The following data is part of a premarket notification filed by Hartalega Sdn Bhd with the FDA for Patient Examination Gloves (latex).
| Device ID | K892104 |
| 510k Number | K892104 |
| Device Name: | PATIENT EXAMINATION GLOVES (LATEX) |
| Classification | Latex Patient Examination Glove |
| Applicant | HARTALEGA SDN BHD 9 JALAN KUANG BULAN TAMAN KEPONG INDUSTRIAL ESTATE Kuala Lumpur, MY 52100 |
| Contact | Kam Hon |
| Correspondent | Kam Hon HARTALEGA SDN BHD 9 JALAN KUANG BULAN TAMAN KEPONG 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 | 1989-04-03 |
| Decision Date | 1989-05-31 |