(89 days)
The Surgical Gowns are intended to be worn by operating room personnel during surgical procedures to protect the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate matter. This is a single use, disposable device, provided sterile.
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 and Reinforced Surgical Gown met the requirements for Level 3 classification.
The proposed device Surgical Gown its body, sleeve and belt are made of SMMS non-woven material, and cuff is made of cotton. The proposed device is available in S(110×130cm), M(120×140cm), L(130×150cm), XL(140×160cm), XXL(150×170cm), XXXL(155×180cm) sizes . This proposed device can meet the requirements for Level 3 per ANSI/AAMI PB70:2012.
The proposed device Reinforced Surgical Gown is its body, sleeve and belt are made of SMMS nonwoven material, and cuff is made of cotton. The reinforced and critical zone is front chest and sleeves. This zone is reinforced with PP/PE composite breathable film. The proposed device is available in S(110×130cm), M(120×140cm), L(130×150cm), XL(140×160cm), XXL(150×170cm), XXXL(155×180cm) sizes. This proposed device can meet the requirements for Level 3 per ANSI/AAMI PB70:2012.
The proposed devices are disposable medical devices and provided in sterile.
The provided FDA 510(k) summary for the Surgical Gown and Reinforced Surgical Gown details the device's technical specifications and non-clinical testing for substantial equivalence to a predicate device, rather than an AI/ML-driven medical device. Therefore, the information requested regarding acceptance criteria, study methodologies, and performance related to AI/ML device evaluation (such as sample sizes for test/training sets, expert consensus, MRMC studies, or ground truth establishment) is not applicable to this document.
The document focuses on the physical and barrier properties of surgical gowns. Here is a summary of the acceptance criteria and performance as presented in the non-clinical testing section:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Item | Test Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Seam strength | ASTM D1683M-17 | ≥30N (7lbf) per standard F2407-20 for level 3 | PASS (59.21 N average from 30 samples) |
| Breaking strength | ASTM D5034-09 (2017) | ≥ 30N (7lbf) per standard F2407-20 for level 3 | PASS (MD: 144.87N, CD: 88.89N average from 30 samples) |
| Tear strength (N) | ASTM D5587-15 | ≥ 10N | PASS (MD: 69.61N, CD: 32.25N average from 30 samples) |
| Lint and other generation in dry state | ISO 9073-10:2003(E) | Log10(particle count) < 4 | PASS (1.9 average from 6 samples) |
| Flammability | CPSC 16 CFR Part 1610-2008 | Class I | PASS (Class I) |
| Water Penetration Resistance | AATCC 42-2013 | ≤ 1.0g AQL: 4% Level 3 per standard ANSI/AAMI PB70:2012 for level 3 | PASS (≤ 1.0g) |
| Static hydrostatic resistance | AATCC 127-2014 | ≥ 50 cmH2O per standard ANSI/AAMI PB70:2012 for level 3 AQL: 4% | PASS (≥ 50 cm) |
| EO and ECH sterilization residual | ISO 10993-7:2008 | EO ≤ 4mg/d, ECH ≤ 9mg/d | PASS (EO ≤ 4mg/d, ECH ≤ 9mg/d) |
| Cytotoxicity | ISO 10993-5 | Non-Cytotoxic | PASS (Non-cytotoxic) |
| Irritation | ISO 10993-10 | Non-Irritating | PASS (Non-irritating) |
| Sensitization | ISO 10993-10 | Non-Sensitizing | PASS (Non-sensitizing) |
2. Sample sizes for test set and data provenance:
- Seam strength: Reported result is an average from 30 samples.
- Breaking strength: Reported result is an average from 30 samples.
- Tear strength: Reported result is an average from 30 samples.
- Lint and other generation in the dry state: Reported result is an average from 6 samples.
- The document does not specify the country of origin of the data or whether the tests were retrospective or prospective, beyond stating "Non-clinical tests were conducted to verify that the proposed device met all design specifications."
3. Number of experts used to establish the ground truth for the test set and their qualifications:
- This is not applicable as the device is a physical product (surgical gown) and not an AI/ML-driven device requiring expert interpretation for ground truth. Performance is measured against established physical and chemical standards.
4. Adjudication method for the test set:
- Not applicable for physical product testing. Performance is determined by quantitative measurements against predefined criteria in laboratory settings.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- Not applicable. This type of study is relevant for AI-assisted diagnostic or interpretative devices, not for surgical gowns.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable as this is not an AI/ML driven device.
