Dukal Sterile AAMI Level 3 Reinforced Surgical Gown, Sterile AAMI Level 3 Surgical Gown, Sterile AAMI Level 4 Surgical Gown, and Sterile AAMI Level 4 Splicing Surgical Gown

K203237 · Dukal Corporation · FYA · Mar 18, 2022 · General, Plastic Surgery

Device Facts

• Record ID: K203237
• Device Name: Dukal Sterile AAMI Level 3 Reinforced Surgical Gown, Sterile AAMI Level 3 Surgical Gown, Sterile AAMI Level 4 Surgical Gown, and Sterile AAMI Level 4 Splicing Surgical Gown
• Applicant: Dukal Corporation
• Product Code: FYA · General, Plastic Surgery
• Decision Date: Mar 18, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

The Dukal Sterile AAMI Level 3 Reinforced Surgical Gown, Sterile AAMI Level 3 Surgical Gown, Sterile AAMI Level 4 Surgical Gown, and Sterile AAMI Level 4 Splicing Surgical Gown 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. Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, Dukal AAMI Level 3 Reinforced Surgical Gown and Sterile AAMI Level 3 Surgical Gown met the requirements for Level 3 classification; Dukal Sterile AAMI Level 4 Surgical Gown and Sterile AAMI Level 4 Splicing Surgical Gown met the requirements for Level 4 classification. The Dukal Sterile AAMI Level 3 Reinforced Surgical Gown, Sterile AAMI Level 3 Surgical Gown, Sterile AAMI Level 4 Surgical Gown, and Sterile AAMI Level 4 Splicing Surgical Gown are single use, disposable medical devices, and are provided sterile.

Device Story

Surgical gowns designed for operating room personnel protection; barrier against microorganisms, body fluids, and particulates. Available in AAMI Level 3 (SMS nonwoven) and Level 4 (BVB material) classifications. Features include hook and loop closures, belt ties, and knitted cuff sleeves. Provided sterile for single-use, disposable application. Protects both patient and wearer during surgical procedures.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Materials: SMS nonwoven (Level 3) and BVB (Level 4). Reinforced versions use laminated material. Features: hook and loop closures, belt ties, knitted cuffs. Sterilization: Ethylene Oxide (EO). Standards: ANSI/AAMI PB70:2012, ASTM D5034, ASTM D5733, ASTM D1683, ISO 9073-10, ASTM D737, 16 CFR 1610, ISO 10993-5/7/10.

Indications for Use

Indicated for operating room personnel during surgical procedures to protect patient and personnel from transfer of microorganisms, body fluids, and particulate material. Single-use, disposable, sterile.

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

• Xuchang Zhengde Environstar Medical Products Co., Ltd SMS Standard Surgical Gown (level 3), SMS Surgical Gown with Reinforcement (level 3), BVB Surgical Gown (level 4), BVB Splicing Surgical Gown (level 4) (K192290)

Submission Summary (Full Text)

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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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

April 7, 2022 Dukal Corporation Megan Quevedo Quality and Regulatory Affairs Engineer 2 Fleetwood Court Ronkonkoma, New York 11779

# Re: K203237

Trade/Device Name: Dukal Sterile AAMI Level 3 Reinforced Surgical Gown, Sterile AAMI Level 3 Surgical Gown, Sterile AAMI Level 4 Surgical Gown, and Sterile AAMI Level 4 Splicing Surgical Gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FYA

Dear Megan Quevedo:

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 dated March 18, 2022. Specifically, FDA is updating this SE Letter for a correction to the 510(k) Summary as an administrative correction.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Bifeng Qian, M.D., Ph.D., Office of Surgical and Infection Control Devices, at via phone: [phone] or email: [e-mail].

Sincerely,

# Bifeng Qian -S

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

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Image /page/1/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.

March 18, 2022

Dukal Corporation Megan Quevedo Quality and Regulatory Affairs Engineer 2 Fleetwood Court Ronkonkoma, New York 11779

Re: K203237

Trade/Device Name: Dukal Sterile AAMI Level 3 Reinforced Surgical Gown, Sterile AAMI Level 3 Surgical Gown, Sterile AAMI Level 4 Surgical Gown, and Sterile AAMI Level 4 Splicing 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 16, 2022

Dear Megan Quevedo:

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); 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.

