Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015820879

FEI Number

3015820879

Entity Name

KENPAX INTERNATIONAL LIMITED

City/State/Country

Kowloon, HK

Establishment Address

Flat 5, 5/F., Wing On Plaza, 62 Mody Road, Tsim Sha Tsui, Kowloon 999077, HK

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Kenpax International Limited (Owner Number: 10062935)

Owner / Operator Contact Address

Flat 5, 5/F., Wing On Plaza, 62 Mody Road, Tsim Sha Tsui, Kowloon, HK-NOTA 999077, HK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Isolation Gown AAMI Level 3 PE Film Gown

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	2021-05-24
FYC	Gown, Isolation, Surgical	General, Plastic Surgery	Class 2	878.4040	2022-12-29
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2020-03-13

Official Correspondent

Scott Sun

US Agent Details

Solomon Chen Email: solomon@aplusgroup.net Phone: (909) 4387898

Related Public Records

Same Entity

Kenpax International 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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015820879. Last updated year: 2026. Please use registration number 3015820879 when referencing this establishment in official correspondence.