The following data is part of a premarket notification filed by Hartalega Sdn Bhd with the FDA for Blue Powder Free Nitrile Examination Gloves.
Device ID | K052583 |
510k Number | K052583 |
Device Name: | BLUE POWDER FREE 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 | Kuan Kam Hon |
Correspondent | Kuan Kam Hon 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 | 2005-09-20 |
Decision Date | 2006-06-14 |