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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 K945031
Device Name ROYALSHIELD NON-STERILE POWDER-FREE
Applicant
SHIELD GLOVES MANUFACTURER (M) SDN BHD
89 2ND FLOOR JALAN SS 15/4C,
SUBANG JAYA
SELANGOR DARUL EHSAN,  MY 47500
Applicant Contact KATHERINE OOI
Correspondent
SHIELD GLOVES MANUFACTURER (M) SDN BHD
89 2ND FLOOR JALAN SS 15/4C,
SUBANG JAYA
SELANGOR DARUL EHSAN,  MY 47500
Correspondent Contact KATHERINE OOI
Regulation Number880.6250
Classification Product Code
LYY  
Date Received10/13/1994
Decision Date 01/11/1995
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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