Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021486363

FEI Number

3021486363

Entity Name

SAFESOURCE DIRECT

City/State/Country

Broussard, LA, US

Establishment Address

200 St. Nazaire Road, Broussard, LA 70518, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SafeSource Direct (Owner Number: 10084021)

Owner / Operator Contact Address

200 St. Nazaire Road, Broussard, LA 70518, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SafeSource Direct Universal Shoe Cover SafeSource Direct XL Extra Traction Shoe Cover SafeSource Direct Universal Extra Traction Shoe Cover SafeSource Direct XL Shoe Cover SafeSource DIrect Procedure Mask with Ear Loops -Level 3 SafeSource DIrect Surgical Mask with Ties - Level 3 SafeSource DIrect Surgical Mask with Ties - Level 1 SafeSource DIrect Procedure Mask with Ear Loops - Level 1 Level 2 Isolation Gown Level 1 Isolation Gown SafeSource DIrect Plant Based Procedural Masks with Earloops - Level 3 PRECISION ECO Compostable / Plant Based Procedural Mask with Earloops PADM PRECISION ECO Compostable / Plant Based Procedural Mask with Earloops SafeSource Direct Disposable Bouffant SafeSource Direct Lay Flat Bouffant

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	2022-01-10
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2022-05-19
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2023-11-29
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2024-04-18
FYF	Cap, Surgical	General, Plastic Surgery	Class 1	878.4040	2023-11-27

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

SafeSource Direct

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3024999439	SafeSource Direct Glove Plant	Broussard, LA, US

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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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 3021486363. Last updated year: 2026. Please use registration number 3021486363 when referencing this establishment in official correspondence.