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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 K892130
Device Name DURAPRO (PATIENT EXAMINATION GLOVES)
Applicant
Perfekta Intl., Ltd.
25 Chong Yip St.
Kwun Tong
Kowloon, Hong Kong,  HK
Applicant Contact YOUNG
Correspondent
Perfekta Intl., Ltd.
25 Chong Yip St.
Kwun Tong
Kowloon, Hong Kong,  HK
Correspondent Contact YOUNG
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/04/1989
Decision Date 05/31/1989
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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