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, Blue Color, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate.
| Device ID | K193555 |
| 510k Number | K193555 |
| Device Name: | Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate |
| Classification | Patient Examination Glove, Specialty |
| 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 91730 |
| Product Code | LZC |
| Subsequent Product Code | LZA |
| Subsequent Product Code | QDO |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-20 |
| Decision Date | 2020-06-04 |