The following data is part of a premarket notification filed by Hartalega Sdn Bhd with the FDA for Polymer Coated Powder-free Latex Examination Gloves.
| Device ID | K954416 |
| 510k Number | K954416 |
| Device Name: | POLYMER COATED POWDER-FREE LATEX EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | HARTALEGA SDN BHD 9 JALAN KUANG BULAN TAMAN KEPONG INDUSTRIAL ESTATE Kuala Lumpur, MY 52100 |
| Contact | Kuan Kam Hon |
| Correspondent | Kuan 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 | 1995-09-21 |
| Decision Date | 1996-10-11 |