The following data is part of a premarket notification filed by Aok Tooling Limited with the FDA for Aok 95a Medical Mask (20200049).
| Device ID | K220876 |
| 510k Number | K220876 |
| Device Name: | AOK 95A Medical Mask (20200049) |
| Classification | Mask, Surgical |
| Applicant | AOK Tooling Limited Flat 2009, 20/F, Kowloon Plaza, No.485, Castle Peak Road Cheung Sha Wan, Kowloon, CN 518122 |
| Contact | Francis Nithyananthan |
| Correspondent | Paul Dryden AOK Tooling Limited C/o ProMedic, LLC 131 Bay Point Dr. NE St. Petersburg, FL 33704 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-25 |
| Decision Date | 2022-07-27 |