(269 days)
Not Found
No
The 510(k) summary describes a standard procedure mask and the performance studies focus on material properties and filtration efficiency, with no mention of AI or ML.
No
The device is a procedure mask intended for infection control by filtering microorganisms and particulate material, not for treating a disease or condition.
No
Explanation: The device description and intended use clearly state that these are procedure masks designed for protection against microorganisms, body fluids, and particulate matter. There is no indication that they are used to analyze patient data, diagnose conditions, or provide information about a person's health status. The performance metrics focus on filtration, breathability, and fluid resistance, which are all related to protective barrier function, not diagnostic capabilities.
No
The device description clearly states it is a three-layer mask constructed of non-woven materials with earloops and a malleable nosepiece, indicating it is a physical hardware device. The performance studies also focus on physical properties like filtration efficiency, breathability, and fluid resistance.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the masks are for protecting both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. This is a barrier function, not a diagnostic one.
- Device Description: The description details the physical construction and materials of the mask, consistent with a protective barrier.
- Performance Studies: The performance studies focus on the mask's ability to filter particles and fluids, breathability, and safety (flame resistance, biocompatibility). These are all related to its function as a physical barrier and not to the diagnosis of any condition.
- Lack of Diagnostic Elements: There is no mention of the device being used to test samples (like blood, urine, or tissue) or to provide information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This mask does not perform any such function.
N/A
Intended Use / Indications for Use
The HALYARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So Soft Earloops (25867); HALYARD* Level 1 Procedure Mask (48388) are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure of the wearer to blood and body fluids. The HALYARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So Soft Earloops (25867); HALYARD* Level 1 Procedure Mask (48388) are single use, disposable device(s), provided non-sterile.
Product codes (comma separated list FDA assigned to the subject device)
FXX
Device Description
The subject devices are ASTM F2100 Level 1 (yellow in color) Procedure Masks. The ASTM F2100 Level 1 Procedure Mask family of products are a three-layer mask, constructed of well-known non-woven materials used in facial protection. The Procedure Masks are provided with earloops and a malleable nosepiece.
The ASTM F2100 Level 1 Procedure Masks that are the subject of this submission are not provided with a fog-free foam or visor. These masks are single use, disposable devices, provided non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical testing was performed.
Summary of Non-Clinical Testing:
- ASTM F2101: To demonstrate adequate bacterial filtration efficiency. Criteria: Under the conditions of the study, at least 95% efficiency. Result: Pass
- EN 14683:2019+AC Annex C: To demonstrate acceptable breathability. Criteria: Under the conditions of the study, at most 5.0 mm H₂O/cm². Result: Pass
- ASTM F2299: To demonstrate adequate particulate filtration efficiency. Criteria: Under the conditions of the study, at least 95% efficiency. Result: Pass
- ASTM F1862: To demonstrate adequate resistance to liquids. Criteria: Under the conditions of the study, passing at 80 mmHg conditions. Result: Pass
- 16 CFR 1610: To evaluate flame spread resistance. Criteria: Class 1 under the conditions of the testing. Result: Pass
- ASTM F2100-19: To evaluate mask performance. Criteria: Level 1 under the conditions of the evaluation. Result: Pass
- ISO 10993-5: To evaluate the cytotoxic potential of the mask. Criteria: Under the conditions of the study, non-cytotoxic. Result: Pass
- ISO 10993-10 Sensitization: To evaluate the sensitization potential of the mask. Criteria: Under the conditions of the study, not a sensitizer. Result: Pass
- ISO 10993-10 Irritation: To evaluate the irritation potential of the mask. Criteria: Under the conditions of the study, not an irritant. Result: Pass
No clinical testing was performed in support of this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Particulate Filtration Efficiency ASTM F2299: >= 95%
Bacterial Filtration Efficiency ASTM F2101: >= 95%
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4040 Surgical apparel.
(a)
Identification. Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.(b)
Classification. (1) Class II (special controls) for surgical gowns and surgical masks. 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 technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible.
(ii) Analysis and nonclinical testing must:
(A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and
(B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.
(iii) NIOSH approved under its regulation.
