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FDA 510(k) Application Details - K992830

Device Classification Name Polymer Patient Examination Glove

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510(K) Number K992830
Device Name SAFESKIN POLYMER-COATED NITRILE EXAMINATION GLOVES, POWDER-FREE SHIELDMASTER NITRILE GLOVE
Applicant SAFESKIN CORP.
12671 HIGH BLUFF DR.
SAN DIEGO, CA 92130
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Contact EUGENE V GOORCHENKO
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Regulation Number 880.6250

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Classification Product Code LZA
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Date Received 08/23/1999
Decision Date 10/27/1999
Decision SE - Substantially Equivalent
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 N



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