Syntex Healthcare Products Co., Ltd.: FDA filings under this applicant name
FDA lists 17 510(k) clearances under the applicant name “Syntex Healthcare Products Co., Ltd.” (first 2002, latest 2024), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 67 days. 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 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 95 |
| 2024 | 1 | 82 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Syntex Healthcare Products Co., Ltd. took a median 88 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 114 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LZA | Polymer Patient Examination Glove | 11 | 11 |
| LYY | Latex Patient Examination Glove | 6 | 6 |
Review panels
- General Hospital (17)
Most recent Syntex Healthcare Products Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K240080 | Aloe Vera Nitrile Examination Gloves (Green) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | LZA | 2024-04-02 | 82 |
| K231643 | Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) | LZA | 2023-09-08 | 95 |
| K103770 | SAME/VARIOUS DISTRIBUTORS/ WE MAY PRIVATE LABEL | LZA | 2011-04-21 | 115 |
| K102096 | POWDER FREE NITRILE EXAMINATION GLOVES, BLUE | LZA | 2010-10-04 | 69 |
| K052877 | POWDER FREE NITRILE BLUE TEXTURED EXAMINATION GLOVE | LZA | 2005-11-08 | 27 |
| K042226 | SYNTEX POWDER-FREE NITRILE EXAMINATION GLOVE, TESTED FOR CHEMOTHERAPY | LZA | 2004-09-30 | 44 |
| K033777 | ULTRASENSE AF BLUE POWDER-FREE NITRILE EXAMINATION GLOVES | LZA | 2004-02-05 | 63 |
| K023826 | SYNTEX POWDER-FREE LATEX EXAMINATION GLOVE-BLUE COLOR | LYY | 2003-01-24 | 67 |
| K022784 | SYNTEX POWDER-FREE NITRILE EXAMINATION GLOVE, PURPLE COLOR | LZA | 2002-11-13 | 83 |
| K022146 | SYNTEX POWDER-FREE POLYMER-COATED LATEX EXAMINATION GLOVE | LYY | 2002-09-03 | 63 |
7 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Syntex Healthcare Products 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.
- Syntex Corp. (10 510(k)s)
- Syntex Dental Products, Inc. (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Syntex Healthcare Products Co., Ltd.?
FDA lists 17 510(k) clearances under the applicant name “Syntex Healthcare Products Co., Ltd.” (first 2002, latest 2024), 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 Syntex Healthcare Products Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Syntex Healthcare Products Co., Ltd. is 67 days.
Which FDA product codes appear under Syntex Healthcare Products Co., Ltd.?
The most frequent FDA product codes under this applicant name are LZA (Polymer Patient Examination Glove, 11); LYY (Latex Patient Examination Glove, 6).
Next steps
- See all 17 Syntex Healthcare Products Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code LZA, Syntex Healthcare Products 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.