Disposable Surgical Gown, Disposable Reinforced Surgical Gown

K212869 · Fugou County Shenxiang Manufacturing Co., Ltd. · FYA · Dec 13, 2021 · General, Plastic Surgery

Device Facts

• Record ID: K212869
• Device Name: Disposable Surgical Gown, Disposable Reinforced Surgical Gown
• Applicant: Fugou County Shenxiang Manufacturing Co., Ltd.
• Product Code: FYA · General, Plastic Surgery
• Decision Date: Dec 13, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

Disposable Surgical Gown and Disposable Reinforced Surgical Gown are 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. Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, Disposable Surgical Gown ML515M45U met the requirements for Level 3 classification, Disposable Surgical Gown GD524ME65 and Disposable Reinforced Surgical Gown met the requirements of Level 4 classification.

Device Story

Disposable surgical gowns (reinforced and non-reinforced) designed for use by operating room personnel; intended to provide a physical barrier against microorganisms, body fluids, and particulates during surgery. Devices are single-use, sterile, and available in six sizes (S-XXXL). Principle of operation relies on material barrier properties (SMS nonwoven, PE film) to meet ANSI/AAMI PB70 Level 3 or Level 4 liquid barrier performance standards. Healthcare providers wear the gown as personal protective equipment; output is the physical protection of the wearer and patient. Benefits include reduced risk of cross-contamination and infection transmission in the surgical environment.

Clinical Evidence

No clinical data. Bench testing only. Performance verified via AATCC 127 (hydrostatic pressure), AATCC 42 (water impact), ISO 9073-10 (linting), ASTM D5034 (breaking strength), ASTM D5587 (tearing strength), ASTM D737 (air permeability), and ASTM F1671 (blood-borne pathogen resistance). Biocompatibility confirmed via ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation/sensitization).

Technological Characteristics

Materials: SMS nonwoven, PE film, polyester, blue masterbatch. Barrier levels: AAMI PB70 Level 3 and Level 4. Sterilization: Ethylene Oxide (EO) to SAL 10^-6. Physical properties: Class I flammability, >50cm hydrostatic pressure, <1.0g water impact. Sizes: S-XXXL.

Indications for Use

Indicated for operating room personnel during surgical procedures to protect the patient and personnel from the transfer of 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

• Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown (K211422)
• SMS Standard Surgical Gown; SMS Surgical Gown with Reinforcement; BVB Surgical Gown; BVB Splicing Surgical Gown (K192290)
• Surgical Gown (K121152)

Submission Summary (Full Text)

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December 21, 2021 Fugou County Shenxiang Manufacturing Co., LTD. % Diana Hong General Manager Mid-Link Consulting Co.,Ltd P.O.box 120-119 Shanghai, 200120 China

Re: K212869

Trade/Device Name: Disposable Surgical Gown, Disposable Reinforced Surgical Gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FYA

Dear Diana Hong:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter for your device cleared on December 13, 2021. Specifically, FDA is updating this SE letter due to the clearance date not appearing on the original letter.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Clarence W. Murray III, Assistant Director of Office of Surgical and Infection Control Devices, at Tel: [phone] or Email: [e-mail].

Sincerely,

# Bifeng Qian -S

For Clarence W. Murray, III, 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

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Image /page/1/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 USA 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.

Fugou County Shenxiang Manufacturing Co., LTD. % Diana Hong General Manager Mid-Link Consulting Co.,Ltd P.O.box 120-119 Shanghai, 200120 China

Re: K212869

Trade/Device Name: Disposable Surgical Gown, Disposable Reinforced Surgical Gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYA Dated: August 19, 2021 Received: September 9, 2021

Dear Diana Hong:

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 (DICE(@fda.hhs.gov) or phone [phone] or 301-796-7100).

Sincerely,

# Bifeng Qian -S

For Clarence W. Murray, III, 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known) K212869

Device Name

Disposable Surgical Gown, Disposable Reinforced Surgical Gown

#### Indications for Use (Describe)

Disposable Surgical Gown and Disposable Reinforced Surgical Gown are 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.

Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, Disposable Surgical Gown ML515M45U met the requirements for Level 3 classification, Disposable Surgical Gown GD524ME65 and Disposable Reinforced Surgical Gown met the requirements of Level 4 classification.

| 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)

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# K212869

This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.

- 1. Date of Preparation: 12/13/2021
- 2. Sponsor Identification

Fugou County Shenxiang Manufacturing Co., LTD. Industrial Clusters, No.2 Road, Fugou County, Henan Province, China

Establishment Registration Number: 3017149307

Contact Person: Carina Si Position: Business Manager Tel: [phone] Fax: [phone] Email: mike.xu(@fgshenxiang.com

- 3. Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Jinlei Tang (Alternative Contact Person)

#### Mid-Link Consulting Co., Ltd.

P.O. Box 120-119, Shanghai, 200120, China

Tel: [phone], Fax: [phone] Email: [e-mail]

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#### Identification of Proposed Device 4.

Trade Name: Disposable Surgical Gown, Disposable Reinforced Surgical Gown Common Name: Surgical Gown

#### Regulatory Information

Classification Name: Gown, Surgical Classification: II; Product Code: FYA; Regulation Number: 21 CFR 878.4040 Review Panel: General Hospital;

#### Indication for use:

Disposable Surgical Gown and Disposable Reinforced Surgical Gown are 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.

Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, Disposable Surgical Gown ML515M45U met the requirements for Level 3 classification, Disposable Surgical Gown GD524ME65 and Disposable Reinforced Surgical Gown met the requirements of Level 4 classification.

Device Description:

The proposed devices are 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 proposed devices are single use, disposable medical devices and are provided in sterile.

There are two types of surgical gown: Disposable Surgical Gown and Disposable Reinforced Surgical Gown. And each type of surgical gown is available in six product sizes, including S, M, L, XL, XXL and XXXL. Disposable Surgical Gown have two models: ML515M45U and GD524ME65. Disposable Reinforced Surgical Gown have one model: PA528ME45R. Disposable Surgical Gown ML515M45U met the requirements for Level 3 classification, Disposable Surgical Gown GD524ME65 and Disposable Reinforced Surgical Gown met the requirements of Level 4 classification.

Table 1. Surgical Gowns Description

| Proposed | Model | Size | Color | Style | AAMI | Material |
|----------|-------|------|-------|-------|------|----------|
|----------|-------|------|-------|-------|------|----------|

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| device | | | | Level | | |
|--------------------------------|----------------------------------------------|------------------------------|------------------------------|----------------|------------|---------------------------------------------------------------------------|
| Disposable<br>Surgical<br>Gown | ML515M45U | S, M, L, XL,<br>XXL,<br>XXXL | Blue | Non-reinforced | 3 | 45g/m² PP SMS<br>nonwoven, Polyester,<br>Blue masterbatch |
| | GD524ME65 | S, M, L, XL,<br>XXL,<br>XXXL | Blue | Non-reinforced | 4 | 45g/m² SMS<br>nonwoven, 20g/m² PE<br>film, Polyester, Blue<br>masterbatch |
| | Disposable<br>Reinforced<br>Surgical<br>Gown | PA528ME45R | S, M, L, XL,<br>XXL,<br>XXXL | Blue | Reinforced | 4 |

#### 5. Identification of Predicate Devices

Predicate Device 1 510(k) Number: K211422 Product Name: Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown

Predicate Device 2 510(k) Number: K192290 Product Name: SMS Standard Surgical Gown; SMS Surgical Gown with Reinforcement; BVB Surgical Gown; BVB Splicing Surgical Gown

Predicate Device 3 510(k) Number: K121152 Product Name: Surgical Gown

- 6. Summary of Clinical Testing
No clinical study is included in this submission.

