The following data is part of a premarket notification filed by Hartalega Sdn Bhd with the FDA for Powdered Sterile Latex Surgical Glove, With Protein Content Labeling Claim (200 Micrograms Or Less).
| Device ID | K001959 |
| 510k Number | K001959 |
| Device Name: | POWDERED STERILE LATEX SURGICAL GLOVE, WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) |
| Classification | Surgeon's Gloves |
| Applicant | HARTALEGA SDN BHD 9 JALAN KUANG BULAN TAMAN KEPONG INDUSTRIAL ESTATE Kuala Lumpur, MY 52100 |
| Contact | Nuru Aisyah Kong |
| Correspondent | Nuru Aisyah Kong HARTALEGA SDN BHD 9 JALAN KUANG BULAN TAMAN KEPONG INDUSTRIAL ESTATE Kuala Lumpur, MY 52100 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-06-27 |
| Decision Date | 2000-07-26 |