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510(k) Data Aggregation
K Number
K212926Device Name
AllureTM Surgical Mask
Manufacturer
Date Cleared
2022-09-16
(367 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Allure Gift Wraps Private Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
ALLURETM Surgical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.
Device Description
ALLURE™ Surgical mask is valve less, consisting of 5 layers made up of breathable PP non-woven, hot air insulation cotton, two layers of melt blown fabrics, non-woven fabrics and plastic nose strips and Elastic cord. The device is designed and tested as per its device specific guidance; "Surgical Masks-Premarket Notification 510(k) Submissions".
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