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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 K953496
Device Name ROYAL SHIELD NON-STERILE POWDER-FREE HYPOALLERGENIC LATEX EXAMINATION GLOVES
Applicant
Shield Gloves Manufacturer (M) Sdn Bhd
89, 2nd Floor , Jalan Ss, 15/4-C,
Subang Jaya
Selangor,  MY 47500
Applicant Contact ONG LAY MAU
Correspondent
Shield Gloves Manufacturer (M) Sdn Bhd
89, 2nd Floor , Jalan Ss, 15/4-C,
Subang Jaya
Selangor,  MY 47500
Correspondent Contact ONG LAY MAU
Regulation Number880.6250
Classification Product Code
LYY  
Date Received07/26/1995
Decision Date 09/08/1995
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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