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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 K022671
Device Name FREEFORM BLUE POWDERFREE NITRILE EXAMINATION GLOVES
Applicant
Hartalega Sdn Bhd
2301 Robb Dr.
Reno,  NV  89523
Applicant Contact TITO ALDAPE
Correspondent
Hartalega Sdn Bhd
2301 Robb Dr.
Reno,  NV  89523
Correspondent Contact TITO ALDAPE
Regulation Number880.6250
Classification Product Code
LZA  
Date Received08/12/2002
Decision Date 11/18/2002
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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