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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 K213739
Device Name Nitrile Examination Gloves
Applicant
Hangzhou Runheng Medical Co., Ltd.
Rm. 201, Shunfeng Bldg., #109 Hongxing Rd.,
Qiaonan Block
Hangzhou,  CN 311215
Applicant Contact Yaya Lu
Correspondent
Hangzhou Runheng Medical Co., Ltd.
Rm. 201, Shunfeng Bldg., #109 Hongxing Rd.,
Qiaonan Block
Hangzhou,  CN 311215
Correspondent Contact Yaya Lu
Regulation Number880.6250
Classification Product Code
LZA  
Date Received11/29/2021
Decision Date 06/22/2022
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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