARE & ELECTRONIC CO.,LTD.	Guangzhou Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3033848619. Last updated year: 2026. Please use registration number 3033848619 when referencing this establishment in official correspondence.