The following data is part of a premarket notification filed by Medtecs (taiwan) Corp. with the FDA for Coveru Disposable Gown With Tape Aami Level 4 Isolation Gown, Model Number: Il-4036yktp-l4, Coveru Disposable Gown With Tape Aami Level 4 Isolation Gown, Model Number: Il-4063wktp-l4, Coveru Disposable Gown With Tape Chemo Gown, Model Number: Il-4036.
| Device ID | K210414 |
| 510k Number | K210414 |
| Device Name: | CoverU Disposable Gown With Tape AAMI Level 4 Isolation Gown, Model Number: IL-4036YKTP-L4, CoverU Disposable Gown With Tape AAMI Level 4 Isolation Gown, Model Number: IL-4063WKTP-L4, CoverU Disposable Gown With Tape Chemo Gown, Model Number: IL-4036 |
| Classification | Gown, Isolation, Surgical |
| Applicant | Medtecs (Taiwan) Corp. 11F., No. 9, Songgao Road, Xinyi Dist. Taipei City, TW 11073 |
| Contact | William Yang |
| Correspondent | Sandy Liu Jin Services Co. 9F-1, No13, Lane41, Zhangrong Rd, Sec. 5, North District Tainan City, TW 70447 |
| Product Code | FYC |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-11 |
| Decision Date | 2022-10-21 |