(56 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 Level 2 standard surgical gowns met the requirements for Level 2 classification, the Level 3 standard surgical gowns and Level 3 reinforced surgical gowns met the requirements for Level 3 classification.
The proposed devices 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. The proposed devices are single use, disposable medical devices and are provided in sterile.
There are three types of surgical gown: Level 2 standard surgical gown, Level 3 standard surgical gown and Level 3 reinforced surgical gown. And each type of surgical gown is available in seven product sizes, including XS, S, M, L, XL, XXL and XXXL. The barrier protection level for Level 2 standard surgical gown meets AAMI Level 2, while the barrier protection level for Level 3 standard surgical gown and Level 3 reinforced surgical gown meet AAMI Level 3.
Acceptance Criteria and Device Performance Study for Surgical Gowns (K211422)
This document describes the acceptance criteria and the studies performed to demonstrate that the Jiangsu Medplus Non-woven Manufacturer Co., Ltd. Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, and Level 3 Reinforced Surgical Gown meet these criteria.
1. Table of Acceptance Criteria and Reported Device Performance
| Name of Testing Methodology | Acceptance Criteria (Proposed Device) | Reported Device Performance |
|---|---|---|
| Flammability (16 CFR Part 1610) | Meets Class 1 requirements | Pass |
| Hydrostatic pressure (AATCC 127: 2017) | Level 2 Standard Surgical Gown: >20 cmLevel 3 Standard Surgical Gown: >50 cmLevel 3 Reinforced Surgical Gown: >50 cm | Level 2 Standard Surgical Gown: 37.6 cmLevel 3 Standard Surgical Gown: 52.6 cmLevel 3 Reinforced Surgical Gown: 83.1 cm |
| Water impact (AATCC 42: 2017) | ≤1.0 g | Level 2 Standard Surgical Gown: 0.4 gLevel 3 Standard Surgical Gown: 0.5 gLevel 3 Reinforced Surgical Gown: 0.2 g |
| Breaking strength (ASTM D5034: 2009(2017)) | >20N | Level 2 Standard Surgical Gown: 73NLevel 3 Standard Surgical Gown: 70.3NLevel 3 Reinforced Surgical Gown: 45.6N |
| Tearing strength (ASTM D5587: 2015(2019)) | >20N | Level 2 Standard Surgical Gown: 24.1NLevel 3 Standard Surgical Gown: 48.4NLevel 3 Reinforced Surgical Gown: 24.6N |
| Linting (ISO 9073-10: 2003) | Log10 (particle count) < 4 | Level 2 Standard Surgical Gown: 2.85Level 3 Standard Surgical Gown: 2.85Level 3 Reinforced Surgical Gown: 2.86 |
| Air permeability (ASTM D737: 2018) | >30 ft³/min/ft² | Level 2 Standard Surgical Gown: 32.9 ft³/min/ft²Level 3 Standard Surgical Gown: 33.8 ft³/min/ft²Level 3 Reinforced Surgical Gown: 31.7 ft³/min/ft² |
| EO/ECH Residue (ISO 11135:2014 Annex B) | EO: < 4 mg/deviceECH: < 9 mg/device | Level 2 Standard Surgical Gown: 0.22 mg/device EO, 0.08 mg/device ECHLevel 3 Standard Surgical Gown: 0.22 mg/device EO, 0.12 mg/device ECHLevel 3 Reinforced Surgical Gown: 0.35 mg/device EO, 0.24 mg/device ECH |
| Cytotoxicity (ISO 10993-5: 2009) | Non-cytotoxic | Under the conditions of the study, the device is non-cytotoxic. |
| Irritation (ISO 10993-10: 2010) | Non-irritating | Under the conditions of the study, the device is non-irritating. |
| Sensitization (ISO 10993-10: 2010) | Non-sensitizing | Under the conditions of the study, the device is non-sensitizing. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes for each non-clinical test. However, it indicates "the test sample" for each test, implying that a representative sample for each product type (Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3 Reinforced Surgical Gown) was used for testing.
The data provenance is for the proposed device (K211422). Based on the manufacturer and correspondent information (Jiangsu Medplus Non-woven Manufacturer Co., Ltd. located in China, and Mid-Link Consulting Co., Ltd. in China), the data is most likely generated in China. The studies are retrospective in the sense that they were conducted on already manufactured devices to demonstrate compliance with standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable as the studies conducted are non-clinical performance and biocompatibility tests for medical devices (surgical gowns). These tests rely on standardized methodologies (e.g., AATCC, ASTM, ISO, CFR) and objective measurements rather than expert human interpretation for establishing ground truth. The "ground truth" is defined by the parameters and thresholds set by recognized international and national standards for medical device performance.
4. Adjudication Method for the Test Set
This information is not applicable as the studies are non-clinical laboratory tests with objective, measurable outcomes. There is no human adjudication process involved in comparing different interpretations of results. The results are compared directly against predefined numerical or qualitative acceptance criteria from the specified standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic or AI-assisted interpretation devices to assess human reader performance with and without AI. The devices in question are surgical gowns, and their effectiveness is evaluated through physical and material property tests rather than clinical diagnostic interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. The device is a surgical gown, not an algorithm or AI system. Therefore, the concept of "standalone performance" for an algorithm without human involvement does not apply.
