Comfort Gown, Safewear Gown

K213893 · Xuchang Zhengde Environstar Medical Products Co., Ltd. · FYA · Dec 21, 2022 · General, Plastic Surgery

Device Facts

• Record ID: K213893
• Device Name: Comfort Gown, Safewear Gown
• Applicant: Xuchang Zhengde Environstar Medical Products Co., Ltd.
• Product Code: FYA · General, Plastic Surgery
• Decision Date: Dec 21, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

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, Comfort Gown met the requirements for Level 1 and Level 2 Standard Surgical Gown classifications, and Safewear Gown met the requirements for Level 3 Standard Surgical Gown, Level 3 Standard Plus Surgical Gown, Level 3 Reinforced Surgical Gown and Level 3 Reinforced Plus Surgical Gown classifications. The gowns are provided sterile and non-sterile gowns are to be sold in bulk to re-packager/re-labeler establishments for ethylene oxide (EtO) sterilization according to ISO 11135 prior to marketing to the end users and Sterile surgical gowns are to be sold directly to users after EtO sterilization validation to ISO 11135.

Device Story

Single-use, disposable surgical gowns; available in Comfort Gown (Level 1-2) and Safewear Gown (Level 3) variants. Protects operating room personnel and patients from fluid/microorganism transfer. Constructed from non-woven materials (SMS, polyester, polyamide) with optional PE breathable film reinforcement. Provided sterile or non-sterile for bulk re-packaging/sterilization. Used in surgical settings; worn by operating room staff. Performance verified via AAMI PB70:2012 standards for liquid barrier protection. Benefits include reduced risk of cross-contamination during surgery.

Clinical Evidence

No clinical data. Bench testing only. Compliance demonstrated with 16 CFR 1610 (flammability), AATCC 127/42 (water resistance), ISO 9073-10 (linting), ASTM D1683/D5587/D5034/D737/F88/F1929 (mechanical/seal strength), and ISO 10993-5/7/10 (biocompatibility/sterilization residuals).

Technological Characteristics

Materials: SMS nonwoven, polyester, polyamide, PE breathable film. Construction: Non-reinforced or reinforced styles. Energy: None. Connectivity: None. Sterilization: Ethylene Oxide (ISO 11135). Standards: ANSI/AAMI PB70:2012 (Level 1-3), ASTM F2407.

Indications for Use

Indicated for operating room personnel during surgical procedures to protect the patient and personnel from transfer of microorganisms, body fluids, and particulate material. Available in AAMI Level 1, 2, and 3 classifications.

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

• SMS Standard Surgical Gown, SMS Surgical Gown with Reinforcement, BVB Surgical Gown, BVB Splicing Surgical Gown (K192290)
• Surgical Gown (K172987)

Submission Summary (Full Text)

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December 21, 2022

Xuchang Zhengde Environstar Medical Products Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co.,Ltd P.O.box 120-119 Shanghai. 200120 China

Re: K213893

Trade/Device Name: Comfort Gown, Safewear Gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYA Dated: November 22, 2022 Received: November 30, 2022

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 mediation-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,

# Allan Guan -S

For Bifeng Qian, M.D., 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) K213893

Device Name Comfort Gown, Safewear Gown

### Indications for Use (Describe)

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, Comfort Gown met the requirements for Level 1 and Level 2 Standard Surgical Gown classifications, and Safewear Gown met the requirements for Level 3 Standard Surgical Gown, Level 3 Standard Plus Surgical Gown, Level 3 Reinforced Surgical Gown and Level 3 Reinforced Plus Surgical Gown classifications.

