The following data is part of a premarket notification filed by Hartalega Sdn Bhd with the FDA for Powder-free Latex Examination Gloves With Protein Labeling Claim (green).
Device ID | K980572 |
510k Number | K980572 |
Device Name: | POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (GREEN) |
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 | 1998-02-17 |
Decision Date | 1998-03-13 |