(178 days)
Not Found
No
The 510(k) summary describes a surgical gown made of non-woven fabric and focuses on its physical properties and performance against standards, with no mention of AI or ML.
No
The device, a surgical gown, is intended for protection against microorganisms and fluids, not for treating or diagnosing a disease or condition.
No
The device is a surgical gown, which is a protective barrier, not a diagnostic tool used to identify or analyze medical conditions. Its purpose is to prevent the transfer of microorganisms and fluids.
No
The device description clearly indicates it is a physical surgical gown made of fabric, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the gown is for protecting operating room personnel and patients from the transfer of microorganisms, body fluids, and particulate material during surgical procedures. This is a physical barrier function, not a diagnostic test performed on a sample from the human body.
- Device Description: The description details the physical components and material of the gown. There is no mention of reagents, assays, or any components used for analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes)
- Providing information for diagnosis, monitoring, or treatment decisions based on sample analysis.
- Performance Studies: The performance studies focus on the physical properties of the gown (strength, resistance to fluids, flammability), which are relevant to its barrier function, not diagnostic accuracy.
In summary, the device is a surgical gown, which is a medical device used for protection, not for performing in vitro diagnostic tests.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
FYA
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
operating room personnel / surgical procedure
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Break strength: >30N
- Tear strength: >20N
- Seam strength: >30N
- Evaporative Resistance: >0.14 KPa.m²/W
- Lint: Log1050 cmH2O
- Water impact: Average Amount of Penetration
§ 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.
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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ 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 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, |
| Jiangsu | |
| Contact Person: | Zhang Yanwen |
| Mobile Phone: 15162512333 | |
| 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 | |
| Manufacturer: | Wujiang Tutaike Textiles & Finishing Co., Ltd. |
| No.1599, South 3rd Ring Road, Shengze, Wujiang, Suzhou, | |
| 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 & | ||
| Finishing Co., Ltd. | Beijing Biosis Healing | ||
| Biological Technology Co., | |||
| Ltd | -- | ||
| Common | |||
| Name | Surgical Gown | Medical Surgical | |
| Gowns | -- | ||
| Classification | Class II | Class II | Same |
| Product Code | FYA | FYA | Same |
| Intended 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. | The Medical 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. | Same | ||
| Durability | Disposable | Disposable | Same |
| Color | Blue | Blue | Same |
| Labeling | Conform with 21CFR Part | ||
| 801 | Conform with 21CFR | ||
| 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 | |||
| Permeability/ | |||
| Evaporative | |||
| Resistance | >0.14 kPa.m²/W and 15 cm3 /s/cm² (29 | ||
| ft3/min/ft2) | Discussion | ||
| Lint | Log1050 cmH2O | >50 cmH2O | Same |
| Water impact | 30N | >30N in machine | |
| Tear strength | ASTM D5587 | >15N | >20N |
| Seam strength | ASTM D 1683/D1683M- | ||
| 17(2018) | >30N | >30N | |
| Evaporative Resistance | ASTM F1868-17 | N/A | >0.14 KPa.m²/W |
| Lint | ISO 9073-10:2003 | N/A | Log1050 cmH2O |
| Pressure >50 cmH2O |
7
| Water impact | AATCC Test Method 42 |