(106 days)
The Surgical Isolation Cover Gown is intended to protect health care persomel from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. In addition, the Surgical Isolation Cover Gown meets the requirements of an AAMI Level 3 barrier protection for an isolation gown per ANSI/A AMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities (ANSI/AAMI PB70). The Surgical Isolation Cover Gown is a single use, disposable medical device provided non-sterile.
The proposed device is intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. The proposed device is a single use, disposable medical device provided non-sterile. The proposed device is available in nine sizes, including XS, S, M, L, XL, 2XL, 3XL, 4XL, 5XL. The barrier protection level for Surgical Isolation Cover Gown meets AAMI Level 3. The proposed device is provided in yellow.
The provided document is a 510(k) premarket notification for a medical device, specifically a "Surgical Isolation Cover Gown." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel clinical effectiveness or diagnostic accuracy for an AI/ML powered device.
Therefore, the information typically requested for AI/ML device studies (such as sample sizes for test/training sets, expert ground truth establishment, MRMC studies, standalone algorithm performance, and effect sizes) is not applicable to this document. This document details the physical and biological performance characteristics of a protective garment.
However, I can extract the acceptance criteria and reported device performance from the provided tables, as well as information about the testing methodology for this type of medical device.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Flammability | Evaluate the flammability of the test sample in accordance with 16 CFR Part 1610 Standard for the Flammability of Clothing Textiles. | Meets Class 1 requirements | Class 1 |
| Hydrostatic Pressure | Determine the hydrostatic pressure of the test sample in accordance with AATCC 127: 2017 Water Resistance: Hydrostatic Pressure Test. | >50 cm H2O | Mean = 70.63 cm H2O (Max = 72.33 cm H2O, Min = 68.88 cm H2O) |
| Water Impact | Determine the water impact of the test sample in accordance with AATCC 127: 2017 Water Resistance: Hydrostatic Pressure Test. | ≤1.0 g | Mean = 0.58 g (Max = 0.69 g, Min = 0.49 g) |
| Breaking Strength | Evaluate the breaking strength of the test sample in accordance with ASTM D 5034:2009(2017) Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test). | >20 N | MD: Mean = 74.82 N (Max = 79.64 N, Min = 70.43 N) CD: Mean = 49.35 N (Max = 55.18 N, Min = 40.96 N) |
| Tearing Strength | Evaluate the tearing strength of the test sample in accordance with ASTM D5587:2015(2019) Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure. | >20 N | MD: Mean = 62.92 N (Max = 69.72 N, Min = 62.01 N) CD: Mean = 32.57 N (Max = 34.99 N, Min = 30.05 N) |
| Linting | Evaluate the linting of the test sample in accordance with ISO 9073-10:2003 Textiles-Test Methods for Nonwovens-Part 10: Lint and Other Particles Generation in the Dry State. | Log10(particle count) < 4 | Side A: Log10(lint count): Mean 3.4 Side B: Log10(lint count): Mean 3.4 |
| Seam Strength | Evaluate the seam strength of the test sample in accordance with ASTM D1683/D1683M: 2017(2018) Standard Test Method for Failure in Sewn Seams of Woven Fabrics. | >50 N | Mean = 102.92 N (Max = 109.98 N, Min = 95.37 N) |
| Air Permeability | Evaluate the air permeability of the test sample in accordance with ASTM D737: 2018 Standard Test Method for Air Permeability of Textile Fabrics. | >30 ft³/min/ft² | Mean 35.4 ft³/min/ft² |
| Cytotoxicity | Evaluate the cytotoxicity of the test sample in accordance with ISO 10993-5:2009. | Viability $\ge$ 70% of the blank. 50% extract should have $\ge$ 100% extract viability. | Viability $\ge$ 70% of the blank. 50% extract had higher viability than 100% extract. Non-cytotoxic. |
| Sensitization | Evaluate the sensitization of the test sample in accordance with ISO 10993-10:2010. | Non-sensitizing | Non-sensitizing. |
| Irritation | Evaluate the irritation of the test sample in accordance with ISO 10993-10:2010. | Non-irritating | Non-irritating. |
| Barrier Protection Level | - | Level 3 per AAMI PB 70 | Level 3 per AAMI PB 70 |
Study Proving Device Meets Acceptance Criteria:
The study proving the device meets the acceptance criteria is a series of non-clinical performance tests conducted according to recognized international and national standards.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not explicitly state the number of individual garments or test specimens used for each particular test (e.g., how many samples were used to calculate the mean Hydrostatic Pressure). However, standard testing protocols for these types of materials and products typically involve multiple specimens to ensure representative results.
