The following data is part of a premarket notification filed by Hartalega Sdn Bhd with the FDA for Nitrile Powder Free Examination Glove With Low Dermatitis Potential Claim (blue).
Device ID | K150593 |
510k Number | K150593 |
Device Name: | Nitrile Powder Free Examination Glove With Low Dermatitis Potential Claim (Blue) |
Classification | Polymer Patient Examination Glove |
Applicant | HARTALEGA SDN BHD C-G-1 JALAN DATARAN SD1 DATARAN SD PJU 9 Bandar Sri Damansara, MY 52200 |
Contact | Kuan Kam Hon |
Correspondent | Nurul Aisyah Kong HARTALEGA SDN BHD NO. 7, KAWASAN PERUSAHAAN SURIA Bestari Jaya, Selangor, MY 45600 |
Product Code | LZA |
CFR Regulation Number | 880.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-03-09 |
Decision Date | 2015-06-09 |