Purna Bina Sdn Bhd: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Purna Bina Sdn Bhd” (first 1989, latest 2014), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 74 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 | 1 | 585 |
| 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 | 6 | 6 |
| KGO | Surgeon'S Gloves | 1 | 1 |
Review panels
- General Hospital (7)
Most recent Purna Bina Sdn Bhd 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K130450 | SURGTEX POWDERED SURGICAL GLOVE, SURGTEX POWDERFREE POLYMER COATED SURGICAL GLOVE | KGO | 2014-09-30 | 585 |
| K083571 | ILLUSION POWDER FREE EXAM GLOVES, NATURAL COLOR WITH VANILLA SCENT, ORANGE COLOR WITH CITRIC SCENT AND PINK COLOR | LYY | 2009-08-13 | 253 |
| K041004 | ILLUSION POWDER FREE-POLYMER COATED COLOR SCENTED NR LATEX EXAMINATION GLOVES (BLUE) | LYY | 2004-07-02 | 74 |
| K022659 | ILLUSION POWDER FREE-PLOYMER COATED COLOR SCENTED NR LATEX EXAMINATION GLOVES (BLUE) | LYY | 2002-09-25 | 47 |
| K003904 | POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES | LYY | 2001-01-24 | 36 |
| K994420 | POWDER FREE LATEX EXAMINATION PATIENT GLOVES | LYY | 2000-09-18 | 264 |
| K891507 | PATIENT EXAMINATION GLOVES (LATEX) | LYY | 1989-04-06 | 21 |
Recalls
openFDA lists no recalls under a recalling firm named Purna Bina Sdn Bhd.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Purna Bina Sdn Bhd?
FDA lists 7 510(k) clearances under the applicant name “Purna Bina Sdn Bhd” (first 1989, latest 2014), across 2 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 Purna Bina Sdn Bhd?
The median time from FDA receipt to decision across 510(k)s cleared under the name Purna Bina Sdn Bhd is 74 days.
Which FDA product codes appear under Purna Bina Sdn Bhd?
The most frequent FDA product codes under this applicant name are LYY (Latex Patient Examination Glove, 6); KGO (Surgeon'S Gloves, 1).
Next steps
- See all 7 Purna Bina Sdn Bhd clearances with predicates and recalls
- Run predicate analysis for product code LYY, Purna Bina Sdn Bhd'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.