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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 K952588
Device Name ROYAL SHIELD NON-STERILE LATEX EXAMINATION GLOVES
Applicant
Shield Gloves Manufacturer Sdn. Bhd. C/O Lenty, Inc.
89 2nd Floor, Jalan Ss 15/4c
Subang Jaya
Petaling Jaya,  MY 47500
Applicant Contact KATHERINE OOI
Correspondent
Shield Gloves Manufacturer Sdn. Bhd. C/O Lenty, Inc.
89 2nd Floor, Jalan Ss 15/4c
Subang Jaya
Petaling Jaya,  MY 47500
Correspondent Contact KATHERINE OOI
Regulation Number880.6250
Classification Product Code
LYY  
Date Received06/05/1995
Decision Date 10/12/1995
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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