The following data is part of a premarket notification filed by Elm Tree Medical, Inc. with the FDA for Dilacheck Nitrile Powder Free Examination Glove, (sterile).
| Device ID | K163035 |
| 510k Number | K163035 |
| Device Name: | DilaCheck Nitrile Powder Free Examination Glove, (Sterile) |
| Classification | Polymer Patient Examination Glove |
| Applicant | Elm Tree Medical, Inc. 1543 Sloat Blvd. #320725 San Francisco, CA 94132 |
| Contact | Eva Martin |
| Correspondent | Paul Dryden ProMedic, LLC 24301 Woodsage Dr. Bonita Springs, FL 34134 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-31 |
| Decision Date | 2017-07-07 |