Multisafe Sdn Bhd
BIDOR Perak, MY
MULTISAFE SDN BHD appears in FDA device records in BIDOR Perak, MY. FDA records list 8 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 8 510(k) clearances for Multisafe Sdn Bhd between 2000 and 2018. The busiest year on record is 2000, with 4. The most recent is 2018, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2000 | 4 |
| 2001 | 1 |
| 2007 | 2 |
| 2018 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K161085 | Nitrile Patient Examination Powder Free Glove, Textured, Black | LZA | Substantially Equivalent | |
| K062526 | BLUE POWDERED LATEX EXAMINATION GLOVES, NON-STERILE | LYY | Substantially Equivalent | |
| K062527 | BLUE POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE | LYY | Substantially Equivalent | |
| K011293 | POWDER FREE POLYMER COATED LATEX MEDICAL EXAMINATION GLOVES, NON-STERILE W/ PROTEIN CONTENT LABELING CLAIM 50 MCG OR LES | LYY | Substantially Equivalent | |
| K001619 | MULTISAFE POWDER FREE NITRILE GLOVES, NON STERILE (BLUE) | LZA | Substantially Equivalent | |
| K001497 | MULTISAFE-POWDERED NITRILE GLOVES, NON-STERILE (BLUE) | LZA | Substantially Equivalent | |
| K000999 | MULTISAFE POWDER-FREE PATIENT LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) | LYY | Substantially Equivalent | |
| K993811 | MULTISAFE POWDERED LATEX EXAMINATION GLOVES, NONSTERILE | LYY | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9615095 | 3004360380 | MULTISAFE SDN BHD | LOT 764, BIDOR Perak 35500 MY | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain