Flexitech Sdn. Bhd.: FDA clearances and approvals
Flexitech Sdn. Bhd. has 6 FDA 510(k) clearances (first 1999, latest 2000), across 2 product codes in 1 review panel. Median 510(k) review time: 44 days.
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 |
|---|---|---|---|
| LYY | Latex Patient Examination Glove | 4 | 4 |
| LZA | Polymer Patient Examination Glove | 2 | 2 |
Review panels
- General Hospital (6)
Most recent Flexitech Sdn. Bhd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K994416 | POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES, BLUE | LYY | 2000-02-03 | 36 |
| K994354 | POLYMER COATED, POWDER FREE, LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) | LYY | 2000-01-31 | 39 |
| K990502 | PREPOWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS) | LYY | 1999-04-02 | 44 |
| K990501 | POWDER FREE LATEX EXAMINATION GLOVES, W/ PROTEIN LABELING CLAIM | LYY | 1999-04-02 | 44 |
| K990499 | PREPOWDERED NITRILE EXAMINATION GLOVES | LZA | 1999-04-02 | 44 |
| K990495 | POWDER FREE NITRILE EXAMINATION GLOVES | LZA | 1999-04-02 | 44 |
Recalls
openFDA lists no recalls under a recalling firm named Flexitech Sdn. Bhd..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Flexitech Sdn. Bhd. have?
Flexitech Sdn. Bhd. has 6 FDA 510(k) clearances (first 1999, latest 2000), across 2 product codes in 1 review panel.
How long does FDA take to clear Flexitech Sdn. Bhd.'s 510(k)s?
The median time from FDA receipt to decision across Flexitech Sdn. Bhd.'s cleared 510(k)s is 44 days.
What devices does Flexitech Sdn. Bhd. make?
Its most frequent FDA product codes are LYY (Latex Patient Examination Glove, 4); LZA (Polymer Patient Examination Glove, 2).
Has Flexitech Sdn. Bhd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Flexitech Sdn. Bhd. Related entities may recall under other names.
Next steps
- See all 6 Flexitech Sdn. Bhd. clearances with predicates and recalls
- Run predicate analysis for product code LYY, Flexitech Sdn. Bhd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.