Protect X Level 3 Isolation Gown

Gown, Isolation, Surgical

AZAC Group

The following data is part of a premarket notification filed by Azac Group with the FDA for Protect X Level 3 Isolation Gown.

Pre-market Notification Details

Device IDK211538
510k NumberK211538
Device Name:Protect X Level 3 Isolation Gown
ClassificationGown, Isolation, Surgical
Applicant AZAC Group 17870 Castleton St. Suite 121 City Of Industry,  CA  91748
ContactYen Ping Shan
CorrespondentRobert Seiple
QPM Consulting, LLC 3817 Seville Rd Denton,  TX  76205
Product CodeFYC  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-05-18
Decision Date2021-11-17

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