The following data is part of a premarket notification filed by Masif Healthcare Products Sdn. Bhd. with the FDA for Masif Powder-free Patient Examination Gloves.
| Device ID | K000377 |
| 510k Number | K000377 |
| Device Name: | MASIF POWDER-FREE PATIENT EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | MASIF HEALTHCARE PRODUCTS SDN. BHD. LADANG PINJI, BAHAGIAN SENGAT, KAMPUNG KEPAYANG IPOH/PERAK, MY 31300 |
| Contact | YEOH SENG GUAN |
| Correspondent | YEOH SENG GUAN MASIF HEALTHCARE PRODUCTS SDN. BHD. LADANG PINJI, BAHAGIAN SENGAT, KAMPUNG KEPAYANG IPOH/PERAK, MY 31300 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-07 |
| Decision Date | 2000-06-09 |