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FDA 510(k), K062138, POWDER FREE STERILE NITRILE EXAMINATION GLOVES, BLUE; POWDER FREE POLYCHLOROPRENE STERILE EXAMINATION GLOVE
FDA 510(k), K062138, POWDER FREE STERILE NITRILE EXAMINATION GLOVES, BLUE; POWDER FREE POLYCHLOROPRENE STERILE EXAMINATION GLOVE
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510(K) Number: K062138
Device Name: POWDER FREE STERILE NITRILE EXAMINATION GLOVES, BLUE; POWDER FREE POLYCHLOROPRENE STERILE EXAMINATION GLOVE
Manufacturer: MOLNLYCKE HEALTH CARE, INC.
Device Classification Name: polymer patient examination glove
Regulation Number: 880.6250
Classification Product Code: LZA
Date Received: 07/26/2006
Decision Date: 10/05/2006
Regulation Medical Specialty: General Hospital
Device Name: POWDER FREE STERILE NITRILE EXAMINATION GLOVES, BLUE; POWDER FREE POLYCHLOROPRENE STERILE EXAMINATION GLOVE
Manufacturer: MOLNLYCKE HEALTH CARE, INC.
Device Classification Name: polymer patient examination glove
Regulation Number: 880.6250
Classification Product Code: LZA
Date Received: 07/26/2006
Decision Date: 10/05/2006
Regulation Medical Specialty: General Hospital
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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