FDA applicant
Top Quality Mfg., Inc.
FDA records 4 decisions for Top Quality Mfg., Inc. (Appollo Beach, FL) from 2000 to 2002: 4 510(k) clearances. Most are in product codes LYY (Latex Patient Examination Glove) and LZA (Polymer Patient Examination Glove). Its devices cite 1 predicate, 1 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 Top Quality Mfg., Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Top Quality Mfg., Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Top Quality Mfg., Inc.’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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