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 |