Medline Orbis Surgical Gown

Gown, Surgical

Medline Industries, Inc.

The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Medline Orbis Surgical Gown.

Pre-market Notification Details

Device IDK202447
510k NumberK202447
Device Name:Medline Orbis Surgical Gown
ClassificationGown, Surgical
Applicant Medline Industries, Inc. Three Lakes Drive Northfield,  IL  60093
ContactAdam Ostrower
CorrespondentAdam Ostrower
Medline Industries, Inc. Three Lakes Drive Northfield,  IL  60093
Product CodeFYA  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-26
Decision Date2021-04-02

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.