Surgical Gown

K211077 · Wujiang Tutaike Textiles & Finishing Co., Ltd. · FYA · Oct 7, 2021 · General, Plastic Surgery

Device Facts

• Record ID: K211077
• Device Name: Surgical Gown
• Applicant: Wujiang Tutaike Textiles & Finishing Co., Ltd.
• Product Code: FYA · General, Plastic Surgery
• Decision Date: Oct 7, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

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.

Device Story

Disposable surgical gown constructed from SMS (spunbond-meltblown-spunbond) breathable non-woven polyethylene fabric. Designed for use by operating room personnel to provide barrier protection against transfer of microorganisms, body fluids, and particulates during surgical procedures. Features include collar, gown body, sleeves, and lacing for secure fit. Available in sizes S through XXL. Device is provided sterile via ethylene oxide. Healthcare providers wear the gown during surgery to maintain sterile fields and protect both patient and staff. Performance characteristics include AAMI PB 70 Level 3 protection, meeting standards for break strength, tear strength, seam strength, hydrostatic pressure, and water impact resistance.

Clinical Evidence

No clinical data. Substantial equivalence is supported by non-clinical bench testing, including break strength (ASTM D5034), tear strength (ASTM D5587), seam strength (ASTM D1683), evaporative resistance (ASTM F1868-17), lint generation (ISO 9073-10), flammability (16 CFR 1610), hydrostatic pressure (AATCC 127), and water impact (AATCC 42).

Technological Characteristics

Material: SMS breathable non-woven polyethylene. Form factor: One-piece gown with sleeves and lacing. Sterilization: Ethylene oxide. Performance: AAMI PB 70 Level 3. Standards: ASTM D5034 (break strength), ASTM D5587 (tear strength), ASTM D1683 (seam strength), ASTM F1868-17 (evaporative resistance), ISO 9073-10 (lint), 16 CFR 1610 (flammability), AATCC 127 (hydrostatic pressure), AATCC 42 (water impact).

Indications for Use

Indicated for operating room personnel during surgical procedures to provide barrier protection against microorganisms, body fluids, and particulate material.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Medical Surgical Gowns (K202844)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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# 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> |

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# 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: [phone]<br>Email: [e-mail] |
| 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 | |

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## 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 |

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# 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 |

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| 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.