Better Care Plastic Technology Co., Ltd.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Better Care Plastic Technology Co., Ltd.” (first 2014, latest 2025), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 91 days. Since 2017 the median was 88 days, against 116 days for all cleared 510(k)s in the same product codes. 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 |
|---|---|---|
| 2014 | 1 | 98 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 2 | 64 |
| 2018 | 1 | 70 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 2 | 49 |
| 2023 | 4 | 110 |
| 2024 | 0 | — |
| 2025 | 1 | 204 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Better Care Plastic Technology Co., Ltd. took a median 88 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 116 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LZA | Polymer Patient Examination Glove | 8 | 8 |
| KGO | Surgeon'S Gloves | 2 | 2 |
| LZC | Medical Glove, Specialty | 1 | 1 |
Review panels
- General Hospital (11)
Most recent Better Care Plastic Technology Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K242533 | Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | LZA | 2025-03-18 | 204 |
| K232266 | Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | LZA | 2023-11-03 | 95 |
| K232070 | Biodegradable Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black, Green) | LZA | 2023-10-11 | 91 |
| K231567 | Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and select other drugs (Blue) | LZA | 2023-10-04 | 126 |
| K223713 | Powder Free Nitrile Examination Glove (Grey) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | LZA | 2023-08-07 | 238 |
| K222449 | Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue) | LZC | 2022-08-27 | 12 |
| K221269 | Powder Free Nitrile Examination Gloves (Blue),Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | LZA | 2022-07-27 | 86 |
| K182600 | Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue) | LZA | 2018-11-30 | 70 |
| K171898 | Sterile Polyisoprene Powder Free Surgical Gloves, Tested for Use With Chemotherapy Drugs | KGO | 2017-08-18 | 53 |
| K171047 | Sterile Polyisoprene Powder Free Surgical Gloves | KGO | 2017-06-22 | 76 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Better Care Plastic Technology 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.
- Better Water, Inc. (4 510(k)s)
- Better Care Plastic Technology Cp., Ltd. (2 510(k)s)
- Better Diagnostics AI Corp. (2 510(k)s)
- Better Hearing, Inc. (2 510(k)s)
- Better Care S.L. (1 510(k)s)
- Better Health Medical Products Co., Ltd. (1 510(k)s)
- Better Life Medical Technologies, Inc. (1 510(k)s)
- Better Plastic Co., Ltd. (1 510(k)s)
- Better Water, LLC (1 510(k)s)
- Better Therapeutics (0 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Better Care Plastic Technology Co., Ltd.?
FDA lists 11 510(k) clearances under the applicant name “Better Care Plastic Technology Co., Ltd.” (first 2014, latest 2025), 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 Better Care Plastic Technology Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Better Care Plastic Technology Co., Ltd. is 91 days. Since 2017: 88 days, versus 116 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Better Care Plastic Technology Co., Ltd.?
The most frequent FDA product codes under this applicant name are LZA (Polymer Patient Examination Glove, 8); KGO (Surgeon'S Gloves, 2); LZC (Medical Glove, Specialty, 1).
Next steps
- See all 11 Better Care Plastic Technology Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code LZA, Better Care Plastic Technology 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.