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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Polymer Patient Examination Glove
510(k) Number K972757
Device Name ROYAL SHIELD NON-STERILE POWDERFREE, COLORED NITRILE EXAMINATION GLOVE
Applicant
Shield Gloves Manufacturer (M) Sdn Bhd
87, 2nd Floor , Jalan Ss, 15/4-C,
Subang Jaya
Petaling Jaya, Selangor,  MY 47500
Applicant Contact ONG LAY MAU
Correspondent
Shield Gloves Manufacturer (M) Sdn Bhd
87, 2nd Floor , Jalan Ss, 15/4-C,
Subang Jaya
Petaling Jaya, Selangor,  MY 47500
Correspondent Contact ONG LAY MAU
Regulation Number880.6250
Classification Product Code
LZA  
Date Received07/23/1997
Decision Date 10/29/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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