ResQ300 Plus Surgical Face Mask
by Cross Protection (M) Sdn Bhd
510(k) K212273
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK212273 | Date17 Aug 2022 | 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- Withdrawn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
- Cross Protection ResQ300 Plus Surgical Face Mask
- 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 ResQ300 Plus Surgical Face Mask is a three-ply disposable surgical mask designed to provide moderate barrier protection against low-to-moderate levels of aerosols, sprays, and fluids. Classified as a surgical mask under product code FXX, it meets the EN 14683 Type IIR and ASTM F2100 Level 2 standards, ensuring reliable protection against common pathogens and particulates while maintaining breathability. Its construction adheres to medical compliance requirements for surgical applications, offering a balance of filtration and comfort for healthcare settings.
This mask is supplied in sterile, single-use packaging, available in earloop or tie-on styles, with 50 masks per box and 20 boxes per carton. It is intended for use in clinical environments where surgical protection is required, such as operating rooms, dental procedures, and other medical settings. The device is FDA-cleared under 510(k) K212273 as substantially equivalent to a predicate device, with no third-party involvement in the review process. Storage should follow manufacturer guidelines to maintain sterility and performance.
Other devices from Cross Protection (M) Sdn Bhd
Questions
AI-generated answers, 1 Oct 2026
What is the ResQ300 Plus Surgical Face Mask designed to protect against?
The ResQ300 Plus Surgical Face Mask is engineered to provide moderate barrier protection against low-to-moderate levels of aerosols, sprays, and fluids. It meets EN 14683 Type IIR and ASTM F2100 Level 2 standards, ensuring reliable defense against common pathogens and particulates while maintaining breathability for extended wear in healthcare environments.
How is the ResQ300 Plus Surgical Face Mask supplied, and what packaging options are available?
The mask is supplied in sterile, single-use packaging to ensure contamination-free use. It comes in two styles: earloop and tie-on. Each box contains 50 masks, and cartons are packed with 20 boxes, making it convenient for bulk clinical or procedural needs.
Is the ResQ300 Plus Surgical Face Mask reusable or single-use?
This mask is explicitly designed for single-use only. Its sterile packaging and disposable construction align with medical best practices to prevent cross-contamination and ensure patient and clinician safety during procedures.
What storage guidelines should be followed to maintain the mask’s sterility and performance?
To preserve sterility and performance, store the ResQ300 Plus Surgical Face Mask in its original packaging, away from direct sunlight, moisture, and extreme temperatures. Keep boxes sealed until use, and avoid exposing them to chemicals or contaminants that could compromise the mask’s integrity.
What regulatory clearance does the ResQ300 Plus Surgical Face Mask hold?
The mask is FDA-cleared under 510(k) number K212273, determined to be substantially equivalent to a predicate device. The review process did not involve third-party involvement, and it is classified under product code FXX for surgical masks.