CROSSTEX ISOFLUID PLUS SURGICAL EARLOOP MASK-BLUE, CROSSTEX ISOFLUID PLUS FOGFREE SURGICAL EARLOOP FACE MASK-BLUE, CROSS
FDA 510(k) clearance K111343 · decided 2011-10-06
Clearance details
- K-number
- K111343
- Device name
- CROSSTEX ISOFLUID PLUS SURGICAL EARLOOP MASK-BLUE, CROSSTEX ISOFLUID PLUS FOGFREE SURGICAL EARLOOP FACE MASK-BLUE, CROSS
- Applicant
- Crosstex International, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-05-13
- Decision date
- 2011-10-06
- Days to decision
- 146 days
- Clearance type
- Traditional
- Product code
- FXX
- Device class
- 2
- Regulation number
- 878.4040
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Minneapolis, MN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|
| HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with WrapAround Visor (K251967) | O&M Halyard, Inc. | 2026-03-18 |
| Surgical Face Mask (Ear mount) (K252534) | Zhejiang Hangkang Medical Equipment Co., Ltd. | 2026-03-03 |
| Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300) (K253398) | Efofex, Inc. | 2026-02-19 |
| Disposable Surgical Face Mask (3P00B, C2900) (K252830) | Beatles Medical Supplies (Xiantao) Co., Ltd. | 2026-01-12 |
| Disposable Medical Face Mask (K252650) | Makrite Industries, Inc. | 2026-01-05 |
| KP Protective Face Mask (K243342) | Kp Trading Co., Ltd. | 2025-12-22 |
| HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops (K252941) | O&M Halyard, Inc. | 2025-12-11 |
| PRIMED Surgical and Procedure Masks (K252964) | Primed Medical Products, Inc. | 2025-11-04 |
| Vitaform Procedural Mask - Blue (Vitaform Blue); Vitaform Procedural Mask with Shield (Vitaform-FS) (K251902) | Vitacore Industries, Inc. | 2025-09-17 |
| Procedure mask/Surgical mask/Face mask (K250082) | Winner Medical Co., Ltd. | 2025-06-18 |
| Fluidshield * 3 Fog-Free Surgical Mask with Wraparound Anti-Glare Visor (28804); Fluidshield * 3 Surgical Mask with SO SOFT* Lining (48208); Fluidshield * 3 Fog-Free Surgical Mask with SO SOFT* Lining (48207); Fluidshield * 3 Fog-Free Surgical Mask with SO SOFT* Lining, with Visor (48237); Fluidshield* 3 Fog-Free Surgical Mask with SO SOFT* Lining, Anti-Glare WrapAround Visor (48247); Fluidshield * 3 Fog-Free Procedure Mask with SO SOFT* Earloops (28797); Fluidshield * 3 Fog-Free Proce (K243010) | Owens & Minor (O&M) Halyard, Inc. | 2025-05-30 |
| Aurelia Surgical Mask ASTM Level-3 (2130) (K242502) | Supermax Healthcare Canada – Supermax Medical | 2024-11-12 |
Recalls involving this device
No recalls on record reference this clearance.