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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 K220375
Device Name Intercept Free, Nitrile Two Toned White/Green, Textured Fingertips, Powder-Free, Non-sterile, Ambidextrous, Beaded Cuff, Medical Examination Gloves, Tested for Use with Opioids Fentanyl citrate, Heroin, and both Opioids in simulated Gastric Acid (Vomit)
Applicant
Summit Glove, Inc.
310 S. Grant St.
Minerva,  OH  44657
Applicant Contact James Hull
Correspondent
Truscott Medsci Associates, LLC
180 Burkemeade Ct.
Roswell,  GA  30075
Correspondent Contact Wava Truscott
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Code
QDO  
Date Received02/09/2022
Decision Date 04/13/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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