Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with Safety Seal and So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 2 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, White, Regular and Small
FDA 510(k) K233022 · Owens & Minor (O&M) Halyard, Inc.
Submission
- Device name
- Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with Safety Seal and So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 2 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, White, Regular and Small
- Applicant
- Owens & Minor (O&M) Halyard, Inc.
Mechanicsville, VA, US - Received
- September 22, 2023
- Decision date
- January 12, 2024
- 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 |
|---|---|---|---|
| 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 |
| 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 |
More from Alpha Protech, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K243010 | Fluidshield * 3 Fog-Free Surgical Mask with Wraparound Anti-Glare Visor (28804)…FXX · Abbreviated | 05/30/2025SE |
| K232824 | FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White…FXX · Traditional | 07/02/2024SE |
| K232777 | FLUIDSHIELD* 1 Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender…FXX · Traditional | 07/01/2024SE |
| K232807 | Fluidshield* 1 Procedure Mask with SO SOFT* Lining and SO SOFT Earloops (25869)…FXX · Traditional | 06/21/2024SE |
| K232812 | Fluidshield* 2 Fog-Free Surgical Mask (62113); Fluidshield* 2 Fog-Free Surgical Mask…FXX · Traditional | 06/14/2024SE |
| K232806 | HALYARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So Soft Earloops (25867)…FXX · Traditional | 06/07/2024SE |
| K232820 | HALYARD* FLUIDSHIELD* 1 Fog-Free Surgical Mask with So Soft Lining (28806)FXX · Traditional | 06/04/2024SE |
| K232849 | Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer AAMI 3…FYC · Abbreviated | 05/16/2024SE |
| K232894 | HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SO SOFT* Lining…FXX · Traditional | 01/08/2024SE |
| K214007 | HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization WrapFRG · Traditional | 07/27/2022SE |
Questions and answers
When was Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with Safety Seal and So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 2 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, White, Regular and Small cleared by the FDA?
Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with Safety Seal and So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 2 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, White, Regular and Small (K233022) received a 510(k) decision of Substantially Equivalent on January 12, 2024, 112 days after the submission was received.
What is the product code of K233022?
The FDA product code is MSH – Respirator, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.4040.