The following data is part of a premarket notification filed by Ever Growth (vietnam) Co. Ltd. with the FDA for Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, White Color, Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, Orange Color.
| Device ID | K190860 |
| 510k Number | K190860 |
| Device Name: | Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, White Color, Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, Orange Color |
| Classification | Polymer Patient Examination Glove |
| Applicant | Ever Growth (Vietnam) Co. Ltd. Long Khanh Industrial Zone Binhloc Village Binhloc Village, VN 810000 |
| Contact | Ming Lee |
| Correspondent | Elizabeth Deng Elizabeth Deng 5748 Eaglewood Place Rancho Cucamonga, CA 91730 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-02 |
| Decision Date | 2019-12-23 |
| Summary: | summary |