The gowns are provided sterile and non-sterile gowns are to be sold in bulk to re-packager/re-labeler establishments for ethylene oxide (EtO) sterilization according to ISO 11135 prior to marketing to the end users and Sterile surgical gowns are to be sold directly to users after EtO sterilization validation to ISO 11135.

| 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

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

The assigned 510(k) Number: K213893

- 1. Date of Preparation: 12/20/2022
- 2. Sponsor Identification

### Xuchang Zhengde Environstar Medical Products Co., Ltd.

Area B, Baihua Road East, South Side of Erji river, Industry Cluster District, Yanling County, 461200 Xuchang, Henan, CHINA

Establishment Registration Number: 3009114792

Contact Person: Vincent Yu Position: Regulatory Engineer Tel: [phone] Email: yjf(@zhende.com

- 3. Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Ying Xu (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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#### 4. Identification of Proposed Device

Trade Name: Comfort Gown, Safewear 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;

#### Indications for use:

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, Comfort Gown met the requirements for Level 1 and Level 2 Standard Surgical Gown classifications, and Safewear Gown met the requirements for Level 3 Standard Surgical Gown, Level 3 Standard Plus Surgical Gown, Level 3 Reinforced Surgical Gown and Level 3 Reinforced Plus Surgical Gown classifications. The gowns are provided sterile. Non-sterile gowns are to be sold in bulk to re-packager/re-labeler establishments for ethylene oxide (EtO) sterilization according to ISO 11135 prior to marketing to the end users and Sterile surgical gowns are to be sold directly to users after EtO sterilization validation to ISO 11135

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 can be provided in sterile and non-sterile.

There are two types of surgical gown: Comfort Gown and Safewear Gown. And each type of surgical gown is available in five product sizes, including M, L, XL, XXL and XXXL.

Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the Comfort Gown include Level 1 standard surgical gown which met the requirements for Level 1 classification, and Level 2 standard surgical gown which

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met the requirements for Level 2 classification. It is made of the same material and is classified as Level 1 and Level 2 standard surgical gowns based on marketing reasons.

Safewear gown include Level 3 standard surgical gown, Level 3 standard plus surgical gown, Level 3 reinforced surgical gown and Level 3 reinforced plus surgical gown, which all met the requirements for AAMI Level 3. The four Level 3 surgical gowns differ in the weight of non-woven and whether there are reinforcements, which is 45g/m² and 50g/m² for Level 3 standard surgical gown, 50g/m² for Level 3 standard plus surgical gown, 35g/m² for Level 3 reinforced surgical gown with 35g/m² PE breathable film reinforcement and 45g/m2 for Level 3 reinforced plus surgical gown with 35g/m² PE breathable film reinforcement. Detailed specifications for the proposed device are shown in the table below.

| Proposed<br>device | Type | Size | Style | AAMI<br>Level |
|--------------------|---------------------------------------|---------------------|----------------|---------------|
| Comfort<br>Gown | Level 1 Standard Surgical Gown | M, L, XL, XXL, XXXL | Non-reinforced | 1 |
| Comfort<br>Gown | Level 2 Standard Surgical Gown | M, L, XL, XXL, XXXL | Non-reinforced | 2 |
| Comfort<br>Gown | Level 3 Standard Surgical Gown | M, L, XL, XXL, XXXL | Non-reinforced | 3 |
| Safewear<br>Gown | Level 3 Standard Plus Surgical Gown | M, L, XL, XXL, XXXL | Non-reinforced | 3 |
| Safewear<br>Gown | Level 3 Reinforced Surgical Gown | M, L, XL, XXL, XXXL | Reinforced | 3 |
| Safewear<br>Gown | Level 3 Reinforced Plus Surgical Gown | M, L, XL, XXL, XXXL | Reinforced | 3 |

Specification of Surgical Gown Table1

- 5. Identification of Predicate Devices
- 6. Predicate Device 1

510(k) Number: K192290

Product Name: SMS Standard Surgical Gown, SMS Surgical Gown with Reinforcement, BVB Surgical Gown, BVB Splicing Surgical Gown

Predicate Device 2 510(k) Number: K172987 Product Name: Surgical Gown (used AE series as predicate device)

- 7. Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications as was same/similar to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

- A 16 CFR Part 1610 Standard for the Flammability of Clothing Textiles;
- > AATCC 127: 2017 Water Resistance: Hydrostatic Pressure Test;

