The following data is part of a premarket notification filed by Humanwell Healthcare Group Medical Supplies Co., Ltd. with the FDA for Medical Examination Gloves (nitrile) (xs, S, M, L, Xl).
| Device ID | K222498 |
| 510k Number | K222498 |
| Device Name: | Medical Examination Gloves (Nitrile) (XS, S, M, L, XL) |
| Classification | Polymer Patient Examination Glove |
| Applicant | Humanwell Healthcare Group Medical Supplies Co., Ltd. 14th F, 1500# Century Avenue Wuhan, CN |
| Contact | Aixue Yao |
| Correspondent | Ivy Wang Shanghai Sungo Management Consulting Company Limited 14th F, 1500# Century Avenue Shanghai, CN 200122 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-08-18 |
| Decision Date | 2022-10-26 |