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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 K223298
Device Name Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L)
Applicant
Shandong Intco Medical Products Co, Ltd.
9888 Qiwang Rd., Naoshan Industrial Park
Qingzhou,  CN 2625000
Applicant Contact Min Gao
Correspondent
Shanghai SUNGO Management Consulting Co., Ltd.
14th Floor, 1500# Century Ave.
Shanghai,  CN 200122
Correspondent Contact Ivy Wang
Regulation Number880.6250
Classification Product Code
LYY  
Date Received10/27/2022
Decision Date 02/22/2023
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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