The following data is part of a premarket notification filed by Showa Best Glove, Inc. with the FDA for Showa(r) Medical Exam Glove (green) Powder-free, Disposable Nitrile Glove.
| Device ID | K190159 |
| 510k Number | K190159 |
| Device Name: | Showa(R) Medical Exam Glove (Green) Powder-free, Disposable Nitrile Glove |
| Classification | Patient Examination Glove, Specialty |
| Applicant | Showa Best Glove, Inc. 579 Edison Street Menlo, GA 30731 -6355 |
| Contact | Jefferey Richardson |
| Correspondent | Lee Rosebush BakerHostetler 1050 Connecticut Avenue, NW, Suite 1100 Washington, DC 20036 -5304 |
| Product Code | LZC |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-01-30 |
| Decision Date | 2019-05-06 |