1
/
of
0
FDA 510(k), K160974, Gammex Cut-Resistant Glove Liner
FDA 510(k), K160974, Gammex Cut-Resistant Glove Liner
Regular price
$89.00 USD
Regular price
Sale price
$89.00 USD
Unit price
/
per
510(K) Number: K160974
Device Name: Gammex Cut-Resistant Glove Liner
Manufacturer: ROBERT MAHLER
Device Classification Name: Surgeon'S Gloves
Regulation Number: KGO
Classification Product Code: KXA
Date Received: 04/07/2016
Decision Date: 10/28/2016
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
Device Name: Gammex Cut-Resistant Glove Liner
Manufacturer: ROBERT MAHLER
Device Classification Name: Surgeon'S Gloves
Regulation Number: KGO
Classification Product Code: KXA
Date Received: 04/07/2016
Decision Date: 10/28/2016
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