The following data is part of a premarket notification filed by Rhino Health Inc. with the FDA for Rhino Non-sterile, Powder-free Nitrile Exam Gloves – Periwinkle Color Tested For Use With Chemotherapy Drugs, And Fentanyl.
| Device ID | K221082 |
| 510k Number | K221082 |
| Device Name: | Rhino Non-Sterile, Powder-Free Nitrile Exam Gloves – Periwinkle Color Tested For Use With Chemotherapy Drugs, And Fentanyl |
| Classification | Polymer Patient Examination Glove |
| Applicant | Rhino Health Inc. 309 A East, Route 66 Church Rock, NM 87311 |
| Contact | Mark Lee |
| Correspondent | Suzan Davis Global Regulatory Partners Inc. 550 Cochituate Road, East Wing, Floor 4, Suite 25 Framingham, MA 01701 |
| Product Code | LZA |
| Subsequent Product Code | LZC |
| Subsequent Product Code | OPJ |
| Subsequent Product Code | QDO |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-04-13 |
| Decision Date | 2022-11-30 |