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,blue Color, Tested For Use With Chemotherapy Drugs.
| Device ID | K190736 |
| 510k Number | K190736 |
| Device Name: | Disposable Powder Free Nitrile Examination Glove,Blue Color, Tested For Use With Chemotherapy Drugs |
| 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 Ranch 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 | 2019-03-21 |
| Decision Date | 2019-12-23 |
| Summary: | summary |