Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Foshan Nanhai Plus Medical Co, Ltd. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
225 daysmedian FDA review time
632 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K222480 | Standard Surgical Gown (AAMI Level 2); Reinforced Surgical G | Foshan Nanhai Plus Medical Co, Ltd. | 2022-11-14 | 89 | 0 |
| K213177 | Plus Medical Cover Gown | Foshan Nanhai Plus Medical Co, Ltd. | 2022-05-11 | 225 | 0 |
| K211036 | Plus Medical Chemotherapy Gown | Foshan Nanhai Plus Medical Co, Ltd. | 2022-05-04 | 392 | 0 |
| K212698 | Plus Medical Isolation Gown Level 3 | Foshan Nanhai Plus Medical Co, Ltd. | 2022-03-02 | 189 | 0 |
| K212610 | Surgical Face Mask | Foshan Nanhai Plus Medical Co, Ltd. | 2022-01-26 | 162 | 0 |
| K210143 | Standard Surgical Gown (AAMI Level 3), Reinforced Surgical G | Foshan Nanhai Plus Medical Co, Ltd. | 2021-07-22 | 184 | 0 |
| K133075 | Plus Surgical Gowns (EO Sterilized), PMGB-XXX | Foshan Nanhai Plus Medical Co, Ltd. | 2015-06-24 | 632 | 0 |
| K133080 | Plus Surgical Drapes (EO Sterilized), PMDB-XXX | Foshan Nanhai Plus Medical Co, Ltd. | 2015-06-24 | 632 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda