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FDA 510(k) Application Details - K972757
Device Classification Name
Polymer Patient Examination Glove
More FDA Info for this Device
510(K) Number
K972757
Device Name
Polymer Patient Examination Glove
Applicant
SHIELD GLOVES MANUFACTURER (M) SDN BHD
87, 2ND FL., JALAN SS, 15/4-C,
SUBANG JAYA
PETALING JAYA, SELANGOR 47500 MY
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Contact
ONG LAY MAU
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Regulation Number
880.6250
More FDA Info for this Regulation Number
Classification Product Code
LZA
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More FDA Info for this Product Code
Date Received
07/23/1997
Decision Date
10/29/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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