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- 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 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 F88/F88M: 2015 Standard Test Method for Seal Strength of Flexible Barrier Materials;
- A ASTM F1929: 2015 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;

| Test<br>Methodology | Test Purpose | Acceptance Criteria | Results |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Flammability | The test was performed in<br>accordance with 16 CFR<br>Part 1610 Standard for the<br>Flammability of Clothing<br>Textiles to evaluate the<br>flammability of the test<br>sample. | Meets Class1<br>requirements | Class 1 |
| Hydrostatic<br>pressure | The test was performed in<br>accordance with AATCC<br>127:2017 Water<br>Resistance Hydrostatic<br>Pressure Test to determine<br>the hydrostatic pressure of<br>the test sample. | Level 2 Surgical<br>Gown: >20 cm H2O;<br>Level 3 Surgical<br>Gown: >50 cm H2O;<br>AQL 4.0 | Level 2 Standard Surgical<br>Gown: PASS;<br>Level 3 Standard Surgical<br>Gown: PASS;<br>Level 3 Standard Plus<br>Surgical Gown: PASS;<br>Level 3 Reinforced<br>Surgical Gown: PASS;<br>Level 3 Reinforced Plus<br>Surgical Gown: PASS |
| Water impact | The test was performed in | <1.0 g | Level 2 Standard Surgical |
| | accordance with AATCC<br>42:2017 Water resistance:<br>impact penetration test to<br>determine the hydrostatic<br>pressure of the test sample. | AQL 4.0 | Gown: PASS;<br>Level 3 Standard Surgical<br>Gown: PASS;<br>Level 3 Standard Plus<br>Surgical Gown: PASS;<br>Level 3 Reinforced<br>Surgical Gown: PASS;<br>Level 3 Reinforced Plus<br>Surgical Gown: PASS; |
| Breaking<br>strength | The test was performed in<br>accordance with ASTM D<br>5034:2009(2017) Standard<br>Test Method for Breaking<br>Strength and Elongation of<br>Textile Fabrics (Grab Test)<br>to evaluate the breaking<br>strength of the test sample | ≥30N | Level 2 Standard Surgical<br>Gown:<br>MACHINE<br>DIRECTION:101.4N<br>CROSS<br>DIRECTION:66.6N<br>Level 3 Standard Surgical<br>Gown:<br>MACHINE<br>DIRECTION:101.4N<br>CROSS<br>DIRECTION:66.6N<br>Level 3 Standard Plus<br>Surgical Gown:<br>MACHINE<br>DIRECTION:107.7N<br>CROSS<br>DIRECTION:61.6N<br>Level 3 Reinforced<br>Surgical Gown:<br>MACHINE<br>DIRECTION:101.4N<br>CROSS<br>DIRECTION:66.6N<br>Level 3 Reinforced Plus<br>Surgical Gown:<br>MACHINE<br>DIRECTION:120.0N<br>CROSS<br>DIRECTION:101.1N |
| Tearing | The test was performed in | ≥10N | Level 2 Standard Surgical |
| strength | | | |
| | accordance with ASTM<br>D5587:2015(2019)<br>Standard Test Method for<br>Tearing Strength of<br>Fabrics by Trapezoid<br>Procedure to evaluate the<br>tearing strength of the test<br>sample. | | Gown:<br>MACHINE<br>DIRECTION:36.0N<br>CROSS<br>DIRECTION:21.5N<br>Level 3 Standard Surgical<br>Gown:<br>MACHINE<br>DIRECTION:35.9N<br>CROSS<br>DIRECTION:22.8N<br>Level 3 Standard Plus<br>Surgical Gown:<br>MACHINE<br>DIRECTION:44.1N<br>CROSS<br>DIRECTION:30.8N<br>Level 3 Reinforced<br>Surgical Gown:<br>MACHINE<br>DIRECTION:36.0N<br>CROSS<br>DIRECTION:21.5N<br>Level 3 Reinforced Plus<br>Surgical Gown:<br>MACHINE<br>DIRECTION:45.9N<br>CROSS<br>DIRECTION:28.8N |
