The following data is part of a premarket notification filed by Ever Global (vietnam) Enterprise Corp with the FDA for Disposable Powder Free Nitrile Examination Glove, White/ Blue/ Black/ Pink Color.
| Device ID | K171422 |
| 510k Number | K171422 |
| Device Name: | Disposable Powder Free Nitrile Examination Glove, White/ Blue/ Black/ Pink Color |
| Classification | Polymer 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 Elizabeth Deng 5748 Eaglewood Place Ranch Cucamonga, CA 91739 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-15 |
| Decision Date | 2018-06-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04719886610123 | K171422 | 000 |
| D7664312222 | K171422 | 000 |
| D7664312232 | K171422 | 000 |
| D7664312242 | K171422 | 000 |
| D7664312252 | K171422 | 000 |
| 04712832889918 | K171422 | 000 |
| 04712832889925 | K171422 | 000 |
| 04712832889932 | K171422 | 000 |
| 04712832889949 | K171422 | 000 |
| 04719886610055 | K171422 | 000 |
| 04719886610062 | K171422 | 000 |
| 04719886610116 | K171422 | 000 |
| D7664312212 | K171422 | 000 |