FDA applicant
Weihai Hongyu Nonwoven Fabric Products Co., Ltd.
FDA records 6 decisions for Weihai Hongyu Nonwoven Fabric Products Co., Ltd. (Weihai, CN) from 2012 to 2022: 6 510(k) clearances. Most are in product codes FYA (Gown, Surgical) and LZA (Polymer Patient Examination Glove). Since 2016 its 510(k)s took a median of 88 days from receipt to decision, against 170 for FDA’s reviews in the same codes and years. Its devices cite 6 predicates, 0 of them its own earlier devices. 1 recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Weihai Hongyu Nonwoven Fabric Products Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2022
2026 so far, outlined.
Recalls per year
1in 2022
Class I Class II/III not classified
Planning a device like Weihai Hongyu Nonwoven Fabric Products…’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) ReportOther applicant names beginning “Weihai”
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