K-number	K220662
Device name	Disposable Barrier Sleeves
Applicant	Premium Plus (Dongguan) Limited
Product code	PEM
Device class	Class II
Decision date	May 11, 2022
Decision	Substantially Equivalent
Regulation	878.4370

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Source

View the full FDA submission: accessdata.fda.gov

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Disposable Barrier Sleeves

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