The following data is part of a premarket notification filed by Ever Global Enterprise Corporation with the FDA for Disposable Powdered Vinyl Exam Glove Yellow Color.
| Device ID | K051498 |
| 510k Number | K051498 |
| Device Name: | DISPOSABLE POWDERED VINYL EXAM GLOVE YELLOW COLOR |
| Classification | Vinyl Patient Examination Glove |
| Applicant | EVER GLOBAL ENTERPRISE CORPORATION LONG THANH INDUSTRIAL ZONE TAMAN VILLAGE, LONG THANH Dist., Dong Nai Province, VN |
| Contact | Nick Bien |
| Correspondent | Nick Bien EVER GLOBAL ENTERPRISE CORPORATION LONG THANH INDUSTRIAL ZONE TAMAN VILLAGE, LONG THANH Dist., Dong Nai Province, VN |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-07 |
| Decision Date | 2005-07-06 |
| Summary: | summary |