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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 K895488
Device Name LATEX PATIENT EXAMINATION GLOVES
Applicant
Zhong YI Latex Products Factory
1061 N. Broadway, Rm. 6
North Massapequa,  NY  11758
Applicant Contact WIN PAN
Correspondent
Zhong YI Latex Products Factory
1061 N. Broadway, Rm. 6
North Massapequa,  NY  11758
Correspondent Contact WIN PAN
Regulation Number880.6250
Classification Product Code
LYY  
Date Received09/01/1989
Decision Date 12/01/1989
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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