(276 days)
The Fluidshield* 2 Surgical Mask 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 Fluidshield* 2 Surgical Mask is a single use, disposable device, provided non-sterile.
The Fluidshield* 2 Procedure Mask 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 Fluidshield* 2 Procedure Mask is a single use, disposable device, provided non-sterile.
The subject device(s) are ASTM Level 2 Surgical and Procedure Mask(s). Fluidshield* 2 Surgical Mask(s), Fluidshield* 2 Procedure Mask(s) family of products are a four-layer mask, constructed of well-known non-woven materials used in facial protection. The Surgical Masks are provided with ties while the Procedure Masks are provided with earloops and a malleable nosepiece.
The Fluidshield* 2 Surgical Mask(s), Fluidshield* 2 Procedure Mask(s) family will be provided in designs with and without a protective visor. The Fluidshield* 2 Surgical Mask(s), Fluidshield* 2 Procedure Mask(s) family are single use, disposable devices, provided non-sterile.
The provided document is a 510(k) Premarket Notification for medical devices, specifically surgical and procedure masks. It describes non-clinical performance testing to demonstrate substantial equivalence to a predicate device, rather than a study proving the device meets acceptance criteria derived from clinical performance. Therefore, many of the requested items (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set sample size, ground truth for training set) are not applicable or cannot be extracted from this document as it pertains to a different type of evaluation.
However, I can extract information related to the acceptance criteria and reported device performance from the non-clinical testing section.
1. Table of acceptance criteria and the reported device performance:
| Purpose | Test | Acceptance Criteria | Reported Device Performance (Result) |
|---|---|---|---|
| Level 2 - Face Mask Performance | ASTM F2100 | ASTM Level 2 | Pass |
| Bacterial Filtration Efficiency | ASTM F2101 | >98% | Pass |
| Particulate Filtration Efficiency | ASTM F2299 | >98% | Pass |
| Differential Pressure | EN 14683 | <6.0 mmH2O/cm² | Pass |
| Fluid Resistance | ASTM F1862 | 120 mmHg | Pass |
| Flammability | 16 CFR Part 1610 | Class 1 | Pass |
| Biocompatibility (Cytotoxicity) | ISO 10993-5 | Non-cytotoxic | Pass |
| Biocompatibility (Sensitization) | ISO 10993-10 | Non-sensitizing | Pass |
| Biocompatibility (Irritation) | ISO 10993-10 | Non-irritant | Pass |
2. Sample size used for the test set and the data provenance:
- Sample size used for the test set: Not specified in the provided document. The document refers to "testing" the proposed device(s) but does not detail the number of units or samples tested for each criteria.
- Data provenance: Not explicitly stated, but these are non-clinical (laboratory) tests performed on the device by the manufacturer as part of the 510(k) submission process. It's retrospective in the sense that the testing was completed before the submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This document describes non-clinical performance testing against established standards, not a study involving expert-established ground truth for a diagnostic device.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This pertains to expert review for diagnostic studies, not laboratory performance testing of physical characteristics.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is a 510(k) submission for surgical and procedure masks, not an AI-assisted diagnostic device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a 510(k) submission for surgical and procedure masks, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical tests, the "ground truth" is defined by the established international and national standards (e.g., ASTM F2100, ASTM F2101, EN 14683, ISO 10993 series). The device's performance is measured against the quantitative or qualitative criteria set forth in these standards.
8. The sample size for the training set:
- Not applicable. This document describes material and physical performance testing of a physical device, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable for the same reason as above.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
June 14, 2024
Owens & Minor (O&M) Halyard, Inc. Angela Bunn Sr. Director, Global Regulatory Affairs 9120 Lockwood Blvd Mechanicsville, Virginia 23116
Re: K232812
Trade/Device Name: Fluidshield* 2 Fog-Free Surgical Mask (62113); Fluidshield* 2 Fog-Free Surgical Mask with Wraparound Visor (62114); Fluidshield* 2 Procedure Mask with SO SOFT* Earloops (62115); Fluidshield* 2 Procedure Mask with SO SOFT* Earloops and WrapAround Visor (62116) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: May 9, 2024 Received: May 9, 2024
Dear Angela Bunn:
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.
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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,
Image /page/1/Picture/7 description: The image shows the text "Allan Guan-S" in a large, sans-serif font. The text is black and is set against a white background. There is a faint, light blue watermark in the background that is partially obscured by the text.
