The following data is part of a premarket notification filed by Tomarc (m) Sdn Bhd with the FDA for Latex Decontamination/procedure Gloves (non-ster).
| Device ID | K890440 |
| 510k Number | K890440 |
| Device Name: | LATEX DECONTAMINATION/PROCEDURE GLOVES (NON-STER) |
| Classification | Latex Patient Examination Glove |
| Applicant | TOMARC (M) SDN BHD 5, LORONG HELANG HINDIK, KEPONG BARU INDUSTRIAL ESTATE Kuala Lumpur, MY 52100 |
| Contact | Ss Foo |
| Correspondent | Ss Foo TOMARC (M) SDN BHD 5, LORONG HELANG HINDIK, KEPONG BARU INDUSTRIAL ESTATE Kuala Lumpur, MY 52100 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-01-27 |
| Decision Date | 1989-05-12 |