| Seam<br>strength | The test was performed in<br>accordance with ASTM<br>D1683/D1683M:<br>2017(2018) Standard Test<br>Method for Failure in<br>Sewn Seams of Woven<br>Fabrics to evaluate the<br>seam strength of the test<br>sample. | ≥30N | Level 2 Standard Surgical<br>Gown:<br>Average 37.4N;<br>Level 3 Standard Surgical<br>Gown:<br>Average 36.9N;<br>Level 3 Standard Plus<br>Surgical Gown:<br>Average 111.8N;<br>Level 3 Reinforced<br>Surgical Gown: |
| | | | |
| | | | Average 37.5N; |
| | | | Level 3 Reinforced Plus<br>Surgical Gown: |
| | | | Average 116.1N |
| Linting | The test was performed in<br>accordance with ISO<br>9073-10:2003<br>Textiles-Test Methods for<br>Nonwovens-Pat 10: Lint<br>and Other Particles<br>Generation in the Dry<br>State to evaluate the linting<br>of the test sample. | Log10(particle<br>count) < 4 | Level 2 Standard Surgical<br>Gown:<br>Average 2.97;<br>Level 3 Standard Surgical<br>Gown:<br>Average 2.97;<br>Level 3 Standard Plus<br>Surgical Gown:<br>Average 2.94;<br>Level 3 Reinforced<br>Surgical Gown:<br>Average 2.97;<br>Level 3 Reinforced Plus<br>Surgical Gown:<br>Average 2.99 |
| Air<br>permeability | The test was performed in<br>accordance with ASTM<br>D737: 2018 Standard Test<br>Method for Air<br>Permeability of Textile<br>Fabrics to evaluate the air<br>permeability of the test<br>sample. | >30 ft³/min/ft²<br>(>15 cm³/s/cm²) | Level 2 Standard Surgical<br>Gown:<br>Average 40.55 ft³/min/ft²<br>(20.60 cm³/s/cm²);<br>Level 3 Standard Surgical<br>Gown:<br>Average 33.85 ft³/min/ft²<br>(17.20 cm³/s/cm²);<br>Level 3 Standard Plus<br>Surgical Gown:<br>Average 32.68 ft³/min/ft²<br>(16.60 cm³/s/cm²);<br>Level 3 Reinforced<br>Surgical Gown:<br>Average 40.55 ft³/min/ft²<br>(20.60 cm³/s/cm²);<br>Level 3 Reinforced Plus<br>Surgical Gown:<br>Average 34.84 ft³/min/ft²<br>(17.70 cm³/s/cm²) |
| Test Method | Purpose | Acceptance Criteria | Results |
| Cytotoxicity | The test was performed in accordance<br>with ISO 10993-5 Third edition<br>2009-06-01 Biological evaluation of<br>medical devices - Part 5: Tests for in<br>vitro cytotoxicity to evaluate the<br>cytotoxicity of the test sample. | The viability should<br>be ≥70% of the<br>blank. And the 50%<br>extract of the test<br>sample should have<br>at least the same or a<br>higher viability than<br>the 100% extract. | The viability was ≥70%<br>of the blank. And the<br>50% extract of the test<br>sample had a higher<br>viability than the 100%<br>extract.<br><br>Under the conditions of<br>the study, the proposed<br>device was<br>non-cytotoxic. |
| Sensitization | The test was performed in accordance<br>with ISO 10993-10 Third Edition<br>2010-08-01 Biological evaluation of<br>medical devices - Part 10: Tests for<br>irritation and skin sensitization to<br>evaluate the sensitization of the test<br>sample. | Non-sensitizing | Under the conditions of<br>the study, the proposed<br>device was<br>non-sensitizing. |
| Irritation | The test was performed in accordance<br>with ISO 10993-10 Third Edition<br>2010-08-01 Biological evaluation of<br>medical devices - Part 10: Tests for<br>irritation and skin sensitization to<br>evaluate the irritation of the test<br>sample. | Non-irritating | Under the conditions of<br>the study, the proposed<br>device was non-irritating. |

Summary of Performance Testing Table2

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Table3 Summary of Biocompatibility Testing

#### 8. Clinical Test Conclusion

No clinical study is included in this submission.

