CROSSTEX ISOFLUID Plus Surgical Earloop Mask-Blue, CROSSTEX ISOFLUID Plus Fogfree Surgical Earloop Face Mask-Blue
by Crosstex International, Inc.
510(k) K111343
Active
Valid until
Not listed
FDA recalls
None foundTrust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK111343 | Date6 Oct 2011 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Full name
- Crosstex Isofluid Plus Surgical Earloop Mask-Blue, Crosstex Isofluid Plus Fogfree Surgical Earloop Face Mask-Blue, Cross
- 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, 18 Sep 2026
The CROSSTEX ISOFLUID Plus Surgical Earloop Mask-Blue and Fogfree Surgical Earloop Face Mask-Blue are disposable, non-sterile surgical face masks designed to provide barrier protection for healthcare personnel and patients during surgical procedures. These masks feature earloops for secure fitting and are intended to reduce the transmission of airborne contaminants, including droplets and aerosols, during medical interventions.
These masks are supplied in non-sterile packaging and are intended for single-use only. They are classified under product code FXX and are approved for use in surgical settings. The ISOFLUID Plus Fogfree variant is designed to minimize fogging on eyewear, enhancing visibility for the wearer. Both variants are regulated under FDA 510(k) clearance and EU MDR, ensuring compliance with medical device safety and performance standards.
Other devices from Crosstex International, Inc.
Questions
AI-generated answers, 18 Sep 2026
Are these masks suitable for reuse in a clinical setting, or are they intended for single-use only?
These masks are explicitly designed for single-use only, as stated in the product description. The packaging is non-sterile, and the manufacturer does not recommend or endorse reuse, which could compromise barrier protection and increase infection risks for both healthcare personnel and patients.
What distinguishes the ISOFLUID Plus Fogfree variant from the standard ISOFLUID Plus Surgical Earloop Mask?
The ISOFLUID Plus Fogfree variant is engineered to minimize fogging on eyewear, improving visibility for the wearer during prolonged use. This feature is not present in the standard ISOFLUID Plus mask, making it particularly useful for procedures requiring extended mask wear or where clear vision is critical.
How are these masks supplied, and what should I consider when storing them?
The masks are supplied in non-sterile packaging, meaning they are not pre-sterilized and should not be used for sterile procedures without additional sterilization. Storage should be in a cool, dry place, away from direct sunlight or extreme temperatures, to preserve their integrity and effectiveness. Always check the packaging for expiration dates before use.
Are these masks approved for use in surgical settings, and if so, what regulatory pathways have they followed?
Yes, these masks are approved for use in surgical settings as indicated by their classification under product code FXX. They have undergone FDA 510(k) clearance (K111343) and comply with EU MDR (Medical Device Regulation), ensuring they meet safety and performance standards for healthcare environments.