FDA applicant
Grand Work Plastic Products Co., Ltd.
FDA records 19 decisions for Grand Work Plastic Products Co., Ltd. (Zanhuang County, CN) from 2004 to 2023: 19 510(k) clearances. Most are in product codes LYZ (Vinyl Patient Examination Glove) and LZA (Polymer Patient Examination Glove). Since 2016 its 510(k)s took a median of 104 days from receipt to decision, against 111 for FDA’s reviews in the same codes and years. Its devices cite 16 predicates, 4 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 Grand Work Plastic Products Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
3in 2023
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Grand Work Plastic Products 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) ReportOther applicant names beginning “Grand”
FDA records each applicant name separately; these may or may not be the same firm.