- Data Provenance: The device manufacturer is "Wuhan Dymex Healthcare Co., Ltd." in Wuhan, China. The tests are reported to have been performed in accordance with international (ISO, AATCC) and national (ASTM, 16 CFR) standards. The nature of these tests (material properties) suggests they are prospective tests performed on manufactured samples.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not Applicable. This is a physical and biological performance testing of a medical device (a gown), not an AI/ML device that generates diagnostic outputs requiring expert interpretation or ground truth labeling (e.g., for images or clinical data). The "ground truth" for these tests comes from the physical/chemical measurements themselves against defined standards.
4. Adjudication Method for the Test Set:
- Not Applicable. As per point 3, there's no need for expert adjudication in these types of performance tests. The results are quantitative measurements against predefined physical/chemical standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. This is not an AI/ML or diagnostic imaging device. MRMC studies are used to evaluate the impact of a new technology (e.g., AI assistance) on human reader performance, which is not relevant for a surgical isolation gown.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an algorithm or software device. The "standalone" performance here refers to the gown's inherent physical and biological barrier properties, which were measured directly through the non-clinical tests.
7. The Type of Ground Truth Used:
- For physical properties (e.g., hydrostatic pressure, breaking strength, linting), the "ground truth" is established by direct measurement of the material and product characteristics against the specifications outlined in the referenced standards (e.g., ANSI/AAMI PB70, ASTM, AATCC, ISO).
- For biocompatibility (cytotoxicity, sensitization, irritation), the "ground truth" is established through laboratory testing against the criteria specified in ISO 10993 (e.g., cell viability percentages, absence of specific reactions).
8. The Sample Size for the Training Set:
- Not Applicable. There is no "training set" as this is not an AI/ML device that requires machine learning model training.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. As per point 8, there is no training set for this type of medical device submission.
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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: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
June 10, 2022
Wuhan Dymex Healthcare Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co.,Ltd P.O.box 120-119 Shanghai. 200120 China
Re: K220528
Trade/Device Name: Surgical Isolation Cover Gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYC Dated: May 5, 2022 Received: May 9, 2022
Dear Diana Hong:
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-reporting-
combination-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 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,
Bifeng Qian, M.D., Ph.D. Acting Assistant Director DHT4B: Division of Infection Control and Plastic 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K220528
Device Name Surgical Isolation Cover Gown
Indications for Use (Describe)
The Surgical Isolation Cover Gown is intended to protect health care persomel from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. In addition, the Surgical Isolation Cover Gown meets the requirements of an AAMI Level 3 barrier protection for an isolation gown per ANSI/A AMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities (ANSI/AAMI PB70). The Surgical Isolation Cover Gown is a single use, disposable medical 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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510(k) Summary
This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.
The assigned 510(k) Number: K220528
-
- Date of Preparation: 05/05/2022
-
- Sponsor Identification
Wuhan Dymex Healthcare Co., Ltd. Room 1701, Unit 2, Building 5, Jinsegangwan Phase 5, Dongfeng Avenue, Wuhan, 430000, China. Establishment Registration Number: 3013006775
Contact Person: Lynn Wu Position: Sales Manager Tel: +86-27-85827780 Fax: +86-27-85827780 Email: 1ynn.w@medlinkindustry.com
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Jinlei Tang (Alternative Contact Person)
- Designated Submission Correspondent
Mid-Link Consulting Co., Ltd.
P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850, Fax: 360-925-3199 Email: info@mid-link.net
-
- Identification of Proposed Device
Trade Name: Surgical Isolation Cover Gown Common Name: Isolation Gown
- Identification of Proposed Device
Regulatory Information
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Classification Name: Surgical Isolation Gown Classification: II; Product Code: FYC; Regulation Number: 21 CFR 878.4040 Review Panel: General Hospital;
Indications for Use:
The Surgical Isolation Cover Gown is intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. In addition, the Surgical Isolation Cover Gown meets the requirements of an AAMI Level 3 barrier protection for an isolation gown per ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities (ANSI/AAMI PB70). The Surgical Isolation Cover Gown is a single use, disposable medical device provided non-sterile.
Device Description:
The proposed device is intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. The proposed device is a single use, disposable medical device provided non-sterile.
The proposed device is available in nine sizes, including XS, S, M, L, XL, 2XL, 3XL, 4XL, 5XL. The barrier protection level for Surgical Isolation Cover Gown meets AAMI Level 3. The proposed device is provided in yellow.
