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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 K260806
Device Name Nitrile Disposable Examination Gloves
Applicant
Vista Industries,, LLC
1560 Drumhill Dr., Hacienda Heights, Ca 91745
Los Angeles,  CA  90015
Applicant Contact James Yu
Correspondent
Shanghai SUNGO Management Consulting Co., Ltd.
14th Floor, Dongfang Bldg., 1500# Century Ave.
Shanghai,  CN 200122
Correspondent Contact Andrew Wang
Regulation Number880.6250
Classification Product Code
LZA  
Date Received03/12/2026
Decision Date 06/03/2026
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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