For Bifeng Qian, M.D., Ph.D. Assistant Director
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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
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Indications for Use
510(k) Number (if known) K232812
Device Name
Fluidshield * 2 Fog-Free Surgical Mask (62113)
Fluidshield * 2 Fog-Free Surgical Mask with Wraparound Visor (62114)
Fluidshield * 2 Procedure Mask with SO SOFT* Earloops (62115)
Fluidshield * 2 Procedure Mask with SO SOFT* Earloops and WrapAround Visor (62116)
Indications for Use (Describe)
The Fluidshield* 2 Surgical Mask is intended to be worn to protect 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 Fluidshield* 2 Surgical Mask is a single use, disposable device, provided non-sterile.
The Fluidshield* 2 Procedure Mask is intended to be worn to protect both the patient and healthcare persomel 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 Fluidshield* 2 Procedure Mask 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 Dver-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/4/Picture/0 description: The image shows the Owens & Minor logo, which consists of the letters "OM" in a stylized font, with the words "Owens & Minor" to the right of the letters. The letters "OM" are in a dark red color, while the words "Owens & Minor" are in a light gray color. Below the logo, the text "510(k) Summary K232812" is written in a bold font.
| Date Summarywas Prepared | June 14, 2024 |
|---|---|
| 510(k) Submitter | O & M Halyard, Inc.1 Edison DriveAlpharetta, GA 30005 |
| Primary Contact forthis 510(k) Submission | Angela L. Bunn, RACTel: 470-347-7147Email: angela.bunn@owens-minor.com |
| Marketed CommonName | Surgical Mask and Procedure Mask |
| Device Submission TradeName and Description | Fluidshield * 2 Fog-Free Surgical Mask (62113)Fluidshield * 2 Fog-Free Surgical Mask with Wraparound Visor(62114)Fluidshield * 2 Procedure Mask with SO SOFT* Earloops,(62115)Fluidshield* 2 Procedure Mask with SO SOFT* Earloops andWrapAround Visor (62116) |
| Device Common Name | Surgical Mask and Procedure Mask |
| Device Product Codeand Classification Name | FXX Class II, 21 CFR §878.4040 Surgical Apparel |
| Predicate Device | KC 200 Fluidshield* Surgical Masks and Procedure Masks andKC 300 Fluidshield* Surgical Masks and Procedure Masks(K111402) |
| Subject DeviceDescription | The subject device(s) are ASTM Level 2 Surgical andProcedure Mask(s). Fluidshield* 2 Surgical Mask(s),Fluidshield* 2 Procedure Mask(s) family of products are a four-layer mask, constructed of well-known non-woven |
| materials used in facial protection. The Surgical Masks areprovided with ties while the Procedure Masks are provided withearloops and a malleable nosepiece.The Fluidshield* 2 Surgical Mask(s), Fluidshield* 2 ProcedureMask(s) family will be provided in designs with and without aprotective visor. The Fluidshield* 2 Surgical Mask(s),Fluidshield* 2 Procedure Mask(s) family are single use,disposable devices, provided non-sterile. | |
| Indications for Use | The Fluidshield* 2 Surgical Mask is intended to be worn to protectboth the patient and healthcare personnel from transfer ofmicroorganisms, body fluids, and particulate material. Theseface masks are intended for use in infection control practices toreduce the potential exposure of the wearer to blood and bodyfluids. The Fluidshield* 2 Surgical Mask is a single use,disposable device, provided non-sterile.The Fluidshield* 2 Procedure Mask is intended to be worn toprotect both the patient and healthcare personnel from transfer ofmicroorganisms, body fluids, and particulate material. Theseface masks are intended for use in infection control practices toreduce the potential exposure of the wearer to blood and bodyfluids. The Fluidshield* 2 Procedure Mask is a single use,disposable device, provided non-sterile. |
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Image /page/5/Picture/0 description: The image contains the logo for Owens & Minor. The logo features a stylized "OM" in a dark red color, with the words "Owens & Minor" in a gray serif font to the right of the symbol. The logo is clean and professional, suggesting a well-established company.
| Technological Characteristics Comparison Table | |||
|---|---|---|---|
| Subject Device | Predicate Device(K111402)KC 300 and KC 200Face Masks | Comparison | |
| FDA Product Code | FXX | FXX | Same |
| FDA Classification | Class II | Class II | Same |
| Regulation Number | 21 CFR 878.4040 | 21 CFR 878.4040 | Same |
| Common Name | Surgical Mask | Surgical Mask | Same |
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Image /page/6/Picture/0 description: The image shows the logo for Owens & Minor, a healthcare logistics company. The logo consists of a stylized "OM" in a dark red color, with the words "Owens & Minor" in a light gray color to the right of the "OM" symbol. The "OM" symbol is made up of several horizontal lines, creating a modern and abstract design. The overall design is clean and professional, reflecting the company's focus on healthcare and logistics.
