The following data is part of a premarket notification filed by Rhino Health Inc with the FDA for Rhino Health Non-sterile, Powder-free Nitrile Exam Glove.
| Device ID | K203236 |
| 510k Number | K203236 |
| Device Name: | Rhino Health Non-Sterile, Powder-free Nitrile Exam Glove |
| Classification | Polymer Patient Examination Glove |
| Applicant | Rhino Health Inc 309A East, Route 66 Church Rock, NM 87311 |
| Contact | Mark Lee |
| Correspondent | Lisa Capote Capote Law Firm 13818 SW 152 Street Number 375 Miami, FL 33177 |
| Product Code | LZA |
| Subsequent Product Code | LZC |
| Subsequent Product Code | QDO |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-03 |
| Decision Date | 2021-08-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00883940421711 | K203236 | 000 |
| 00883940421698 | K203236 | 000 |