(541 days)
The Surgical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. When worn properly, these face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single-use, disposable device, provided non-sterile.
The Surgical Face Masks are 3-layer, flat-folded masks constructed of nonwoven polypropylene materials. The mask is provided with ear loops (Spandex) or ties (polypropylene). A malleable nose clip is placed in the layers of facemask for comfort and individualized fit. The surgical face mask will be provided in blue, white, pink, green, vellow and with the option for a visor. The surgical face masks are single-use, disposable devices, provided non-sterile.
The provided document is a 510(k) summary for a Surgical Face Mask and, as such, focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing. It does not contain information related to an AI/ML powered device, comparative effectiveness studies (MRMC), or clinical studies with human readers. Therefore, several requested sections, such as those pertaining to AI/ML, human expert involvement, and ground truth establishment from clinical data, are not applicable based on the provided text.
Here’s an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The device is a Surgical Face Mask, and the performance is evaluated based on ASTM and EN standards relevant to such masks. There are three levels of surgical face masks (Level 1, Level 2, and Level 3), each with specific acceptance criteria. The test results consistently show that the device "PASS"es all specified criteria.
Level 1 Surgical Face Mask (Model: SQ-1001)
| Item | Acceptance Criteria (Level 1) | Reported Device Performance |
|---|---|---|
| Fluid Resistance (ASTM F1862) | 29 out of 32 pass at 80 mmHg | PASS |
| Particulate Filtration Efficiency (ASTM F2299) | ≥ 95% | PASS |
| Bacterial Filtration Efficiency (ASTM F2101) | ≥ 95% | PASS |
| Differential Pressure (EN 14683 Annex C) | < 5.0 mmH2O/cm² | PASS |
| Flammability (16 CFR 1610) | Class 1 | PASS |
| Cytotoxicity (ISO 10993-5) | Non-Cytotoxic | Non-Cytotoxic |
| Irritation (ISO 10993-10) | Non-Irritating | Non-Irritating |
| Sensitization (ISO 10993-10) | Non-Sensitizing | Non-Sensitizing |
Level 2 Surgical Face Mask (Models: SQ-2001, SQ-2001H, SQ-2004, SQ-2004H)
| Item | Acceptance Criteria (Level 2) | Reported Device Performance |
|---|---|---|
| Fluid Resistance (ASTM F1862) | 29 out of 32 pass at 120 mmHg | PASS |
| Particulate Filtration Efficiency (ASTM F2299) | ≥ 98% | PASS |
| Bacterial Filtration Efficiency (ASTM F2101) | ≥ 98% | PASS |
| Differential Pressure (EN 14683 Annex C) | < 6.0 mmH2O/cm² | PASS |
| Flammability (16 CFR 1610) | Class 1 | PASS |
| Cytotoxicity (ISO 10993-5) | Non-Cytotoxic | Non-Cytotoxic |
| Irritation (ISO 10993-10) | Non-Irritating | Non-Irritating |
| Sensitization (ISO 10993-10) | Non-Sensitizing | Non-Sensitizing |
Level 3 Surgical Face Mask (Models: SQ-3001, SQ-3001H)
| Item | Acceptance Criteria (Level 3) | Reported Device Performance |
|---|---|---|
| Fluid Resistance (ASTM F1862) | 29 out of 32 pass at 160 mmHg | PASS |
| Particulate Filtration Efficiency (ASTM F2299) | ≥ 98% | PASS |
| Bacterial Filtration Efficiency (ASTM F2101) | ≥ 98% | PASS |
| Differential Pressure (EN 14683 Annex C) | < 6.0 mmH2O/cm² | PASS |
| Flammability (16 CFR 1610) | Class 1 | PASS |
| Cytotoxicity (ISO 10993-5) | Non-Cytotoxic | Non-Cytotoxic |
| Irritation (ISO 10993-10) | Non-Irritating | Non-Irritating |
| Sensitization (ISO 10993-10) | Non-Sensitizing | Non-Sensitizing |
2. Sample Size Used for the Test Set and the Data Provenance
- Test Set Sample Size:
- For Fluid Resistance (ASTM F1862), the acceptance criteria specify "29 out of 32 pass." This indicates a sample size of 32 units tested for this particular criterion.
- For other performance tests like Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, and Flammability, the sample size is not explicitly stated numerically, but it is indicated that "3 nonconsecutive lots tested" for fluid resistance, and the results for these tests are simply "PASS." This implies that sufficient samples from those lots were tested to demonstrate compliance.
- For Biocompatibility tests (Cytotoxicity, Irritation, Sensitization), the exact number of samples is not provided, but the stated results confirm the device's acceptable biological response.
- Data Provenance: The tests are non-clinical (laboratory-based) and conducted to demonstrate compliance with international standards (ASTM, EN, ISO, CFR). The document originates from Rizhao Sanqi Medical & Health Articles Co., Ltd., located in Shandong Province, China. The data is thus from laboratory testing performed in association with the manufacturer, presumably in China. The studies are retrospective in the sense that they are conducted on manufactured devices to prove compliance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable as the device is a physical product (surgical face mask) and the testing performed is non-clinical performance and biocompatibility testing according to established standards. There is no "ground truth" derived from expert interpretation of data or images in the context of an AI/ML device.
4. Adjudication Method for the Test Set
This is not applicable as the evaluations are objective laboratory tests against predefined physical and chemical performance standards, not subjective interpretations requiring adjudication.
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
This is not applicable. The submission is for a surgical face mask, not an AI/ML software device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The submission is for a surgical face mask, not an AI/ML software device.
7. The Type of Ground Truth Used
The "ground truth" for this medical device is established by objective performance specifications defined in recognized national and international standards (ASTM F1862, ASTM F2299, ASTM F2101, EN 14683, 16 CFR 1610, ISO 10993-5, ISO 10993-10). These standards define measurable thresholds for attributes like fluid resistance, filtration efficiency, differential pressure, flammability, and biological safety. The device performance is directly measured against these established quantitative and qualitative criteria.
8. The Sample Size for the Training Set
This is not applicable. The device is a physical product, not an AI/ML software that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable. The device is a physical product, not an AI/ML software.
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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.
March 24, 2022
Rizhao Sanqi Medical & Health Articles Co., Ltd. % Ivy Wang Technical Manager Shanghai Sungo Management Consulting Co., Ltd. Room 1309, Dongfang Building, 1500# Century Ave., Shanghai, Shanghai 200122 China
Re: K202903
Trade/Device Name: Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: December 24, 2021 Received: December 29, 2021
Dear Ivy Wang:
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 (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 located 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.
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
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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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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,
Clarence W. Murray, III, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K202903
Device Name Surgical Face Mask
Indications for Use (Describe)
The Surgical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. When worn properly, these face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single-use, disposable device, provided non-sterile.
Level 1 Surgical Face Mask models: SQ-1001 Level 2 Surgical Face Mask models: SQ-2001, SQ-2001H, SQ-2004, SQ-2004H Level 3 Surgical Face Mask models: SQ-3001, SQ-3001H
| 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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510(K) Summary
K202903
Date of Summary prepared: 2021-12-24
A. Applicant:
Rizhao Sanqi Medical & Health Articles Co., Ltd. Address: Heshan Industry park, Donggang District, Rizhao, Shandong Province, China Contact person: Julia Yu Title: Sales Manager Tel: +86-633-7663737 Fax: +86-633-7653718 Email: 3qmedical@3qcn.cc
Submission Correspondent:
Primary contact: Ms. Ivy Wang
Shanghai SUNGO Management Consulting Co., Ltd.
Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China
Tel: +86-21-58817802
Email: haiyu.wang@sungoglobal.com
Secondary contact: Mr. Raymond Luo
Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China
Tel: +86-21-68828050
Email: fda.sungo@gmail.com
B. Device:
Trade Name: SURGICAL FACE MASK Common Name: SURGICAL MASK Model:
Table 1 – Surgical face mask model numbers
| Mask Style | Ear loops | Tie-on | Color |
|---|---|---|---|
| Level 1 | SQ-1001 | - | |
| Level 2 | SQ-2001 | SQ-2001H | Blue, white, pink, |
| Level 2 with visor | SQ-2004 | SQ-2004H | green, yellow |
| Level 3 | SQ-3001 | SQ-3001H |
Regulatory Information Classification Name: Surgical Face Mask Classification: Class II Product code: FXX Regulation Number: 878.4040 Review Panel: Surgical Apparel
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| C. Predicate device: | ||
|---|---|---|
| K160269 | Surgical Face Masks (Ear loops and Tie-on) | SAN-M PACKAGE CO., LTD. |
D. Indications for use of the device:
The Surgical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. When worn properly, these face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single-use, disposable device, provided non-sterile.
E. Device Description:
The Surgical Face Masks are 3-layer, flat-folded masks constructed of nonwoven polypropylene materials. The mask is provided with ear loops (Spandex) or ties (polypropylene). A malleable nose clip is placed in the layers of facemask for comfort and individualized fit. The surgical face mask will be provided in blue, white, pink, green, vellow and with the option for a visor. The surgical face masks are single-use, disposable devices, provided non-sterile.
F. Technological Comparison with predicate device
| Device | Subject Device | Predicate Device | Result | |
|---|---|---|---|---|
| 510K # | K202903 | K160269 | ||
| Manufacturer | Rizhao Sanqi Medical & Health ArticlesCo., Ltd. | SAN-M PACKAGE CO., LTD. | ||
| Model Name | SURGICAL FACE MASK | Surgical Face Masks (Ear loopsand Tie-on) | Similar | |
| Classification | Class II Device, FXX (21 CFR878.4040) | Class II Device, FXX (21 CFR878.4040) | Same | |
| Intend use | The Surgical Face Mask is intended tobe worn to protect both the patientand healthcare personnel fromtransfer of microorganisms, bodyfluids, and particulate material.When worn properly, these face masksare intended for use in infectioncontrol practices to reduce thepotential exposure to blood and bodyfluids. This is a single-use, disposabledevice, provided non-sterile. This is asingle use, disposable device(s),provided non-sterile. | The surgical face masks areintended to be worn to protectboth the patient and healthcarepersonnel from transfer ofmicroorganisms, body fluids, andparticulate material. These facemasks are intended for use ininfection control practices toreduce the potential exposure toblood and body fluids. This is asingle-use, disposable device,provided non-sterile. | Same | |
| Materials | Level 1 | Level 1 | - | |
| Level 2 | Level 2 | |||
| Level 3 | Level 3 | |||
| Outer layer | Spunbond Polypropylene | Polypropylene | Same | |
| Inner layer | Spunbond Polypropylene | Polypropylene | Same | |
| Filter layer | Melt-blown | 1. Polypropylene spunbond | Similar | |
| 1.Melt-blown | ||||
| Polypropylene | Polypropylene2.Microporous Film | 2. Polypropylene meltblown | ||
| Nose wire | Steel coated by polypropylene | Polyethylene coated steel wire | Different | |
| Ear loops | Spandex | Polyester, polyurethane | Different | |
| Tie-on | Spunbond Polypropylene | Polypropylene spunbond orpolyester spunbond | Similar | |
| Design Features | Ear Loops, Tie-on | Ear Loops, Tie-on | Same | |
| Offer with visor | Yes | Yes | Same | |
| Mask style | 3 Flat Pleated | 4 Flat Pleated | 4 Flat Pleated | Similar |
| Color | Blue, white, pink, green, yellow | white or blue | Different | |
| Dimension(Length) | 175±5mm | 175±5mm | Same | |
| Dimension(Width) | 95±5mm | 95±5mm | Same | |
| OTC use | Yes | Yes | Same | |
| Sterility | Non-Sterile | Non-Sterile | Same | |
| Use | Single Use, Disposable | Single Use, Disposable | Same | |