5. Identification of Predicate Device
510(k) Number: K171535 Product Name: Surgical Isolation Gown
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6. Summary of Technological characteristics
| Item | Proposed Device | Predicate Device K171535 | Remark |
|---|---|---|---|
| Product Code | FYC | FYC | Same |
| Regulation No. | 21CFR 878.4040 | 21CFR 878.4040 | Same |
| Class | II | II | Same |
| Indications for Use | The Surgical Isolation CoverGown is intended to protect healthcare patients and health carepersonnel from the transfer ofmicroorganisms, body fluids andparticulate material. Not intendedfor use in the operating room. Inaddition, the Surgical IsolationCover Gown meets therequirements of an AAMI Level 3barrier protection for an isolationgown per ANSI/AAMI PB70:2012Liquid Barrier Performance andClassification of ProtectiveApparel Drapes Intended for Usein Health Care Facilities(ANSI/AAMI PB70). The SurgicalIsolation Cover Gown is a singleuse, disposable medical deviceprovided non-sterile. | The Surgical Isolation Gown isintended to protect health carepatients and health care personnelfrom the transfer ofmicroorganisms, body fluids andparticulate material. Not intendedfor use in the operating room. Inaddition, the Surgical IsolationGown meets the requirements ofan AAMI Level 3 barrierprotection for an isolation gownper ANSI/AAMI PB70:2012Liquid Barrier Performance andClassification of ProtectiveApparel Drapes Intended for Usein Health Care Facilities(ANSI/AAMI PB70). The SurgicalIsolation Gown is a single use,disposable medical deviceprovided non-sterile. | Same |
| Design | Neck ClosureYellow Belt TieElastic Cuffs | Medical Tape Neck ClosureWhite Belt TieSnap fastener | Similar |
| Use | Single Use, Disposable | Single Use, Disposable | Same |
| Color | Yellow | Yellow | Same |
| Labeling | Conform with 21CFR Part 801 | Conform with 21CFR Part 801 | Same |
Table 1 General Comparison
| Table 2 Safety and Effectiveness Comparison | |
|---|---|
| --------------------------------------------- | -- |
| Item | Proposed Device | Reference Device K171535 | Remark |
|---|---|---|---|
| Weight per square | 35 g/m² | Testing not performed | Different |
| Size | XS, S, M, L,XL,2XL,3XL,4XL,5XL | U, XL, 2XL | Different |
| Flammability | Class I | Class I | Same |
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| HydrostaticPressure (cm H2O) | Mean = 70.63Max = 72.33Min = 68.88 | CHEST/BACK/SLEEVE:Mean = 69Ind Min = 54Ind Max = 84 | Different | |
|---|---|---|---|---|
| Water impact (g) | Mean = 0.58Max = 0.69Min = 0.49 | Sleeve Seams:Mean = 0.04Ind Min = 0.02Ind Max = 0.08CHEST:Mean = 0.04Ind Min = 0.02Ind Max = 0.05Back:Mean = 0.05Ind Min = 0.04Ind Max = 0.07 | Different | |
| Breakingstrength | MD | Mean = 74.82 NMax = 79.64 NMin = 70.43 N | Mean = 20.71 lbs (92.16 N)Ind Min = 19.73 lbs (87.80 N)Ind Max = 21.87 lbs (97.32 N) | Different |
| Breakingstrength | CD | Mean = 49.35 NMax = 55.18 NMin = 40.96 N | Mean = 12.21 lbs (54.33 N)Ind Min = 11.20 lbs (49.84 N)Ind Max = 14.11 lbs (62.79 N) | Different |
| Tearingstrength | MD | Mean = 62.92 NMax = 69.72 NMin = 62.01 N | Mean = 3.48 lbs (15.49 N)Ind Min = 2.82 lbs (12.55 N)Ind Max = 3.93 lbs (17.49 N) | Different |
| Tearingstrength | CD | Mean = 32.57 NMax = 34.99 NMin = 30.05 N | Mean = 7.15 (31.82 N)Ind Min = 6.20 (27.59 N)Ind Max = 7.70 (34.27 N) | Different |
| Linting | Side A:Log10(lint count): Mean 3.4Side B:Log10(lint count): Mean 3.4 | SIDE A: OUTSIDETOTAL >0.3 1024TOTAL >0.5 658SIDE B: INSIDETOTAL >0.3 1066TOTAL >0.5 697 | Different | |
| Seam strength | Mean = 102.92 NMax = 109.98 NMin = 95.37 N | / | Different | |
| Air permeability | Mean 35.4 ft³/min/ft² | / | Different | |
| Barrier protectionlevel | Level 3 per AAMI PB 70 | Level 3 per AAMI PB 70 | Same |
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| Material | SMS Nonwoven Fabric | Polypropylene SMS non woven | Same |
|---|---|---|---|
| Biocompatibility | |||
| CytotoxicityIrritationSensitization | The test was done against ISO10993-5 and ISO10993-10.The result indicates the gown is noncytotoxic, non-irritating, and non-sensitizing per ISO 10993-1. | The test was done against ISO10993-5 and ISO10993-10.The result indicates the gown is noncytotoxic, non-irritating, and non-sensitizing per ISO 10993-1. | Same |
| Sterilization | Non-sterile | Non-sterile | Same |
Similar - Design
The design of the proposed device is not exactly the same as the predicate device. The belt tie of the proposed device is yellow, while the belt tie of the predicate device is white. However, the belt tie is used to close the back of the gown. The difference in the color of belt tie will not affect the device performance.
