Sgmp Co., Ltd.: FDA filings under this applicant name
FDA lists 31 510(k) clearances under the applicant name “Sgmp Co., Ltd.” (first 2000, latest 2012), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 35 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 | 1 | 363 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 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 | 25 | 25 |
| LZA | Polymer Patient Examination Glove | 5 | 5 |
| LZC | Medical Glove, Specialty | 1 | 1 |
Review panels
- General Hospital (31)
Most recent Sgmp Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K112693 | NON-STERILE, POWER FREE YELLOW LATEX EXAMINATION GLOVES | LYY | 2012-09-12 | 363 |
| K101822 | NON-STERILE POWDER-FREE BLUE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS | LZC | 2010-11-19 | 142 |
| K101646 | NON-STERILE, POWDER FREE BLACK NITRILE EXAMINATION GLOVES WITH CHERRY FLAVOR | LZA | 2010-09-08 | 89 |
| K072403 | NON-STERILE, POWDERED, PINK LATEX EXAMINATION GLOVES WITH CHERRY FLAVOUR AND PROTEIN LABELING CLAIMS (200 UG OR LESS) | LYY | 2008-03-27 | 213 |
| K072400 | NON-STERILE, POWDER-FREE, BLACK NITRILE EXAMINATION GLOVES | LZA | 2008-03-27 | 213 |
| K072406 | NON-STERILE, POWDER FREE, PINK LATEX EXAMINATION GLOVES WITH CHERRY FLAVOUR AND PROTEIN LABELING CLAIMS (50 UG OR LESS) | LYY | 2008-03-21 | 207 |
| K071060 | NON-STERILE, LATEX POWDER FREE PATIENT EXAMINATION GLOVES (MULTICOLORED WITH XYLITOL AND CALCIUM CARBONATE) | LYY | 2007-07-26 | 101 |
| K052016 | NON-STERILE POWDER FREE MULTICOLOR - RED, BLUE, PURPLE AND YELLOW LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING | LYY | 2005-09-01 | 37 |
| K042879 | NON-STERILE POWDER-FREE BLUE NITRILE EXAMINATION GLOVES, WITH VANILLA SCENTING | LZA | 2005-01-13 | 87 |
| K023537 | NON-STERILE POWDER FREE GREEN LATEX PATIENT EXAM GLOVES WITH SURFACE COATING & PROTEIN LABELING CLAIM (<50UG/DM2) | LYY | 2003-11-20 | 395 |
21 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Sgmp 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Sgmp Co., Ltd.?
FDA lists 31 510(k) clearances under the applicant name “Sgmp Co., Ltd.” (first 2000, latest 2012), 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 Sgmp Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sgmp Co., Ltd. is 35 days.
Which FDA product codes appear under Sgmp Co., Ltd.?
The most frequent FDA product codes under this applicant name are LYY (Latex Patient Examination Glove, 25); LZA (Polymer Patient Examination Glove, 5); LZC (Medical Glove, Specialty, 1).
Next steps
- See all 31 Sgmp Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code LYY, Sgmp 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 (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.