The following data is part of a premarket notification filed by Glovmaster Sdn. Bhd. with the FDA for Glovmaster Nitrile Examination Glove Powder Free.
Device ID | K212914 |
510k Number | K212914 |
Device Name: | Glovmaster Nitrile Examination Glove Powder Free |
Classification | Polymer Patient Examination Glove |
Applicant | Glovmaster SDN. BHD. 154, Jalan 4, Kawasan Perindustrian Olak Lempit Banting, MY 42700 |
Contact | Zarina Binti Hamid |
Correspondent | Manoj Zacharias Liberty Management Group Limited 75 Executive Drive Suite 114 Aurora, IL 60504 |
Product Code | LZA |
CFR Regulation Number | 880.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-09-13 |
Decision Date | 2021-12-22 |