Disposable Surgical Gowns (S,M,L,XL,XXL,XXXL)

K223401 · Xiamen Probtain Medical Techology Co., Ltd. · FYA · Mar 7, 2023 · General, Plastic Surgery

Device Facts

• Record ID: K223401
• Device Name: Disposable Surgical Gowns (S,M,L,XL,XXL,XXXL)
• Applicant: Xiamen Probtain Medical Techology Co., Ltd.
• Product Code: FYA · General, Plastic Surgery
• Decision Date: Mar 7, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

The Disposable Surgical Gowns are intended to be worn by operating room personnel during surgical procedures to protect the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate matter. This is a single use, disposable device, provided sterile.

Device Story

Disposable surgical gown; worn by operating room personnel during surgical procedures; provides barrier protection against microorganisms, body fluids, and particulate matter. Constructed from SMMS nonwoven material (body, sleeve, belt) and cotton (cuff). Single-use; provided sterile via ethylene oxide gas. Available in sizes S through XXXL. Meets ANSI/AAMI PB70:2012 Level 3 requirements for liquid barrier performance. Protects both patient and clinician by reducing transfer of contaminants.

Clinical Evidence

No clinical data. Bench testing only. Performance verified via ISO 10993 (biocompatibility), ANSI/AAMI PB70:2012 (barrier protection), and ASTM standards for physical strength (tensile, tear, seam).

Technological Characteristics

Materials: SMMS nonwoven (body/sleeve/belt), cotton (cuff). Sterilization: Ethylene Oxide (ISO 10993-7). Barrier Performance: ANSI/AAMI PB70:2012 Level 3. Physical testing: ASTM D5034-09 (breaking strength), ASTM D5587-15 (tearing strength), ASTM D1683/D1683M-17 (seam strength), AATCC 42 (water impact), AATCC 127 (hydrostatic pressure). Flammability: 16 CFR Part 1610 Class I.

Indications for Use

Indicated for operating room personnel during surgical procedures to provide a barrier against microorganisms, body fluids, and particulate matter. Single-use, sterile device.

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

• Disposable Surgical Gown (K212591)

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, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size, also in blue.

March 7, 2023

Xiamen Probtain Medical Technology Co., Ltd % Jarvis Wu Shanghai SUNGO Management Consulting Co., Ltd. 14th Floor, Dongfang Building, 1500# Century Ave. Shanghai 200122, China

Re: K223401

Trade/Device Name: Disposable Surgical Gowns (S,M,L,XL,XXL,XXXL) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYA Dated: March 1, 2023 Received: March 1, 2023

#### Dear Jarvis Wu:

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 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

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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).

Sincerelv.

# Allan Guan -S

For Bifeng Qian, MD, 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

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

Submission Number (if known)

K223401

Device Name

Disposable Surgical Gowns (S,M,L,XL,XXL,XXXL)

Indications for Use (Describe)

The Disposable Surgical Gowns are intended to be worn by operating room personnel during surgical procedures to protect the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate matter. This is a single use, disposable device, provided sterile.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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# XIAMEN PROBTAIN MEDICAL TECHNOLOGY CO., LTD 4th Floor,No.1 Building,No.6 Ji'an Road,Tong'an District,Xiamen, Fujian,361100, China

#### 510(K) Summary

## K223401

Document prepared date: 2023/03/01

# A. Applicant:

XIAMEN PROBTAIN MEDICAL TECHNOLOGY CO., LTD Address: 4th Floor,No.1 Building,No.6 Ji'an Road,Tong'an District,Xiamen,Fujian,361100,China Contact Person: Jianli Kang [phone] Tel: Fax: [phone] Email: [e-mail]

Submission Correspondent: Primary contact: Mr. Jarvis Wu Shanghai SUNGO Management Consulting Co., Ltd. 14th Floor, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: [phone] Email: [e-mail] Secondary contact: Mr. Raymond Luo 14th Floor, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: [phone] Email: fda.sungo@@gmail.com

## B. Device:

Trade Name: Disposable Surgical Gowns (S,M,L,XL,XXL,XXXL) Common Name: Surgical Gown Model: S,M,L,XL,XXL,XXXL

Regulatory Information Classification Name: Gown, Surgical Classification: Class II Product code: FY A Regulation Number: 21 CFR 878.4040 Review Panel: Surgical Apparel

# C. Predicate device:

K212591 Disposable Surgical Gown Suzhou JaneE Medical Technology Co., Ltd.

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# XIAMEN PROBTAIN MEDICAL TECHNOLOGY CO., LTD

4th Floor,No.1 Building,No.6 Ji'an Road,Tong'an District,Xiamen, Fujian,361100, China

## D. Intended use of the device/ Indications for Use:

The Disposable Surgical Gowns are intended to be worn by operating room personnel during surgical procedures to protect the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate matter. This is a single use, disposable device, provided sterile.