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#### 7. Summary of Technological characteristics

| Item | Proposed Device | Predicate Device K211422 | Remark |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Product Code | FYA | FYA | Same |
| Regulation No. | 21CFR 878.4040 | 21CFR 878.4040 | Same |
| Class | II | II | Same |
| Indication for Use | Disposable Surgical Gown and<br>Disposable Reinforced Surgical<br>Gown are intended to be worn by<br>operating room personnel during<br>surgical procedure to protect both<br>the surgical patient and the<br>operating room personnel from<br>transfer of microorganisms, body<br>fluids, and particulate material.<br>Per ANSI/AAMI PB70:2012<br>Liquid barrier performance and<br>classification of protective apparel<br>and drapes intended for use in<br>health care facilities, Disposable<br>Surgical Gown ML515M45U met<br>the requirements for Level 3<br>classification, Disposable Surgical<br>Gown GD524ME65 and<br>Disposable Reinforced Surgical<br>Gown met the requirements of<br>Level 4 classification. | Surgical gown is intended to be<br>worn by operating room personnel<br>during surgical procedure to<br>protect both the surgical patient<br>and the operating room personnel<br>from transfer of microorganisms,<br>body fluids, and particulate<br>material.<br>Per ANSI/AAMI PB70:2012<br>Liquid barrier performance and<br>classification of protective apparel<br>and drapes intended for use in<br>health care facilities, the Level 2<br>standard surgical gowns met the<br>requirements for Level 2<br>classification, the Level 3 standard<br>surgical gowns and Level 3<br>reinforced surgical gowns met the<br>requirements for Level 3<br>classification. | Same |
| Style | Non-reinforced | Non-reinforced | Same |
| Durability | Disposable | Disposable | Same |
| Color | Blue | Blue | Same |
| Labeling | Conform with 21CFR Part 801 | Conform with 21CFR Part 801 | Same |
| Weight per square (g) | 45g/m2 | Level 3 Standard Surgical Gown:<br>43g/m² | Different |
| Size | S, M, L, XL, XXL, XXXL | XS, S, M, L, XL, XXL, XXXL | Different |
| Flammability | Class I | Class I | Same |
| Hydrostatic pressure | >50 cm | Level 3 Standard Surgical<br>Gown: >50 cm | Same |
| Water impact | <1.0 g | <1.0 g | Same |

| Table 1 Comparison of Technology Characteristics for Level 3 Surgical Gown | |
|----------------------------------------------------------------------------|--|
| | |

4 / 13

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| Breaking strength | >20N | >20N | Same |
|-----------------------------|-----------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|-----------|
| Tearing strength | >20N | >20N | Same |
| Linting | $Log_{10}<4$ | $Log_{10}(particle count) <4$ | Same |
| Air permeability | >30 ft³/min/ft² | >30 ft³/min/ft² | Same |
| Barrier protection<br>level | Level 3 per AAMI PB 70 | Level 3 per AAMI PB 70 | Same |
| Material | SMS, Polyester, Blue masterbatch | Level 3 Standard Surgical Gown:<br>SMS nonwoven, Polyester and<br>Polyamide | Different |
| Biocompatibility | | | |
| Cytotoxicity | Under the conditions of the study, | Under the conditions of the study, | Same |
| Irritation | the device is non-toxic,<br>non-irritating, and | the device is non-toxic,<br>non-irritating, and non-sensitizing. | |
| Sensitization | non-sensitizing. | | |
| Sterilization | Sterile<br>Method: Ethylene Oxide (EO);<br>Sterilization Assurance Level<br>(SAL): 10-6 | Sterile<br>Method: Ethylene Oxide (EO);<br>Sterilization Assurance Level<br>(SAL): 10-6 | Same |

#### Different - Weight per square

The weight per square for the proposed surgical gowns is different from the predicate device. However, the difference in the weight per square will not affect the intended use. In addition, the performance testing results demonstrated that the proposed surgical gowns can meet the barrier protection level 3 requirement as required by PB70. Therefore, this difference will not affect the safety and effectiveness of the proposed device.