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#### 9. Summary of Technological characteristics

| Table4 General Comparison for Comfort Gown | | | Remark |
|--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Item | Proposed Device<br>K213893 | Predicate Device 2<br>K172987 | |
| Product Code | FYA | FYA | Same |
| Regulation<br>No. | 21CFR 878.4040 | 21CFR 878.4040 | Same |
| Class | II | II | Same |
| Indication for<br>Use | Surgical gown is intended to be worn<br>by operating room personnel during<br>surgical procedure to protect both the<br>surgical patient and the operating<br>room personnel from transfer of<br>microorganisms, body fluids, and<br>particulate material. | Surgical gown is intended to be worn<br>by operating room personnel during<br>surgical procedure to protect both the<br>surgical patient and the operating room<br>personnel from transfer of<br>microorganisms, body fluids, and<br>particulate material. | Same |
| | Per ANSI/AAMI PB70:2012 Liquid<br>barrier performance and classification<br>of protective apparel and drapes<br>intended for use in health care<br>facilities, the comfort gown met the<br>requirements for Level 2<br>classification. | Per ANSI/AAMI PB70:2012 Liquid<br>barrier performance and classification<br>of protective apparel and drapes<br>intended for use in health care<br>facilities, the AE series surgical gowns<br>met the requirements for Level 2<br>classification. | Same |
| Style | Non-reinforced | Non-reinforced/Reinforced | Different |
| Durability | Disposable | Disposable | Same |
| Color | Blue | Blue | Same |
| Labeling | Conform with 21CFR Part 801 | Conform with 21CFR Part 801 | Same |
| Weight per<br>square (g) | 35g/m² | 44g/m² | Different |
| Size | M, L, XL, XXL, XXXL | XL | Different |
| Flammability | Class I | Class I | Same |
| Hydrostatic<br>pressure | >20 cm; | AE series: >20 cm; | Same |
| Water impact | ≤1.0 g | ≤1.0 g | Same |
| Breaking<br>strength | ≥30N | >20N | Different |
| Tearing<br>strength | ≥10N | >30N | Different |
| Seam | ≥30N | ≥30N | Same |

| | Table4 General Comparison for Comfort Gown |
|--|----------------------------------------------------|
|--|----------------------------------------------------|

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| strength | | | |
|--------------------------------|-------------------------------------------------------------------------------------------------------------|--------------------------------------------------|-----------|
| Linting | $Log_{10}≤4$ | $Log_{10}≤4$ | Same |
| Air<br>permeability | >30 ft³/min/ft² | >30 ft³/min/ft² | Same |
| Barrier<br>protection<br>level | Level 1/Level 2 per AAMI PB 70 | Level 2 per AAMI PB 70 | Different |
| Material | SMS nonwoven, Polyester, Polyamide; | SMMMS, Polypropylene,<br>Polyethylene, Polyester | Different |
| Cytotoxicity | Under the conditions of the study, the | Under the conditions of the study, the | |
| Irritation | device is non-toxic, non-irritating, and | device is non-toxic, non-irritating, and | Same |
| Sensitization | non-sensitizing. | non-sensitizing. | |
| Sterilization | Sterile/Non-Sterile<br>Sterile Method: Ethylene Oxide (EO);<br>Sterilization Assurance Level (SAL):<br>10-6 | Non-sterile | Different |

#### Different - Weight per square

The weight per square for the proposed surgical gowns is different from the predicate device K172987. 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 requirements as required by PB70. Therefore, this difference will not raise any safety issues.

