3M Vflex Health Care Particulate Respirator and Surgical Mask
K121069 is the FDA 510(k) clearance record for 3M VFLEX HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK, a class II device, cleared for 3M Company on under FDA product code MSH (Respirator, Surgical). FDA's definition for product code MSH reads: "A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific...". FDA records list 146 510(k) clearances for 3M Company, from to . As of , FDA records show no recalls naming K121069.
Clearance record
- Decision date
- Received
- (308 days to decision)
- Product code
- MSH Respirator, Surgical
- Regulation
- 21 CFR 878.4040
- Device class
- Class II
- Review panel
- General, Plastic Surgery
- Applicant
- 3M Company 3m Center, Bldg. 275-5w-06, St. Paul MN
- 510(k) summary
- Summary PDF
- Third party review
- No
Clearances, product code MSH
Trailing 12 monthsFDA records hold no clearances under product code MSH in the trailing twelve months.
Show the numbers
| Month | Clearances |
|---|---|
| November 2025 | 0 |
| December 2025 | 0 |
| January 2026 | 0 |
| February 2026 | 0 |
| March 2026 | 0 |
| April 2026 | 0 |
| May 2026 | 0 |
| June 2026 | 0 |
| July 2026 | 0 |
| August 2026 | 0 |
| September 2026 | 0 |
| October 2026 | 0 |
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