The following data is part of a premarket notification filed by Hartalega Sdn Bhd with the FDA for Chlorinated Powder-free Latex Examination Glove With Protein Content Labeling Claim (50 Micrograms Or Less).
| Device ID | K991616 |
| 510k Number | K991616 |
| Device Name: | CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) |
| 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 | 1999-05-10 |
| Decision Date | 1999-07-14 |