Surgical Gown

{0}------------------------------------------------ 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. October 7, 2021 Wujiang Tutaike Textiles & Finishing Co., Ltd. % Eva Li RA Microkn Business Consulting (Shanghai) Co., Ltd Room 1215, Block A, No 3699, Gonghexin Road, Jingan District Shanghai. China Re: K211077 Trade/Device Name: Surgical Gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYA Dated: March 23, 2021 Received: September 7, 2021 Dear Eva Li: 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 {1}------------------------------------------------ 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, For Clarence Murray, 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 Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K211077 Device Name Surgical Gown Indications for Use (Describe) The Surgical Gowns 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. | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------| | <div> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | 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 of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510K Summary # K211077 According to the requirements Per 21 CFR §878.4040, the following information is provided sufficient detail to understand the basis for a determination of substantial equivalence. | Applicant: | Wujiang Tutaike Textiles & Finishing Co., Ltd. | |-------------------------------------|----------------------------------------------------------------------------------------------------------------------| | Address: | No.1599, South 3rd Ring Road, Shengze, Wujiang, Suzhou,<br>Jiangsu | | Contact Person: | Zhang Yanwen<br>Mobile Phone: 15162512333<br>Email: evonzhang@szttk.com.cn | | Common Name | Surgical Gown | | 510(k) Number: | K211077 | | Product Code: | FYA | | Classification: | Class II | | Regulation number: | 21 CFR 878.4040 | | Legal<br>Manufacturer: | Wujiang Tutaike Textiles & Finishing Co., Ltd.<br>No.1599, South 3rd Ring Road, Shengze, Wujiang, Suzhou,<br>Jiangsu | | Predicate Device | | | Predicate Device: | Medical Surgical Gowns | | 510(k) Number: | K202844 | | 510(k) Preparation Date: 07/30/2021 | | {4}------------------------------------------------ ## 1. Indications for use The 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. ### 2. Description of the Device This product is a new type of SMS breathable non-woven fabric. It consists of collar, gown body and sleeves. The main components of proposed device are: - (1)One-piece non-woven fabric Surgical Gown: - (2)One-piece helps for better protection and good visuals; - (3)Lacing: It is used to tie the belt and fix the shape of the Surgical Gown. #### 3. Model specifications See the table.1 below: | Size | Length | Bust | Sleeve Length | |-----------|--------|------|---------------| | S | 115 | 140 | 61 | | M | 120 | 144 | 63 | | L | 125 | 148 | 65 | | XL | 130 | 152 | 67 | | XXL | 135 | 156 | 69 | | Variation | +2 | +2 | +2 | #### Table 1 Model specifications (unit: cm) #### 4. Comparison of the technological characteristics between the predicate and subject devices | Feature | Proposed Device | Predicate device | Remark | |---------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------| | 510(K)# | K211077 | K202844 | -- | | Manufacturer | Wujiang Tutaike Textiles &<br>Finishing Co., Ltd. | Beijing Biosis Healing<br>Biological Technology Co.,<br>Ltd | -- | | Common<br>Name | Surgical Gown | Medical Surgical<br>Gowns | -- | | Classification | Class II | Class II | Same | | Product Code | FYA | FYA | Same | | Intended Use | The Surgical Gown is<br>intended to be worn by<br>operating room personnel<br>during surgical procedure to<br>protect both the surgical<br>patient and the operating room<br>personnel from transfer of<br>microorganisms, body fluids,<br>and particulate material. | The Medical Surgical<br>Gowns is intended to be<br>worn by operating room<br>personnel during surgical<br>procedure to protect both<br>the surgical patient and the<br>operating room personnel<br>from transfer of<br>microorganisms, body<br>fluids, and particulate<br>material. | Same | | Durability | Disposable | Disposable | Same | | Color | Blue | Blue | Same | | Labeling | Conform with 21CFR Part<br>801 | Conform with 21CFR<br>Part 801 | Same | | Size | S, M, L, XL, XXL | S, M, L, XL, XXL,XXXL | Similar | | Break strength | >20N | >20N | Same | | Tear strength | >20N | >20N | Same | | Air<br>Permeability/<br>Evaporative<br>Resistance | >0.14 kPa.m²/W and <0.3<br>kPa.m²/W | >15 cm3 /s/cm² (29<br>ft3/min/ft2) | Discussion | | Lint | Log10<4.0 | Log10<4.0 | Same | | Flammability | Class I | Class I | Same | | Hydrostatic<br>pressure | >50 cmH2O | >50 cmH2O | Same | | Water impact | <0.1 g | ≤1.0 g | Discussion 2 | | Material | SMS<br>breathable non-woven<br>polyethylene | SMS<br>nonwoven,<br>polyethylene | Same | | Level | Level 3 per AAMI PB 70 | Level 3 per AAMI PB<br>70 | Same | | Biocompatibility | | | | | Cytotoxicity | No Cytotoxicity | No Cytotoxicity | Same | | Skin Irritation | No Irritation | No Irritation | Same | | Sensitization | No Sensitization | No Sensitization | Same | | Sterile | Ethylene oxide sterilization | Ethylene Oxide (EO) | Same | {5}------------------------------------------------ {6}------------------------------------------------ # Discussion 1: The predicted device has passed the requirement of Air permeability according to ASTM D737-18:2018, while the proposed device has pass the ASTM F1868-2017 Standard Test Method for Thermal and Evaporative Resistance of Clothing Materials Using a Sweating Hot Plate. Two standards have the same performance requirement. So, this can be seen as same and don't raise any problem. # Discussion 2: The proposed device has higher performance acceptance criteria for water impact test than the predicate device. # 5. Summary of non-clinical performance test results The following performance data were provided in support of safe and effective use of the proposed device: | Test Item | Test standard | Acceptance Criteria | Result | |------------------------|---------------------------------|---------------------|---------------------------------------| | Break strength | ASTM D5034 | >30N | >30N in machine | | Tear strength | ASTM D5587 | >15N | >20N | | Seam strength | ASTM D 1683/D1683M-<br>17(2018) | >30N | >30N | | Evaporative Resistance | ASTM F1868-17 | N/A | >0.14 KPa.m²/W | | Lint | ISO 9073-10:2003 | N/A | Log10<4.0 | | Flammability | 16 CFR Part 1610.7 | N/A | Class I | | Hydrostatic pressure | AATCC Test Method 127 | >50 cmH2O | Average Failure<br>Pressure >50 cmH2O | {7}------------------------------------------------ | Water impact | AATCC Test Method 42 | <1.0 g | Average Amount of<br>Penetration <0.1 g | |--------------|----------------------|--------|-----------------------------------------| | Level | AAMI PB 70 | N/A | Level 3 | # 6. Clinical Test Conclusion Clinical study is not applicable for the subject device and is not included in this submission. # 7. Conclusion The nonclinical tests performed demonstrate that the subject device, Disposable Medical Surgical Gown, is as safe, as effective, and performs as well as the legally marketed predicate device Medical Surgical Gowns under K202844.