Mulpha Intl. Trading Corp. Bhd.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Mulpha Intl. Trading Corp. Bhd.” (first 1989, latest 1989), across 1 product code in 1 review panel. Median 510(k) review time under this name: 148 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 | 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 | 6 | 6 |
Review panels
- General Hospital (6)
Most recent Mulpha Intl. Trading Corp. Bhd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K891817 | PATIENT EXAM GLOVES (MFG. TERANG NUSA) | LYY | 1989-08-18 | 148 |
| K891816 | PATIENT EXAM GLOVES (MFG. HEALTHCARE GLOVES) | LYY | 1989-08-18 | 148 |
| K891813 | PATIENT EXAM GLOVES (MFG. AEK RUBBER PRODUCTS) | LYY | 1989-08-18 | 148 |
| K891812 | PATIENT EXAM GLOVES (MFG. GETAH GAYAL) | LYY | 1989-08-18 | 148 |
| K891811 | PATIENT EXAM GLOVES (MFG. PALMBASE RUBBER MFG.) | LYY | 1989-08-18 | 148 |
| K891815 | PATIENT EXAM GLOVES (MFG. M.R. RUBBER INDUSTRIES) | LYY | 1989-08-15 | 145 |
Recalls
openFDA lists no recalls under a recalling firm named Mulpha Intl. Trading Corp. 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 Mulpha Intl. Trading Corp. Bhd.?
FDA lists 6 510(k) clearances under the applicant name “Mulpha Intl. Trading Corp. Bhd.” (first 1989, latest 1989), across 1 product code 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 Mulpha Intl. Trading Corp. Bhd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Mulpha Intl. Trading Corp. Bhd. is 148 days.
Which FDA product codes appear under Mulpha Intl. Trading Corp. Bhd.?
The most frequent FDA product codes under this applicant name are LYY (Latex Patient Examination Glove, 6).
Next steps
- See all 6 Mulpha Intl. Trading Corp. Bhd. clearances with predicates and recalls
- Run predicate analysis for product code LYY, Mulpha Intl. Trading Corp. 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.