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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 K210897
Device Name Disposable Nitrile Examination Gloves
Applicant
Shandong DS Safety Technology Co., Ltd.
West Of Yaoqian Rd., Yaogezhuang Community,
Economic Development Zone
Weifang,  CN 261502
Applicant Contact Summer Feng
Correspondent
Pacific Fortune Management, Inc.
2350 Mission College Blvd., Suite 475
Santa Clara,  CA  95054
Correspondent Contact Rafi Wong
Regulation Number880.6250
Classification Product Code
LZA  
Date Received03/25/2021
Decision Date 08/24/2021
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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