Home › Texas Medplast, LLC › Savvy Mask® Level 3 Surgical Face Mask

Savvy Mask® Level 3 Surgical Face Mask

Texas Medplast, LLC · Model SM03 · UDI-DI 00850025566162

FXX

510(k) clearances

569

Adverse events

Recalls

317

Facilities

Description

The Savvy Surgical Face Mask is a disposable, single-use surgical mask. The surgical face masks are nonsterile, 3 layers, flat-pleated style. The outer and inner layers of the face masks consist of a thermal bonded bi-component - polyethylene/polyester nonwoven fabric. The middle layer consists of a melt blown polypropylene filter material. Each mask contains ear bands to secure the mask to the user’s face and mouth, as well as a fully enclosed, soft, bendable nosepiece to fit over the nose. This device is not made from natural rubber latex

Recalls

Date	Firm	Reason
2024-11-08	O&M HALYARD, INC.	Not meeting the bioburden testing requirements of EN 14683 required for masks sold in Europe. Face masks sold in the United States are not required to meet this standard. However,
2024-11-08	O&M HALYARD, INC.	Not meeting the bioburden testing requirements of EN 14683 required for masks sold in Europe. Face masks sold in the United States are not required to meet this standard. However,
2023-12-21	AMD Medicom Inc.	Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products.
2023-12-21	AMD Medicom Inc.	Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products.
2023-12-21	AMD Medicom Inc.	Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products.
2023-01-03	Owens & Minor Distribution, Inc.	Face masks were placed into the incorrect dispenser boxes. The face masks come with ear loops, but the dispenser is incorrectly labeled as face masks with ties instead of ear loops
2019-10-11	AMD Medicom Inc.	Due to an error on the packaging line, some level 2 masks may have been packed in some level 3 mask boxes. The two masks are visually indistinguishable, causing the risk of using a
2019-10-11	AMD Medicom Inc.	Due to an error on the packaging line, some level 2 masks may have been packed in some level 3 mask boxes. The two masks are visually indistinguishable, causing the risk of using a
2013-05-15	Maytex Corp	Recent Lab testing conducted in March 2013 indicates that the product does not meet the standard of "Differential Pressure of only 1.6 Delta P (mm H2O/cm2)" as indicated on the box
2003-06-03	Safco Dental Supply Co. Inc.	The product labeling incorrectly lists the particle filtration efficiency as exceeding 99% at 0.1 micron when it should state 95% filtration.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.