AllureTM Surgical Mask
K-Number: K212926 · 2022-09-16
ApplicantAllure Gift Wraps Private Limited
Decision Date2022-09-16
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
AllureTM Surgical Mask is a medical device manufactured by Allure Gift Wraps Private Limited. It received FDA 510(k) clearance on 2022-09-16 under approval number K212926. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the AllureTM Surgical Mask?
AllureTM Surgical Mask is a medical device that received FDA 510(k) clearance on 2022-09-16. It is manufactured by Allure Gift Wraps Private Limited. The 510(k) number is K212926.
When was AllureTM Surgical Mask approved by the FDA?
AllureTM Surgical Mask received FDA 510(k) clearance on 2022-09-16, under approval number K212926.
What company makes AllureTM Surgical Mask?
AllureTM Surgical Mask is manufactured by Allure Gift Wraps Private Limited.
What is the FDA product code for AllureTM Surgical Mask?
The FDA product code for AllureTM Surgical Mask is FXX.
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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.