Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9616876

FEI Number

1000346129

Entity Name

MASTER & FRANK ENT. CO., LTD.

City/State/Country

TAIPEI, TW

Establishment Address

19 F., NO. 57, SEC. 2,, TUN HWA S. ROAD, TAIPEI 106, TW

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

MASTER & FRANK ENT. CO., LTD. (Owner Number: 9043426)

Owner / Operator Contact Address

19 F., NO. 57, SEC. 2, TUN HWA S. ROAD, TAIPEI, TW-NOTA 106, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K020393

PMA Number

N/A

All Registered Proprietary Names

Gown Particulate Respirator DRAPE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2008-03-21
MSH	Respirator, Surgical	General, Plastic Surgery	Class 2	878.4040	2021-11-18
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2008-03-21

Official Correspondent

SHERRY HUANG

US Agent Details

Gary Wang Business: MAYTEX CORP. Email: MAYTEX18@AOL.COM Phone: (510) 8874888

Related Public Records

Same Entity

MASTER & FRANK ENT. 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
K892118	Paramount Products, Inc.	NON-STERILE MASKS AND CAPS	1989-04-20
K102092	Prestige Ameritech	PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK, REGULAR SIZE MODEL RP CERIES	2010-10-06
K914369	Deroyal Industries, Inc.	QUALTEX MAGNETIC INSTRUMENT DRAPE	1991-12-02
K812809	Abco Dealers, Inc.	STERILE ADHERENT DRAPES	1981-11-06
K910084	Biocor Medical, Inc.	SURGICAL DRAPE	1991-03-19

Similar Registrations

Registration Number	Establishment Name	Location
3042245424	Sino Protection Holding Co Limited Egypt Branch Ismailia Free Zone	Ismailia Al Isma'iliyah, EG
3016678045	Schneider ASR B.V.	Rotterdam-Albrandswaard Zuid-Holland, NL
8030672	Cirpro de Delicias S. de R.L. de C.V.	DELICIAS Chihuahua, MX
1527607	SRI Healthcare, LLC	MASON, OH, US
3027977504	MEDLINE CHILE SPA	Pudahuel Region Metropolitana, CL

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9616876. Last updated year: 2026. Please use registration number 9616876 when referencing this establishment in official correspondence.