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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 K952590
Device Name ROYAL SHIELD NON-STERILE PINK COLOERED, STRAWBERRY SCENTED LATEX EXAMINATION GLOVES
Applicant
Shield Gloves Manufacturer Sdn. Bhd. C/O Lenty, Inc.
89, 2nd Floor,Jalan Ss 15/4c,
47500 Subang Jaya,
Selangor Darul Ehsan,  MY
Applicant Contact KATHERINE OOI
Correspondent
Shield Gloves Manufacturer Sdn. Bhd. C/O Lenty, Inc.
89, 2nd Floor,Jalan Ss 15/4c,
47500 Subang Jaya,
Selangor Darul Ehsan,  MY
Correspondent Contact KATHERINE OOI
Regulation Number880.6250
Classification Product Code
LYY  
Date Received06/05/1995
Decision Date 08/14/1995
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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