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FDA 510(k), K212578, Nitrile disposable examination gloves
FDA 510(k), K212578, Nitrile disposable examination gloves
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$149.00 USD
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$149.00 USD
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510(K) Number: K212578
Device Name: Nitrile disposable examination gloves
Manufacturer: Cathrine Luan
Device Classification Name: Polymer Patient Examination Glove
Regulation Number: LZA
Classification Product Code: 08/16/2021
Date Received: 12/02/2021
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
Device Name: Nitrile disposable examination gloves
Manufacturer: Cathrine Luan
Device Classification Name: Polymer Patient Examination Glove
Regulation Number: LZA
Classification Product Code: 08/16/2021
Date Received: 12/02/2021
Decision Date: Substantially Equivalent (SESE)
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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