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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 K983612
Device Name POWDER-FREE NON STERILE VINYL EXAMINATION GLOVES
Applicant
Shanghai Jiatai Plastic Products Co., Ltd.
30798 Us Hwy. 19n
Palm Harbor,  FL  34684
Applicant Contact DON MORRIS
Correspondent
Shanghai Jiatai Plastic Products Co., Ltd.
30798 Us Hwy. 19n
Palm Harbor,  FL  34684
Correspondent Contact DON MORRIS
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received10/14/1998
Decision Date 11/05/1998
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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