#### Different - Size

The size for the proposed surgical gowns is different from the predicate device. The proposed surgical gowns are available in 6 product sizes, including S, M, L, XL, XXL and XXXL. However, the difference in the size will not affect the device performance. And the specifications of the proposed device can be covered by the predicated products. Different size can be selected by surgeon's condition. Therefore, this difference will not affect the safety and effectiveness of the proposed device.

#### Different- Material

The material for the proposed surgical gowns is different from the predicated device. However, the biocompatibility test for proposed device was performed and the results showed no adverse effect. Therefore, this difference will not affect the safety and effectiveness of the proposed device.

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| Item | Proposed Device | Predicate Device K192290 | Predicate Device K121152 | Remark |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Product Code | FYA | FYA | FYA | Same |
| Regulation No. | 21CFR 878.4040 | 21CFR 878.4040 | 21CFR 878.4040 | Same |
| Class | II | II | II | Same |
| Indication for Use | Disposable Surgical Gown and Disposable Reinforced Surgical Gown are 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. | 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. Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, SMS Standard Surgical Gown and SMS Surgical Gown with Reinforcement met the requirements for Level 3 classification; BVB Surgical Gown and BVB Splicing Surgical Gown met the requirements for Level 4 classification. | Jiangsu Guangda's Reinforced Surgical Gowns, Model Number GD-SG-01, are non-sterile, single use surgical gowns intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. This product may be sterilized using Ethylene Oxide (EO) following the Validation and routine control under ANSI/AAMI/ISO 11135. | Same |
| Style | Non-reinforced/Reinforced | Non-reinforced | Reinforced | Different |
| Durability | Disposable | Disposable | Disposable | Same |
| Color | Blue | Blue | Blue | Same |
| Labeling | Conform with 21CFR Part 801 | Conform with 21CFR Part 801 | Conform with 21CFR Part 801 | Same |
| Weight per | Level 4 Standard Surgical | 68 g/m² | 45 g/m² | Different |
| square (g) | Gown: 45g/m² and 20g/m²<br>PE film<br>Level 4 Reinforced Surgical<br>Gown: 45g/m² and 25g/m²<br>PE film reinforced film | | | |
| Size | S, M, L, XL, XXL, XXXL | M, L, XL, XXL, XXXL,<br>XXXL-XLONG | XL | Different |
| Flammability | Class I | Class I | Class I | Same |
| Hydrostatic<br>pressure | Level 4 Standard Surgical<br>Gown: >50 cm;<br>Level 4 Reinforced Surgical<br>Gown: >50 cm | >50 cm | >20 | Same |
| Water impact | ≤1.0 g | ≤1.0 g | ≤1.0 g | Same |
| Breaking strength | Level 4 Standard Surgical<br>Gown:<br>latitude: 111 N<br>longitude: 184 N<br>Level 4 Reinforced Surgical<br>Gown:<br>latitude: 109 N<br>longitude: 122 N | latitude: 92.3N<br>longitude: 177.11N | Passed | Different |
| Tearing strength | Level 4 Standard Surgical<br>Gown:<br>latitude: 90 N<br>longitude: 137 N<br>Level 4 Reinforced Surgical<br>Gown:<br>latitude: 80 N<br>longitude: 137 N | latitude: 35.30N<br>longitude: 56.46N | Passed | Different |
| Linting | Log10<4 | Log10<4 | Log10<4 | Same |
| Bacterial<br>Penetration | No detectable transfer of the<br>Phi-X174 Bacteriophage | No detectable transfer of the<br>Phi-X174 Bacteriophage | No detectable transfer of the<br>Phi-X174 Bacteriophage | Same |
| Barrier protection<br>level | Level 4 per AAMI PB 70 | Level 4 per AAMI PB 70 | Level 4 per AAMI PB 70 | Same |
| Material | Level 4 Standard Surgical<br>Gown: SMS nonwoven, PE<br>film, Polyester and blue<br>masterbatch;<br>Level 4 Reinforced Surgical<br>Gown: SMS nonwoven | SMS nonwoven, white<br>knitted cuff, white<br>spunbond, and BVB | SMS and PE+PP two layer<br>compound | Different |
| | Polyester, PE film reinforced<br>film and Blue masterbatch | | | |
| Biocompatibility | | | | |
| Cytotoxicity | Under the conditions of the<br>study, the device is<br>non-toxic, non-irritating, and<br>non-sensitizing. | No Cytotoxicity<br>No Irritation<br>No Sensitization | Passed | Same |
| Irritation | | | Passed | |
| Sensitization | | | Passed | |
| Sterilization | Sterile<br>Method: Ethylene Oxide (EO);<br>Sterilization Assurance Level<br>(SAL): 10-6 | Ethylene Oxide (EO) | Although sold non-sterile,<br>gowns can be EO Sterilized | Same |

