The following data is part of a premarket notification filed by Kenpax International Limited with the FDA for Isolation Gown Aami Level 3.
| Device ID | K212504 |
| 510k Number | K212504 |
| Device Name: | Isolation Gown AAMI Level 3 |
| Classification | Gown, Isolation, Surgical |
| Applicant | Kenpax International Limited Flat 5, 5/F, Wing On Plaza, 62 Mody Road Tsim Sha Tsui, Kowloon Hong Kong, CN 999077 |
| Contact | Solomon Chen |
| Correspondent | Joyce Yang Shenzhen Joyantech Consulting Co., Ltd. 1713A, 17th Floor, Block A, Zhongguan Times Square, Nanshan District Shenzhen, CN 518100 |
| Product Code | FYC |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-09 |
| Decision Date | 2021-11-07 |