(129 days)
Surgical gown is intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.
Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the surgical gown met the requirements for Level 3 classification.
The proposed device is intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. The proposed device is single use, disposable medical devices and are provided in sterile. The surgical gown is available in six product sizes, including S, M, L, XL, XXL and XXXL. The barrier protection level for surgical gown met AAMI Level 3.
This document describes the non-clinical testing performed for a Surgical Gown (K211809) to demonstrate its equivalence to a predicate device. The information provided heavily focuses on physical and biological performance criteria.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Flammability | Evaluate the flammability of the test sample in accordance with 16 CFR Part 1610. | Meets requirements (implicitly Class 1, as per standard) | Class 1 Pass |
| Hydrostatic Pressure | Determine the hydrostatic pressure of the test sample in accordance with AATCC 127: 2017. | >50 cm | Average 72.05 cm |
| Water Impact | Evaluate the water impact of the test sample in accordance with AATCC 42: 2017. | ≤1.0 g | Average 0.45g |
| Breaking Strength | Evaluate the breaking strength of the test sample in accordance with ASTM D 5034:2009(2017). | >20N | MD: Average 74.88N CD: Average 50.73N |
| Tearing Strength | Evaluate the tearing strength of the test sample in accordance with ASTM D5587:2015(2019). | >20N | MD: Average 63.87N CD: Average 34.91N |
| Linting | Evaluate the linting of the test sample in accordance with ISO 9073-10:2003. | Log10(particle count) < 4 | Average 3.4 (This implicitly means Log10(particle count) is less than 4) |
| Air Permeability | Evaluate the air permeability of the test sample in accordance with ASTM D737: 2018. | >30 ft³/min/ft² | Average 35.3 ft³/min/ft² |
| EO/ECH Residue (Ethylene Oxide Sterilization Residuals) | Evaluate the level of sterilant residues in accordance with ISO 10993-7:2008. | EO: < 4 mg/device ECH: < 9 mg/device | EO: Average 0.95 mg/device ECH: Average 0.98 mg/device |
| Cytotoxicity | Evaluate the cytotoxicity of the test sample in accordance with ISO 10993-5:2009. | The viability should be ≥ 70% of the blank. And the 50% extract of the test sample should have at least the same or a higher viability than the 100% extract. | The viability was ≥ 70% of the blank. And the 50% extract of the test sample had a higher viability than the 100% extract. Under the conditions of the study, the proposed device was non-cytotoxic. |
| Sensitization | Evaluate the sensitization of the test sample in accordance with ISO 10993-10:2010. | Non-sensitizing | Under the conditions of the study, the proposed device was non-sensitizing. |
| Irritation | Evaluate the irritation of the test sample in accordance with ISO 10993-10:2010. | Non-irritating | Under the conditions of the study, the proposed device was non-irritating. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample sizes for each of the non-clinical tests conducted. The provenance of the data is implied to be from the manufacturer's testing, Wuhan Dymex Healthcare Co., Ltd., based in China (Wuhan, China). The tests are prospective, meaning they were conducted specifically for this submission to assess the device's performance against established standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. These are non-clinical, laboratory-based tests on a physical product (surgical gown) and do not involve human expert interpretation or ground truth establishment in the way clinical studies with medical imaging or diagnoses would. The "ground truth" is defined by the objective measurement standards of the relevant ASTM, AATCC, ISO, and CFR standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This concept applies to clinical studies where human interpretation or diagnostic agreement is being assessed. These are objective, standardized laboratory tests.
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 submission for a surgical gown, which is a physical medical device, not an AI-powered diagnostic or assistive technology that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm. The non-clinical tests are "standalone" in the sense that they evaluate the device's physical and biological properties objectively.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the non-clinical tests is established by internationally recognized and industry-accepted performance standards (e.g., ANSI/AAMI PB70:2012, 16 CFR Part 1610, AATCC 127, ASTM D5034, ISO 10993 series). The device's performance is measured against the criteria defined within these standards.
8. The sample size for the training set
Not applicable. This is a physical medical device, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As explained above, there is no training set for a physical surgical gown.
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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 is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 18, 2021
Wuhan Dymex Healthcare Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O.box 120-119 Shanghai. 200120 China
Re: K211809
Trade/Device Name: Surgical Gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYA Dated: September 6, 2021 Received: September 14, 2021
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-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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K211809
Device Name Surgical Gown
Indications for Use (Describe)
Surgical gown is intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.
Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the surgical gown met the requirements for Level 3 classification.
| Prescription Use (Part 21 CFR 801 Subpart D) X Over-The-Counter Use (21 CFR 801 Subpart C) CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect
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Type of Use (Select one or both, as applicable)
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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: K211809
-
- Date of Preparation: 09/08/2021
-
- 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: lynn.w(@medlinkindustry.com
-
- Designated Submission Correspondent Ms.
Diana Hong (Primary Contact Person) Ms. Jinlei Tang (Alternative Contact Person)
- Designated Submission Correspondent Ms.
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
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4. Identification of Proposed Device
Trade Name: Surgical Gown Common Name: Surgical Gown
Regulatory Information
Classification Name: Gown, Surgical Classification: II; Product Code: FYA; Regulation Number: 21 CFR 878.4040 Review Panel: General Hospital;
Indication for use:
Surgical gown is intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.
Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the surgical gown met the requirements for Level 3 classification.
Device Description:
The proposed device is intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. The proposed device is single use, disposable medical devices and are provided in sterile. The surgical gown is available in six product sizes, including S, M, L, XL, XXL and XXXL. The barrier protection level for surgical gown met AAMI Level 3.
-
ર : Identification of Predicate Device
510(k) Number: K172987; GMAX Industries, Inc. Product Name: Surgical Gown (AE1001, AE2001, AE3001) -
Technological Characteristics Comparison With The Predicate Device 6.
| Table 1. General Comparison | |
|---|---|
| Item | Proposed Device | Predicate Device K172987 | Comparison |
|---|---|---|---|
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| Product Code | FYA | FYA | Same |
|---|---|---|---|
| Regulation No. | 21CFR 878.4040 | 21CFR 878.4040 | Same |
| Class | II | II | Same |
| Indications for Use | Surgical gown is intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the surgical gown met the requirements for Level 3 classification. | Surgical gown is intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the AE series surgical gowns met the requirements for Level 2 classification, the AG series surgical gowns met the requirements for Level 3 classification. | Different |
| Style | Non-reinforced | Non-reinforced/ Fabric-reinforced/ Poly-reinforced | Similar |
| Durability | Disposable | Disposable | Same |
| Color | Blue | Blue | Same |
| Labeling | Conform with 21CFR Part 801 | Conform with 21CFR Part 801 | Same |
Different - Indications for Use
The proposed device and predicate device are intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Per ANSI/AAMI PB70:2012, the proposed device met the requirements for Level 3 classification, while the predicate device met the requirements for Level 2 and Level 3 classification. The indications for use for the proposed device can be covered by the predicate device.
Similar – Style
The style for the proposed device is different from the predicate device. The proposed device is a nonreinforced device, while the predicate device is available in three types, non-reinforced, fabric
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reinforced and poly-reinforced. The style for the proposed device can be covered by the predicate device.
| Item | Proposed Device | Predicate Device K172987 | Comparison |
|---|---|---|---|
| Weight per square (g) | 43g/m2 | 44g/m2 | Different |
| Size | S, M, L, XL, XXL, XXXL | XL | Different |
| Flammability | Class I | Class I | Same |
| Hydrostatic pressure | >50 cm | AE series: >20 cm;AG series: >50 cm | Same |
| Water impact | ≤1.0 g | ≤1.0 g | Same |
| Breaking strength | >20N | ≥20N | Same |
| Tearing strength | >20N | >30N | Different |
| Linting | Log10≤4 | Log10<4 | Same |
| Air permeability | >30 ft³/min/ft² | >30 ft³/min/ft² | Same |
| Barrier protection level | Level 3 per AAMI PB 70 | Level 2/Level 3 per AAMI PB 70 | Similar |
| Material | SMS, Polyester, Nylon | SMMMS, Polypropylene, PE(Poly Ethylene), Polyester | Different |
| Biocompatibility | |||
| CytotoxicityIrritationSensitization | Under the conditions of the study, the device is non-toxic, non-irritating, and non-sensitizing. | Under the conditions of the study, the device is non-toxic, non-irritating, and non-sensitizing. | Same |
| Sterilization | SterileMethod: Ethylene Oxide (EO);Sterilization Assurance Level(SAL): 10-6 | Non-sterile | Different |
Table 2.Technological Comparison
Different - Weight per square
The weight per square for the proposed device is different from the predicate device.
Different - Size
The size for the proposed device is different from the predicate device. The proposed device is available in 6 product sizes, including S, M, L, XL, XXL and XXXL.
Different - Tearing strength
The tearing strength for the proposed device is different from the predicate device,
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Similar - Barrier protection level
The barrier protection level for the proposed device is different from the predicate device.
Different - Material
The material for the proposed device is different from the predicate device.