7. The type of ground truth used:
- The "ground truth" for this device's performance is established by physical and chemical measurement standards (e.g., ASTM, ISO, AATCC, CPSC standards) and the specified acceptance criteria for each test. For example, a seam strength greater than or equal to 30N is the "ground truth" for acceptable seam strength.
8. The sample size for the training set:
- Not applicable. There is no AI/ML component requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable. There is no AI/ML component or training set.
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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.
August 22, 2023
Xiantao Zhibo Non-Woven Products Co., Ltd. % Jarvis Wu Consultant Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Central Avenue Shanghai, Shanghai 200122 China
Re: K231510
Trade/Device Name: Surgical Gown (S,M,L,XL,XXL,XXXL); Reinforced Surgical Gown (S,M,L,XL,XXL,XXL,XXXL) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYA Dated: April 25, 2023 Received: May 25, 2023
Dear Jarvis Wu:
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,
Bifeng Qian -S
Bifeng Qian, M.D., Ph.D. 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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Indications for Use
510(k) Number (if known) K231510
Device Name Surgical Gown (S,M,L,XL,XXL,XXXL); Reinforced Surgical Gown (S.M.L.XL.XXL.XXXL)
Indications for Use (Describe)
The Surgical Gowns are intended to be worn by operating room personnel during surgical procedures to protect the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate matter. This is a single use, disposable device, provided sterile.
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 and Reinforced Surgical Gown 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 K231510
Document prepared date: 2023/8/22
A. Applicant:
Name: XIANTAO ZHIBO NON-WOVEN PRODUCTS CO.,LTD. Address: No.8 Hefeng Industrial Park, Pengchang Town, Xiantao City, Hubei Province, China. Contact Person: Fen Peng Tel: +86 18872609993 Mail: 260993463@qq.com Submission Correspondent: Primary contact: Mr. Jarvis Wu Shanghai SUNGO Management Consulting Co., Ltd. 14th Floor, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: zxfda@sungoglobal.com Secondary contact: Mr. Raymond Luo 14th Floor, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: fda.sungo@gmail.com
B. Device:
Trade Name: Surgical Gown, Reinforced Surgical Gown Common Name: Surgical Gown Model(s): S, M, L, XL, XXL, XXXL Regulatory Information Classification Name: Gown, Surgical Classification: Class II Product code: FYA Regulation Number: 878.4040 Review Panel: Surgical Apparel
C. Predicate device:
K212861 Surgical Gown, Reinforced Surgical Gown Wuhan Zonsen Medical Products Co.,Ltd
D. Intended use/Indications for use:
The Surgical Gowns are intended to be worn by operating room personnel during surgical procedures to protect the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate matter. This is a single use, disposable device, provided sterile.
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XIANTAO ZHIBO NON-WOVEN PRODUCTS CO.,LTD.
No.8 Hefeng Industrial Park, Pengchang Town, Xiantao City, Hubei Province, China
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 and Reinforced Surgical Gown met the requirements for Level 3 classification.
E. Device Description:
The proposed device Surgical Gown its body, sleeve and belt are made of SMMS non-woven material, and cuff is made of cotton. The proposed device is available in S(110×130cm), M(120×140cm), L(130×150cm), XL(140×160cm), XXL(150×170cm), XXXL(155×180cm) sizes . This proposed device can meet the requirements for Level 3 per ANSI/AAMI PB70:2012.
The proposed device Reinforced Surgical Gown is its body, sleeve and belt are made of SMMS nonwoven material, and cuff is made of cotton. The reinforced and critical zone is front chest and sleeves. This zone is reinforced with PP/PE composite breathable film. The proposed device is available in S(110×130cm), M(120×140cm), L(130×150cm), XL(140×160cm), XXL(150×170cm), XXXL(155×180cm) sizes. This proposed device can meet the requirements for Level 3 per ANSI/AAMI PB70:2012.
The proposed devices are disposable medical devices and provided in sterile.