| Biocompatibility | Non-cytotoxic, Non-sensitizing,non-irritating | Non-cytotoxic, Non-sensitizing,non-irritating | Same | |
| PerformanceTesting (ASTM2100) | Level 1 | Level 2 Level 3 | Level 1 Level 2 Level 3 | - |
| FluidResistance | Meet ASTM F1862-17 | Meet ASTM F1862-13 | similar | |
| ParticulateFiltrationEfficiency | Meet ASTM F2299-17 | Meet ASTM F2299-03 | Similar | |
| BacterialFiltrationEfficiency | Meet ASTM F2101-19 | Meet ASTM F2101-14 | Similar | |
| DifferentialPressure | Meet EN 14683: 2019, Annex C | Meet MIL-M36945C | Different | |
| Flammability | Meet 16 CFR 1610 | Meet 16 CFR 1610 | Similar | |
| Biocompatibility | Non-cytotoxic, non-sensitizing,non-irritating | Non-cytotoxic, non-sensitizing,non-irritating | Same |
Table 2 General Comparison
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Rizhao Sanqi Medical & Health Articles Co., Ltd. Heshan Industry park, Donggang District, Rizhao, Shandong Province, China
G. Non-Clinical Test Conclusion
Non-clinical tests were conducted to verify that the proposed device met all design specifications as was same to the predicate device. The test results demonstrated that the proposed device complies with the following standards and the requirements stated in the Guidance for Industry and FDA Staff: Surgical Masks – Premarket Notification [510(k)] Submission issued on March 5, 2004:
- A ISO 10993-5: 2009 Biological Evaluation of Medical Devices -- Part 5: Tests For In VitroCytotoxicity
-
ISO 10993-10: 2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin
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Sensitization
-
ASTM F2100, Standard Specification for Performance of Materials Used In Medical Face Masks
-
ASTM F1862, Standard Test Method for Resistance of Medical Face Masks To Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume At A Known Velocity);
-
EN 14683, Medical Face Masks-Requirements and Test Methods;
-
ASTM F2101, Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) Of Medical Face Mask Materials, Using A Biological Aerosol of Staphylococcus Aureus;
-
ASTM F2299, Standard test method for determining the initial efficiency of materials used in medical face masks to penetration by particulates using latex spheres;
-
16 CFR 1610, Standard for the Flammability of clothing textiles;
| Mask Style | Ear loops | Tie-on | Color |
|---|---|---|---|
| Level 1 | SQ-1001 | - | |
| Level 2 | SQ-2001 | SQ-2001H | Blue, white, pink, |
| Level 2 with visor | SQ-2004 | SQ-2004H | green, yellow |
| Level 3 | SQ-3001 | SQ-3001H |
For level 1: SQ-1001
| Item | Purpose | Acceptance CriteriaLevel 1 | Result |
|---|---|---|---|
| Fluid ResistancePerformance ASTMF1862 | The purpose of the performance testing is to demonstrate the functionality of the subject device. | 29 out of 32 pass at 80 mmHg | 3 nonconsecutive lots testedPASS |
| Particulate FiltrationEfficiency ASTM F2299 | $\ge$ 95% | PASS | |
| Bacterial FiltrationEfficiency ASTM F2101 | $\ge$ 95% | PASS | |
| Differential Pressure(Delta P) EN 14683Annex C | <5.0 mmH2O/cm² | PASS | |
| Flammability 16 CFR1610 | Class 1 | PASS |
For: Blue, white, pink, green, yellow
| Item | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| Cytotoxicity | The purpose of the testing is to demonstrate the safety of the subject device. | Non-Cytotoxic | Under the conditions of the study, the device is non-cytotoxic. |
| Irritation | The purpose of the testing is to demonstrate the safety of the subject device. | Non-Irritating | Under the conditions of the study, the device is non-irritating. |
| Sensitization | The purpose of the testing is to demonstrate the safety of the subject device. | Non-Sensitizing | Under the conditions of the study, the device is non-sensitizing |
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For level 2: SQ-2001 and SQ-2001H
| Item | Purpose | Acceptance CriteriaLevel 2 | Result |
|---|---|---|---|
| Fluid ResistancePerformance ASTMF1862 | The purpose of theperformance testing isto demonstrate thesubject device. | 29 out of 32pass at 120 mmHg | 3 nonconsecutive lots testedPASS |
