(265 days)
KC100 Face Masks (K110455)
Not Found
No
The device description and performance metrics relate to the physical properties and filtration capabilities of a surgical mask, with no mention of AI or ML technologies.
No.
The device is a surgical mask intended for protection and infection control, not for treating a disease or condition.
No
Explanation: The device is a surgical mask intended for protection against microorganisms, body fluids, and particulate material, not for diagnosing medical conditions.
No
The device description clearly states it is a physical surgical mask made of non-woven materials with ties and a malleable nosepiece, indicating it is a hardware device.
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 mask is for protecting against the transfer of microorganisms, body fluids, and particulate material, and reducing exposure to blood and body fluids. This is a physical barrier function, not a diagnostic function performed in vitro (outside the body).
- Device Description: The description details the physical construction and materials of a surgical mask.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening. The performance metrics listed (filtration efficiency, fluid resistance, etc.) are related to the physical barrier properties of the mask, not diagnostic accuracy.
IVD devices are specifically designed to perform tests on biological samples to provide diagnostic information. This surgical mask does not fit that description.
N/A
Intended Use / Indications for Use
HALYARD* FLUIDSHIELD* 1 Fog-Free Surgical Mask with So Soft Lining (28806) 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 Fog-Free Surgical Mask with So Soft Lining (28806) is a single use, disposable device, provided non-sterile.
Product codes (comma separated list FDA assigned to the subject device)
FXX
Device Description
The subject device is an ASTM F2100 Level 1 (green in color) Surgical Mask. The ASTM F2100 Level 1 Surgical Mask family of products are a three-layer mask, constructed of well-known non-woven materials used in facial protection. The Surgical Masks are provided with ties and a malleable nosepiece.
The HALYARD* FLUIDSHIELD* 1 Fog-Free Surgical Mask with So Soft Lining (28806) is provided with fog-free foam. 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)
Summary of Non-Clinical Performance Testing:
Performance testing of the HALYARD* FLUIDSHIELD* 1 Fog-Free Surgical Mask with So Soft Lining (28806) was evaluated, and the results showed that acceptance criteria were met.
Test results:
- Face Mask Performance (ASTM F2100): Pass (ASTM F2100 Level 1)
- Bacterial Filtration Efficiency (ASTM F2101): Pass (≥95%)
- Particulate Filtration Efficiency (ASTM F2299): Pass (≥95%)
- Differential Pressure (EN 14683): Pass (
§ 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 4, 2024
Owens & Minor (O&M) Halyard, Inc. Anureet Singh Regulatory Affairs Manager 9120 Lockwood Blvd Mechanicsville, Virginia 23116
Re: K232820
Trade/Device Name: HALYARD* FLUIDSHIELD* 1 Fog-Free Surgical Mask with So Soft Lining (28806) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: October 30, 2023 Received: October 30, 2023
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.
1
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" (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 QS 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 mediation-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
2
DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K232820
Device Name HALYARD* FLUIDSHIELD* 1 Fog-Free Surgical Mask with So Soft Lining (28806)
Indications for Use (Describe)
HALYARD* FLUIDSHIELD* 1 Fog-Free Surgical Mask with So Soft Lining (28806) 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 Fog-Free Surgical Mask with So Soft Lining (28806) is a single use, disposable device, provided non-sterile.
