The following data is part of a premarket notification filed by Multisafe Sdn Bhd with the FDA for Multisafe Powdered Latex Examination Gloves, Nonsterile.
| Device ID | K993811 |
| 510k Number | K993811 |
| Device Name: | MULTISAFE POWDERED LATEX EXAMINATION GLOVES, NONSTERILE |
| Classification | Latex Patient Examination Glove |
| Applicant | MULTISAFE SDN BHD LOT 764 BIDOR INDUSTRIAL ESTATE 35500 Bidor, Perak, MY 35500 |
| Contact | Goh Seok Huei |
| Correspondent | Goh Seok Huei MULTISAFE SDN BHD LOT 764 BIDOR INDUSTRIAL ESTATE 35500 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 | 1999-11-10 |
| Decision Date | 2000-03-02 |