Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Better Care Plastic Technology Co., Ltd. · Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
91 daysmedian FDA review time
204 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K242533 | Powder Free Nitrile Patient Examination Gloves, Blue Colored | Better Care Plastic Technology Co., Ltd. | 2025-03-18 | 204 | 0 |
| K232266 | Powder Free Nitrile Patient Examination Gloves, Blue Colored | Better Care Plastic Technology Co., Ltd. | 2023-11-03 | 95 | 0 |
| K232070 | Biodegradable Nitrile Examination Gloves Tested for Use with | Better Care Plastic Technology Co., Ltd. | 2023-10-11 | 91 | 0 |
| K231567 | Biodegradable Nitrile Powder Free Examination Gloves Tested | Better Care Plastic Technology Co., Ltd. | 2023-10-04 | 126 | 0 |
| K223713 | Powder Free Nitrile Examination Glove (Grey) Tested for Use | Better Care Plastic Technology Co., Ltd. | 2023-08-07 | 238 | 0 |
| K222449 | Nitrile Powder Free Examination Gloves, Tested For Use With | Better Care Plastic Technology Co., Ltd. | 2022-08-27 | 12 | 0 |
| K221269 | Powder Free Nitrile Examination Gloves (Blue),Tested for Use | Better Care Plastic Technology Co., Ltd. | 2022-07-27 | 86 | 0 |
| K182600 | Powder Free Nitrile Examination Glove, Tested for Use with C | Better Care Plastic Technology Co., Ltd. | 2018-11-30 | 70 | 0 |
| K171898 | Sterile Polyisoprene Powder Free Surgical Gloves, Tested for | Better Care Plastic Technology Co., Ltd. | 2017-08-18 | 53 | 0 |
| K171047 | Sterile Polyisoprene Powder Free Surgical Gloves | Better Care Plastic Technology Co., Ltd. | 2017-06-22 | 76 | 0 |
| K140816 | POWDER FREE NITRILE EXAMINATION GLOVE, TESTED FOR USE WITH C | Better Care Plastic Technology Co., Ltd. | 2014-07-08 | 98 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda