The following data is part of a premarket notification filed by Multisafe Sdn Bhd with the FDA for Multisafe-powdered Nitrile Gloves, Non-sterile (blue).
| Device ID | K001497 |
| 510k Number | K001497 |
| Device Name: | MULTISAFE-POWDERED NITRILE GLOVES, NON-STERILE (BLUE) |
| Classification | Polymer Patient Examination Glove |
| Applicant | MULTISAFE SDN BHD LOT 764 BIDOR INDUSTRIAL ESTATE Bidor, Perak, MY 35500 |
| Contact | Abd. Hadi Bin Husin |
| Correspondent | Abd. Hadi Bin Husin MULTISAFE SDN BHD LOT 764 BIDOR INDUSTRIAL ESTATE Bidor, Perak, MY 35500 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-15 |
| Decision Date | 2000-07-26 |