The following data is part of a premarket notification filed by Megine Industries Sdn Bhd with the FDA for Nitrile Powder Free Examination Gloves, Non-sterile - Blue, Black, Orange.
| Device ID | K220232 |
| 510k Number | K220232 |
| Device Name: | Nitrile Powder Free Examination Gloves, Non-Sterile - Blue, Black, Orange |
| Classification | Polymer Patient Examination Glove |
| Applicant | Megine Industries Sdn Bhd B-05-02, The Vertical Business Suites, 8, Jalan Kerinchi, Bangsar South Kuala Lumpur, MY 59200 |
| Contact | Benjamin Ng Soong Jing |
| Correspondent | Prithul Bom REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2022-01-27 |
| Decision Date | 2022-02-20 |