The following data is part of a premarket notification filed by B.j.zh.f.panther Medical Equipment Co., Ltd. with the FDA for Surgical Gown (sterile), Surgical Gown (non-sterile).
| Device ID | K202706 |
| 510k Number | K202706 |
| Device Name: | Surgical Gown (Sterile), Surgical Gown (Non-sterile) |
| Classification | Gown, Surgical |
| Applicant | B.J.ZH.F.Panther Medical Equipment CO., LTD. Floor 3, Building1, 28 Huoju Street, Changping S&T Park, Changping District Beijing, CN 102200 |
| Contact | Wenyue Han |
| Correspondent | Diana Hong Mid-Link Consulting Co., Ltd P.O. Box. 120-119 Shanghai, CN 200120 |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-16 |
| Decision Date | 2020-12-31 |