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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vinyl Patient Examination Glove
510(k) Number K033308
Device Name VINYL EXAMINATION GLOVES, POWDERED
Applicant
Tangshan Transocean Plastic Products Co., Ltd.
# 188 Benhu Rd.
Luannan County
Tangshan City; Hebei,  CN 063500
Applicant Contact IRIS YANG
Correspondent
Tangshan Transocean Plastic Products Co., Ltd.
# 188 Benhu Rd.
Luannan County
Tangshan City; Hebei,  CN 063500
Correspondent Contact IRIS YANG
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received10/14/2003
Decision Date 12/22/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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