(2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 7, 2024
Owens & Minor (O&M) Halyard, Inc. Anureet Singh Regulatory Affairs Manager 9120 Lockwood Blvd Mechanicsville, Virginia 23116
Re: K232806
Trade/Device Name: HALYARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So Soft Earloops (25867); HALYARD* Level 1 Procedure Mask (48388) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: April 26, 2024 Received: April 26, 2024
Dear Anureet Singh:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Allan Guan -S
For Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices
2
OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K232806
Device Name
HALY ARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So Soft Earloops (25867); HALY ARD* Level 1 Procedure Mask (48388)
Indications for Use (Describe)
The HALY ARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So Soft Earloops (25867); HALY ARD* Level 1 Procedure Mask (48388) are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure of the wearer to blood and body fluids. The HALYARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So Soft Earloops (25867); HALYARD* Level 1 Procedure Mask (48388) are single use, disposable device(s), provided non-sterile.
| Type of Use (Select one or both, as applicable) |
|---|
| Restricted Use (Part 21 CFR 801.2 Labeling) |
| Over-The-Counter Use (21 CFR 801.2 Labeling) |
| | Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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4
510(k) Summary — K232806
| Date of Summary | June 06, 2024 |
|---|---|
| 510(k) Submitter | O&M Halyard, Inc. |
| 9120 Lockwood Boulevard | |
| Mechanicsville, VA 23116 | |
| Phone: 804-723-7000/800-488-8850 | |
| Fax: 804-723-7100 | |
| Primary Contact for this | |
| 510(k) Submission | Anureet Singh |
| Regulatory Affairs Manager | |
| Marketed Common Name | Surgical Mask and Procedure Mask |
| Device Submission Trade | |
| Name and Description | HALYARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So Soft |
| Earloops (25867) |
HALYARD* Level 1 Procedure Mask (48388) |
| Device Product Code,
Class and
Classification Name | FXX
II
Surgical Mask (21 CFR 878.4040) |
| Predicate Device | K110455
Kimberly-Clark KC100 Face Masks
FXX Surgical Mask
Surgical Apparel (21 CFR 878.4040) |
| Subject Device Description | The subject devices are ASTM F2100 Level 1 (yellow in color) Procedure Masks.
The ASTM F2100 Level 1 Procedure Mask family of products are a three-layer
mask, constructed of well-known non-woven materials used in facial
protection. The Procedure Masks are provided with earloops and a malleable
nosepiece.
The ASTM F2100 Level 1 Procedure Masks that are the subject of this
submission are not provided with a fog-free foam or visor. These masks are
single use, disposable devices, provided non-sterile. |
| Indications for Use | The HALYARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So Soft
Earloops (25867); HALYARD* Level 1 Procedure Mask (48388) are intended to
be worn to protect both the patient and healthcare personnel from transfer of
microorganisms, body fluids, and particulate material. These face masks are
intended for use in infection control practices to reduce the potential exposure
of the wearer to blood and body fluids. The HALYARD* FLUIDSHIELD* 1
Procedure Mask with So Soft Lining and So Soft Earloops (25867); HALYARD*
Level 1 Procedure Mask (48388) are single use, disposable device(s), provided
non-sterile. |
5
| Technological Characteristics Comparison Table | ||||
|---|---|---|---|---|
| Subject Device | ||||
| HALYARDFLUIDSHIELD 1 | ||||
| Procedure Mask with So | ||||
| Soft Lining and So Soft | ||||
| Earloops (25867) | Subject Device | |||
| HALYARD* Level 1 | ||||
| Procedure Mask | ||||
| (48388) | Predicate Device | |||
| KC100 Face Masks | ||||
| (K110455) | Comparison | |||
| FDA Product | ||||
| Code | FXX | FXX | FXX | Same |
| FDA | ||||
| Classification | Class II | Class II | Class II | Same |
| Regulation | ||||
| Number | 21 CFR 878.4040 | 21 CFR 878.4040 | 21 CFR 878.4040 | Same |
