The following data is part of a premarket notification filed by Showa Best Glove, Inc. with the FDA for Sbg Black Nitrile Powder Free Medical Examination Glove.
| Device ID | K180468 |
| 510k Number | K180468 |
| Device Name: | SBG Black Nitrile Powder Free Medical Examination Glove |
| Classification | Polymer Patient Examination Glove |
| Applicant | Showa Best Glove, Inc. 579 Edison Street Menlo, CA 30731 -6335 |
| Contact | Jeffrey Richardson |
| Correspondent | Jeffrey Richardson Showa Best Glove, Inc. 579 Edison Street Menlo, CA 30731 -6335 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-02-21 |
| Decision Date | 2018-10-10 |
| Summary: | summary |