Different - Sterilization
The product status of the proposed device is different from the predicate device. The proposed device is sterilized and the predicate device is non-sterilized.
7. Non-Clinical Test Conclusion
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 demonstrated that the proposed device complies with the following standards:
-
16 CFR Part 1610 Standard for the Flammability of Clothing Textiles;
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AATCC 127: 2017 Water Resistance: Hydrostatic Pressure Test;
-
AATCC 42: 2017 Water Resistance: Impact Penetration Test;
- A ISO 9073-10: 2003 Textiles-Test Methods for Nonwovens-Part 10: Lint and Other Particles Generation in the Dry State;
- A 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);
- A ASTM D737: 2018 Standard Test Method for Air Permeability of TextileFabrics;
- A ASTM F88/F88M: 2015 Standard Test Method for Seal Strength of Flexible Barrier Materials;
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ASTM F1929: 2015 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration;
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ISO 10993-7: 2008 Biological Evaluation of Medical Devices-Part 7: Ethylene Oxide Sterilization Residuals;
-
ISO 10993-5: 2009 Biological Evaluation of Medical Devices-Part 5: Tests for in Vitro Cytotoxicity;
- A ISO 10993-10: 2010 Biological Evaluation of Medical Devices-Part 10: Tests for Irritation and Skin Sensitization;
| Table 3. Performance Testing | ||
|---|---|---|
| -- | ------------------------------ | -- |
| Test Method | Purpose | Acceptance Criteria | Results | |
|---|---|---|---|---|
| Flammability | The test was performed in accordancewith 16 CFR Part 1610 Standard forthe Flammability of Clothing Textilesto evaluate the flammability of the testsample. | Meetsrequirements | Class 1Pass | |
| Hydrostaticpressure | The test was performed in accordancewith AATCC 127: 2017Water Resistance: Hydrostatic PressureTest to determine the hydrostaticpressure ofthe test sample. | >50 cm | Average 72.05 cm | |
| Water impact | The test was performed in accordancewith AATCC 42: 2017 WaterResistance: Impact Penetration Test toevaluate the water impact of the testsample. | ≤1.0 g | Average 0.45g | |
| Breaking strength | 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. | >20N | MD: Average 74.88CD: Average 50.73 | |
| Tearing strength | The test was performed in accordancewith ASTM D5587:2015(2019)Standard Test Method for TearingStrength of Fabrics by TrapezoidProcedure to evaluate the tearingstrength of the test sample. | >20N | MD: Average 63.87CD: Average 34.91 | |
| 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 of thetest sample. | $Log_{10}(particle count) < 4$ | Average 3.4 | |
| Air permeability | The test was performed in accordancewith ASTM D737: 2018 Standard TestMethod for Air Permeability of TextileFabrics to evaluate the air permeabilityof the test sample. | >30 ft³/min/ft² | Average 35.3 | |
| EO/ECHResidue | The test was performed in accordancewith ISO 10993-7:2008 Biologicalevaluation of medical devices - Part 7:Ethylene oxide sterilization residuals toevaluate the level of sterilant residues. | EO: < 4 mg/deviceECH: < 9 mg/device | EO: Average 0.95 mg/deviceECH: Average 0.98 mg/device |
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| Test Method | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| Cytotoxicity | The test was performed in accordancewith ISO 10993-5 Third edition 2009-06-01 Biological evaluation of medicaldevices - Part 5: Tests for in vitrocytotoxicity to evaluate the cytotoxicityof the test sample. | The viability shouldbe $≥$ 70% of theblank. And the 50%extract of the testsample should haveat least the same or ahigher viability thanthe 100% extract | The viability was $≥$ 70%of the blank. And the50% extract of the testsample had a higherviability than the 100%extract. Under theconditions of the study,the proposed device wasnon-cytotoxic. |
| Sensitization | The test was performed in accordancewith ISO 10993-10 Third Edition2010-08-01 Biological evaluation ofmedical devices - Part 10: Tests forirritation and skin sensitization toevaluate the sensitization of the testsample. | Non-sensitizing | Under the conditions ofthe study, the proposeddevicewasnon-sensitizing. |
| Irritation | The test was performed in accordancewith ISO 10993-10 Third Edition2010-08-01 Biological evaluation ofmedical devices - Part 10: Tests forirritation and skin sensitization toevaluate the irritation of the testsample. | Non-irritating | Under the conditions ofthe study, the proposeddevice was non-irritating. |
Table 4. Biocompatibility Testing
8. Clinical Test Conclusion
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 K172987.
§ 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.