# Clarence W. Murray III -S

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

Enclosure

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# Indications for Use

510(k) Number (if known) K203237

#### Device Name

Dukal Sterile AAM Level 3 Reinforced Surgical Gown, Sterile AAMI Level 3 Surgical Gown, Sterile AAMI Level 4 Surgical Gown, and Sterile AAMI Level 4 Splicing Surgical Gown

#### Indications for Use (Describe)

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

The Dukal Sterile AAM Level 3 Reinforced Surgical Gown, Sterile AAMI Level 3 Surgical Gown, Sterile AAMI Level 4 Surgical Gown, and Sterile AAMI Level 4 Splicing Surgical Gown are single use, disposable medical devices, and are provided sterile.

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------|---------------------------------------------------------------------------------|
| <input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | <input checked="" type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) |

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# 510(k) SUMMARY K203237 510(k) Premarket Notification for Dukal Sterile AAMI Level 3 Reinforced Surgical Gown, Sterile AAMI Level 3 Surgical Gown, Sterile AAMI Level 4 Surgical Gown, and Sterile AAMI Level 4 Splicing Surgical Gown

| 1. Submitter: | Dukal, LLC<br>2 Fleetwood Court<br>Ronkonkoma NY 11779<br>Phone: [phone]<br>Fax: [phone] |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. FDA Registration Number: | 2435946 |
| 3. Regulatory Affairs Contact: | Megan Quevedo<br>Quality and Regulatory Affairs Supervisor<br>2 Fleetwood Court<br>Ronkonkoma NY 11779<br>Telephone Number: 631-656-3800 ext. 133<br>Fax Number: 631-656-3810 |
| 4. Date Summary Prepared: | April 7, 2022 |
| 5. Name of Device: | Dukal Sterile AAMI Level 3 Reinforced<br>Surgical Gown, Sterile AAMI Level 3 Surgical Gown,<br>Sterile AAMI Level 4 Surgical Gown, Sterile AAMI Level 4<br>Splicing Surgical Gown |
| 6. Trade Name: | Dukal Sterile AAMI Level 3 Reinforced<br>Surgical Gown, Sterile AAMI Level 3 Surgical Gown,<br>Sterile AAMI Level 4 Surgical Gown, Sterile AAMI Level 4<br>Splicing Surgical Gown |
| 7. Common/Classification Name: | Surgical Gowns |
| 8. Regulation Number: | 21 CFR §878.4040 |
| 9. Device Class: | Class II |
| 10. Regulation Name: | Surgical Apparel |
| 11. Product Code: | FYA |
| 12. Predicate Device: | Xuchang Zhengde Environstar Medical Products Co., Ltd |

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SMS Standard Surgical Gown (level 3), SMS Surgical Gown with Reinforcement (level 3), BVB Surgical Gown (level 4), BVB Splicing Surgical Gown (level 4).

- 510k #K192290, cleared on 4/30/2020. .
#### 13. Device Description:

14. Packaging:

Surgical Gowns 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. The Dukal Sterile AAMI Level 3 Reinforced Surgical Gown, Sterile AAMI Level 3 Surgical Gown, Sterile AAMI Level 4 Surgical Gown, and Sterile AAMI Level 4 Splicing Surgical Gown are single use, disposable medical devices, and are provided sterile. Each type of Surgical Gown is available in six product sizes: M, L, XL, XXL, XXXL and XXXL-XL.

Dukal Sterile AAMI Level 3 Reinforced Surgical Gown and Sterile AAMI Level 3 Surgical Gown are made with SMS nonwoven material. The Dukal Sterile AAMI Level 4 Surgical Gown and Sterile AAMI Level 4 Splicing Surgical Gown are made with BVB material.

Only the Dukal Sterile AAMI Level 3 Reinforced Surgical Gown is reinforced with laminated material. Dukal Sterile AAMI Level 3 Surgical Gown, Sterile AAMI Level 4 Surgical Gown, Sterile AAMI Level 4 Splicing Surgical Gown are non-reinforced.

Only the Sterile AAMI Level 4 Splicing Surgical gown has a different material for the back of the gown (SMS nonwoven fabric). The back of the gown for the Sterile AAMI Level 4 Surgical gown is made with BVB material.

All gowns are blue, with hook and loop closures, belt ties, and knitted cuff sleeves.