#### Different - Size

The size for the proposed surgical gowns is different from the predicate device K172987. The proposed surgical gowns are available in 5 product sizes, including 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 breaking strength for the proposed surgical gowns is different from the predicate device K172987, however, the breaking strength of the proposed device is large than the predicate device. It can be considered that the proposed device showed a better performance to resist breaking. Therefore, this difference will not raise any safety issues.

### Different - Tearing strength

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The tearing strength for the proposed surgical gowns is different from the predicate device K172987, the tearing strength of the proposed device is less than the predicate device. The proposed acceptance criteria not less than 10N was sourced from ASTM F2407. In addition, the test result demonstrated the proposed device can meet the acceptance criteria. Therefore, this difference will not raise any safety issues.

#### Different - Barrier protection level

The barrier protection level of proposed device is not same as the predicate device K172987, the proposed Comfort Gown is available in level 2 two protection levels. These two levels gowns are exactly same and classified as Level 1 and Level 2 standard surgical gowns based on marketing reasons. The level 2 can be covered by the predicate device K172987. Although the level 1 is not covered by the predicate device K172987, since the proposed level 2 gowns are same, therefore, this difference will not raise any safety issues. In addition, the performance testing results demonstrated that the proposed surgical gowns can meet the barrier protection requirements as required by PB70.

#### Different - Material

The material for the proposed surgical gowns is different from the predicated device. However, the biocompatibility for proposed device was evaluated and the results showed no adverse effect. Therefore, this difference will not raise any safety issues.

#### Different - Sterilization

The product status of the proposed device is different from the predicate device. The proposed device can be provided in sterile and non-sterile, and the predicate device is non-sterilized. However, although the predicate device is non-sterile, it shall be further sterilized prior to use. In addition, sterilization process for the proposed device has been validated per ISO 11135 and the result demonstrated that sterilization method is valid. Therefore, this difference will not raise any safety issues.

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| Item | Proposed Device<br>K213893 | Predicate Device 1<br>K192290 | Remark |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Product Code | FYA | FYA | Same |
| Regulation<br>No. | 21CFR 878.4040 | 21CFR 878.4040 | Same |
| Class | II | II | Same |
| Indication for<br>Use | Surgical gown is intended to be worn<br>by operating room personnel during<br>surgical procedure to protect both the<br>surgical patient and the operating<br>room personnel from transfer of<br>microorganisms, body fluids, and<br>particulate material. | Surgical gown is intended to be worn<br>by operating room personnel during<br>surgical procedure to protect both the<br>surgical patient and the operating room<br>personnel from transfer of<br>microorganisms, body fluids, and<br>particulate material. | Same |
| | Per ANSI/AAMI PB70:2012 Liquid<br>barrier performance and classification<br>of protective apparel and drapes<br>intended for use in health care<br>facilities, the Level 3 Standard<br>Surgical Gown and level 3 Standard<br>Plus Surgical Gown met the<br>requirements for Level 3<br>classification. | Per ANSI/AAMI PB70:2012 Liquid<br>barrier performance and classification<br>of protective apparel and drapes<br>intended for use in health care<br>facilities, SMS Standard Surgical<br>Gown and SMS Surgical Gown with<br>Reinforcement met the requirements<br>for Level 3 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<br>square (g) | $45g/m^2 +50 g/m^2, 50g/m^2;$ | $50g/m^2$ | Different |
| Size | M, L, XL, XXL, XXXL | M, L, XL, XXL, XXXL,<br>XXXL-XLONG | Different |
| Flammability | Class I | Class I | Same |
| Hydrostatic<br>pressure | >50 cm; | >50 cm | Same |
| Water impact | ≤1.0 g | ≤1.0 g | Same |
| Breaking<br>strength | ≥30N | cross direction: 61.17N<br>machine direction: 107.35N | Different |
| Tearing | >10N | cross direction: 19.71N | Different |

| Table5 General Comparison for level 3 standard surgical gown & level 3 standard plus |
|--------------------------------------------------------------------------------------|
| surgical gown of Safewear Gown |

