The following data is part of a premarket notification filed by Megine Industries Sdn Bhd with the FDA for Amadex - Nitrile Powder Free Examination Gloves Non-sterile (blue, Black, Orange).
Device ID | K211310 |
510k Number | K211310 |
Device Name: | AMADEX - 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 | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2021-04-30 |
Decision Date | 2021-06-16 |