| Device Trade Name | Fluidshield * 2 Fog-FreeSurgical Mask (62113) | KC200 Procedure Mask | Similar |
|---|---|---|---|
| Fluidshield * 2 Fog-FreeSurgical Mask withWraparound Visor (62114) | KC200 Procedure Mask,fog-free with visor | ||
| Fluidshield * 2 ProcedureMask with SO SOFT*Earloops, (62115) | KC200 Surgical Mask,fog-free | ||
| Fluidshield* 2 ProcedureMask with SO SOFT*Earloops and WrapAroundVisor (62116) | KC200 Surgical Mask,fog-free with visor | ||
| KC300 Procedure Mask,Fluidshield*, fog-free | |||
| KC300 Procedure Mask,Fluidshield*, fog-free withvisor | |||
| KC300 Surgical Mask,Fluidshield*, fog-free | |||
| KC300 Surgical Mask,Fluidshield*, fog-free withvisor | |||
| Intended Use | The Fluidshield* 2 SurgicalMask is intended to be wornto protect both the patientand healthcare personnelfrom transfer ofmicroorganisms, bodyfluids, and particulatematerial. These face masksare intended for use ininfection control practices toreduce the potentialexposure of the wearer toblood and body fluids. TheFluidshield* 2 SurgicalMask is a single use, | The Kimberly-Clark,KC200 and KC300 FaceMask(s) are intended to.beworn to protect both thepatient and healthcarepersonnel from transfer ofmicroorganisms, bodyfluids, and particulatematerial. These face masksare intended for use ininfection control practicesto reduce the potentialexposure of the wearer toblood and body fluids. TheKimberly-Clark, KC200 | SameThissubmissioncovers the KC300 and KC200 BlueSurgical orProcedureMasks. |
| device, provided non-sterile.The Fluidshield* 2Procedure Mask is intendedto be worn to protect boththe patient and healthcarepersonnel from transfer ofmicroorganisms, bodyfluids, and particulatematerial. These face masksare intended for use ininfection control practices toreduce the potentialexposure of the wearer toblood and body fluids. TheFluidshield* 2 ProcedureMask is a single use,disposable device, providednon-sterile. | and KC300 face mask(s) isa single use, disposabledevice(s), provided non-sterile. | ||
| Materials of Construction for Surgical Mask Family (Codes 62113 and 62114) |
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Image /page/7/Picture/0 description: The image shows the logo for Owens & Minor. The logo consists of the letters "OM" in a stylized font, with the "O" made up of horizontal lines. To the right of the letters is the text "Owens & Minor" in a serif font. The "OM" is in a dark red color, while the "Owens & Minor" text is in gray.
| Structure | Material of Layer forK232812 | Material cleared underK111402 | Same or Different |
|---|---|---|---|
| Code 62113 Materials of Construction | |||
| Outer Layer | Polyester Cellulose | Spunbond polypropylene(or) Polyester Cellulose | Same |
| 2nd Layer | Spunbond polypropylene | Spunbond polypropylene | Same |
| Media Filter | Meltblown polypropylene | Meltblown polypropylene | Same |
| Inner Layer | Polyester Cellulose | Polyester Cellulose | Same |
| Top Binding | Spunbond polypropylene | Spunbond polypropylene,Polyester spunlace | Same |
| Lower Binding | Spunbond polypropylene | Spunbond polypropylene,Polyester spunlace | Same |
| Ties (Surgical) | Spunbond polypropylene | Polyester spunlace | Different |
| Foam | Polyester/PolyesterSpunlace laminate | Polyester/PolyesterSpunlace laminate | Same |
| Foam | Polyester | Polyester | Same |
| Nose Wire | Aluminum | Aluminum | Same |
| Code 62114 Materials of Construction | |||
| Outer Layer | Polyester Cellulose | Spunbond polypropylene(or) Polyester Cellulose | Same |
| 2nd Layer | Spunbond polypropylene | Spunbond polypropylene | Same |
| Media Filter | Meltblown polypropylene | Meltblown polypropylene | Same |
| Inner Layer | Polyester Cellulose | Polyester Cellulose | Same |
| Top Binding | Spunbond polypropylene | Spunbond polypropylene(or) Polyester spunlace | Same |
| Lower Binding | Polyester spunlace | Spunbond polypropylene(or) Polyester spunlace | Same |
| Ties (Surgical) | Polyester spunlace | Polyester spunlace | Same |
| Foam | Polyester | Polyester/Polyester | Same |
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Image /page/8/Picture/0 description: The image shows the logo for Owens & Minor. The logo consists of the letters "OM" in a stylized font, with the word "Owens" above the word "Minor" to the right of the letters. The letters "OM" are in a dark red color, while the words "Owens" and "Minor" are in a gray color.
