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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 K093759
Device Name MULTIPLE NAME MODEL MULTIPLE
Applicant
Gx Corporation Sdn Bhd (Plant 1)
Lot 6487-A, Batu 5 3/4 Sementa
Jalan Kapar
Klang, Selangor,  MY
Applicant Contact CHO SOW FONG
Correspondent
Gx Corporation Sdn Bhd (Plant 1)
Lot 6487-A, Batu 5 3/4 Sementa
Jalan Kapar
Klang, Selangor,  MY
Correspondent Contact CHO SOW FONG
Regulation Number880.6250
Classification Product Code
LZA  
Date Received12/07/2009
Decision Date 02/19/2010
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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