Mask, Surgical

O&M Halyard Procedure Mask with SO SOFT* Earloops, Yellow-Disposable surgical mask

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, if the standard is printed on the packaging, compliance is required.

O&M Halyard SOFT TOUCH II Surgical Mask, Blue-Disposable surgical mask

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, if the standard is printed on the packaging, compliance is required.

HENRY SCHEIN CRITERION EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-2448)

Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products.

HENRY SCHEIN CRITERION ANTI-FOG EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-3281)

Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products.

PATTERSON PROCEDURE EARLOOP MASKS- ANTI-FOG, ASTM LEVEL 3 (BLUE) (item code 127-7573)

Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products.

FLUIDSHIELD 3 Fog-Free Procedure Mask with SO SOFT Lining and SO SOFT Earloops, Orange, WrapAround Visor

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.

Comfort brand Ear-Loop Face Mask, Item #: 3100, Model Numbers: # 3100B, # 3100P, # 3100G, # 3100Y, # 3100W; Product is manufactured and distributed by Maytex Co

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/package of the product; and also product manufactured between 2008 - 2012 cannot be guaranteed as Fluid Resistant.

Supergrade Earloop Masks, surgical mask; 50 masks per box; Distributed by Safco Dental Supply Co., Northbrook, IL 60062

The product labeling incorrectly lists the particle filtration efficiency as exceeding 99% at 0.1 micron when it should state 95% filtration.

Ear Loop Procedure Masks, For one time use only, Glass-Free, Reorder No. 2201, packed in a cardboard box (unit box). Manufactured for dynarex Corporation, Bre

Product labeled as 'latex free' but recent tests indicate that it contains minute amounts of latex.

Ear Loop Procedure Masks With Plastic Shield, For one time use only, Glass-Free, Reorder No. 2202, packed in a cardboard box (unit box). Manufactured for dyn

Product labeled as 'latex free' but recent tests indicate that it contains minute amounts of latex.