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510(k) Data Aggregation
K Number
K012602Device Name
CROSSTEX ISOLITE EARLOOP FACE MASKS-BLUE, PINK, CROSSTEX ISOFLUID EARLOOP FACE MASKS-BLUE, PINK, WHITE, GREEN. CROSSTEX
Manufacturer
CROSSTEX INTL.
Date Cleared
2002-01-22
(162 days)
Product Code
FXX
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
CROSSTEX INTL.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The following Crosstex® Surgical Masks are intended for use in infection control practices to minimize contamination caused by inhaled and exhaled microorganisms and reduce the potential exposure of the wearer to blood and body fluids.
- Crosstex® Isolite® Earloop Face Masks Blue, Pink .
- Crosstex® Isofluid® Earloop Face Masks -- Blue, Pink, White, Green .
- Crosstex® Isofluid FogFree® Earloop Face Masks Blue, Peach .
- Crosstex® Isofluid FogFree® Face Masks with Splash Visor Blue, Peach ●
- Crosstex® Procedural Earloop Face Masks Blue, Pink, Yellow ●
- Crosstex® Ultra Fluid Resistant No-Fog® Earloop Face Masks Blue ●
- Crosstex® Ultra Fluid Resistant No-Fog® Face Masks with Splash Visor -. Blue
Device Description
The seven (7) Crosstex® Surgical Masks are constructed of either an inner/outer facing of medical grade tissue or 100% spunbonded polypropylene, a 100% facing of mediour grade tiesas of Tea, with white elastic loops and/or a fogfree strip. monown performs most (7) Crosstex® Surgical Masks is 27 gauge aluminum wire, some have an anti-fog strip, with the Crosstex® Ultra Fluid Resistant No Fog® having a vapor barrier. All of the materials used in the construction of the Crosstex® Surgical Masks are being used in currently marketed devices (see predicate information).
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K Number
K984187Device Name
CROSSTEX NON-WOVEN SPONGES
Manufacturer
CROSSTEX INTL.
Date Cleared
1999-02-18
(87 days)
Product Code
EFQ
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
CROSSTEX INTL.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Crosstex Non-Woven Sponges are intended, for medical purposes, to be placed directly on a patient's wound or burn to absorb excess body fluids or exudate.
Device Description
The Crosstex Non-Woven Sponges consist of non-woven materials quarter folded into:
- 2 X 2" (light) 4-Ply
- 2 X 2" (light)
- 3 X 3" (Premium) 4-Ply
- 4 X 4" (Premium) 4-Ply
sponges used for the absorption of liquids from the patient's skin.
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