The following data is part of a premarket notification filed by Multisafe Sdn Bhd with the FDA for Blue Powder Free Latex Examination Gloves, Non-sterile.
| Device ID | K062527 |
| 510k Number | K062527 |
| Device Name: | BLUE POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE |
| Classification | Latex 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 | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-28 |
| Decision Date | 2007-02-20 |
| Summary: | summary |