#### Packaging for Level 3 Gowns:

Sizes M and L: 1 gown/pouch, 28 pouches/case Sizes XL: 1 gown/pouch, 26 pouches/case Sizes XXL, XXXL and XXXL-XL: 1 gown/pouch, 24pouches/case

#### Packaging for Level 4 Gowns:

Sizes M: 1 gown/pouch, 28 pouches/case Sizes L and XL: 1 gown/pouch, 26 pouches/case

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Sizes XXL, XXXL and XXXL-XL: 1 gown/pouch, 24pouches/case

15. Indications for Use: The Dukal Sterile AAMI Level 3 Reinforced Surgical Gown, Sterile AAMI Level 3 Surgical Gown, Sterile AAMI Level 4 Surgical Gown, and Sterile AAMI Level 4 Splicing Surgical Gown 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. Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, Dukal AAMI Level 3 Reinforced Surgical Gown and Sterile AAMI Level 3 Surgical Gown met the requirements for Level 3 classification; Dukal Sterile AAMI Level 4 Surgical Gown and Sterile AAMI Level 4 Splicing Surgical Gown met the requirements for Level 4 classification. The Dukal Sterile AAMI Level 3 Reinforced Surgical Gown, Sterile AAMI Level 3 Surgical Gown, Sterile AAMI Level 4 Surgical Gown, and Sterile AAMI Level 4 Splicing Surgical Gown are single use, disposable medical devices, and are provided sterile.

### 16. Comparison of Technological Characteristics with the Predicate Device:

| Element of<br>Comparison | Predicate Device Xuchang<br>Zhengde Environstar Medical<br>Products Co., Ltd SMS<br>Standard Surgical Gown (Level<br>3) & SMS Surgical Gown with<br>Reinforcement (Level 3)<br>(K192290) | Subject Device Dukal<br>Sterile AAMI Level 3<br>Reinforced Surgical Gown<br>& Sterile AAMI Level 3<br>Surgical Gown | Comparison |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Indications for<br>Use | Surgical gown is intended to be<br>worn by operating room<br>personnel during surgical<br>procedure to protect both the<br>surgical patient and the<br>operating room personnel from<br>transfer of microorganisms,<br>body fluids, and particulate<br>material. | Surgical gown is intended<br>to be worn by operating<br>room personnel during<br>surgical procedures to<br>protect both the surgical<br>patient and the operating<br>room personnel from<br>transfer of<br>microorganisms, body<br>fluids, and particulate<br>material. | Same |
| Style | Non-reinforced/Reinforced | Non-reinforced/Reinforced | Same |
| Weight per square (g/m²) | 50 g/m² for SMS Standard Surgical Gown (Level 3), 45 g/m² for SMS Surgical Gown with Reinforcement (Level 3) | 50 g/m² for Sterile AAMI Level 3 Surgical Gown, 45 g/m² for Sterile AAMI Level 3 Reinforced Surgical Gown | Same |
| Material Composition | SMS nonwoven, Laminated material (only for SMS Surgical Gown with Reinforcement (Level 3)), white knitted cuff, white spunbond | SMS nonwoven, Laminated material (only for Sterile AAMI Level 3 Reinforced Surgical Gown), white knitted cuff, white spunbond | Same |
| Regulation, Classification, Product Code | Regulation Number: 21 CFR §878.4040<br>Device Class: Class II<br>Regulation Name: Surgical Apparel<br>Product Code: FYA | Regulation Number: 21 CFR §878.4040<br>Device Class: Class II<br>Regulation Name: Surgical Apparel<br>Product Code: FYA | Same |
| Product Color | Blue | Blue | Same |
| Product Sizes | M, L, XL, XXL, XXXL and XXXL-XL | M, L, XL, XXL, XXXL and XXXL-XL | Same |
| Sterility | Sterile (EO) | Sterile (EO) | Similar |
| Level | Level 3 per AAMI PB70 | Level 3 per AAMI PB70 | Same |
| Use | Single Use; Disposable | Single Use; Disposable | Same |
| Biocompatibility | Under the conditions of each study, the Xuchang Zhengde Environstar Medical Products Co., Ltd SMS Standard Surgical Gown (Level 3) & SMS Surgical Gown with Reinforcement (Level 3) are non-cytotoxic (ISO 10993-5), are non-irritating (ISO 10993-10), and are non-sensitizing (ISO 10993-10) | Under the conditions of each study, the Dukal Sterile AAMI Level 3 Reinforced Surgical Gown & Sterile AAMI Level 3 Surgical Gown are non-cytotoxic (ISO 10993-5), are non-irritating (ISO 10993-10), and are non-sensitizing (ISO 10993-10) | Same |

AAMI Level 3 Surgical Gowns:

