3M Vflex Health Care Particulate Respirator and Surgical Mask
FDA 510(k) K121069 · 3M Company
510(k) numberK121069
Submission
- Device name
- 3M Vflex Health Care Particulate Respirator and Surgical Mask
- Applicant
- 3M Company
St. Paul, MN, US - Received
- April 9, 2012
- Decision date
- February 11, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MSH – Respirator, Surgical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4040
- Specialty
- General, Plastic Surgery
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 amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating…
Other 510(k)s with product code MSH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K233022 | Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with So Soft…MSH · Traditional | Owens & Minor (O&M) Halyard, Inc. | 01/12/2024SE |
| K172963 | Master-Frank N95 Particulate RespiratorMSH · Traditional | Master & Frank Enterprise Co., Ltd. | 04/04/2018SE |
| K171116 | 3M VFlex Health Care Particulate Respirator and Surgical Mask , Models 1804/1804SMSH · Traditional | 3M Healthcare | 08/10/2017SE |
| K160271 | N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12MSH · Abbreviated | San-M Package Co., Ltd. | 07/15/2016SE |
| K141876 | Pasture F550S Surgical N95 Respirator, Pasture F550CS Surgical N95 Respirator, Pasture…MSH · Traditional | Pasture Pharma Pte, Ltd. | 10/28/2015SE |
| K102923 | Barrier N95 Particulate RespiratorMSH · Abbreviated | Molnlycke Health Care | 11/19/2010SE |
| K102092 | Pro Gear N95 Particulate Filter Respirator & Surgical Mask, Regular Size Model RP CeriesMSH · Abbreviated | Prestige Ameritech | 10/06/2010SE |
| K102173 | Moldex-Metric Health Care N95 Particulate Respirator and Surgical Mask, Model 1712MSH · Abbreviated | Moldex/Metric, Inc. | 09/13/2010SE |
| K100139 | Safe Life N95 Respirator and Surgical Mask, Models B130 and B150MSH · Traditional | Safelife Corp. | 05/04/2010SE |
| K092824 | N95 Respirator Mask, Positive Facial Lock with Magic Arch, Model 695MSH · Abbreviated | Alpha Protech, Inc. | 10/21/2009SE |
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| K222508 | 3M Comply Hydrogen Peroxide Chemical Indicator 1248JOJ · Traditional | 11/01/2022SE |
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Questions and answers
When was 3M Vflex Health Care Particulate Respirator and Surgical Mask cleared by the FDA?
3M Vflex Health Care Particulate Respirator and Surgical Mask (K121069) received a 510(k) decision of Substantially Equivalent on February 11, 2013, 308 days after the submission was received.
What is the product code of K121069?
The FDA product code is MSH – Respirator, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.4040.