F. Comparison with predicate device
| Device | Proposed Device | Predicate Device | Remark |
|---|---|---|---|
| Manufacturer | XIANTAO ZHIBO NON-WOVEN PRODUCTS CO.,LTD. | Wuhan Zonsen Medical ProductsCo.,Ltd | - |
| 510K number | K231510 | K212861 | - |
| Model Name | Surgical Gown,Reinforced Surgical Gown, | Surgical Gown,Reinforced Surgical Gown, | Same |
| Classification | Class II Device, FYA (21CFR878.4040) | Class II Device, FYA(21CFR878.4040) | Same |
| Intend use/Indications foruse | Surgical Gown is intended to beworn by room personnel duringsurgical procedures or otherinvasive tests to protect both thesurgical patient and operating roompersonnel from the transfer ofmicroorganisms, body fluids andparticulate material. This is singleuse, disposable device, providedsterile. | Surgical Gown is intended to beworn by room personnel duringsurgical procedures or otherinvasive tests to protect both thesurgical patient and operatingroom personnel from the transferof microorganisms, body fluidsand particulate material. This issingle use, disposable device,provided sterile. | Same |
| Per ANSI/AAMI PB70:2012Liquid barrier performance andclassification of protective appareland drapes intended for use inhealth care facilities, the SurgicalGown and Reinforced SurgicalGown met the requirements forLevel 3 classification | Per ANSI/AAMI PB70:2012Liquid barrier performance andclassification of protectiveapparel and drapes intended foruse in health care facilities, thesurgical gown met therequirements for Level 2classification, and the reinforced |
Table 1 General Comparison
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| surgical gowns met therequirements for Level 3classification. | |||
|---|---|---|---|
| Style | Non-reinforced/Reinforced | Non-reinforced/Reinforced | Same |
| Use | Single Use; Disposable | Single Use; Disposable | Same |
| Color | Blue | Blue | Same |
| Labeling | Conform with 21CFR Part 801 | Conform with 21CFR Part 801 | Same |
Table 2 Safety and Performance Comparison
| Item | Proposed Device | Predicate Device(K212861) | Remark |
|---|---|---|---|
| Weightpersquare (g) | Surgical Gown: 50g/ m2;Reinforced Surgical Gown: 50g/m2 | Surgical Gown: 45g/ m2;Reinforced Surgical Gown: 45g/m2 | Differenceresolvedbyperformance testing |
| Size | S、M、L、XL、XXL、XXXL | M, L, XL | Different.No affecton safetyor efficacy |
| Flammability | Class I | Class I | Same |
| Hydrostaticpressure | Surgical Gown: >50 cm;Reinforced SurgicalGown: >50 cm | Surgical Gown: >20 cm;Reinforced SurgicalGown: >50 cm | Same |
| Water impact | ≤1.0 g | ≤1.0 g | Same |
| Breakingstrength | >20N | >20N | Same |
| Tearing strength | >20N | >20N | Same |
| SeamStrength | >30N | >30N | Same |
| EO residue | EO ≤ 4mg/dECH ≤ 9mg/d | EO ≤ 4mg/dECH ≤ 9mg/d | Same |
| Shelf life | 3 years | 3 years | Same |
| Barrierprotection level | Level 3 per AAMI PB 70 | Level 2 and 3 per AAMI PB 70 | Similar |
| Surgical Gown:SMMS non-woven, Cotton, | Surgical Gown:SMMS non-woven, Cotton, and |
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| and Nylon | Nylon | ||
|---|---|---|---|
| Material | Reinforced Surgical Gown:SMMS non-woven, Cotton, Polypropylene and Polyethylene | Reinforced Surgical Gown:SMMS non-woven, Cotton, Nylon, Polypropylene and Polyethylene | Different |
| Sterility | Sterile | Sterile | Same |
| Biocompatibility | 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 |
Analvsis
The subject surgical gowns are substantially equivalent to the predicate device, in terms of general in tended use, performance testing, and configuration. The weight per square (g) ,size and material are slightly different from those of the predicate device. The proposed device has been tested according to ASTM D5587-15, ASTM D5034-09 (2017) and ASTM D1683/D1683M-17(2018) respectively, and met the requirements of the standard.
Difference of the materials will not raise safe and effectiveness concerns. The biocompatibility and performance tests have been conducted to verify the safety and effectiveness of the gowns. Under the conditions of each study, the subject surgical gowns are non-cytotoxic, non-sensitizing and negligibly irritating per ISO-10993 and have met the requirements of ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities for AAMI Level 3 surgical gowns.
