N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12
FDA 510(k) K160271 · San-M Package Co., Ltd.
Submission
- Device name
- N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12
- Applicant
- San-M Package Co., Ltd.
Shimada-City, JP - Received
- February 2, 2016
- Decision date
- July 15, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 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 |
| K141876 | Pasture F550S Surgical N95 Respirator, Pasture F550CS Surgical N95 Respirator, Pasture…MSH · Traditional | Pasture Pharma Pte, Ltd. | 10/28/2015SE |
| K121069 | 3M Vflex Health Care Particulate Respirator and Surgical MaskMSH · Traditional | 3M Company | 02/11/2013SE |
| 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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Questions and answers
When was N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12 cleared by the FDA?
N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12 (K160271) received a 510(k) decision of Substantially Equivalent on July 15, 2016, 164 days after the submission was received.
What is the product code of K160271?
The FDA product code is MSH – Respirator, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.4040.