| Particulate FiltrationEfficiency ASTM F2299 | The purpose of theperformance testing isto demonstrate thesubject device. | $\ge$ 98% | PASS |
| Bacterial FiltrationEfficiency ASTM F2101 | The purpose of theperformance testing isto demonstrate thesubject device. | $\ge$ 98% | PASS |
| Differential Pressure(Delta P) EN 14683Annex C | The purpose of theperformance testing isto demonstrate thesubject device. | <6.0 mmH2O/cm² | PASS |
| Flammability 16 CFR1610 | The purpose of theperformance testing isto demonstrate thesubject device. | Class 1 | PASS |
For: Blue, white, pink, green, yellow
| Item | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| Cytotoxicity | The purpose of thetesting is todemonstrate thesafety of the subjectdevice. | Non-Cytotoxic | Under the conditions of the study, thedevice is non-cytotoxic. |
| Irritation | The purpose of thetesting is todemonstrate thesafety of the subjectdevice. | Non-Irritating | Under the conditions of the study, thedevice is non-irritating. |
| Sensitization | The purpose of thetesting is todemonstrate thesafety of the subjectdevice. | Non-Sensitizing | Under the conditions of the study, thedevice is non-sensitizing |
For Level 2 with visor: SQ-2004 and SQ-2004H
| Item | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| Level 2 | 3 nonconsecutive lots tested | ||
| Fluid ResistancePerformance ASTMF1862 | The purpose of theperformance testing isto demonstrate thefunctionality of thesubject device. | 29 out of 32pass at 120 mmHg | PASS |
| Particulate FiltrationEfficiency ASTM F2299 | $\ge$ 98% | PASS | |
| Bacterial FiltrationEfficiency ASTM F2101 | $\ge$ 98% | PASS |
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Rizhao Sanqi Medical & Health Articles Co., Ltd. Heshan Industry park, Donggang District, Rizhao, Shandong Province, China
| DifferentialPressure | ||
|---|---|---|
| (Delta P) EN 14683Annex C | <6.0 mmH2O/cm² | PASS |
| Flammability 16 CFR1610 | Class 1 | PASS |
For: Blue, white, pink, green, yellow
| Item | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| Cytotoxicity | The purpose of thetesting is todemonstrate thesafety of the subjectdevice. | Non-Cytotoxic | Under the conditions of the study, thedevice is non-cytotoxic. |
| Irritation | The purpose of thetesting is todemonstrate thesafety of the subjectdevice. | Non-Irritating | Under the conditions of the study, thedevice is non-irritating. |
| Sensitization | The purpose of thetesting is todemonstrate thesafety of the subjectdevice. | Non-Sensitizing | Under the conditions of the study, thedevice is non-sensitizing. |
For level 3: SQ-3001 and SQ-3001H
| Item | Purpose | Acceptance CriteriaLevel 3 | Result |
|---|---|---|---|
| Fluid ResistancePerformance ASTMF1862 | The purpose of theperformance | 29 out of 32 pass at 160 mmHg | 3 nonconsecutive lots testedPASS |
| Particulate FiltrationEfficiency ASTM F2299 | testing is to demonstrate | $\geq$ 98% | PASS |
| Bacterial FiltrationEfficiency ASTM F2101 | the functionality | $\geq$ 98% | PASS |
| Differential Pressure(Delta P) EN 14683Annex C | of the subject device. | <6.0 mmH2O/cm2 | PASS |
| Flammability 16 CFR1610 | Class 1 | PASS |
For: Blue, white, pink, green, yellow
| Item | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| Cytotoxicity | The purpose of the testing is to demonstrate the safety of the subject device. | Non-Cytotoxic | Under the conditions of the study, the device is non-cytotoxic. |
| Irritation | The purpose of the testing is to demonstrate the safety of the subject device. | Non-Irritating | Under the conditions of the study, the device is non-irritating. |
| Sensitization | The purpose of the testing is to demonstrate the safety of the subject device. | Non-Sensitizing | Under the conditions of the study, the device is non-sensitizing |
H. Clinical Test Conclusion
No clinical study is included in this submission.
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l. Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device K160269.
§ 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.