(105 days)
Disposable Surgical Gown is 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 material. In addition, this surgical gown meets the requirements of AAMI Level 4 barrier protection for a surgical gown per ANSU AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities. It is single use, disposable medical devices, provided sterile.
The subject devices 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 materials.
In addition, this surgical gown meets the requirements of AAMI Level 4 barrier protection for a surgical gown per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities.
The proposed device is single use, disposable medical devices and provided sterile.
The main materials of device are SMS nonwoven +TPU membrane, PP and Polyester fiber, and the main manufacturing technique are Ultrasonic welding and Sewing.
The provided text is a 510(k) Summary for a medical device (Disposable Surgical Gown) and does not describe an AI/ML-driven device or study. Therefore, most of the requested information regarding acceptance criteria, training/test sets, ground truth establishment, expert adjudication, or MRMC studies for an AI/ML device is not applicable.
Instead, the document details the device's physical properties, material composition, and performance against established industry standards for surgical gowns. The "study" mentioned is a series of non-clinical tests to verify the device meets design specifications and relevant standards.
Here's a breakdown of the relevant information from the document, tailored to the non-AI/ML context:
Device Description: Disposable Surgical Gown
Purpose of the "Study" (Non-Clinical Testing): To verify that the proposed device (Disposable Surgical Gown) meets all design specifications and complies with relevant standards for surgical gowns, demonstrating its safety and effectiveness compared to a legally marketed predicate device.
1. Table of Acceptance Criteria and Reported Device Performance:
The document provides a table of non-clinical tests conducted, their purpose, acceptance criteria, and results.
| Test Method | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| AATCC 127 | Water resistance Hydrostatic Pressure | >50 cm | Passed |
| AATCC 42 | Water Resistance impact penetration Nonwoven and plastic Barriers | ≤1.0 g | Passed |
| ASTM D5034-09 | Tensile Strength | MD Mean≥30 lbs; CD Mean≥25 lbs | Passed |
| ASTM D5587-19 | Tearing Strength | MD Mean≥9 lbs; CD Mean≥18 lbs | Passed |
| ASTM F1868-17 | Evaporative Resistance of fabrics | Mean Evaporative Resistance (Ref)≥0.06(kPa·m2/W). | Passed |
| 16 CFR 1610 | Flammability testing | Meets requirements of Flame Resistant CPSC 1610 Class 1 | Meets requirements |
| ASTM D1683-17 | Seam Strength | >50N | Passed |
| ASTM F1671 | Resistance to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage | No virus through, “None Seen” | Passed |
| ISO 9073-10:2003 | Lint and Other particles generation in the dry state | Log 10 < 4 | Passed |
| ISO 10993-5 | Tests for In vitro cytotoxicity | Device must not be cytotoxic | Device is noncytotoxic |
| ISO 10993-10 | Tests for irritation and skin sensitization (Irritation) | Device must not be irritant | Device is not an irritant |
| ISO 10993-10 | Tests for irritation and skin sensitization (Sensitization) | Device must not be sensitizer | Device is not a sensitizer |
| ISO 10993-7 | Ethylene Oxide Sterilization Residuals | Residual Ethylene oxide levels must be below limits | Ethylene Oxide residual levels are below limitations |
| USP43<85> | Bacterial Endotoxin Test | <20EU/piece | Passed |
Additional Performance Claim: The device also meets the requirements of AAMI Level 4 barrier protection for a surgical gown per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities. This is a key difference and perceived improvement over the predicate device, which met Level 3.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes for each specific test, nor does it detail the provenance of the materials tested (e.g., country of origin). However, it implies standardized testing conducted to meet regulatory and industry standards. The tests are "non-clinical" and laboratory-based, focused on material properties of the manufactured gown samples.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable as this is not an AI/ML-driven study requiring expert interpretation of data/images. The "ground truth" is established by the specified industry standards and test methodologies (e.g., ASTM, AAMI, ISO, AATCC, 16 CFR).
4. Adjudication Method for the Test Set:
Not applicable. Performance is determined by standardized physical and chemical tests against defined numerical criteria, not by human adjudication of qualitative data.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This is not an AI/ML diagnostic or assistive device. The comparison is between the proposed device's physical properties and the requirements of recognized standards, as well as a direct comparison of specifications with a predicate device.
6. Standalone (Algorithm Only) Performance:
Not applicable. This is a physical medical device, not an algorithm.
7. Type of Ground Truth Used:
The "ground truth" for the performance evaluation is based on established industry standards and test methodologies (e.g., ANSI/AAMI PB70:2012 for liquid barrier performance, ASTM F2407-06 for specifications of surgical gowns, ISO 10993 for biocompatibility). The device must demonstrate that its physical and chemical properties meet or exceed the requirements set forth in these standards.
8. Sample Size for the Training Set:
Not applicable. There is no concept of a "training set" for this type of device and non-clinical testing. The manufacturing process and material selection are validated against the final product specifications.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no training set. The "ground truth" for establishing the device's design and performance goals is rooted in existing regulatory requirements and recognized consensus standards for surgical apparel.
