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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 K924906
Device Name POWDER-FREE LATEX EXAMINATION GLOVES
Applicant
Jentera Jaya Sdn Bhd
3523 S. Higuera
Suite D
San Luis Opispo,  CA  93401
Applicant Contact ROBERT HATCH
Correspondent
Jentera Jaya Sdn Bhd
3523 S. Higuera
Suite D
San Luis Opispo,  CA  93401
Correspondent Contact ROBERT HATCH
Regulation Number880.6250
Classification Product Code
LYY  
Date Received09/29/1992
Decision Date 12/22/1993
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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