Type of Use (Select one or both, as applicable)
| | Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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4
510(k) Summary – K232820
| Date of Summary | June 04, 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 |
| Device Submission Trade | |
| Name and Description | HALYARD* FLUIDSHIELD* 1 Fog-Free Surgical Mask with So Soft Lining (28806) |
| Device Product Code, | FXX |
| Class and | |
| Classification Name | II |
| Surgical Mask (21 CFR 878.4040) | |
| Predicate Device | KC100 Face Masks (K110455) |
| Subject Device | |
| Description | The subject device is an ASTM F2100 Level 1 (green in color) Surgical Mask. The |
| ASTM F2100 Level 1 Surgical Mask family of products are a three-layer mask, | |
| constructed of well-known non-woven materials used in facial protection. The | |
| Surgical Masks are provided with ties and a malleable nosepiece. |
The HALYARD* FLUIDSHIELD* 1 Fog-Free Surgical Mask with So Soft Lining
(28806) is provided with fog-free foam. These masks are single use, disposable
devices, provided non-sterile. |
| Indications for Use | HALYARD* FLUIDSHIELD* 1 Fog-Free Surgical Mask with So Soft Lining (28806)
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 Fog-Free Surgical Mask with So Soft Lining (28806) is a single
use, disposable device, provided non-sterile. |
| Technological Characteristics Comparison Table | |||
|---|---|---|---|
| Subject Device | Predicate Device | Comparison | |
| HALYARD* FLUIDSHIELD* 1 Fog- | |||
| Free Surgical Mask with So Soft | |||
| Lining (28806) | KC100 Face Masks | ||
| (K110455) | |||
| FDA Product | |||
| Code | FXX | FXX | Same |
| FDA | |||
| Classification | Class II | Class II | Same |
5
| Regulation
| Number | 21 CFR 878.4040 | 21 CFR 878.4040 | Same |
|---|---|---|---|
| Common Name | Surgical Mask | Surgical Mask | Same |
| Device Trade | |||
| Name | HALYARD* FLUIDSHIELD* 1 Fog- | ||
| Free Surgical Mask with So Soft | |||
| Lining (28806) | KC100 Surgical Mask with Fog- | ||
| Free Strip | Different | ||
| Indications for | |||
| Use | HALYARD* FLUIDSHIELD* 1 Fog- | ||
| Free Surgical Mask with So Soft | |||
| Lining (28806) 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 Fog-Free Surgical | |||
| Mask with So Soft Lining (28806) 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 |
| Design Attributes | |||
|---|---|---|---|
| Subject Device | Predicate Device | Comparison | |
| HALYARD* FLUIDSHIELD* 1 Fog- | |||
| Free Surgical Mask with So Soft | |||
| Lining (28806) | KC100 Face Masks | ||
| (K110455) | |||
| Outer Layer | Spunbond polypropylene | Spunbond polypropylene | Same |
| Middle Layer | Meltblown polypropylene | Meltblown polypropylene | Same |
| Inner Layer | Polyethylene/polyester | Polyethylene/polyester | Same |
| Bindings | Spunbond polypropylene | Spunbond polypropylene or polyester | |
| spunlace | Same | ||
| Ties | Spunbond polypropylene | Spunbond polypropylene or polyester | |
| spunlace | Same | ||
| Foam | Polyester foam/polyester | ||
| spunlace laminate, blue | Polyester foam/polyester spunlace | ||
| laminate, blue | Same | ||
| Nose wire | Aluminum | Aluminum or polyethylene coated | |
| steel | Same | ||
| Number of Layers | 3 | 3 | Same |
| Color | Green | Yellow, blue, green, white, lavender | Similar |
| Style | Pleated with ties | Pleated with ties | Same |
| ASTM Level | 1 | 1 | Same |
6
| EN 14683 (Type II) | ત્વની દિવેલા તાલુકામાં આવેલું એક ગામના લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામમાં મુખ્યત્વે ખેત-ઉપયોગ તાલુકામાં આવેલું એક ગામના લોકોનો મુખ્ય વ્યવસાય ખે | No | Different |
|---|---|---|---|
| Single Use | ત્વની દિવેલા તાલુકામાં આવેલું એક ગામના લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામમાં મુખ્યત્વે ખેત-ઉપયોગ તાલુકામાં આવેલું એક ગામના લોકોનો મુખ્ય વ્યવસાય ખે | Yes | Same |
| Sterility | Non-sterile | Non-sterile | Same |
Summary of Non-Clinical Performance Testing:
Performance testing of the HALYARD* FLUIDSHIELD* 1 Fog-Free Surgical Mask with So Soft Lining (28806) was evaluated, and the results showed that acceptance criteria were met.
| Purpose | Test | Acceptance Criteria | Result |
|---|---|---|---|
| Face Mask Performance | ASTM F2100 | ASTM F2100 Level 1 | Pass |
| Bacterial Filtration Efficiency | ASTM F2101 | ≥95% | Pass |
| Particulate Filtration Efficiency | ASTM F2299 | ≥95% | Pass |
| Differential Pressure | EN 14683 |