The following data is part of a premarket notification filed by Qingdao Bestex Rubber & Plastic Products Co.,ltd. with the FDA for Disposable Surgical Face Mask (fm-34ee,fm-44ee).
| Device ID | K220597 |
| 510k Number | K220597 |
| Device Name: | Disposable Surgical Face Mask (FM-34EE,FM-44EE) |
| Classification | Mask, Surgical |
| Applicant | Qingdao Bestex Rubber & Plastic Products Co.,Ltd. No.8-5 Guangzhou Road, Pingdu Qingdao, CN 266701 |
| Contact | Lucy Wang |
| Correspondent | Ivy Wang Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Century Avenue Shanghai, CN 200122 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-01 |
| Decision Date | 2022-05-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D930240070040 | K220597 | 000 |
| D930240070060 | K220597 | 000 |
| D930240040010 | K220597 | 000 |
| D930240040020 | K220597 | 000 |
| D930240040030 | K220597 | 000 |
| D930240010030 | K220597 | 000 |
| D930240010040 | K220597 | 000 |
| D930240010050 | K220597 | 000 |
| D930240010060 | K220597 | 000 |
| D930240010070 | K220597 | 000 |
| D930240070010 | K220597 | 000 |
| D930240070020 | K220597 | 000 |
| D930240070030 | K220597 | 000 |
| D930240070050 | K220597 | 000 |