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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 K212290
Device Name Examination gloves -Type C (Nitrile gloves)
Applicant
Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd.
316 National Rd., Xinju, Changshan Town, Jinxian County
Nanchang,  CN 331724
Applicant Contact Jenny Huang
Correspondent
Shanghai Mind-Link Consulting Co., Ltd.
639 Jiaozhou Rd.
Shanghai,  CN 200040
Correspondent Contact Evan Hu
Regulation Number880.6250
Classification Product Code
LZA  
Date Received07/21/2021
Decision Date 10/28/2021
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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