Biopro (M) Sdn Bhd: FDA clearances and approvals
Biopro (M) Sdn Bhd has 5 FDA 510(k) clearances (first 1998, latest 2000), across 2 product codes in 1 review panel. Median 510(k) review time: 70 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 |
|---|---|---|---|
| LZA | Polymer Patient Examination Glove | 3 | 3 |
| LYY | Latex Patient Examination Glove | 2 | 2 |
Review panels
- General Hospital (5)
Most recent Biopro (M) Sdn Bhd 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K994281 | BIOPRO, NITRILE, CORRECT TOUCH NITRILE POWDER FREE EXAMINATION GLOVES (GRREN, PURPLE) | LZA | 2000-10-20 | 305 |
| K994276 | BIOPRO, NITRILON, CORRECT TOUCH- NITRILE POWDERED EXAMINATION GLOVES (GREEN/ PURPLE) | LZA | 2000-10-20 | 305 |
| K994043 | CORRECT TOUCH LATEX POWDERED EXAMINATION GLOVES | LYY | 2000-01-11 | 43 |
| K992358 | CORRECT TOUCH POWDER FREE 911 LATEX EXAMINATION GLOVES, (BLUE) | LYY | 1999-09-10 | 58 |
| K981333 | NITRILON CORRECT-TOUCH | LZA | 1998-06-22 | 70 |
Recalls
openFDA lists no recalls under a recalling firm named Biopro (M) 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 Biopro (M) Sdn Bhd have?
Biopro (M) Sdn Bhd has 5 FDA 510(k) clearances (first 1998, latest 2000), across 2 product codes in 1 review panel.
How long does FDA take to clear Biopro (M) Sdn Bhd's 510(k)s?
The median time from FDA receipt to decision across Biopro (M) Sdn Bhd's cleared 510(k)s is 70 days.
What devices does Biopro (M) Sdn Bhd make?
Its most frequent FDA product codes are LZA (Polymer Patient Examination Glove, 3); LYY (Latex Patient Examination Glove, 2).
Has Biopro (M) Sdn Bhd had device recalls?
openFDA lists no recalls under a recalling firm name matching Biopro (M) Sdn Bhd. Related entities may recall under other names.
Next steps
- See all 5 Biopro (M) Sdn Bhd clearances with predicates and recalls
- Run predicate analysis for product code LZA, Biopro (M) 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.