Crosstex Isolite and Isofluid Earloop Face Masks, Isofluid FogFree Face Masks With and Without Splash Visor
510(k) K082258
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK082258 | Date16 Oct 2008 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Crosstex Isolite and Isofluid Earloop Face Masks and Isofluid Fogfree Face Masks with and Without Splash Visor
- 510(k) Number
- FDA Product Code
- FXX
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4040
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The device is a face mask designed for surgical and procedural use, classified under the General, Plastic Surgery category. These masks feature an earloop design with fluid-resistant outer layers and breathable inner layers, providing barrier protection against low levels of fluid, spray, and aerosols. The Isofluid FogFree variant includes an additional anti-fog treatment to maintain visibility during use. The Isolite variant is intended for general surgical procedures, while the Splash Visor option offers enhanced protection against splashes.
These masks are single-use, disposable devices supplied sterile in individual packaging. They are intended for use in surgical and clinical settings where minimal fluid exposure is anticipated. The earloop design ensures secure positioning, and the FogFree variant is MRI-safe as it contains no metallic components beyond the aluminum nosepiece. Sizes are standardized for adult use, and storage requires protection from moisture and direct sunlight. The product holds FDA 510(k) clearance under the Traditional review pathway, classified under product code FXX.
Other devices from Crosstex International, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the CROSSTEX Isofluid FogFree Face Mask with Splash Visor designed for?
This mask is designed for surgical and procedural use in clinical settings where minimal fluid exposure is anticipated. The Isofluid FogFree variant includes an anti-fog treatment to maintain clear visibility during use, while the Splash Visor option provides enhanced protection against splashes. It is ideal for procedures where maintaining visibility and barrier protection are critical.
How is the CROSSTEX Isofluid Face Mask supplied and what is its sterility status?
The masks are supplied sterile in individual packaging, ensuring readiness for immediate use in sterile environments. Each mask is single-use and disposable, adhering to standard surgical and procedural hygiene protocols to prevent contamination.
Are these masks reusable or single-use?
These masks are explicitly designed as single-use, disposable devices. This design ensures patient safety by preventing cross-contamination and maintains sterility between uses, which is critical in surgical and clinical settings.
What sizes are available for the CROSSTEX Isofluid and Isolite Face Masks?
The masks are standardized for adult use only. No pediatric or custom-sized variants are available, aligning with typical adult surgical and procedural requirements where these devices are intended for use.
How should the CROSSTEX Isofluid Face Masks be stored?
Storage requires protection from moisture and direct sunlight to preserve sterility and material integrity. The individual sterile packaging should remain intact until use, and masks should be stored in a cool, dry environment to prevent degradation.