Disposable Barrier Sleeves
K-Number: K220662 · 2022-05-11
ApplicantPremium Plus (Dongguan) Limited
Decision Date2022-05-11
Product CodePEM
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Disposable Barrier Sleeves is a medical device manufactured by Premium Plus (Dongguan) Limited. It received FDA 510(k) clearance on 2022-05-11 under approval number K220662. The device is classified under product code PEM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Disposable Barrier Sleeves?
Disposable Barrier Sleeves is a medical device that received FDA 510(k) clearance on 2022-05-11. It is manufactured by Premium Plus (Dongguan) Limited. The 510(k) number is K220662.
When was Disposable Barrier Sleeves approved by the FDA?
Disposable Barrier Sleeves received FDA 510(k) clearance on 2022-05-11, under approval number K220662.
What company makes Disposable Barrier Sleeves?
Disposable Barrier Sleeves is manufactured by Premium Plus (Dongguan) Limited.
What is the FDA product code for Disposable Barrier Sleeves?
The FDA product code for Disposable Barrier Sleeves is PEM.
Other Devices by Premium Plus (Dongguan) Limited
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K163447Premium Plus Disposable Barrier SleevePremium Plus International Limited
K191448Barrier SleevesIvoclar Vivadent, AG
K190484BH Medical Dental Barrier Sleeves and Barrier FilmBh Medical Products Co., Ltd.
K190949ScanX Barrier EnvelopesAir Techniques, Inc.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.