SafeSource Direct Glove Plant

FDA Device Registration & Listing · Broussard, LA, US · Registration 3024999439

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3024999439
FEI Number
3024999439
Entity Name
SafeSource Direct Glove Plant
City/State/Country
Broussard, LA, US
Establishment Address
142 Lake Talon 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
N
Expiration Date (Year)
2026
510(k) Number
K222898
PMA Number
N/A

All Registered Proprietary Names

SafeSource Direct Ameri-Tuff Nitrile Gloves SafeSource Direct Ameri-Touch Nitrile Exam Gloves

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2022-11-10
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2022-11-10

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
3021486363 SAFESOURCE DIRECT Broussard, LA, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
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
K981039 Sri Johani Sdn. Bhd. POWDERFREE GREEN NITRILE EXAMINATION GLOVES (POLYMER COATED) 1998-04-21
K101595 Better Care Plastic Technology Cp., Ltd. POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE 2010-08-06

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3024999439. Last updated year: 2026. Please use registration number 3024999439 when referencing this establishment in official correspondence.
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