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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 K252117
Device Name Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate-Simulated Gastric Acid Solution
Applicant
Sw Technologies, Inc.
33278 Central Ave.
Suite 102
Union City,  CA  94587
Applicant Contact Michael Van Sunder
Correspondent
Sw Technologies, Inc.
33278 Central Ave.
Suite 102
Union City,  CA  94587
Correspondent Contact Michael Van Sunder
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Codes
LZC   OPJ   QDO  
Date Received07/07/2025
Decision Date 06/24/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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