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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 K242812
Device Name NITRILE EXAMINATION GLOVES (Tested For Use With Chemotherapy Drugs)
Applicant
Nb Medical Company Limited
Tay An Industrial Cluster, Tien Hai Town, Tien Hai District
Thai Binh Province,  VN
Applicant Contact Thi Vinh Vu
Correspondent
Wenzhou Thiwe Business Consulting Co., Ltd.
Rm. 1203, Bldg. C, Hua’Ou Jiayuan, #50 Tangjiaqiao
South Rd., Longwan District
Wenzhou,  CN 325000
Correspondent Contact Wendy Huang
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Codes
LZC   OPJ  
Date Received09/18/2024
Decision Date 10/12/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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