Multisafe Sdn. Bhd.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Multisafe Sdn. Bhd.” (first 2000, latest 2018), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 92 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 | 1 | 808 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Multisafe Sdn. Bhd. took a median 808 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 114 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LYY | Latex Patient Examination Glove | 5 | 5 |
| LZA | Polymer Patient Examination Glove | 3 | 3 |
Review panels
- General Hospital (8)
Most recent Multisafe Sdn. Bhd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K161085 | Nitrile Patient Examination Powder Free Glove, Textured, Black | LZA | 2018-07-05 | 808 |
| K062526 | BLUE POWDERED LATEX EXAMINATION GLOVES, NON-STERILE | LYY | 2007-04-13 | 228 |
| K062527 | BLUE POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE | LYY | 2007-02-20 | 176 |
| K011293 | POWDER FREE POLYMER COATED LATEX MEDICAL EXAMINATION GLOVES, NON-STERILE W/ PROTEIN CONTENT LABELING CLAIM 50 MCG OR LES | LYY | 2001-07-10 | 71 |
| K001619 | MULTISAFE POWDER FREE NITRILE GLOVES, NON STERILE (BLUE) | LZA | 2000-07-26 | 62 |
| K001497 | MULTISAFE-POWDERED NITRILE GLOVES, NON-STERILE (BLUE) | LZA | 2000-07-26 | 72 |
| K000999 | MULTISAFE POWDER-FREE PATIENT LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) | LYY | 2000-05-22 | 55 |
| K993811 | MULTISAFE POWDERED LATEX EXAMINATION GLOVES, NONSTERILE | LYY | 2000-03-02 | 113 |
Recalls
openFDA lists no recalls under a recalling firm named Multisafe 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 Multisafe Sdn. Bhd.?
FDA lists 8 510(k) clearances under the applicant name “Multisafe Sdn. Bhd.” (first 2000, latest 2018), 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 Multisafe Sdn. Bhd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Multisafe Sdn. Bhd. is 92 days.
Which FDA product codes appear under Multisafe Sdn. Bhd.?
The most frequent FDA product codes under this applicant name are LYY (Latex Patient Examination Glove, 5); LZA (Polymer Patient Examination Glove, 3).
Next steps
- See all 8 Multisafe Sdn. Bhd. clearances with predicates and recalls
- Run predicate analysis for product code LYY, Multisafe 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.