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# AAMI Level 4 Surgical Gown:

| Element of<br>Comparison | Predicate Device Xuchang<br>Zhengde Environstar Medical<br>Products Co., Ltd BVB Surgical<br>Gown (Level 4) & BVB Splicing<br>Surgical Gown (Level 4)<br>(K192290) | Subject Device Dukal<br>Sterile AAMI Level 4<br>Surgical Gown & Sterile<br>AAMI Level 4 Splicing<br>Surgical Gown | Comparison |
|------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Indications for<br>Use | Surgical gown is intended to be<br>worn by operating room<br>personnel during surgical<br>procedure to protect both the<br>surgical patient and the<br>operating room personnel from<br>transfer of microorganisms,<br>body fluids, and particulate<br>material. | The Dukal surgical gowns<br>are intended to be worn<br>by operating room<br>personnel during surgical<br>procedures to protect<br>both the surgical patient<br>and the operating room<br>personnel from transfer of<br>microorganisms, body<br>fluids, and particulate<br>material. | Same |
| Material<br>Composition | SMS nonwoven, white knitted<br>cuff, white spunbond, and BVB<br><br>Note: BVB Splicing Surgical<br>Gown (Level 4) has a different<br>material for the back of the<br>gown (SMS nonwoven fabric).<br>The back of the gown for the<br>BVB Surgical Gown (Level 4) is<br>made with BVB material. | SMS nonwoven, white<br>knitted cuff, white<br>spunbond, and BVB<br><br>Note: Sterile AAMI Level 4<br>Splicing Surgical gown has<br>a different material for<br>the back of the gown (SMS<br>nonwoven fabric). The<br>back of the gown for the<br>Sterile AAMI Level 4<br>Surgical gown is made<br>with BVB material. | Same |
| Regulation,<br>Classification,<br>Product Code | Regulation Number: 21 CFR<br>§878.4040<br>Device Class: Class II<br>Regulation Name: Surgical<br>Apparel<br>Product Code: FYA | Regulation Number: 21<br>CFR §878.4040<br>Device Class: Class II<br>Regulation Name: Surgical<br>Apparel<br>Product Code: FYA | Same |
| Product Color | Blue | Blue | Same |
| Style | Non-Reinforced | Non-Reinforced | Same |
| Weight per<br>square (g/m²) | For level 4 Surgical gown: 68<br>g/m² for gown body material<br><br>For level 4 Splicing Surgical<br>Gown: 68 g/m² for gown front<br>and sleeve material, with 40<br>g/m² for gown back material | For level 4 Surgical gown:<br>68 g/m² for gown body<br>material<br><br>For level 4 Splicing<br>Surgical Gown: 68 g/m²<br>for gown front and sleeve<br>material, with 40 g/m² for<br>gown back material | Same |
| Product Sizes | M, L, XL, XXL, XXXL and XXXL-XL | M, L, XL, XXL, XXXL and<br>XXXL-XL | Same |
| Sterility | Sterile (EO) | Sterile (EO) | Similar |
| Level | Level 4 per AAMI PB70 | Level 4 per AAMI PB70 | Same |
| Use | Single Use; Disposable | Single Use; Disposable | Same |
| Biocompatibility | | | |
| Biocompatibility | Under the conditions of each<br>study, the Xuchang Zhengde<br>Environstar Medical Products<br>Co., Ltd BVB Surgical Gown<br>(Level 4) & BVB Splicing Surgical<br>Gown (Level 4) are non-<br>cytotoxic (ISO 10993-5), are<br>non-irritating (ISO 10993-10),<br>and are non-sensitizing (ISO<br>10993-10). | Under the conditions of<br>each study, the Dukal<br>Sterile AAMI Level 4<br>Surgical Gown & Sterile<br>AAMI Level 4 Splicing<br>Surgical Gown are non-<br>cytotoxic (ISO 10993-5),<br>are non-irritating (ISO<br>10993-10), and are non-<br>sensitizing (ISO 10993-10). | Same |

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# Comparison Summary of Non-Clinical Testing Results