G. Summary of Non-Clinical Testing
Non-clinical tests were conducted to verify that the proposed device met all design specifications. The subject surgical gown was assessed for performance using the following Standards and Test Methods. The test results demonstrated that the proposed device met its acceptance criteria or testing endpoints.
| Test Item | Test standard | Acceptance Criteria | Result |
|---|---|---|---|
| Seam strengthASTM D1683M-17 Standard TestMethod forFailure in SewnSeams of WovenFabrics. | The test was performedIn accordance withASTM D1683M-17Standard. Test Methodfor Seam Strength ofTextile Fabrics (GrabTest) to evaluate Failurein Sewn Seams of the testsample. | ≥30N(7lbf)per standardF2407-20 for level 3 | PASS59.21 N(Average result from 30samples) |
| BreakingstrengthASTM D5034-09(2017)Standard TestMethod forBreaking Strengthand Elongation ofTextile Fabrics(Grab Test) | The test was performedIn accordance withD5034-09 (2017) .Standard. Test Methodfor Breaking Strengthand Elongation of TextileFabrics (Grab Test) toevaluate thebreaking strength of thetest sample. | $\ge$ 30N(7lbf)per standardF2407-20 for level 3 | PASSMD: 144.87NCD: 88.89N(Average result from 30samples) |
| Tear strength(N)ASTM D5587-15,Standard TestMethod forTearing Strengthof Fabrics byTrapezoidProcedure | The test was performedin accordance withASTM D5587:2015(2019) StandardTest Method for TearingStrength of Fabrics byTrapezoid Procedure toevaluatethe tearing strength of thetest sample. | $\ge$ 10N | PASSMD: 69.61NCD: 32.25N(Average result from 30samples) |
| Lint and othergeneration in thedry stateISO 9073-10:2003(E) | The test was performedin accordance with ISO9073-10: 2003 Textiles-Test Methods forNonwovens-Part 10: Lintand Other ParticlesGeneration in the DryState to evaluate thelinting of the testsample. | Log10(particle count)< 4 | PASS1.9(Average result from 6samples ) |
| FlammabilityCPSC 16 CFRPart1610-2008,Standard for theFlammability ofclothing textiles | The test was performedin accordance with 16CFR Part 1610Standard for theFlammability of ClothingTextiles to evaluate theflammability of the testsample. | Class I | PASSClass I |
| WaterPenetrationResistanceAATCC 42-2013,ImpactPenetration Test | The test was performedin accordance withAATCC 42: 2013Water Resistance: ImpactPenetration Test toevaluate the water impactof the test sample. | $\le$ 1.0g AQL: 4%Level 3 per standardANSI/AAMIPB70:2012 for level 3 | PASS$\le$ 1.0g |
| StatichydrostaticresistanceAATCC 127-2014 | The test was performedin accordance withAATCC 127: 2014Water Resistance:Hydrostatic Pressure Test | $\ge$ 50 cmH2O perstandard ANSI/AAMIPB70:2012 for level 3AQL: 4% | PASS$\ge$ 50 cm |
| Water Resistance:HydrostaticPressure Test; | to determine thehydrostatic pressure ofthe test sample. | ||
| EO and ECHsterilizationresidualISO 10993-7:2008Ethylene oxidesterilizationresiduals | The test was performedin accordance with ISO10993-7:2008Ethylene oxidesterilization residuals todetermine the EO andECH residuals of the testsample. | $EO \le 4mg/d$$ECH \le 9mg/d$ | PASS$EO \le 4mg/d$$ECH \le 9mg/d$ |
| CytotoxicityISO 10993-5Biologicalevaluation ofmedical devices— Part 5: Testsfor in vitrocytotoxicity | The test was performedin accordance with ISO10993-10 to determinecytotoxicity of the testsample | Non-Cytotoxic | PASSUnder the conditions of thestudy, the device is non-cytotoxic. |
| IrritationISO 10993-10BiologicalEvaluation ofMedical Devices -Part 10: Tests ForIrritation AndSkin Sensitization | The test was performedin accordance with ISO10993-5 to determineIrritation of the testsample | Non-Irritating | PASSUnder the conditions of thestudy, the device is non-irritating. |
| SensitizationISO 10993-10BiologicalEvaluation ofMedical Devices -Part 10: Tests ForIrritation AndSkin Sensitization | The test was performedin accordance with ISO10993-10 to determineskin sensitization of thetest sample | Non-Sensitizing | PASSUnder the conditions of thestudy, the device is non-sensitizing |
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H. Summary of Clinical Test
No clinical study is included in this submission.
I. Conclusion
The conclusions drawn from the non-clinical tests demonstrate that the proposed devices are as safe, as effective, and perform as well as or better than the legally marketed predicate device under K212861.
§ 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.