FDA applicant
Shanghai PM Plastics Enterise Co., Ltd.
FDA records 5 decisions for Shanghai PM Plastics Enterise Co., Ltd. (Shongjiang County, Shanghai, CN) from 1993 to 2002: 5 510(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 PM Plastics Enterise Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Shanghai PM Plastics Enterise Co., Ltd. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Shanghai PM Plastics Enterise 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