# E. Device Description:

The proposed device Disposable Surgical Gowns have body, sleeve and belt are made of SMMS nonwoven material, and cuff is made of cotton. The Disposable Surgical Gowns are blue color, sterilized by ethylene oxide gas, single use and disposable medical device. The proposed device is available in S (115×140cm), M (120×150cm), L (130×160cm), XL (140×170cm), XXL (150×175cm), and XXXL (170×180cm).

This proposed device can meet the requirements for Level 3 per ANSI/AAMI PB70:2012.

| Device | Predicate Device | Proposed Device | Comparison |
|--------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|
| Manufacturer | Suzhou JaneE Medical<br>Technology Co., Ltd. | XIAMEN PROBTAIN<br>MEDICAL TECHNOLOGY<br>CO., LTD | |
| 510K number | K212591 | K223401 | |
| Product Name | Disposable Surgical Gown | Disposable Surgical Gowns | Same |
| Product Code | FYA | FYA | Same |
| Classification | Class II Device, FYA (21<br>CFR878.4040) | Class II Device, FYA<br>(21 CFR878.4040) | Same |
| Intend use | The Disposable Surgical<br>Gowns are intended to be<br>worn by operating room<br>personnel during surgical<br>procedures to protect the<br>surgical patient and operating<br>room personnel from the<br>transfer of microorganisms,<br>body fluids and particulate<br>matter. This is a single use,<br>disposable device, provided<br>sterile. | The Disposable Surgical Gowns<br>are intended to be worn by<br>operating room personnel<br>during surgical procedures to<br>protect the surgical patient and<br>operating room personnel from<br>the transfer of microorganisms,<br>body fluids and particulate<br>matter. This is a single use,<br>disposable device, provided<br>sterile. | Same |
| Material<br>Composition | Polyolefin (Polypropylene)<br>SMS nonwoven | Sleeve/body/belt (SMMS non-<br>woven)<br>Cuff (Cotton) | Similar |
| Sterility | Sterile | Sterile | Same |
| Sterilization | Ethylene Oxide (EtO) | Ethylene Oxide (EtO) | Same |
| Method | | | |
| Sterilization<br>Residuals | EO ≤ 4mg/day<br>ECH ≤ 9mg/day | EO ≤ 4mg/day<br>ECH ≤ 9mg/day | Same |
| Color | Blue | Blue | Same |
| Size | M,L,XL,TL | S、M、L、XL、XXL、<br>XXXL | Similar. No<br>effect on<br>safety or<br>efficacy |
| Weight per<br>square(g) | Critical Area: 87.8g/m²<br>Non-Critical Area: 45.12g/m² | 44g/m² | Similar. No<br>effect on<br>safety or |
| | | | efficacy. |
| Tensile<br>(Breaking<br>strength)<br>D5034-09 | MD: 16.18 lbs (72N)<br>CD: 13.26 lbs (59N) | MD: 156.87N<br>CD: 125.20N | Similar. No<br>effect on<br>safety or<br>efficacy.<br>Both passed<br>performance<br>tests. |
| Tearing<br>Strength<br>ASTM<br>D5587-15 | MD:22.25 lbs (99 N)<br>CD:18.20 lbs (81N) | MD: 66.34N<br>CD: 38.44N | Similar. No<br>effect on<br>safety or<br>efficacy.<br>Both passed<br>performance<br>tests. |
| Seam Strength<br>ASTM<br>D16383M-17 | Sleeve Seam:68.3N<br>Side Seam:69.7N<br>Belt Seam:71N | 77.54N | Similar. No<br>effect on<br>safety or<br>efficacy.<br>Both passed<br>performance<br>tests. |
| Hydrostatic<br>Pressure(cm)<br>AATCC-127 | >50 cm | >50 cm | Same |
| Water Impact<br>(g) AATCC-42 | ≤1.0 g | ≤1.0 g | Same |
| Resistance to<br>blood and liquid<br>penetration | Level 3 AAMI PB70 | Level 3 AAMI PB70 | Same |
| Biocompatibility | Under the conditions of the<br>study, the device extract was<br>not cytotoxic. | Under the conditions of the<br>study, the device extract was<br>not cytotoxic | Same |

#### F. Comparison with predicate device

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# XIAMEN PROBTAIN MEDICAL TECHNOLOGY CO., LTD 4th Floor,No.1 Building,No.6 Ji'an Road,Tong'an District,Xiamen, Fujian,361100, China

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# XIAMEN PROBTAIN MEDICAL TECHNOLOGY CO., LTD 4th Floor,No.1 Building,No.6 Ji'an Road,Tong'an District,Xiamen, Fuijan,361100, China

| Under the conditions of the<br>study, the non-polar and polar<br>device extracts were not found<br>to be an irritant. Under<br>conditions of the study, the<br>non-polar and polar device<br>extracts were not found to be a<br>sensitizer. | Under the conditions of the<br>study, the non-polar and polar<br>device extracts were not found<br>to be an irritant. Under<br>conditions of the study, the<br>non-polar and polar device<br>extracts were not found to be a<br>sensitizer. |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

# Different analysis:

The proposed surgical gowns are similar to the predicate device, in terms of general intended use, performance testing, material composition, and configuration. The tearing strength, breaking strength and seam strength are slightly different from those of the predicate device. The proposed device has been tested according to ASTM D5587-15, ASTM D5034-09 (2017) and ASTM D1683/ D1683M-17(2018) respectively, and met the requirements of the standard.

