The following data is part of a premarket notification filed by Tomarc (m) Sdn Bhd with the FDA for Gloves, Patient Examination.
| Device ID | K890344 |
| 510k Number | K890344 |
| Device Name: | GLOVES, PATIENT EXAMINATION |
| Classification | Susceptibility Test Discs, Antimicrobial |
| Applicant | TOMARC (M) SDN BHD 5, LORONG HELANG HINDIK, KEPONG BARU INDUSTRIAL ESTATE Kuala Lumpur, MY 52100 |
| Contact | Foo |
| Correspondent | Foo TOMARC (M) SDN BHD 5, LORONG HELANG HINDIK, KEPONG BARU INDUSTRIAL ESTATE Kuala Lumpur, MY 52100 |
| Product Code | JTN |
| CFR Regulation Number | 866.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-01-23 |
| Decision Date | 1989-04-26 |