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Image /page/0/Picture/0 description: The image contains 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.
April 12, 2022
Weihai Hongyu Nonwoven Fabric Products Co., Ltd. Ray Wang Gerneral Manager Beijing Believe-Med Technology Service Co., Ltd. Rm.912 Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District Beijing, Beijing 102401 China
Re: K214088
Trade/Device Name: Disposable Surgical Gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYA Dated: March 10, 2022 Received: March 15, 2022
Dear Ray Wang:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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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 and Part 809); 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 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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Indications for Use
510(k) Number (if known) K214088
Device Name Disposable Surgical Gown
Indications for Use (Describe)
Disposable Surgical Gown is 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 material. In addition, this surgical gown meets the requirements of AAMI Level 4 barrier protection for a surgical gown per ANSU AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities. It is single use, disposable medical devices, provided 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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The assigned 510(k) Number: K214088
510(k) Summary
This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.
-
- Date of Preparation: 2022/04/12
-
- Sponsor Identification
Weihai Hongyu Nonwoven Fabric Products Co., Ltd.
No.567, Gushan Road, Area of Economy And Technique, 264207, Weihai City, Shandong, P.R.China Contact Person: Bin Dong Position: Manager Tel: +86-0631-3636942 Fax: +86-0631-3636910 Email: dbfeel@163.com
-
- Designated Submission Correspondent
Mr. Ray Wang
- Designated Submission Correspondent
Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, Beijing, 102401, China
Tel: +86-18910677558 Fax: +86-10-56335780 Email: information@believe-med.com
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4. Identification of Proposed Device
Trade Name: Disposable Surgical Gown Common Name: Gown, Surgical
Regulatory Information Classification Name: Gown, Surgical Classification: 2 Product Code: FYA Regulation Number: 21 CFR 878.4040 Review Panel: General Hospital
Indication For Use Statement:
Disposable Surgical Gown is 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 material. In addition, this surgical gown meets the requirements of AAMI Level 4 barrier protection for a surgical gown per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities. It is single use, disposable medical devices, provided sterile.
5. Identification of Predicate Device(s)
Predicate Device 510(k) Number: K173847 Product Name: Disposable Ultra Reinforced Surgical Gown Manufacturer: Xiantao Rayxin Medical Products Co., ltd.
Device Description 6.
The subject devices 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 materials.
In addition, this surgical gown meets the requirements of AAMI Level 4 barrier protection for a surgical gown per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities.
The proposed device is single use, disposable medical devices and provided sterile.
The main materials of device are SMS nonwoven +TPU membrane, PP and Polyester fiber, and the main manufacturing technique are Ultrasonic welding and Sewing.
-
- Summary of Non-Clinical Testing
Non clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:
- Summary of Non-Clinical Testing
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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.
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ISO 10993-7: 2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
-
ASTM F2407-06, Standard Specification For Surgical Gowns Intended For Use In Healthcare Facilities.
-
AAMI/ANSI PB70:2012, Liquid Barrier Performance and Classification of protective Apparel and Drapes Intended For Use In Health Care Facilities.
-
ISO 11135-1:2014 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices [Including: Amendment 1 (2018)]
| Test Method | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| AATCC 127 | Water resistanceHydrostatic Pressure | >50 cm | Passed |
| AATCC 42 | Water Resistance impactpenetration Nonwoven andplastic Barriers | ≤1.0 g | Passed |
| ASTM D5034-09 | Tensile Strength | MD Mean≥30 lbs;CD Mean≥25 lbs | Passed |
| ASTM D5587-19 | Tearing Strength | MD Mean≥9 lbs;CD Mean≥18 lbs | Passed |
| ASTM F1868-17 | Evaporative Resistance offabrics | Mean EvaporativeResistance(Ref)≥0.06(kPa·m2/W). | Passed |
| 16 CFR 1610 | Flammability testing | Meets requirements ofFlame Resistant CPSC1610 Class 1 | Meetsrequirements |
| ASTM D1683-17 | Seam Strength | >50N | Passed |
| ASTM F1671 | Resistance to Penetrationby Blood-Borne PathogensUsingPhi-X174BacteriophageASTM F1671 | No virus through, “NoneSeen” | Passed |
| ISO 9073-10:2003 | Lint and Other particlesgeneration in the dry state | Log 10 < 4 | Passed |
| ISO 10993-5 | Tests for In vitrocytotoxicity | Device must not becytotoxic | Device isnoncytotoxic |
| ISO 10993-10 | Tests for irritationand skin | Device must not beirritant | Device is not anirritant |
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| Irritation | |||
|---|---|---|---|
| ISO 10993-10 | Tests for irritationand skinsensitization | Device must not besensitizer | Device is not asensitizer |
| ISO 10993-7 | Ethylene OxideSterilization Residuals | Residual Ethylene oxidelevels must be belowlimits | Ethylene Oxideresidual levels arebelow limitations |
| USP43<85> | Bacterial Endotoxin Test | <20EU/piece | Passed |
Summary of Clinical Testing 8.
