FDA-Device2016-11-16Class II

Covidien Devon Light Glove packaged in sterile surgical kits Reference: 31140208 Product Usage: A disposable, sterile, single-use cover for compatible surgical light handles

Covidien LLC
Hazard

Added Instructions for Use: After application, inspect the Light Glove for barrier integrity

Sold states
Worldwide Distribution - US Nationwide Foreign: Canada: Andorra Austria Belgium Czech Republic Denmark Finland France Germany Greece Ireland Israel Italy Latvia Luxembourg Monaco Netherlands Norway Poland Portugal Russian Federation Saudi Arabia Slovenia South Africa Spain Sweden Switzerland United Arab Emirates United Kingdom
Affected count
13,786,893 in total Distributed in USA
Manufactured in
60 Middletown Ave, North Haven, CT, United States
Products
Covidien Devon Light Glove packaged in sterile surgical kits Reference: 31140208 Product Usage: A disposable, sterile, single-use cover for compatible surgical light handles

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0364-2017

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