Jiangsu Cureguard Glove Co., Ltd.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Jiangsu Cureguard Glove Co., Ltd.” (first 2007, latest 2022), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 72 days. Since 2017 the median was 116 days, against 109 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 4 | 116 |
| 2022 | 2 | 87 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Jiangsu Cureguard Glove Co., Ltd. took a median 116 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 109 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LYZ | Vinyl Patient Examination Glove | 6 | 6 |
| LZA | Polymer Patient Examination Glove | 5 | 5 |
Review panels
- General Hospital (11)
Most recent Jiangsu Cureguard Glove Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K222937 | Disposable Nitrile Examination Glove | LZA | 2022-10-01 | 5 |
| K213121 | Disposable Nitrile Examination Glove | LZA | 2022-03-15 | 169 |
| K211354 | Disposable Synthetic Vinyl Nitrile Examination Glove | LYZ | 2021-08-08 | 97 |
| K211608 | Disposable Nitrile Medical Examination Glove (Tested for Use with Chemotherapy Drugs) | LZA | 2021-08-05 | 72 |
| K210691 | Disposable Nitrile Medical Examination Glove | LZA | 2021-07-30 | 144 |
| K210684 | Disposable Nitrile Medical Examination Glove | LZA | 2021-07-20 | 134 |
| K093576 | RUBBER-LIKE POWDER FREE VINYL PATIENT EXAMINATION GLOVES, WHITE COLOR | LYZ | 2010-03-04 | 106 |
| K081657 | POWDERED VINYL PATIENT EXAMINATION GLOVES, (LIGHT YELLOW) | LYZ | 2008-08-20 | 69 |
| K081655 | POWDER FREE VINYL PATIENT EXAMINATION GLOVES (LIGHT YELLOW) | LYZ | 2008-07-21 | 39 |
| K070076 | POWDER FREE VINYL PATINET EXAMINATION GLOVES, CLEAR (NON-COLORED) | LYZ | 2007-02-22 | 45 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Jiangsu Cureguard Glove Co., Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Jiangsu Caina Medical Co.,Ltd (15 510(k)s)
- Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. (15 510(k)s)
- Jiangsu Vedkang Medical Science and Technology Co., Ltd. (7 510(k)s)
- Jiangsu Jumao X-Care Medical Equipment Co., Ltd. (5 510(k)s)
- Jiangsu Kangbao Medical Equipment Co., Ltd. (5 510(k)s)
- Jiangsu Micsafe Medical Technology Co., Ltd. (5 510(k)s)
- Jiangsu Intco Medical Equipment & Supply Co., Ltd. (4 510(k)s)
- Jiangsu Sunshine Plastic Products, Co., Ltd. (4 510(k)s)
- Jiangsu Intco Medical Products Co., Ltd. (3 510(k)s)
- Jiangsu Jaysun Glove Co., Ltd. (3 510(k)s)
- Jiangsu Shenli Medical Production Co., Ltd. (3 510(k)s)
- Jiangsu Alfa Glove Co., Ltd. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Jiangsu Cureguard Glove Co., Ltd.?
FDA lists 11 510(k) clearances under the applicant name “Jiangsu Cureguard Glove Co., Ltd.” (first 2007, latest 2022), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Jiangsu Cureguard Glove Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Jiangsu Cureguard Glove Co., Ltd. is 72 days. Since 2017: 116 days, versus 109 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Jiangsu Cureguard Glove Co., Ltd.?
The most frequent FDA product codes under this applicant name are LYZ (Vinyl Patient Examination Glove, 6); LZA (Polymer Patient Examination Glove, 5).
Next steps
- See all 11 Jiangsu Cureguard Glove Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code LYZ, Jiangsu Cureguard Glove Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.