Qingdao Bestex Rubber & Plastic Products Co., Ltd.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Qingdao Bestex Rubber & Plastic Products Co., Ltd.” (first 2000, latest 2022), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 70 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 | 1 | 86 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Qingdao Bestex Rubber & Plastic Products Co., Ltd. took a median 86 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 123 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LYY | Latex Patient Examination Glove | 4 | 4 |
| FXX | Mask, Surgical | 1 | 1 |
| LZA | Polymer Patient Examination Glove | 1 | 1 |
Review panels
- General Hospital (6)
Most recent Qingdao Bestex Rubber & Plastic Products Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K220597 | Disposable Surgical Face Mask (FM-34EE,FM-44EE) | FXX | 2022-05-26 | 86 |
| K042645 | POWDER FREE LATEX EXAMINATION GLOVES WITH ALOE VERA, NATURAL WATER, SOLUBLE VITAMIN E AND VITAMIN C AND PROTEIN LABELING | LYY | 2004-11-26 | 60 |
| K031157 | POWDER-FREE NITRILE EXAMINATION GLOVE (BLUE) WITH NATURAL WATER SOLUBLE VITAMIN E AND ALOE VERA, PEPPERMINT SCENTED | LZA | 2003-08-15 | 126 |
| K022566 | POWDER-FREE LATEX EXAMINATION GLOVE (GREEN) WITH NATURAL WATER SOLUBLE VITAMIN E AND PROTEIN CONTENT LABELING (50 MICRO | LYY | 2002-10-15 | 74 |
| K012709 | POWDER-FREE LATEX EXAMINATION GLOVES WITH ALOE VERA AND PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (GREEN) | LYY | 2001-10-01 | 48 |
| K002087 | BESTEX POWDER-FREE LATEX EXAM GLOVES WITH LABELING CLAIM. (50 MICROGRAMS OR LESS) | LYY | 2000-09-13 | 65 |
Recalls
openFDA lists no recalls under a recalling firm named Qingdao Bestex Rubber & Plastic Products 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.
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.
- Qingdao Hisense Medical Equipment Co., Ltd. (9 510(k)s)
- Qingdao Kingon Medical Science and Technology Co., Ltd. (6 510(k)s)
- Qingdao Hightop Biotech Co., Ltd. (3 510(k)s)
- Qingdao Bright Moon Biomedical Materials Co., Ltd. (2 510(k)s)
- Qingdao Future Medical Technology Co., Ltd. (2 510(k)s)
- Qingdao Lang Hui Import & Export Co., Ltd. (2 510(k)s)
- Qingdao Yasee Medical Device Co., Ltd. (2 510(k)s)
- Qingdao Youjia Hygiene Technology Co., Ltd. (2 510(k)s)
- Qingdao Hainuo Biological Engineering Co., Ltd. (1 510(k)s)
- Qingdao Kingston Medical Devices, Ltd. (1 510(k)s)
- Qingdao Likangyuan Medical Device Co., Ltd. (1 510(k)s)
- Qingdao Shuang Die Latex Production Co.,Ltd (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Qingdao Bestex Rubber & Plastic Products Co., Ltd.?
FDA lists 6 510(k) clearances under the applicant name “Qingdao Bestex Rubber & Plastic Products Co., Ltd.” (first 2000, latest 2022), 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 Qingdao Bestex Rubber & Plastic Products Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Qingdao Bestex Rubber & Plastic Products Co., Ltd. is 70 days.
Which FDA product codes appear under Qingdao Bestex Rubber & Plastic Products Co., Ltd.?
The most frequent FDA product codes under this applicant name are LYY (Latex Patient Examination Glove, 4); FXX (Mask, Surgical, 1); LZA (Polymer Patient Examination Glove, 1).
Next steps
- See all 6 Qingdao Bestex Rubber & Plastic Products Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code LYY, Qingdao Bestex Rubber & Plastic Products 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, 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.