The following data is part of a premarket notification filed by Ever Global (vietnam) Enterprise Corporation with the FDA for Disposable Powder Free Nitrile Examination Glove, White, Tested For Use With Chemotherapy Drugs, Disposable Powder Free Nitrile Examination Glove, Blue, Tested For Use With Chemotherapy Drugs.
| Device ID | K190403 |
| 510k Number | K190403 |
| Device Name: | Disposable Powder Free Nitrile Examination Glove, White, Tested For Use With Chemotherapy Drugs, Disposable Powder Free Nitrile Examination Glove, Blue, Tested For Use With Chemotherapy Drugs |
| Classification | Polymer Patient Examination Glove |
| Applicant | Ever Global (Vietnam) Enterprise Corporation No.1 Road, Long Thanh Industrial Zone, Taman Village, Long Thanh District Long Tanh District, VN 810000 |
| Contact | Jerry Lin |
| Correspondent | Albert T.w. Li CENTER FOR MEASUREMENT STANDARDS OF INDUSTRIAL BLDG. 16, 321 KUANG FU RD,SEC2 Hsinchu, TW |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2019-02-19 |
| Decision Date | 2019-09-06 |
| Summary: | summary |