The following data is part of a premarket notification filed by Hartalega Sdn Bhd with the FDA for Patient Examination Gloves : Nitrile Examination Gloves.
| Device ID | K963804 |
| 510k Number | K963804 |
| Device Name: | PATIENT EXAMINATION GLOVES : NITRILE EXAMINATION GLOVES |
| Classification | Polymer Patient Examination Glove |
| Applicant | HARTALEGA SDN BHD 9 JALAN KUANG BULAN TAMAN KEPONG INDUSTRIAL ESTATE Kuala Lumpur, MY 52100 |
| Contact | K.h. Kuan |
| Correspondent | K.h. Kuan HARTALEGA SDN BHD 9 JALAN KUANG BULAN TAMAN KEPONG INDUSTRIAL ESTATE Kuala Lumpur, MY 52100 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-23 |
| Decision Date | 1997-02-10 |