| Visor | Polyester Film | Spunlace laminate | Same | ||
|---|---|---|---|---|---|
| Nose Wire | Aluminum | Aluminum | Same | ||
| Materials of Construction for Procedure Mask Family (Codes 62115, 62116) | |||||
| Structure | Material of Layer forK232812 | Material cleared underK111402 | Same or Different | ||
| Code 62115 Materials of Construction | |||||
| Outer Layer | Polyester Cellulose | Spunbond polypropylene(or) Polyester Cellulose | Same | ||
| 2nd Layer | Spunbond polypropylene | Spunbond polypropylene | Same | ||
| Media Filter | Meltblown polypropylene | Meltblown polypropylene | Same | ||
| Inner Layer | Polyester Cellulose | Polyester Cellulose | Same | ||
| Top Binding | Polyester spunlace | Polyester spunlace | Same | ||
| Lower Binding | Polyester spunlace | Polyester spunlace | Same | ||
| Earloops (Procedure) | Polyester lycra | Polyester lycra | Same | ||
| Nose Wire | Aluminum | Aluminum | Same | ||
| Code 62116 Materials of Construction | |||||
| Outer Layer | Polyester Cellulose | Spunbond polypropylene(or) Polyester Cellulose | Same | ||
| 2nd Layer | Spunbond polypropylene | Spunbond polypropylene | Same | ||
| Media Filter | Meltblown polypropylene | Meltblown polypropylene | Same | ||
| Inner Layer | Polyester Cellulose | Polyester Cellulose | Same | ||
| Top Binding | Polypropylene spunbond | Polyester spunlace | Different | ||
| Lower Binding | Polyester spunlace | Polyester spunlace | Same | ||
| Earloops (Procedure) | Polyester lycra | Polyester lycra | Same | ||
| Foam | Polyester foam/polyesterspunlace laminate | Polyester foam/polyesterspunlace laminate | Same | ||
| Visor | Polyester Film | Polyester Film | Same | ||
| Nose Wire | Aluminum | Aluminum | Same | ||
| Design Attributes for Surgical Masks | |||||
| # of Layers | 4-layer | 4-layer | Same | ||
| Color | Blue with Orange Print | Blue with Orange Print | Same | ||
| Ties (Surgical) | Yes | Yes | Same | ||
| Visor | Some designs contain avisor | Some designs contain avisor | Same | ||
| Nose Wire | Enclosed | Enclosed | Same | ||
| Design Attributes for Procedure Masks | |||||
| # of Layers | 4-layer | 4-layer | Same | ||
| Color | Blue | Blue | Same | ||
| Earloops (Procedure) | Yes | Yes | Same | ||
| Visor | Some designs contain avisor | Some designs contain avisor | Same | ||
| Performance Data/Product Claims | |||||
| Fluid Resistance Level | 2 | 2 and 3 | Same | ||
| EN 14683 | Yes | No | Different |
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Image /page/9/Picture/0 description: The image shows the Owens & Minor logo above a table. The table has two rows and two columns. The first row indicates "Single Use Device" and "Yes", while the second row indicates "Sterility" and "Non-Sterile".
| Single Use Device | Yes | Yes | Same |
|---|---|---|---|
| Sterility | Non-Sterile | Non-Sterile | Same |
Non-Clinical Performance Testing Standards
Non-clinical tests were conducted to verify that the proposed device(s) met all design specifications as was same/similar to the predicate device(s). The test results demonstrated that the proposed device complies with the following standards:
| Purpose | Test | Acceptance Criteria | Result |
|---|---|---|---|
| Level 2 - Face Mask Performance | ASTM F2100 | ASTM Level 2 | Pass |
| Bacterial Filtration Efficiency | ASTM F2101 | >98% | Pass |
| Particulate Filtration Efficiency | ASTM F2299 | >98% | Pass |
| Differential Pressure | EN 14683 | <6.0 mmH2O/cm2 | Pass |
| Fluid Resistance | ASTM F1862 | 120 mmHg | Pass |
| Flammability | 16 CFR Part 1610 | Class 1 | Pass |
| Biocompatibility | ISO 10993 | ||
| Cytotoxicity | ISO 10993-5 | Non-cytotoxic | Pass |
| Sensitization | ISO 10993-10 | Non-sensitizing | Pass |
| Irritation | ISO 10993-10 | Non-irritant | Pass |
Summary of Clinical Performance Testing:
Not applicable
Conclusion:
The conclusions drawn from the nonclinical tests demonstrate that the Fluidshield* 2 Surgical Mask(s), and Fluidshield* 2 Procedure Mask(s) are as safe, as effective and perform as well as or better than the legally marketed KC200 and KC300 Face Masks (K111402).
§ 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.