AAMI Level 3 Surgical Gowns:

| Test | Test Results of Predicate Device<br>Xuchang Zhengde Environstar<br>Medical Products Co., Ltd SMS<br>Standard Surgical Gown (Level 3)<br>& SMS Surgical Gown with<br>Reinforcement (Level 3)<br>(K192290) (Conforms to<br>ANSI/AAMI PB70:2012 Level 3<br>requirements) | Test Results of Subject Device<br>Dukal Sterile AAMI Level 3<br>Reinforced Surgical Gown &<br>Sterile AAMI Level 3 Surgical<br>Gown (Conforms to<br>ANSI/AAMI PB70:2012 Level<br>3 requirements) | Comparison |
|---------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Flammability<br>(16 CFR 1610) | Class I | Class I | Same |
| Water<br>Resistance-<br>Hydrostatic<br>Pressure<br>(AATCC 127) | ≥50 cm H2O | ≥50 cm H2O | Same |
| Water<br>Resistance-<br>Impact<br>Penetration<br>(AATCC 42) | ≤1.0 g | ≤1.0 g | Same |
| Tensile strength<br>(ASTM D 5034) | Latitude/Transverse: ≥30N<br>Longitude: ≥30N | Latitude/Transverse: ≥30N<br>Longitude: ≥30N | Same |
| Tear strength<br>(ASTM D 5733) | Latitude/Transverse: ≥10N<br>Longitude: ≥10N | Latitude/Transverse: ≥10N<br>Longitude: ≥10N | Same |
| Seam Strength<br>(ASTM D 1683) | ≥70 N | ≥70 N | Same |
| Lint Generation<br>(ISO 9073-10) | Size of particles counted: 3mcg-25mcg | Size of particles counted: 3mcg-25mcg | Same |
| Air Permeability<br>(ASTM D737-18) | Test Pressure: 125Pa; Test area 38 cm² | Test Pressure: 125Pa; Test area 38 cm² | Same |
| Biocompatibility-Cytotoxicity<br>(ISO 10993-5),<br>Irritation & Sensitization<br>(ISO 10993-10);<br>EO Sterilization Residual (ISO 10993-7) | Under the conditions of the study, the device did not show cytotoxicity potential. Under the conditions of the study, the irritation response category of the device was classified as Negligible. Under the conditions of the study, the device showed no significant evidence of causing delayed dermal contact sensitization. For the sterile surgical gown: the device passed the Ethylene Oxide Sterilization Residuals testing. The residual of EO did not exceed 4mg/device and ECH did not exceed 9mg/device. The TCL of EO did not exceed 10 µg/cm² and ECH did not exceed 5000µg/cm². | Under the conditions of the study, the device did not show cytotoxicity potential. Under the conditions of the study, the irritation response category of the device was classified as Negligible. Under the conditions of the study, the device showed no significant evidence of causing delayed dermal contact sensitization. For the sterile surgical gown: the device passed the Ethylene Oxide Sterilization Residuals testing. The residual of EO did not exceed 4mg/device and ECH did not exceed 9mg/device. The TCL of EO did not exceed 10 µg/cm² and ECH did not exceed 5000µg/cm². | Same |

