510(k) Report

FDA applicant

Xiantao Zhibo Non-Woven Products Co., Ltd.

Xiantao, CN2 decisions2019–20230 recalls

FDA records 2 decisions for Xiantao Zhibo Non-Woven Products Co., Ltd. (Xiantao, CN) from 2019 to 2023: 2 510(k) clearances. Most are in product codes FYA (Gown, Surgical) and FXX (Mask, Surgical). 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 and plastic surgery panel, where it files most

How often FDA has decided Xiantao Zhibo Non-Woven Products Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2019: 12023: 1
2019high 1 (2019) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Xiantao Zhibo Non-Woven Products Co., Ltd. by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Xiantao”

FDA records each applicant name separately; these may or may not be the same firm.