Shanghai Antares Industries, Inc.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Shanghai Antares Industries, Inc.” (first 1998, latest 2005), across 1 product code in 1 review panel. Median 510(k) review time under this name: 57 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 |
|---|---|---|---|
| LYZ | Vinyl Patient Examination Glove | 14 | 14 |
Review panels
- General Hospital (14)
Most recent Shanghai Antares Industries, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K052612 | DISPOSABLE POWDER FREE VINYL EXAM GLOVES WITH VITAMIN COMPLEX, NOPAL AND LANOLIN BLUE COLOR | LYZ | 2005-11-22 | 61 |
| K021853 | DISPOSABLE VINYL EXAMINATION GLOVES, YELLOW COLOR, POWDER FREE WITH VITAMIN E | LYZ | 2002-08-01 | 56 |
| K020943 | STERILE DISPOSABLE VINYL EXAM GLOVES, POWDER FREE | LYZ | 2002-06-06 | 73 |
| K012499 | ENVIRON-NP POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVES | LYZ | 2001-10-16 | 74 |
| K012339 | ENVIORN-NP POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVES, YELLOW | LYZ | 2001-10-16 | 84 |
| K003321 | DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES WITH ALOE VERA, GREEN COLOR | LYZ | 2000-11-22 | 29 |
| K000953 | DISPOSABLE POWDERED VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR | LYZ | 2000-04-20 | 27 |
| K000872 | DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR | LYZ | 2000-04-05 | 16 |
| K993049 | DISPOSABLE PVC POWDERED SYNTHETIC EXAMINATION GLOVES | LYZ | 1999-11-19 | 70 |
| K992017 | DISPOSABLE PVC SYNTHETIC EXAMINATION GLOVES, POWDER FREE | LYZ | 1999-08-05 | 51 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Shanghai Antares Industries, 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.
- Shanghai United Imaging Healthcare Co., Ltd. (85 510(k)s)
- Shanghai AnQing Medical Instrument Co., Ltd. (14 510(k)s)
- Shanghai Apolo Medical Technology Co., Ltd. (14 510(k)s)
- Shanghai Palomar Mountain Industries, Inc. (12 510(k)s)
- Shanghai Sanyou Medical Co, Ltd. (9 510(k)s)
- Shanghai Chenguang Medical Technologies Co, Ltd. (8 510(k)s)
- Shanghai Motex Healthcare Co., Ltd. (8 510(k)s)
- Shanghai Poseidon Plastic Products Co., Ltd. (8 510(k)s)
- Shanghai Champion Plastic Products Co., Ltd. (6 510(k)s)
- Shanghai PT Plastics Enterprise Company, Ltd. (6 510(k)s)
- Shanghai SeeGen Photoelectric Technology Co., Ltd. (6 510(k)s)
- Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd (6 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Shanghai Antares Industries, Inc.?
FDA lists 14 510(k) clearances under the applicant name “Shanghai Antares Industries, Inc.” (first 1998, latest 2005), across 1 product code 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 Shanghai Antares Industries, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Shanghai Antares Industries, Inc. is 57 days.
Which FDA product codes appear under Shanghai Antares Industries, Inc.?
The most frequent FDA product codes under this applicant name are LYZ (Vinyl Patient Examination Glove, 14).
Next steps
- See all 14 Shanghai Antares Industries, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LYZ, Shanghai Antares Industries, 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.