No clinical study is included in this submission.
Comparison of Technological Characteristics with the Predicate Device 9.
| ITEM | Proposed Device K214088 | Predicate Device K173847 | Remark |
|---|---|---|---|
| IntendedUse/Indication ForUse | Disposable Surgical Gown isintended to be worn by operatingroom personnel during surgicalprocedures to protect the surgicalpatient and operating roompersonnel from the transfer ofmicroorganisms, body fluids andparticulate material. In addition,this surgical gown meets therequirements of AAMI Level 4barrier protection for a surgicalgown per ANSI/AAMI PB70:2012Liquid barrier performance andclassification of protective appareland drapes intended for use inhealth care facilities. It is singleuse, disposable medical devices,provided sterile. | The Disposable Ultra ReinforcedSurgical Gown is intended to beworn by operating roompersonnel during surgicalprocedures to protect the surgicalpatient and operating roompersonnel from the transfer ofmicroorganisms, body fluids andparticulate material. In addition,this surgical gown meets therequirements of AAMI Level 3barrier protection for a surgicalgown per ANSI/AAMIPB70:2012 Liquid barrierperformance and classification ofprotective apparel and drapesintended for use in health carefacilities. It is single use,disposable medical devices,provided sterile. | SIMILAR |
| Product Code | FYA | FYA | SAME |
| Use | Single Use; Disposable | Single Use; Disposable | SAME |
| Material Composition | SMS nonwoven + TPU membrane | SMS polypropylene nonwoven | SIMILAR |
| Prescription vs. OTC | OTC | OTC | SAME |
| Sterile | Sterile | Sterile | SAME |
| Color | Blue | Blue | SAME |
| Sterilization Method | EO | EO | SAME |
| Weight per square (g) | 67g/m² | 44 g/m² | SIMILAR |
| Tensile | MD Mean≥30 lbs;CD Mean≥25 lbs | MD Mean≥30 lbs;CD Mean≥25 lbs | SAME |
| Tear | MD Mean≥9 lbs;CD Mean≥18 lbs | MD Mean≥9 lbs;CD Mean≥18 lbs | SAME |
| Hydrostatic Pressure(cm)AATCC-127 | >50 cm | >50 cm | SAME |
| Water Impact (g)AATCC-42 | ≤1.0 g | ≤1.0 g | SAME |
| Seam Strength | >58 N | Not Known | / |
| Linting | Log 10<4 | Not Known | / |
| Resistance to bloodand liquid penetration | Level 4 AAMI PB70 | Level 3 AAMI PB70 | DIFFERENCE |
| Resistance toPenetration byBlood-BornePathogens UsingPhi-X174BacteriophageASTM F1671 | No virus through, “None Seen” | Not Appliable for Level 3. | / |
| Size | S, M, L, XL, XXL, XXXL | S, M, L, XL | SIMILAR |
| 16 CFR Part 1610 | Meets requirements of Flame | Meets requirements of Flame | SAME |
| Flammability | Resistant CPSC 1610 Class 1 | Resistant CPSC 1610 Class 1 | SAME |
| Biocompatibility | Under the conditions of the study, the device extract was not cytotoxic.Under the conditions of the study, the non-polar and polar device extractswere not found to be an irritant.Under conditions of the study, the non-polar and polar device extractswere not found to be a sensitizer. | Under the conditions of the study, the device extract was not cytotoxic.Under the conditions of the study, the non-polar and polar device extractswere not found to be an irritant.Under conditions of the study, the non-polar and polar device extractswere not found to be a sensitizer. | SAME |
| Shelf Life | 1 years | 2 years | DIFFERENCE |
| Sterilization Method& SAL | Ethylene Oxide (EO), SAL=10-6The EO/ECH residues meet therequirements of ISO 10993-7 | Ethylene Oxide (EO), SAL=10-6The EO/ECH residues meet therequirements of ISO 10993-7 | SAME |
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Analysis:
The proposed device is different from the predicate device in Seam Strength and Linting, because the predicate device is not known on these two testing results meet the requirements of ASTM F2407.
The proposed device is different from the predicate device, the resistance to blood and liquid penetration of the proposed device comply with AAMI PB70 Level 4, the predicate device comply with AAMI PB70 Level 3, but this difference would not affect its safety and effectiveness. The proposed
{8}------------------------------------------------
device has one more performance advantage than the predicate device in resistance to blood and liquid penetration, this performance has been verified, the results meet the requirements of AAMI PB70 Level.
The proposed device has better performance to the predicate device. Both proposed device and predicate device are safe and effective, so we consider which is same with the predicate device.
The proposed device is different from the predicate device in shelf life, the 1 year shelf life real time aging validation has been conducted, and the results shown that the proposed device could maintain its performance at the end of 1 year shelf life claimed, so we consider this difference would not raise any safety or effectiveness concerns.
10. Conclusion
Based on the nonclinical tests performed, the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device, Disposable Surgical Gown cleared under K173847.
§ 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.