The following data is part of a premarket notification filed by Xiantao S&j Protective Products Co., Ltd. with the FDA for Disposable Ear-loop Medical Face Mask, Disposable Tie-on Medical Face Mask.
| Device ID | K211462 |
| 510k Number | K211462 |
| Device Name: | Disposable Ear-loop Medical Face Mask, Disposable Tie-On Medical Face Mask |
| Classification | Mask, Surgical |
| Applicant | Xiantao S&J Protective Products Co., Ltd. 103 Mianyang Road Xiantao, CN 433000 |
| Contact | Dove Wei |
| Correspondent | Diana Hong Mid-Link Consulting Co., Ltd P.O. BOX 120-119 Shanghai, CN 200120 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-11 |
| Decision Date | 2021-08-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06974960061132 | K211462 | 000 |
| 16974960067100 | K211462 | 000 |
| 06974960067103 | K211462 | 000 |
| 16974960062235 | K211462 | 000 |
| 06974960062238 | K211462 | 000 |