510(k) Report

FDA applicant

Shandong Xingyu Gloves Co., Ltd.

Gaomi, CN4 decisions2017–20240 recalls

FDA records 4 decisions for Shandong Xingyu Gloves Co., Ltd. (Gaomi, CN) from 2017 to 2024: 4 510(k) clearances. Most are in product codes LZA (Polymer Patient Examination Glove) and FXX (Mask, Surgical). Since 2016 its 510(k)s took a median of 59 days from receipt to decision, against 119 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 Shandong Xingyu Gloves Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2017: 22022: 12024: 1
2017high 2 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Shandong Xingyu Gloves Co., Ltd. by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Shandong Xingyu Gloves 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 Glove3decisions
  • FXXMask, Surgical1decision

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 59 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 119 days; 3 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:

Who builds on its devices?

Later devices cite its devices 6 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.

  • K171615Xingyu Nitrile Powder Free Patient Examination Gloves, White colorShandong Xingyu Gloves Co., Ltd. · 20173cite it
  • K221272Medical Face MaskShandong Xingyu Gloves Co., Ltd. · 20222cite it
  • K171616Xingyu Powder Free Nitrile Patient Examination Gloves, Blue colorShandong Xingyu Gloves Co., Ltd. · 20171cites it

What has FDA decided for it lately?

  • K233990Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl (D5000)Shandong Xingyu Gloves Co., Ltd. · 2024
  • K221272Medical Face MaskShandong Xingyu Gloves Co., Ltd. · 2022
  • K171615Xingyu Nitrile Powder Free Patient Examination Gloves, White colorShandong Xingyu Gloves Co., Ltd. · 2017
  • K171616Xingyu Powder Free Nitrile Patient Examination Gloves, Blue colorShandong Xingyu Gloves Co., Ltd. · 2017

All 4 as Shandong Xingyu Gloves Co., Ltd. →