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| strength | | machine direction: 62.28N | |
|--------------------------|----------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|-----------|
| Seam strength | ≥30N | ≥30N | Same |
| Linting | Log10<4 | Log10<4 | Same |
| Air permeability | >30 ft³/min/ft² | >30 ft³/min/ft² | Same |
| Barrier protection level | Level 3 per AAMI PB 70 | Level 3 per AAMI PB 70 | Same |
| Material | SMS nonwoven, Polyester, Polyamide; | SMS nonwoven, Polyester, Polyamide; | Same |
| Cytotoxicity | Under the conditions of the study, the | Under the conditions of the study, the | Same |
| Irritation | device is non-toxic, non-irritating, and | device is non-toxic, non-irritating, and | |
| Sensitization | non-sensitizing. | non-sensitizing. | |
| Sterilization | Sterile/Non-Sterile<br>Sterile Method: Ethylene Oxide (EO);<br>Sterilization Assurance Level (SAL): 10-6 | Sterile<br>Sterile Method: Ethylene Oxide (EO);<br>Sterilization Assurance Level (SAL): 10-6 | Different |

#### Different - Weight per square

The weight per square for the proposed surgical gowns is different from the predicate device K19290. 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 requirements as required by PB70. Therefore, this difference will not raise any safety issues.

### Different - Size

The size for the proposed surgical gowns is different from the predicate device K192290. The proposed surgical gowns are available in 5 product sizes, including 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 breaking strength for the proposed surgical gowns is different from the predicate device K192290. The proposed acceptance criteria not less than 30N was sourced from ASTM F2407. In addition, the test result demonstrated the proposed device can meet the acceptance criteria. Therefore, this difference will not raise any safety issues.

## Different - Tearing strength

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The tearing strength for the proposed surgical gowns is different from the predicate device K192290, the tearing strength of the proposed device is less than the predicate device. The proposed acceptance criteria not less than 10N was sourced from ASTM F2407. In addition, the test result demonstrated the proposed device can meet the acceptance criteria. Therefore, this difference will not raise any safety issues.

#### Different - Sterilization

The product status of the proposed device is different from the predicate device. The proposed device can be provided in sterile and non-sterile, and the predicate device is non-sterilized. However, although the predicate device is non-sterile, it shall be further sterilized prior to use. In addition, sterilization process for the proposed device has been validated per ISO 11135 and the result demonstrated that sterilization method is valid. Therefore, this difference will not raise any safety issues.

{17}------------------------------------------------

| Item | Proposed Device | Predicate Device 1 | Remark |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| | K213893 | K192290 | |
| Product Code | FYA | FYA | Same |
| Regulation<br>No. | 21CFR 878.4040 | 21CFR 878.4040 | Same |
| Class | II | II | Same |
| Indication for<br>Use | Surgical gown is intended to be worn<br>by operating room personnel during<br>surgical procedure to protect both the<br>surgical patient and the operating<br>room personnel from transfer of<br>microorganisms, body fluids, and<br>particulate material.<br>Per ANSI/AAMI PB70:2012 Liquid<br>barrier performance and<br>classification of protective apparel<br>and drapes intended for use in health<br>care facilities, the Level 3<br>Reinforced Surgical Gown and Level<br>3 reinforced plus surgical gown met<br>the requirements for Level 3<br>classification. | Surgical gown is intended to be worn by<br>operating room personnel during<br>surgical procedure to protect both the<br>surgical patient and the operating room<br>personnel from transfer of<br>microorganisms, body fluids, and<br>particulate material.<br>Per ANSI/AAMI PB70:2012 Liquid<br>barrier performance and classification of<br>protective apparel and drapes intended<br>for use in health care facilities, SMS<br>Standard Surgical Gown and SMS<br>Surgical Gown with Reinforcement met<br>the requirements for Level 3<br>classification. | Same |
| Style | Reinforced | Reinforced | Same |
| Durability | Disposable | Disposable | Same |
| Color | Blue | Blue…