Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003167283

FEI Number

3003167283

Entity Name

M J WINSTON INTERNATIONAL, LTD.

City/State/Country

Brea, CA, US

Establishment Address

555 W. Lambert Rd Suite O, Brea, CA 92821, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

M J WINSTON INTERNATIONAL, LTD. (Owner Number: 9078943)

Owner / Operator Contact Address

555 W. LAMBERT RD. SUITE O, --, Brea, CA 92821, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Smartmed Face Mask Smartmed Face Mask Spot Acne Patch

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MSH	Respirator, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-10-15
KHA	Mask, Scavenging	Anesthesiology	Class 1	868.5590	2020-10-14
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2016-12-08

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

M J WINSTON INTERNATIONAL, 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
K881936	Iberhospitex, S.A.	OPER-FILM-ADHESIVE MEMBRANE	1988-08-31

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-2019	COVIDIEN LLC	1	Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the dressing.
Z-0014-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m), REF 6715 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0015-2019	COVIDIEN LLC	1	Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, REF 7880 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0016-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100 Cotton, 8 Ply, Large 4-1/2 x 9.3 (11.4 cm x 2.8 m), REF 6716 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0017-2019	COVIDIEN LLC	1	Dermacea Gauze Fluff Roll, 6 Ply, 4-1/2 x 4-1/8 yd (11.4 cm x 3.7 m), REF 441103 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.

Similar Registrations

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3020623413	NITTA S.A.	Bogota, CO
3016765490	XIAMEN CHUANFUTANG PHARMACEUTICAL CO.,LTD	xiamen Fujian, CN
3041850200	RISKWISE SUPPLIES LLC	Lorton, VA, US
3018382937	MID-AMERICA SAFETY CORP	Elk Grove Village, IL, US
3010141571	Xiantao Zhongyi Safety & Protection Products Co.,Ltd.	Xiantao City Hubei, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003167283. Last updated year: 2026. Please use registration number 3003167283 when referencing this establishment in official correspondence.