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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 K030331
Device Name ON-LINE POWDER-FREE LATEX EXAMINATION GLOVE, TYPE II,LOW MODULUS, WITH PROTEIN LABELING CLAIM
Applicant
Perusahaan Getah Asas Sdn. Bhd.
1301 Defense Hwy.
Gambrills,  MD  21054
Applicant Contact JAMES F LOGAN
Correspondent
Perusahaan Getah Asas Sdn. Bhd.
1301 Defense Hwy.
Gambrills,  MD  21054
Correspondent Contact JAMES F LOGAN
Regulation Number880.6250
Classification Product Code
LYY  
Date Received01/31/2003
Decision Date 03/21/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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