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FDA 510(k), K034052, BLACK COLOUR POWDER-FREE NITRILE RUBBER EXAMINATION GLOVES
FDA 510(k), K034052, BLACK COLOUR POWDER-FREE NITRILE RUBBER EXAMINATION GLOVES
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510(K) Number: K034052
Device Name: BLACK COLOUR POWDER-FREE NITRILE RUBBER EXAMINATION GLOVES
Manufacturer: LATEXX MANUFACTURING SDN.BHD.
Device Classification Name: polymer patient examination glove
Regulation Number: 880.6250
Classification Product Code: LZA
Date Received: 12/30/2003
Decision Date: 03/15/2004
Regulation Medical Specialty: General Hospital
Device Name: BLACK COLOUR POWDER-FREE NITRILE RUBBER EXAMINATION GLOVES
Manufacturer: LATEXX MANUFACTURING SDN.BHD.
Device Classification Name: polymer patient examination glove
Regulation Number: 880.6250
Classification Product Code: LZA
Date Received: 12/30/2003
Decision Date: 03/15/2004
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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