The following data is part of a premarket notification filed by At Glove Engineering Sdn. Bhd with the FDA for At.
| Device ID | K212645 |
| 510k Number | K212645 |
| Device Name: | AT |
| Classification | Polymer Patient Examination Glove |
| Applicant | AT Glove Engineering SDN. BHD No. 9, Jalan Chepor 11/7 Kawasan Perusahaan Seramik Chepor, MY 31200 |
| Contact | L. A. Choong |
| 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 | 2021-08-20 |
| Decision Date | 2021-12-16 |