The following data is part of a premarket notification filed by Ever Global (vietnam) Enterprise Corp with the FDA for Disposable Powder Free Vinyl Exam Glove, Clear/yellow.
| Device ID | K170575 |
| 510k Number | K170575 |
| Device Name: | Disposable Powder Free Vinyl Exam Glove, Clear/Yellow |
| Classification | Vinyl Patient Examination Glove |
| Applicant | Ever Global (Vietnam) Enterprise Corp Long Thanh Industrial Zone Taman Village Dong Nai Province, VN 810000 |
| Contact | Jerry Lin |
| Correspondent | Elizabeth Deng N/A 5748 Eaglewood Place Rancho Cucamonga, CA 91739 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-02-27 |
| Decision Date | 2017-05-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04007418924528 | K170575 | 000 |
| 04007418924511 | K170575 | 000 |