Different - Weight per square
No information was available on the Weight per square of the predicate device. The weight per square for the proposed device is 35g/m², which is similar to the most products on the market. And the difference in the weight per square will not affect the intended use. In addition, the performance testing was conducted on the proposed device and the results demonstrate that the proposed device can meet the barrier protection level 3 requirement as required by PB70.
Different - Size
The size for the proposed device is different from the predicate device. The proposed device is available in nine size, including XS, S, M, L, XL,2XL,3XL,4XL,5XL, while the predicate device is available in three size, U, XL and 2XL. However, the difference in the size will not affect the device performance. Different sizes can be selected by surgeon's condition.
Different - Hydrostatic pressure
The hydrostatic pressure for the proposed device is different from the predicate device. the higher the hydrostatic pressure value, the higher the protection of the isolation gown. The hydrostatic pressure of the proposed device is 70.63 cm H2O, which is greater than the 69 cm H2O of the predicate device.
Different - Water impact
The water impact for the proposed device is different from the predicate device. However, the water in impact test was conducted on the proposed device and the results demonstrate that the proposed device meets the barrier protection level 3 requirement, i.e., no more than 1.0g, as required by PB70.
Different - Breaking strength
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The breaking strength for the proposed device is different from the predicate device. Although the MD and CD breaking strength of the proposed device is smaller than the predicate device, the MD and CD breaking strength of the proposed device meets ASTM F2407-20's requirement of greater than 30N.
Different - Tearing strength
The tearing strength for the proposed device is different from the predicate device. Tearing strength is one of the indicators to evaluate the ability of the isolation gown to withstand destructive force. The greater the tearing strength value, the stronger the ability to withstand destructive force. The tearing strength of the proposed device is larger than the predicate device.
Different - Linting
The linting for the proposed device is different from the predicate device. However, the linting test was conducted on the proposed device and the testing results demonstrate that the proposed device can meet the requirements of log10<4.
Different - Seam strength
The seam strength was conducted on the proposed device and the testing results demonstrate that the seam strength of the proposed device meets ASTM F2407-20's requirement of greater than 30N.
Different - Air permeability
The air permeability was conducted on the proposed device and the testing results demonstrate that the air permeability of the proposed device meets the requirement of greater than 30 ft3/min/ft2.