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| | AAMI Level 4 Surgical Gowns: | | |
|------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Test | Test Results of Predicate Device<br>Xuchang Zhengde Environstar<br>Medical Products Co., Ltd BVB<br>Surgical Gown (Level 4) & BVB<br>Splicing Surgical Gown (Level 4)<br>(K192290)(Conforms to<br>ANSI/AAMI PB70:2012 Level 4<br>requirements) | Test Results of Subject Device<br>Dukal Sterile AAMI Level 4<br>Surgical Gown & Sterile AAMI<br>Level 4 Splicing Surgical Gown<br>(Conforms to ANSI/AAMI<br>PB70:2012 Level 4<br>requirements) | Comparison |
| Flammability<br>(16 CFR 1610) | Class I<br>Passed | Class I<br>Passed | Same |
| Resistance<br>Bacteriophage<br>Phi-X174 (ASTM<br>F1671/F1671M-<br>13) | ≥120 cm H2O | ≥120 cm H2O | Same |
| Water<br>Resistance-<br>Hydrostatic<br>Pressure<br>(AATCC 127) | ≤1.0 g | ≤1.0 g | Same |
| Water<br>Resistance-<br>Impact<br>Penetration(AA<br>TCC 42) | ≤1.0 g | ≤1.0 g | Same |
| Tensile strength<br>(ASTM D 5034) | Latitude/Transverse: ≥30N<br>Longitude: ≥30N | Latitude/Transverse: ≥30N<br>Longitude: ≥30N | Same |
| Tear strength<br>ASTM D 5733 | Latitude/Transverse: ≥10N<br>Longitude: ≥10N | Latitude/Transverse: ≥10N<br>Longitude: ≥10N | Same |
| Seam Strength<br>(ASTM D 1683) | ≥70 N | ≥70 N | Same |
| Lint Generation<br>(ISO 9073-10) | Size of particles counted: 3mcg-<br>25mcg | Size of particles counted:<br>3mcg-25mcg | Same |
| Air Permeability<br>(ASTM D737-18) | Test Pressure: 125Pa; Test area<br>38 cm² | Test Pressure: 125Pa; Test<br>area 38 cm² | Same |
| Biocompatibility-Cytotoxicity<br>(ISO 10993-5),<br>Irritation &<br>Sensitization<br>(ISO 10993-10);<br>EO Sterilization<br>Residual (ISO<br>10993-7) | Under the<br>conditions of the study,<br>the device did not show<br>cytotoxicity potential. Under the<br>conditions of the study,<br>the irritation response<br>category of the device<br>was classified as<br>Negligible. Under the<br>conditions of the study,<br>the device showed no<br>significant evidence of<br>causing delayed dermal<br>contact sensitization. For the sterile<br>surgical gown: the device<br>passed the Ethylene<br>Oxide Sterilization<br>Residuals testing. The<br>residual of EO did not<br>exceed 4mg/device and<br>ECH did not exceed<br>9mg/device. The TCL of<br>EO did not exceed 10<br>µg/cm² and ECH did not<br>exceed 5000µg/cm². | Under the<br>conditions of the study,<br>the device did not show<br>cytotoxicity potential. Under the<br>conditions of the study,<br>the irritation response<br>category of the device<br>was classified as<br>Negligible. Under the<br>conditions of the study,<br>the device showed no<br>significant evidence of<br>causing delayed dermal<br>contact sensitization. For<br>the sterile surgical<br>gown: the device<br>passed the Ethylene<br>Oxide Sterilization<br>Residuals testing. The<br>residual of EO did not<br>exceed 4mg/device<br>and ECH did not<br>exceed 9mg/device.<br>The TCL of EO did not<br>exceed 10 µg/cm² and<br>ECH did not exceed<br>5000µg/cm². | Same |

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## Non-Clinical Test Results:

The subject surgical gowns were tested and found conformance 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
- . ASTM F1671/F1671M-13 Standard Test Method for Resistance to Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage as a Test System

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- ANSI AAMI PB70: 2012 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended For Use in Health Care Facilities
- . ISO 9073-10:2003 Textiles-Test Methods for Nonwovens-Part 10: Lint and Other Particles Generation in the Dry State
- . ASTM D1683/D1683M-17:2017/(R)2018 Standard Test Method for Failure in Sewn Seams of Woven Fabrics
- . ASTM D5733-99 Standard Test Method for Tearing Strength of Nonwoven Fabrics by the Trapezoid Procedure
- ASTM D5034-09:2017 Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test)
- ASTM D737-18:2018 Standard Test Method for Air Permeability of Textile Fabrics
- . ASTM F88/F88M-15 Standard Test Method for Seal Strength of Flexible Barrier Materials
- ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
- . ISO 10993-7:2008 Biological Evaluation of Medical Devices-Part 7:Ethylene Oxide Sterilization Residuals
- . 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

## Summary for Non-Clinical Testing:

| Test Item | Test<br>Standard<br>Methods | Test Requirements | Test Results of Subject<br>Device Dukal Sterile AAMI<br>Level 3 Reinforced Surgical<br>Gown & Sterile AAMI Level<br>3 Surgical Gown | Remark |
|-----------------------------------------|------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|
| Impact<br>penetration | AATCC 42 | ≤1.0g (for AAMI Level 3) | ≤1.0g | Meets requirement |
| Hydrostatic<br>pressure | AATCC 127 | ≥50cm H2O (for AAMI<br>Level 3) | ≥50cm H2O | Meets requirement |
| Tensile strength | ASTM D<br>5034 | Latitude/Transverse:<br>≥30N<br>Longitude: ≥30N | Latitude/Transverse: ≥30N<br>Longitude: ≥30N | Meets requirement |
| Tear resistance | ASTM D<br>5733 | Latitude/Transverse:<br>≥10N<br>Longitude: ≥10N | Latitude/Transverse: ≥10N<br>Longitude: ≥10N | Meets requirement |
| Seam strength | ASTM D<br>1683 | ≥30N | ≥70N | Meets requirement |
| Dye penetration | ASTM F<br>1929 | No leakage | No leakage | Meets requirement |
| Sealing strength | ASTM F 88 | ≥3N (180°) | ≥3N (180°)…