Medline Orbis Chemo Surgical Gown

Gown, Surgical

Medline Industries LP

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

Pre-market Notification Details

Device IDK214108
510k NumberK214108
Device Name:Medline Orbis Chemo Surgical Gown
ClassificationGown, Surgical
Applicant Medline Industries LP Three Lakes Drive Northfield,  IL  60093
ContactAdam Ostrower
CorrespondentAdam Ostrower
Medline Industries LP Three Lakes Drive Northfield,  IL  60093
Product CodeFYA  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-12-29
Decision Date2022-05-06

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