FDA applicant
Shanghai PT Plastics Enterprise Company, Ltd.
FDA records 6 decisions for Shanghai PT Plastics Enterprise Company, Ltd. (Songjiang County Shanghai, CN) from 1996 to 2002: 6 510(k) clearances. All are in product code LYZ (Vinyl Patient Examination Glove). No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Shanghai PT Plastics Enterprise Company, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Shanghai PT Plastics Enterprise Company, Ltd. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Shanghai PT Plastics Enterprise…’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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