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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 K892091
Device Name PATIENT EXAMINATION GLOVES (LATEX)
Applicant
RISING CROWN INDUSTRIES LTD.
FLAT A7-A9, BLK "A". 10/F.
HONG KONG IND CENTRE 489-491
CASTLE PEAK RD. KOWLOON,  HK
Applicant Contact YING CHOI
Correspondent
RISING CROWN INDUSTRIES LTD.
FLAT A7-A9, BLK "A". 10/F.
HONG KONG IND CENTRE 489-491
CASTLE PEAK RD. KOWLOON,  HK
Correspondent Contact YING CHOI
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/03/1989
Decision Date 12/11/1989
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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