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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 K213859
Device Name Stronghold Group Nitrile Examination Glove, Powder Free
Applicant
Stronghold Group LLC
98 Foxfire Lane
Lewisberry,  PA  17339
Applicant Contact David Henderson
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number880.6250
Classification Product Code
LZA  
Date Received12/10/2021
Decision Date 01/13/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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