510(k) Report

FDA applicant

Wuxi Shenzhou Plastic Products Co., Ltd.

Haidian District, Beijing, CN2 decisions2007–20070 recalls

FDA records 2 decisions for Wuxi Shenzhou Plastic Products Co., Ltd. (Haidian District, Beijing, CN) in 2007: 2 510(k) clearances. All are in product code LYZ (Vinyl Patient Examination Glove). 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 hospital panel, where it files most

How often FDA has decided Wuxi Shenzhou Plastic Products Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2007

2007: 2
2007high 2 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Wuxi Shenzhou Plastic Products Co., Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Wuxi Shenzhou Plastic 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.

See the 510(k) Report

Which product codes does it file in?

  • LYZVinyl Patient Examination Glove2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 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.

  • K070149Powder-Free Vinyl Patient Examination GlovesWuxi Shenzhou Plastic Products Co., Ltd. · 20072cite it

What has FDA decided for it lately?

  • K070145Powdered Vinyl Patient Examination GlovesWuxi Shenzhou Plastic Products Co., Ltd. · 2007
  • K070149Powder-Free Vinyl Patient Examination GlovesWuxi Shenzhou Plastic Products Co., Ltd. · 2007

All 2 as Wuxi Shenzhou Plastic Products Co., Ltd. →

Other applicant names beginning “Wuxi”

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

Wuxi Jiajian Medical Instrument Co., Ltd. 12Wuxi Hisky Medical Technologies Co., Ltd. 5Wuxi Nest Biotechnology Co., Ltd. 4Wuxi Xinzhongrui Baby Supplies Co., Ltd. 3Wuxi Yushou Medical Applicances Co., Ltd. 3Wuxi EA Medical Instruments Technologies Limited. 2Wuxi Yushou Medical Appliances Co., Ltd. 2Wuxi Shukang Medical Appliance Co., Ltd. 1Wuxi Beien Surgery Device Co., Ltd. 1Wuxi Exanovo Medical Instrument Co., Ltd. 1Wuxi Bingfa Gainlite Gloves Cp., Ltd. 1Wuxi Medical Instrument Factory 1