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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Surgeon'S Gloves
510(k) Number K202090
Device Name Biogel Eclipse / Biogel Eclipse Indicator Underglove, Biogel Surgeons / Biogel Indicator Underglove, Biogel PI Micro Indicator Underglove, Biogel PI UltraTouch S Surgical Glove with a Low Dermatitis Potential Claim, Biogel PI UltraTouch S Indicator Underglove with a Low Dermatitis Potential Claim
Applicant
Molnlycke Health Care Us, LLC
5445 Triangle Pkwy.
Suite 400
Peachtree Corners,  GA  30092
Applicant Contact Leonard Stewart
Correspondent
Molnlycke Health Care Us, LLC
5445 Triangle Pkwy.
Suite 400
Peachtree Corners,  GA  30092
Correspondent Contact Leonard Stewart
Regulation Number878.4460
Classification Product Code
KGO  
Subsequent Product Code
LZC  
Date Received07/28/2020
Decision Date 11/22/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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