The following data is part of a premarket notification filed by Ever Global (vietnam) Enterprise Corporation with the FDA for Disposable Powder Free Vinyl Exam Glove, Black/blue/purple.
| Device ID | K220992 |
| 510k Number | K220992 |
| Device Name: | Disposable Powder Free Vinyl Exam Glove, Black/Blue/Purple |
| Classification | Vinyl Patient Examination Glove |
| Applicant | Ever Global (Vietnam) Enterprise Corporation Long Thanh Industrial Zone, Taman Village Long Thanh, VN 810000 |
| Contact | Jerry Lin |
| Correspondent | Elizabeth Deng Elizabeth Deng 5748 Eaglewood Place Ranch Cucamonga, CA 91739 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-04-04 |
| Decision Date | 2022-10-19 |