Data / Medical devices / Malaysia / Multisafe Sdn Bhd
Multisafe Sdn Bhd: FDA-registered device maker in BIDOR Perak, Malaysia, 8 510(k) clearances
Multisafe Sdn Bhd is registered with the FDA (registration 9615095) in BIDOR Perak, Malaysia. It lists 2 device types. The FDA files 8 510(k) clearances under its listings, the newest dated July 5, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9615095
- FEI number
- 3004360380
- Address
- Lot 764 Bidor Industrial Estate, BIDOR Perak, Malaysia, 35500
- Owner or operator
- MULTISAFE SDN BHD (9039578)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- January 25, 2008
- Registered through
- 2026
- Brand names listed
- CARBON, CRANBERRY, MULTIPLE, MULTISAFE, VARIOUS
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Latex Patient Examination Glove | LYY | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 5, 2018 | K161085 | Nitrile Patient Examination Powder Free Glove, Textured, Black | LZA | Substantially Equivalent | Multisafe Sdn. Bhd. | accessdata.fda.gov |
| April 13, 2007 | K062526 | BLUE POWDERED LATEX EXAMINATION GLOVES, NON-STERILE | LYY | Substantially Equivalent | Multisafe Sdn. Bhd. | accessdata.fda.gov |
| February 20, 2007 | K062527 | BLUE POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE | LYY | Substantially Equivalent | Multisafe Sdn. Bhd. | accessdata.fda.gov |
| July 10, 2001 | K011293 | POWDER FREE POLYMER COATED LATEX MEDICAL EXAMINATION GLOVES, NON-STERILE W/ PROTEIN CONTENT LABELING CLAIM 50 MCG OR LES | LYY | Substantially Equivalent | Multisafe Sdn. Bhd. | accessdata.fda.gov |
| July 26, 2000 | K001619 | MULTISAFE POWDER FREE NITRILE GLOVES, NON STERILE (BLUE) | LZA | Substantially Equivalent | Multisafe Sdn. Bhd. | accessdata.fda.gov |
| July 26, 2000 | K001497 | MULTISAFE-POWDERED NITRILE GLOVES, NON-STERILE (BLUE) | LZA | Substantially Equivalent | Multisafe Sdn. Bhd. | accessdata.fda.gov |
| May 22, 2000 | K000999 | MULTISAFE POWDER-FREE PATIENT LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) | LYY | Substantially Equivalent | Multisafe Sdn. Bhd. | accessdata.fda.gov |
| March 2, 2000 | K993811 | MULTISAFE POWDERED LATEX EXAMINATION GLOVES, NONSTERILE | LYY | Substantially Equivalent | Multisafe Sdn. Bhd. | accessdata.fda.gov |
Compare with other makers
Updated July 5, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.