| Common Name | Surgical Mask | Surgical Mask | Surgical Mask | Same |
| Device Trade | ||||
| Name | HALYARD* FLUIDSHIELD* 1 | |||
| Procedure Mask with So | ||||
| Soft Lining and So Soft | ||||
| Earloops (25867) | HALYARD* Level 1 | |||
| Procedure Mask | ||||
| (48388) | KC100 Procedure | |||
| Mask | Different | |||
| Indications for | ||||
| Use | The HALYARD* | |||
| FLUIDSHIELD* 1 | ||||
| Procedure Mask with So | ||||
| Soft Lining and So Soft | ||||
| Earloops (25867) is | ||||
| intended to be worn to | ||||
| protect both the patient | ||||
| and healthcare personnel | ||||
| from transfer of | ||||
| microorganisms, body | ||||
| fluids, and particulate | ||||
| material. These face masks | ||||
| are intended for use in | ||||
| infection control practices | ||||
| to reduce the potential | ||||
| exposure of the wearer to | ||||
| blood and body fluids. The | ||||
| HALYARD* FLUIDSHIELD* 1 | ||||
| Procedure Mask with So | ||||
| Soft Lining and So Soft | ||||
| Earloops (25867) is a single | ||||
| use, disposable device, | ||||
| provided non- sterile. | The HALYARD* Level 1 | |||
| Procedure Mask | ||||
| (48388) is intended to | ||||
| be worn to protect | ||||
| both the patient and | ||||
| healthcare personnel | ||||
| from transfer of | ||||
| microorganisms, body | ||||
| fluids, and particulate | ||||
| material. These face | ||||
| masks are intended | ||||
| for use in infection | ||||
| control practices to | ||||
| reduce the potential | ||||
| exposure of the | ||||
| wearer to blood and | ||||
| body fluids. The | ||||
| HALYARD* Level 1 | ||||
| Procedure Mask | ||||
| (48388) is a single use, | ||||
| disposable device, | ||||
| provided | ||||
| non-sterile. | The Kimberly-Clark | |||
| KC100 Face Mask(s) is | ||||
| intended to be worn | ||||
| to protect both the | ||||
| patient and | ||||
| healthcare personnel | ||||
| from transfer of | ||||
| microorganisms, body | ||||
| fluids, and particulate | ||||
| material. These face | ||||
| masks are intended | ||||
| for use in infection | ||||
| control practices to | ||||
| reduce the potential | ||||
| exposure of the | ||||
| wearer to blood and | ||||
| body fluids. The | ||||
| Kimberly-Clark KC100 | ||||
| face mask(s) is a single | ||||
| use, disposable | ||||
| device(s), provided | ||||
| non-sterile. | Same | |||
| The device | ||||
| trade names | ||||
| are different | ||||
| Over-the- | ||||
| Counter / | ||||
| Prescription | OTC | OTC | OTC | Same |
| Design Attributes | ||||
| Number of | ||||
| Layers | 3 | 3 | 3 | Same |
| Color | Yellow | Yellow | Yellow, blue, green, | |
| white, lavender | Same | |||
| Style | Pleated with earloops | Pleated with earloops | Pleated with earloops | Same |
| Outer Layer | Spunbond polypropylene | Spunbond | ||
| polypropylene | Spunbond | |||
| polypropylene | Same | |||
| Middle Layer | Meltblown polypropylene | Meltblown | ||
| polypropylene | Meltblown | |||
| polypropylene | Same | |||
| Inner Layer | Polyethylene/polyester | Spunbond | ||
| polypropylene | Polyethylene/polyester | Different | ||
| Bindings | Polyester spunlace | Spunbond | ||
| polypropylene | Spunbond | |||
| polypropylene or | ||||
| polyester spunlace | Same | |||
| Earloop | Polyester/lycra | Polyester/lycra | Polyester/lycra | Same |
| Nose wire | Polyethylene coated steel | Polyethylene coated | ||
| steel | Aluminum or | |||
| polyethylene coated | ||||
| steel | Same | |||
| Mask | ||||
| Dimension | ||||
| Length | 6.875" ± 0.125" | 6.875" ± 0.125" | 6.875" ± 0.125" | Same |
| Mask | ||||
| Dimension | ||||
| Width (Flat) | 3.625" +/- 0.125" | 3.625" +/- 0.125" | 3.625" +/- 0.125" | Same |
| Performance Data/Product Claims | ||||
| ASTM F2100 | ||||
| Level | 1 | 1 | 1 | Same |
| EN 14683 | Yes | Yes | No | Different |
| Single Use | Yes | Yes | Yes | Same |
| Sterility | Non-sterile | Non-sterile | Non-sterile | Same |
| Fluid Resistance | ||||
| ASTM F1862 | 80 mmHg | 80 mmHg | 80 mmHg | Same |
| Particulate | ||||
| Filtration | ||||
| Efficiency | ||||
| ASTM F2299 | ≥ 95% | ≥ 95% | ≥ 95% | Same |
| Differential | ||||
| pressure |