510(k) Report

FDA applicant

Fitone Latex Products Co., Ltd. Guangdong

Zhanjiang, CN4 decisions2021–20230 recalls

FDA records 4 decisions for Fitone Latex Products Co., Ltd. Guangdong (Zhanjiang, CN) from 2021 to 2023: 4 510(k) clearances. Most are in product codes LZA (Polymer Patient Examination Glove) and LYY (Latex Patient Examination Glove). Since 2016 its 510(k)s took a median of 120 days from receipt to decision, against 131 for FDA’s reviews in the same codes and years. Its devices cite 4 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 Fitone Latex Products Co., Ltd. Guangdong’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2021: 12022: 22023: 1
2021high 2 (2022) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Fitone Latex Products Co., Ltd. Guangdong by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Fitone Latex Products Co., Ltd.…’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • LZAPolymer Patient Examination Glove2decisions
  • LYYLatex Patient Examination Glove1decision
  • KGOSurgeon'S Gloves1decision

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 120 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 131 days; 2 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K231446Single-Use Latex Sterile Surgical Gloves (SG100)Fitone Latex Products Co., Ltd. Guangdong · 2023
  • K221747Nitrile Patient Examination Gloves Tested For Use With Chemotherapy DrugsFitone Latex Products Co., Ltd. Guangdong · 2022
  • K222693Single-use medical latex examination gloves (LG100)Fitone Latex Products Co., Ltd. Guangdong · 2022
  • K211927Nitrile examination glovesFitone Latex Products Co., Ltd. Guangdong · 2021

All 4 as Fitone Latex Products Co., Ltd. Guangdong →