510(k) Report

FDA applicant

Xiantao Topmed Nonwoven Protective Products Co., Ltd.

Xiantao, CN2 decisions2022–20220 recalls

FDA records 2 decisions for Xiantao Topmed Nonwoven Protective Products Co., Ltd. (Xiantao, CN) in 2022: 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 Topmed Nonwoven Protective Products Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2022

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

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

FIG. 1 — Xiantao Topmed Nonwoven Protective Products Co., Ltd. by year, 2022–2026Sources: 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.