The following data is part of a premarket notification filed by Hartalega Sdn Bhd with the FDA for Polymer Coated Chlorinated Powder-free Latex Examination Gloves.
Device ID | K954221 |
510k Number | K954221 |
Device Name: | POLYMER COATED CHLORINATED 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 | Eu Jin Kuan |
Correspondent | Eu Jin Kuan 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 | 1995-09-11 |
Decision Date | 1996-05-03 |