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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Polymer Patient Examination Glove
510(k) Number K221082
Device Name Rhino Non-Sterile, Powder-Free Nitrile Exam Gloves – Periwinkle Color Tested for Use with Chemotherapy Drugs, and Fentanyl
Applicant
Rhino Health, Inc.
309 A E., Rte. 66
Church Rock,  NM  87311
Applicant Contact Mark Lee
Correspondent
Global Regulatory Partners, Inc.
550 Cochituate Rd., E. Wing, Floor 4, Suite 25
Framingham,  MA  01701
Correspondent Contact Suzan Davis
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Codes
LZC   OPJ   QDO  
Date Received04/13/2022
Decision Date 11/30/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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