1
/
of
0
FDA 510(k), K212578, Nitrile disposable examination gloves
FDA 510(k), K212578, Nitrile disposable examination gloves
Regular price
$49.00 USD
Regular price
Sale price
$49.00 USD
Unit price
/
per
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: KXA
Date Received: 08/16/2021
Decision Date: 12/02/2021
Decision: 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: KXA
Date Received: 08/16/2021
Decision Date: 12/02/2021
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
Couldn't load pickup availability
- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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.
View full details