The following data is part of a premarket notification filed by Tomarc (m) Sdn Bhd with the FDA for Sterile Hypoallergenic Powder-free Latex Surg. Glv.
| Device ID | K923589 |
| 510k Number | K923589 |
| Device Name: | STERILE HYPOALLERGENIC POWDER-FREE LATEX SURG. GLV |
| Classification | Latex Patient Examination Glove |
| Applicant | TOMARC (M) SDN BHD 5, LORONG HELANG HINDIK, KEPONG BARU INDUSTRIAL ESTATE Kuala Lumpur, MY 52100 |
| Contact | Chuck Jarrell |
| Correspondent | Chuck Jarrell 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 | 1992-07-20 |
| Decision Date | 1993-07-23 |