7. The Type of Ground Truth Used
The "ground truth" for the test results is established by the specified, internationally recognized performance standards (e.g., 16 CFR Part 1610, AATCC 127: 2017, AATCC 42: 2017, ASTM D5034: 2009(2017), ASTM D5587: 2015(2019), ISO 9073-10: 2003, ASTM D737: 2018, ISO 11135:2014 Annex B, ISO 10993-5: 2009, ISO 10993-10: 2010). These standards define the quantitative and qualitative requirements for surgical gown performance and biocompatibility.
8. The Sample Size for the Training Set
This information is not applicable. Surgical gowns are physical medical devices, not AI or machine learning models that require a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for this device.
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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.
July 2, 2021
Jiangsu Medplus Non-woven Manufacturer Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co.,Ltd P.O.box 120-119 Shanghai, Jiangsu 200120 China
Re: K211422
Trade/Device Name: Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3 Reinforced Surgical Gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYA Dated: April 8, 2021 Received: May 7, 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.
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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 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 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)
Device Name
Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3 Reinforced 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 Level 2 standard surgical gowns met the requirements for Level 3 standard surgical gowns and Level 3 reinforced surgical gowns met the requirements for Level 3 classification.
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: K211422
-
- Date of Preparation: 06/24/2021
-
- Sponsor Identification
Jiangsu Medplus Non-woven Manufacturer Co., Ltd. No.217 East Wencheng Road, Economic Development Zone, Siyang, Jiangsu, 223700, China.
Establishment Registration Number: 3017194442
Contact Person: Shuying An Position: Product Manager Tel: +86-527-80300123 Fax: +86-527-80300123 Email: zongzhu@medplusgroup.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
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4. Identification of Proposed Device
Trade Name: Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3 Reinforced 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 Level 2 standard surgical gowns met the requirements for Level 2 classification, the Level 3 standard surgical gowns and Level 3 reinforced surgical gowns met the requirements for Level 3 classification.
Device Description:
The proposed devices 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. The proposed devices are single use, disposable medical devices and are provided in sterile.
There are three types of surgical gown: Level 2 standard surgical gown, Level 3 standard surgical gown and Level 3 reinforced surgical gown. And each type of surgical gown is available in seven product sizes, including XS, S, M, L, XL, XXL and XXXL. The barrier protection level for Level 2 standard surgical gown meets AAMI Level 2, while the barrier protection level for Level 3 standard surgical gown and Level 3 reinforced surgical gown meet AAMI Level 3.
5. Identification of Predicate Device
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510(k) Number: K172987 Product Name: Surgical Gown
6. Comparison of Technological characteristics
| Table 1 General Comparison | |||
|---|---|---|---|
| Item | Proposed Device K211422 | Predicate Device K172987 | Remark |
| Product Code | FYA | FYA | Same |
| Regulation No. | 21CFR 878.4040 | 21CFR 878.4040 | Same |
| Class | II | II | Same |
| 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 Level 2 standard surgical gowns met the requirements for Level 2 classification, the Level 3 standard surgical gowns and Level 3 reinforced surgical gowns 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. | Same |
| Style | Non-reinforced/Reinforced | Non-reinforced/Reinforced | Same |
| Durability | Disposable | Disposable | Same |
| Color | Blue | Blue | Same |
Table 1 General Comparison
| Table 2 Safety and Performance Comparison | |
|---|---|
| Item | Proposed Device | Reference Device K172987 | Remark | |
|---|---|---|---|---|
| Weightsquare (g) | per | Level 2 Standard Surgical Gown:35g/m²;Level 3 Standard Surgical Gown: | 44g/m² | Different |
| 43g/m²Level 3 Reinforced Surgical Gown:35g/m² and 28g/m² | ||||
| Size | XS, S, M, L, XL, XXL, XXXL | XL | Different | |
| Flammability | Class I | Class I | Same | |
| Hydrostaticpressure | Level 2 Standard SurgicalGown: >20 cm;Level 3 Standard SurgicalGown: >50 cm;Level 3 Reinforced SurgicalGown: >50 cm | AE series: >20 cm;AG series: >50 cm | Same | |
| Water impact | ≤1.0 g | ≤1.0 g | Same | |
| Breakingstrength | >20N | >20N | Same | |
| Tearing strength | >20N | >30N | Different | |
