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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 K223859
Device Name Rhino Non-sterile Powder-Free Nitrile Exam Glove – 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
Capote Law Firm
13818 SW 152 St., Suite 375
Miami,  FL  33177
Correspondent Contact Lisa Capote
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Codes
LZC   OPJ   QDO  
Date Received12/23/2022
Decision Date 02/13/2023
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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