Shanghai PT Plastics Enterprise Company, Ltd.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Shanghai PT Plastics Enterprise Company, Ltd.” (first 1996, latest 2002), across 1 product code in 1 review panel. Median 510(k) review time under this name: 34 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 | 6 | 6 |
Review panels
- General Hospital (6)
Most recent Shanghai PT Plastics Enterprise Company, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K022087 | DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA, GREEN COLOR | LYZ | 2002-07-11 | 14 |
| K002870 | DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR | LYZ | 2000-10-16 | 33 |
| K001611 | DISPOSABLE PVC SYNTHETIC EXAMINATION GLOVES, POWDER FREE | LYZ | 2000-06-30 | 36 |
| K001601 | DISPOSABLE PVC POWDERED SYNTHETIC EXAM GLOVES | LYZ | 2000-06-23 | 30 |
| K961521 | PATIENT EXAMINATION GLOVE | LYZ | 1997-01-30 | 283 |
| K963751 | PT SYNTHETIC MEDICAL GLOVES, POWDER FREE | LYZ | 1996-10-29 | 41 |
Recalls
openFDA lists no recalls under a recalling firm named Shanghai PT Plastics Enterprise Company, 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.
- Shanghai United Imaging Healthcare Co., Ltd. (85 510(k)s)
- Shanghai AnQing Medical Instrument Co., Ltd. (14 510(k)s)
- Shanghai Antares Industries, Inc. (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 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 PT Plastics Enterprise Company, Ltd.?
FDA lists 6 510(k) clearances under the applicant name “Shanghai PT Plastics Enterprise Company, Ltd.” (first 1996, latest 2002), 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 PT Plastics Enterprise Company, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Shanghai PT Plastics Enterprise Company, Ltd. is 34 days.
Which FDA product codes appear under Shanghai PT Plastics Enterprise Company, Ltd.?
The most frequent FDA product codes under this applicant name are LYZ (Vinyl Patient Examination Glove, 6).
Next steps
- See all 6 Shanghai PT Plastics Enterprise Company, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code LYZ, Shanghai PT Plastics Enterprise Company, 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.