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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Latex Patient Examination Glove
510(k) Number K213509
Device Name Latex Examination Gloves, Powder Free
Applicant
Shandong Intco Medical Products Co, Ltd.
9888 Qiwang Rd., Naoshan Industrial Park
Qingzhou,  CN 2625000
Applicant Contact Haisheng Yu
Correspondent
Intco Medical Industries, Inc.
805 Barrington Ave.
Ontario,  CA  91764
Correspondent Contact John Zhao
Regulation Number880.6250
Classification Product Code
LYY  
Date Received11/02/2021
Decision Date 04/08/2022
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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