# Table 2 Comparison of Technology Characteristics for Level 4 Surgical Gown

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#### Different - Style

The style of the proposed device is different from the predicate device is available in two styles, non-reinforced and reinforced, which can be covered by predicate device K192290 and reference device K121152. The proposed device offers more options that physician can choose based on clinical conditions. Therefore, this difference will not affect the safety and effectiveness of the proposed device.

#### Different - Weight per square

Although the weight per square of the proposed device and the weight per square of the predicate device are different, the difference in the weight per square will not affect the intended use. In addition, the performance testing results demonstrated that the proposed surgical gowns can meet the barrier protection level 4 requirement as required by PB70. Therefore, this difference will not affect the safety and effectiveness of the proposed device.

#### Different - Size

The size for the proposed surgical gowns is different from the predicate device. The proposed surgical gowns are available in 6 product sizes, including S, M, L, XL, XXL and XXXL. However, the difference in the size will not affect the device performance. Different size can be selected by surgeon's condition. Therefore, this difference will not affect the safety and effectiveness of the proposed device.

#### Different - Breaking strength

The longitude and latitude breaking strength of the Level 4 Standard Surgical Gown is larger than that of the predicate device K192290, so it is better than the predicate device. Although the Breaking strength

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of the longitude of the Level 4 Reinforced Surgical Gown is smaller than that of the predicate device K192290, according to EN 13795-1:2019 Surgical clothing and drapes - Requirements and test methods, the acceptance criteria of breaking strength shall be more than 20N and the test result for Level 4 Reinforced Surgical Gown can meet this acceptance criteria. Therefore, this difference will not affect the safety and effectiveness of the proposed device.

## Different - Tearing strength

Although the longitude and latitude tear strength of the proposed device is different from that of the predicate device K192290, the longitude and latitude tear strength of the proposed device is larger than that of predicate device K192290, so the tearing strength is better than that of the predicate device K192290. Therefore, although the data are different, this difference will not affect the safety and effectiveness of the proposed device.

#### Different - Material

The material for the proposed surgical gowns is different from the predicated device. However, the biocompatibility test for proposed device was performed and the results showed no adverse effect. Therefore, this difference will not affect the safety and effectiveness of the proposed device.

#### Summary of Non-Clinical Tests 8.

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:

- > 16 CFR Part 1610 Standard for the Flammability of Clothing Textiles;
- > AATCC 127: 2017 Water Resistance: Hydrostatic Pressure Test;
- > AATCC 42: 2017 Water Resistance: Impact Penetration Test;
- > ISO 9073-10: 2003 Textiles-Test Methods for Nonwovens-Part 10: Lint and Other Particles Generation in the Dry State;
- > ASTM D1683/D1683M: 2017(2018) Standard Test Method for Failure in Sewn Seams of Woven Fabrics;
- > ASTM D5587: 2015(2019) Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure:
- > ASTM D5034: 2009(2017) Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test);
- > ASTM D737: 2018 Standard Test Method for Air Permeability of Textile Fabrics;
- > ASTM F1886/F1886M: 2016 Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection;
- > ASTM F88/F88M: 2015 Standard Test Method for Seal Strength of Flexible Barrier Materials;

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- > ASTM F…