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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Latex Patient Examination Glove
510(k) Number K894194
Device Name LATEX EXAM GLOVES (MFG: CHINA NAT CHEM CONST CORP)
Applicant
Invent Ent. (U.S.A.) Corp.
3400 Hwy. 35, Suite 1
Hazlet,  NJ  07730
Applicant Contact DANIEL KUO
Correspondent
Invent Ent. (U.S.A.) Corp.
3400 Hwy. 35, Suite 1
Hazlet,  NJ  07730
Correspondent Contact DANIEL KUO
Regulation Number880.6250
Classification Product Code
LYY  
Date Received06/14/1989
Decision Date 11/07/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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