Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016685880

FEI Number

3016685880

Entity Name

ARROW MEDSOURCE GROUP LIMITED

City/State/Country

Hongkong, CN

Establishment Address

FLAT 10, 3/F WAH YIU INDUS, 30-32 AU PUI WAN STREET SHA, TIN, NT, Hongkong 999077, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Arrow Medsource Group Limited (Owner Number: 10064458)

Owner / Operator Contact Address

FLAT 10, 3/F WAH YIU INDUS , 30-32 AU PUI WAN STREET SHA TIN, NT, Hongkong, CN-NOTA None, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Bouffant Cap Ophthalmic Eye Shield Isolation Gown, Chemo Gown; Coverall with tape; Coverall w/o tape; Disposable Coverall; Disposable Isolation Gown Polymer Patient Examination Glove Disposable Shoe Covers Gown Examination Polymer Patient Examination Glove Tubing, Noninvasive

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-04-03
FYF	Cap, Surgical	General, Plastic Surgery	Class 1	878.4040	2020-04-17
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2020-07-27
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2020-05-01
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2021-05-18
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2021-05-18
BWP	Shoe And Shoe Cover, Conductive	General, Plastic Surgery	Class 1	878.4040	2020-04-17
FME	Gown, Examination	General Hospital	Class 1	880.6265	2020-04-17
MSH	Respirator, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-03-25
BYX	Tubing, Pressure And Accessories	Anesthesiology	Class 1	868.5860	2024-02-26
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2021-05-18
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2021-05-18
GAZ	Tubing, Noninvasive	General Hospital	Class 2	880.6740	2024-02-27

Official Correspondent

No official correspondent registered.

US Agent Details

Jaime Lipford Email: rep@healthcarerepoffice.com Phone: (423) 8950374

Related Public Records

Same Entity

Arrow Medsource Group Limited

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
K201622	Guangdong Kingfa Sci. & Tech.Co., Ltd.	Medical surgical mask	2020-11-24
K881618	3M Company	ASEPTEX 1809 FLUID-RESISTANT MOLDED SURGICAL MASK	1988-05-09
K212801	Hong Seng Gloves Sdn Bhd	Powder free nitrile examination glove- black, non sterile	2022-01-09
K260806	Vista Industries,, LLC	Nitrile Disposable Examination Gloves	2026-06-03
K011593	Ansell Healthcare Products, Inc.	MICRO-TOUCH NITRILE POWDER FREE SYNTHETIC MEDICAL EXAMINATION GLOVES, COLOR BLUE NON-STERILE	2001-06-21

Similar Registrations

Registration Number	Establishment Name	Location
3016247944	HYGENIX HEALTH SOLUTIONS LLC	Torrance, CA, US
3016765490	XIAMEN CHUANFUTANG PHARMACEUTICAL CO.,LTD	xiamen Fujian, CN
3018382937	MID-AMERICA SAFETY CORP	Elk Grove Village, IL, US
3017598017	DURIO PPE SDN. BHD.	Johor Bahru, MY
3002813051	IRIS USA INC	Pleasant Prairie, WI, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016685880. Last updated year: 2026. Please use registration number 3016685880 when referencing this establishment in official correspondence.