The following data is part of a premarket notification filed by Crown Name Disposable Hygiene Products Fty.ltd. with the FDA for Disposable Surgical Isolation Gown.
| Device ID | K212422 |
| 510k Number | K212422 |
| Device Name: | Disposable Surgical Isolation Gown |
| Classification | Gown, Isolation, Surgical |
| Applicant | Crown Name Disposable Hygiene Products Fty.Ltd. Chengbei Industrial Zone,Zhucheng Ave,Xinzhou District Wuhan, CN 431400 |
| Contact | Ying Fang |
| Correspondent | Doris Chen Shanghai Jiushun Enterprise Management Technology Service Co Room 1502,BaoAn Buiding,No.800 Dongfang Road Shanghai, CN 200122 |
| Product Code | FYC |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-04 |
| Decision Date | 2022-04-29 |