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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Surgeon'S Gloves
510(k) Number K221748
Device Name Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves
Applicant
Guilin Hbm Health Protections, Inc.
#1-2, Shuijing E. Rd.
Economic And Technological Development Area
Guilin,  CN 541805
Applicant Contact Pu Lei
Correspondent
Landlink Healthcare Technology (Shanghai) Co., Ltd.
Rm. 1308, Baohua International Plz.
West Guangzhong Rd. 555
Shanghai,  CN 200071
Correspondent Contact Stuart Situ
Regulation Number878.4460
Classification Product Code
KGO  
Date Received06/16/2022
Decision Date 09/13/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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