510(k) Report

FDA applicant

Safesource Direct, LLC

Broussard, LA3 decisions2022–20250 recalls

FDA records 3 decisions for Safesource Direct, LLC (Broussard, LA) from 2022 to 2025: 3 510(k) clearances. Most are in product codes LZA (Polymer Patient Examination Glove) and FXX (Mask, Surgical). Since 2016 its 510(k)s took a median of 30 days from receipt to decision, against 111 for FDA’s reviews in the same codes and years. Its devices cite 3 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Safesource Direct, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2022: 22025: 1
2022high 2 (2022) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

FIG. 1 — Safesource Direct, LLC by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LZAPolymer Patient Examination Glove2decisions
  • FXXMask, Surgical1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 30 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 111 days; 3 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K222898SafeSource Direct Blue Powder-Free Nitrile Exam GlovesSafesource Direct, LLC · 20221cites it

What has FDA decided for it lately?

  • K250502SafeSource Direct Blue Powder-Free Nitrile Exam Gloves (AMERI-TUFF Series 4000, AMERI-TOUCH Series 5000)Safesource Direct, LLC · 2025
  • K222898SafeSource Direct Blue Powder-Free Nitrile Exam GlovesSafesource Direct, LLC · 2022
  • K221134Procedure Mask with Ear Loops and Surgical Mask with TiesSafesource Direct, LLC · 2022

All 3 as Safesource Direct, LLC →