Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Jiangsu Cureguard Glove Co., Ltd. — Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
72 daysmedian FDA review time
144 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K222937 | Disposable Nitrile Examination Glove | Jiangsu Cureguard Glove Co., Ltd. | 2022-10-01 | 5 | 0 |
| K213121 | Disposable Nitrile Examination Glove | Jiangsu Cureguard Glove Co., Ltd. | 2022-03-15 | 169 | 0 |
| K211354 | Disposable Synthetic Vinyl Nitrile Examination Glove | Jiangsu Cureguard Glove Co., Ltd. | 2021-08-08 | 97 | 0 |
| K211608 | Disposable Nitrile Medical Examination Glove (Tested for Use | Jiangsu Cureguard Glove Co., Ltd. | 2021-08-05 | 72 | 0 |
| K210691 | Disposable Nitrile Medical Examination Glove | Jiangsu Cureguard Glove Co., Ltd. | 2021-07-30 | 144 | 0 |
| K210684 | Disposable Nitrile Medical Examination Glove | Jiangsu Cureguard Glove Co., Ltd. | 2021-07-20 | 134 | 0 |
| K093576 | RUBBER-LIKE POWDER FREE VINYL PATIENT EXAMINATION GLOVES, WH | Jiangsu Cureguard Glove Co., Ltd. | 2010-03-04 | 106 | 0 |
| K081657 | POWDERED VINYL PATIENT EXAMINATION GLOVES, (LIGHT YELLOW) | Jiangsu Cureguard Glove Co., Ltd. | 2008-08-20 | 69 | 0 |
| K081655 | POWDER FREE VINYL PATIENT EXAMINATION GLOVES (LIGHT YELLOW) | Jiangsu Cureguard Glove Co., Ltd. | 2008-07-21 | 39 | 2 |
| K070076 | POWDER FREE VINYL PATINET EXAMINATION GLOVES, CLEAR (NON-COL | Jiangsu Cureguard Glove Co., Ltd. | 2007-02-22 | 45 | 0 |
| K070075 | POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORE | Jiangsu Cureguard Glove Co., Ltd. | 2007-02-09 | 32 | 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