Siam Sempermed Corp., Ltd.: FDA filings under this applicant name
FDA lists 37 510(k) clearances under the applicant name “Siam Sempermed Corp., Ltd.” (first 1989, latest 2015), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 78 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 | 2 | 126 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 1 | 142 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LYY | Latex Patient Examination Glove | 19 | 19 |
| LZA | Polymer Patient Examination Glove | 17 | 17 |
| OPE | 1 | 1 |
Review panels
- General Hospital (36)
Most recent Siam Sempermed Corp., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K142685 | NITRILE EXAMINATION GLOVES WITH ALOE & VITAMIN E, POWDER- FREE | LZA | 2015-02-11 | 142 |
| K121549 | NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE | LZA | 2012-12-27 | 216 |
| K122363 | NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, BLUE | LZA | 2012-09-10 | 35 |
| K100907 | NON-STERILE, POWDER FREE LATEX EXAMINATION GLOVES AND PROTEIN CLAIM (50 MICROGRAMS OR LESS) MODEL: WHITE: X-SMALL, SMALL | LYY | 2010-07-09 | 99 |
| K082957 | NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE COLOR, POLYMER COATED, TESTED WITH CHEMOTHERAPY DRUGS | LZA | 2009-05-29 | 238 |
| K083755 | NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, LAVENDER BLUE COLOR, POLYMER COATED, TEXTED WITH CHEMOTHERAPY DRUGS | LZA | 2009-03-05 | 78 |
| K081911 | NON-STERILE, POWDERED NITRILE EXAMINATION GLOVE, BLUE | LZA | 2009-01-15 | 196 |
| K081910 | NON-STERILE, POWDERED LATEX EXAMINATION GLOVE | LYY | 2008-09-17 | 76 |
| K081907 | NON-STERILE, POWDER FREE LATEX EXAMINATION GLOVES WITH POLYMER COATING AND PROTEIN CLAIM (50 MICROGRAMS OR LESS) | LYY | 2008-09-03 | 62 |
| K080520 | NON STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE, POLYMER COATING WITH CHEMOTHERAPY CLAIM | LZA | 2008-04-30 | 65 |
27 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Siam Sempermed Corp., 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.
- Siam Ntd Corporation Co., Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Siam Sempermed Corp., Ltd.?
FDA lists 37 510(k) clearances under the applicant name “Siam Sempermed Corp., Ltd.” (first 1989, latest 2015), across 3 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 Siam Sempermed Corp., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Siam Sempermed Corp., Ltd. is 78 days.
Which FDA product codes appear under Siam Sempermed Corp., Ltd.?
The most frequent FDA product codes under this applicant name are LYY (Latex Patient Examination Glove, 19); LZA (Polymer Patient Examination Glove, 17); OPE (device, 1).
Next steps
- See all 37 Siam Sempermed Corp., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code LYY, Siam Sempermed Corp., 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.