FDA applicant

Wuxi Bingfa Gainlite Gloves Cp., Ltd.

Pennington, NJ1 decision2010–20100 recalls

FDA records 1 decision for Wuxi Bingfa Gainlite Gloves Cp., Ltd. (Pennington, NJ) in 2010: 1 510(k) clearance. All are in product code LYZ (Vinyl Patient Examination Glove). Its devices cite 1 predicate, 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 Bingfa Gainlite Gloves Cp., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2010high 1 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Wuxi Bingfa Gainlite Gloves Cp., Ltd. by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Wuxi Bingfa Gainlite Gloves Cp., 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

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

Wuxi Bingfa Gainlite Gloves Cp., Ltd.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Wuxi”