Sinochem (Usa), Inc.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Sinochem (Usa), Inc.” (first 1989, latest 1990), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 100 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 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LYY | Latex Patient Examination Glove | 13 | 13 |
| KGO | Surgeon'S Gloves | 1 | 1 |
Review panels
- General Hospital (14)
Most recent Sinochem (Usa), Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K900980 | LATEX EXAMINATION GLOVES | LYY | 1990-06-01 | 91 |
| K901398 | LATEX SURGEON GLOVES | KGO | 1990-05-16 | 51 |
| K900352 | LATEX EXAM GLOVES (SHANGHAI RONGTONG LATEX GLOVES) | LYY | 1990-03-27 | 63 |
| K893882 | LATEX EXAMINATION GLOVES | LYY | 1989-09-21 | 118 |
| K893694 | LATEX EXAM GLOVES(MFG: SHANG HAI RONGTONG LATEX) | LYY | 1989-08-10 | 86 |
| K892159 | PATIENT EXAM GLOVES (MFG CHAOYANG SYNTHETIC FIBRE) | LYY | 1989-07-14 | 100 |
| K892158 | PATIENT EXAM GLOVES (MFG. SUZHOU LATEX FACTORY) | LYY | 1989-07-14 | 100 |
| K892157 | PATIENT EXAM GLOVES (MFG. RONGCHENG LATEX PRODUCT) | LYY | 1989-07-14 | 100 |
| K892156 | PATIENT EXAM GLOVES (MFG. NO. 1 FACTORY, WUHAN) | LYY | 1989-07-14 | 100 |
| K892155 | PATIENT EXAM GLOVES (MFG. HUBEI TIANMEN LATEX) | LYY | 1989-07-14 | 100 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Sinochem (Usa), Inc..
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.
- Sinochem Ningbo Imp & Exp Corp. (1 510(k)s)
- Sinochem Ningbo Latex Gloves Factory (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Sinochem (Usa), Inc.?
FDA lists 14 510(k) clearances under the applicant name “Sinochem (Usa), Inc.” (first 1989, latest 1990), 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 Sinochem (Usa), Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sinochem (Usa), Inc. is 100 days.
Which FDA product codes appear under Sinochem (Usa), Inc.?
The most frequent FDA product codes under this applicant name are LYY (Latex Patient Examination Glove, 13); KGO (Surgeon'S Gloves, 1).
Next steps
- See all 14 Sinochem (Usa), Inc. clearances with predicates and recalls
- Run predicate analysis for product code LYY, Sinochem (Usa), Inc.'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.