510(k) Report

FDA applicant

Hubei Xinxin Non-Woven Co., Ltd.

Xiantao, CN4 decisions2022–20260 recalls

FDA records 4 decisions for Hubei Xinxin Non-Woven Co., Ltd. (Xiantao, CN) from 2022 to 2026: 4 510(k) clearances. Most are in product codes FYC (Gown, Isolation, Surgical) and FXX (Mask, Surgical). Since 2016 its 510(k)s took a median of 209 days from receipt to decision, against 214 for FDA’s reviews in the same codes and years. Its devices cite 3 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 Hubei Xinxin Non-Woven Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

3in 2022

2022: 32026 (partial year): 1
2022high 3 (2022) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

FIG. 1 — Hubei Xinxin Non-Woven Co., Ltd. by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Hubei Xinxin Non-Woven 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?

  • FYCGown, Isolation, Surgical2decisions
  • FXXMask, Surgical1decision
  • FYAGown, Surgical1decision

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 209 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 214 days; 1 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K212120Surgical MasksHubei Xinxin Non-Woven Co., Ltd. · 20221cites it

What has FDA decided for it lately?

  • K253003Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Surgical Gown (M4025); Non-sterile Reinforced…Hubei Xinxin Non-Woven Co., Ltd. · 2026
  • K214116AAMI4 Isolation GownHubei Xinxin Non-Woven Co., Ltd. · 2022
  • K213832AAMI3 Isolation GownHubei Xinxin Non-Woven Co., Ltd. · 2022
  • K212120Surgical MasksHubei Xinxin Non-Woven Co., Ltd. · 2022

All 4 as Hubei Xinxin Non-Woven Co., Ltd. →