FDA applicant
Shen Wei (Usa), Inc.
FDA records 58 decisions for Shen Wei (Usa), Inc. (Union City, CA) from 1989 to 2022: 58 510(k) clearances. Most are in product codes LZA (Polymer Patient Examination Glove) and LYY (Latex Patient Examination Glove). Since 2016 its 510(k)s took a median of 221 days from receipt to decision, against 111 for FDA’s reviews in the same codes and years. Its devices cite 8 predicates, 6 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Shen Wei USA, Inc.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Shen Wei (Usa), Inc.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2022
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Shen Wei (Usa), Inc.’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 “Shen”
FDA records each applicant name separately; these may or may not be the same firm.