-
- Summary of Non-Clinical Tests
Non-clinical tests were conducted to verify that the proposed device met all design specifications as was same/similar to the predicate device. The test results demonstrate that the proposed device complies with the following standards:
- Summary of Non-Clinical Tests
-
16 CFR Part 1610 Standard for the Flammability of Clothing Textiles;
-
A AATCC 127: 2018 Water Resistance: Hydrostatic Pressure Test;
-
AATCC 42: 2017 Water Resistance: Impact Penetration Test;
-
ISO 9073-10: 2003 Textiles-Test Methods for Nonwovens-Part 10: Lint and Other Particles Generation in the Dry State;
-
ASTM D1683/D1683M: 2017(2018) Standard Test Method for Failure in Sewn Seams of Woven Fabrics;
-
ASTM D5587: 2015(2019) Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure:
-
ASTM D5034: 2009(2017) Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test);
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- ISO 10993-5: 2009 Biological Evaluation of Medical Devices-Part 5: Tests for in Vitro > Cytotoxicity;
-
ISO 10993-10: 2010 Biological Evaluation of Medical Devices-Part 10: Tests for Irritation and Skin Sensitization;
-
ASTM D737-18: 2018 Standard Test Method for Air Permeability of Textile Fabrics
| TestMethodology | Purpose | AcceptanceCriteria | Result |
|---|---|---|---|
| Flammability | The test was performed in accordancewith 16 CFR Part 1610 Standard forthe Flammability of Clothing Textilesto evaluate the flammability of thetest sample. | Meets Class 1requirements | Class 1 |
| Hydrostaticpressure | The test was performed in accordancewith AATCC 127: 2017 WaterResistance: Hydrostatic Pressure Testto determine the hydrostatic pressureof the test sample. | >50 cm H2O | Mean = 70.63 cm H2OMax = 72.33 cm H2OMin = 68.88 cm H2O |
| Water impact | The test was performed in accordancewith AATCC 127: 2017 WaterResistance: Hydrostatic Pressure Testto determine the hydrostatic pressureof the test sample. | ≤1.0 g | Mean = 0.58 gMax = 0.69 gMin = 0.49 g |
| Breakingstrength | The test was performed in accordancewith ASTM D 5034:2009(2017)Standard Test Method for BreakingStrength and Elongation of TextileFabrics (Grab Test) to evaluate thebreaking strength of the test sample. | >20 N | MD:Mean = 74.82 NMax = 79.64 NMin = 70.43 NCD:Mean = 49.35 NMax = 55.18 NMin = 40.96 N |
| Tearingstrength | The test was performed in accordancewithASTMD5587:2015(2019)Standard Test Method for TearingStrength of Fabrics by TrapezoidProcedure to evaluate the tearingstrength of the test sample. | >20 N | MD:Mean = 62.92 NMax = 69.72 NMin = 62.01 NCD:Mean = 32.57 NMax = 34.99 NMin = 30.05 N |
Table 3 Summary of Performance Testing
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| Linting | The test was performed in accordancewith ISO 9073-10:2003 Textiles-TestMethods for Nonwovens-Pat 10: Lintand Other Particles Generation in theDry State to evaluate the linting ofthe test sample. | Log10(particlecount) < 4 | Side A:Log10(lint count): Mean3.4Side B:Log10(lint count): Mean3.4 |
|---|---|---|---|
| Seam strength | The test was performed in accordancewith ASTM D1683/D1683M:2017(2018) Standard Test Method forFailure in Sewn Seams of WovenFabrics to evaluate the seam strengthof the test sample. | >50 N | Mean = 102.92 NMax = 109.98 NMin = 95.37 N |
| Airpermeability | The test was performed in accordancewith ASTM D737: 2018 StandardTest Method for Air Permeability ofTextile Fabrics to evaluate the airpermeability of the test sample. | >30 ft³/min/ft² | Mean 35.4 ft³/min/ft² |
Table 4 Summary of Biocompatibility Testing
| Test Methodology | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| Cytotoxicity | The test was performedin accordance with ISO10993-5 Third edition2009-06-01 Biologicalevaluation of medicaldevices - Part 5: Testsfor in vitro cytotoxicityto evaluate thecytotoxicity of the testsample. | The viability should be$\ge$ 70% of the blank.And the 50% extract ofthe test sample shouldhave at least the same ora higher viability thanthe 100% extract. | The viability was $\ge$ 70%of the blank. And the50% extract of the testsample had a higherviability than the 100%extract. Under theconditions of the study,the proposed devicewas non-cytotoxic. |
| Sensitization | The test was performedin accordance with ISO10993-10 Third Edition2010-08-01 Biologicalevaluation of medicaldevices - Part 10: Testsfor irritation and skinsensitization to evaluatethe sensitization of thetest sample. | Non-sensitizing | Under the conditions ofthe study, the proposeddevice wasnon-sensitizing. |
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| Irritation | The test was performedin accordance with ISO10993-10 Third Edition2010-08-01 Biologicalevaluation of medicaldevices - Part 10: Testsfor irritation and skinsensitization to evaluatethe irritation of the testsample | Non-irritating | Under the conditions ofthe study, the proposeddevicewasnon-irritating. |
|---|---|---|---|
| ------------ | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ---------------- | ---------------------------------------------------------------------------------------- |
Clinical Test Conclusion 8.
No clinical study is included in this submission.
9. Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the proposed devices are as safe, as effective, and perform as well as or better than the legally marketed predicate device K171535.
§ 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.