510(k) Report

FDA applicant

Pt. Maja Agung Latexindo

Chino, CA11 decisions1990–20220 recalls

FDA records 11 decisions for Pt. Maja Agung Latexindo (Chino, CA) from 1990 to 2022: 11 510(k) clearances. Most are in product codes LYY (Latex Patient Examination Glove) and LZA (Polymer Patient Examination Glove). Its devices cite 2 predicates, 0 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 Pt. Maja Agung Latexindo’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2008: 12017: 12022: 1
2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Pt. Maja Agung Latexindo by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Pt. Maja Agung Latexindo’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • LYYLatex Patient Examination Glove7decisions
  • LZAPolymer Patient Examination Glove2decisions
  • KGOSurgeon'S Gloves2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K212408Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs Use and Simulated Gastric Acid)Pt. Maja Agung Latexindo · 20221cites it
  • K081488Powder Free Latex Examination Gloves, Non-SterilePt. Maja Agung Latexindo · 20081cites it

What has FDA decided for it lately?

  • K212408Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs Use and Simulated Gastric Acid)Pt. Maja Agung Latexindo · 2022
  • K161099Powder Free Nitrile Examination Gloves, BlackPt. Maja Agung Latexindo · 2017
  • K081488Powder Free Latex Examination Gloves, Non-SterilePt. Maja Agung Latexindo · 2008
  • K062709Powder Free Latex Examination Gloves, BlackPt. Maja Agung Latexindo · 2006
  • K020040Latex Pre-Powdered Examination Gloves with Protein ClaimPt. Maja Agung Latexindo · 2002
  • K013996Latex Powderfree Sterile Examination Gloves, Models-Extra Small, Small, Medium, Large, Extra LargePt. Maja Agung Latexindo · 2002
  • K001274Latex Surgeon Surgeon's Gloves Powder-Free with Protein Content Labeling Claim (50 Micrograms or Less)Pt. Maja Agung Latexindo · 2000
  • K994255Latex Examination Gloves-Pre-Powdered-SterilePt. Maja Agung Latexindo · 2000

All 11 as Pt. Maja Agung Latexindo →