The following data is part of a premarket notification filed by Mastervest Corp. Sdn Bhd. with the FDA for Vital Surgical Gloves.
| Device ID | K901359 |
| 510k Number | K901359 |
| Device Name: | VITAL SURGICAL GLOVES |
| Classification | Surgeon's Gloves |
| Applicant | MASTERVEST CORP. SDN BHD. NO 18, 18TH FLOOR, BANGUNAN ARAB MALAYSIAN, 55, JALAN RAJA Chulan 50200 Kuala Lumpur, MY |
| Contact | Nam Hue |
| Correspondent | Nam Hue MASTERVEST CORP. SDN BHD. NO 18, 18TH FLOOR, BANGUNAN ARAB MALAYSIAN, 55, JALAN RAJA Chulan 50200 Kuala Lumpur, MY |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-23 |
| Decision Date | 1990-04-03 |