| Linting | Log10(particle count) <4 | Log10(particle count) <4 | Same | |
| Air permeability | >30 ft³/min/ft² | >30 ft³/min/ft² | Same | |
| Barrierprotection level | Level 2 and 3 per AAMI PB 70 | Level 2 and 3 per AAMI PB 70 | Same | |
| Material | Level 2 Standard Surgical Gownand Level 3 Standard SurgicalGown: SMS nonwoven, Polyesterand Polyamide;Level 3 Reinforced Surgical Gown:SMS nonwoven, Polyester,Polyamide and Hydrophilicnonwoven | SMMMS, Polypropylene,Polyethylene, 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 |
Page 3 of 7
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510(k) Summary
7. Summary of non-clinical testing
The following performance and biocompatibility testing data has been provided to demonstrate that the subject device meet the acceptance criteria in the standard
| Name of TestingMethodology | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| Flammability | The test was performed inaccordance with 16 CFRPart 1610 Standard for theFlammability of ClothingTextiles to evaluate theflammability of the testsample. | Meets Class 1 requirements | Pass |
| Hydrostatic pressure | The test was performed inaccordance with AATCC127: 2017 WaterResistance: Hydrostatic Pressure Testto determine thehydrostatic pressure ofthe test sample. | Level 2 StandardSurgical Gown: >20cm;Level 3 StandardSurgical Gown: >50cm;Level 3 ReinforcedSurgical Gown: >50 cm | Level 2 Standard Surgical Gown:37.6 cm;Level 3 Standard Surgical Gown:52.6 cm;Level 3 Reinforced Surgical Gown:83.1 cm |
| Water impact | The test was performed inaccordance with AATCC42: 2017 WaterResistance: ImpactPenetration Test toevaluate the water impactof the testsample. | ≤1.0 g | Level 2 Standard Surgical Gown:0.4 g;Level 3 Standard Surgical Gown:0.5 g;Level 3 Reinforced Surgical Gown:0.2 g |
| Breakingstrength | The test was performedin accordance withASTM D5034:2009(2017) StandardTest Method forBreaking Strength andElongation of TextileFabrics (Grab Test) toevaluate the breakingstrength of the testsample. | >20N | Level 2 Standard SurgicalGown: 73N;Level 3 Standard SurgicalGown: 70.3N;Level 3 Reinforced Surgical Gown:45.6N |
| Table 3 Summary of Performance Testing |
|---|
| ---------------------------------------- |
Page 5 of 7
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| Tearingstrength | The test was performedin accordance withASTM D5587:2015(2019) StandardTest Method for TearingStrength of Fabrics byTrapezoid Procedure toevaluate the tearingstrength of the testsample. | >20N | Level 2 Standard SurgicalGown: 24.1N;Level 3 Standard SurgicalGown: 48.4N;Level 3 Reinforced SurgicalGown: 24.6N |
|---|---|---|---|
| Linting | The test was performedin accordance with ISO9073-10: 2003Textiles-Test Methodsfor Nonwovens-Part 10:Lint and Other ParticlesGeneration in the DryState to evaluate thelinting of the testsample. | $Log_{10}$ (particle count) < 4 | Level 2 Standard SurgicalGown: 2.85;Level 3 Standard SurgicalGown: 2.85;Level 3 Reinforced SurgicalGown: 2.86 |
| Airpermeability | The test was performedin accordance withASTM D737: 2018Standard Test Methodfor Air Permeability ofTextile Fabrics toevaluate the airpermeability of the testsample. | >30 ft3/min/ft2 | Level 2 Standard SurgicalGown: 32.9 ft3/min/ft2;Level 3 Standard SurgicalGown: 33.8 ft3/min/ft2;Level 3 Reinforced SurgicalGown: 31.7 ft3/min/ft2 |
| EO/ECHResidue | The test was performedin accordance withISO 11135:2014 AnnexB to evaluate the level ofsterilant residues. | EO: < 4 mg/deviceECH: < 9 mg/device | Level 2 Standard SurgicalGown: 0.22 mg/device EO0.08 mg/device ECHLevel 3 Standard SurgicalGown: 0.22 mg/deviceEO0.12 mg/device ECHLevel 3 Reinforced SurgicalGown: 0.35 mg/device EO0.24 mg/device ECH |
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| Name ofTestingMethodology | Purpose | Acceptance Criteria | Results | ||
|---|---|---|---|---|---|
| Cytotoxicity | The test was performedin accordance with ISO10993-5: 2009Biological Evaluation ofMedical Devices-Part 5:Tests for in VitroCytotoxicity to evaluatethe cytotoxicity of thetest sample. | Non-cytotoxic | Under the conditions of thestudy, the deviceis non-cytotoxic. | ||
| Irritation | The test was performedin accordance with ISO10993-10: 2010Biological Evaluation ofMedical Devices-Part10: Tests for Irritationand Skin Sensitization toevaluate the irritation ofthe test sample. | Non-irritating | Under the conditions of thestudy, the device is non-irritating. | ||
| Sensitization | The test was performedin accordance with ISO10993-10: 2010Biological Evaluation ofMedical Devices-Part10: Tests for Irritationand Skin Sensitization toevaluate thesensitization of the testsample. | Non-sensitizing | Under the conditions of thestudy, the device is non-sensitizing. |
Table 4 Summary of Biocompatibility Testing
-
- Clinical Test Conclusion
No clinical study is included in this submission.
- Clinical Test Conclusion
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.