FDA applicant
Sheen More Ent. Co., Ltd.
FDA records 6 decisions for Sheen More Ent. Co., Ltd. (Tou-Liu, Yun-Lin, TW) from 1999 to 2002: 6 510(k) clearances. All are in product code LZA (Polymer Patient Examination Glove). Its devices cite 2 predicates, 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
How often FDA has decided Sheen More Ent. Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Sheen More Ent. Co., Ltd. since 2007.
Recalls per year
No recall linked to its devices since 2007.
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