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FDA 510(k), K100058, POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW)
FDA 510(k), K100058, POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW)
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510(K) Number: K100058
Device Name: POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW)
Manufacturer: CHU XIAOAN
Device Classification Name: Vinyl Patient Examination Glove
Regulation Number: LYZ
Classification Product Code: KXA
Date Received: 01/08/2010
Decision Date: 03/05/2010
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
Device Name: POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW)
Manufacturer: CHU XIAOAN
Device Classification Name: Vinyl Patient Examination Glove
Regulation Number: LYZ
Classification Product Code: KXA
Date Received: 01/08/2010
Decision Date: 03/05/2010
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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