Under the conditions of each study, the proposed surgical gown is non-cytotoxic, non-sensitizing and negligibly irritating per ISO-10993 and have met the requirements of ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities for AAMI Level 3 surgical gowns.

# G. Summary of Non-Clinical Test Results

Non-clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device met its acceptance criteria or testing endpoint safe levels using the following standards:

> 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

A ISO 10993-7:2008(R) 2012 Biological evaluation of medical devices -Part 7: Ethylene oxide sterilization residuals

- CPSC 16 CFR Part 1610-2008, Standard for the Flammability of clothing textiles; A
- > ASTM D5034-09, Standard Test Method for Breaking Strength and Elongation of
- Textile Fabrics (Grab Test);F

ASTM D5587-15. Standard Test Method for Tearing Strength of Fabrics by Trapezoid > Procedure;

AAMI/ANSI PB70:2012, Liquid Barrier Performance and Classification of protective > Apparel and Drapes Intended For Use In Health Care Facilities.

A ISO9073-10-2003 Textiles - Test methods for nonwovens - Part 10: Lint and other particles generation in the dry state

ASTM D1683/D1683M-17 (2018) Standard Test Method for Failure in Sewn Seams of A Woven Fabrics

| Test Item | Test standard | Acceptance Criteria | Result |
|---------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|------------------------------------------------------------------------|
| Seam strength<br>ASTM D1683M-17<br>Standard Test Method<br>for Failure in Sewn | The test was performed<br>In accordance with<br>ASTM D1683M-17<br>Standard. Test Method | ≥30N(7lbf)<br>per standard<br>F2407-20 for level 3 | PASS<br>77.54 N |
| Seams of Woven Fabrics. | for Seam Strength of Textile Fabrics (Grab Test) to evaluate Failure in Sewn Seams of the test sample. | | (Average result from 10 samples) |
| Breaking strength<br>ASTM D5034-09<br>(2017) Standard Test<br>Method for Breaking<br>Strength and<br>Elongation of Textile<br>Fabrics (Grab Test) | The test was performed<br>In accordance with<br>D5034-09 (2017) .<br>Standard. Test Method<br>for Breaking Strength<br>and Elongation of Textile<br>Fabrics (Grab Test) to<br>evaluate the<br>breaking strength of the<br>test sample. | ≥30N(7lbf)<br>per standard<br>F2407-20 for level 3 | PASS<br>MD: 156.87N<br>CD: 125.20N<br>(Average result from 10 samples) |
| Tear strength(N)<br>ASTM D5587-15,<br>Standard Test Method<br>for Tearing Strength of<br>Fabrics by Trapezoid<br>Procedure | The test was performed<br>in accordance with<br>ASTM D5587:<br>2015(2019) Standard<br>Test Method for Tearing<br>Strength of Fabrics by<br>Trapezoid Procedure to<br>evaluate<br>the tearing strength of the<br>test sample. | ≥10N | PASS<br>MD: 66.34N<br>CD: 38.44N<br>(Average result from 10 samples) |
| Lint and other<br>generation in the<br>dry state<br>ISO 9073- 10:2003(E) | The test was performed<br>in accordance with ISO<br>9073-10: 2003 Textiles-<br>Test Methods for<br>Nonwovens-Part 10: Lint<br>and Other Particles<br>Generation in the Dry<br>State to evaluate the<br>linting of the test<br>sample. | Log10(particle count)<br>< 4 | PASS<br>2.6<br>(Average result from 10 samples) |
| Flammability<br>CPSC 16 CFR Part<br>1610-2008, Standard<br>for the Flammability of<br>clothing textiles | The test was performed<br>in accordance with 16<br>CFR Part 1610<br>Standard for the<br>Flammability of Clothing<br>Textiles to evaluate the<br>flammability of the test<br>sample. | Class I | PASS<br>Class I |
| Water Penetration<br>Resistance<br>AATCC 42-2013,<br>Impact Penetration Test | The test was performed<br>in accordance with<br>AATCC 42: 2013<br>Water Resistance: Impact<br>Penetration Test to<br>evaluate the water impact | ≤1.0g AQL: 4%<br>Level 3 per standard<br>ANSI/AAMI<br>PB70:2012 for level 3 | PASS<br>≤1.0g |
| Static hydrostatic<br>resistance<br>AATCC 127-2014,<br>Water Resistance:<br>Hydrostatic Pressure<br>Test; | The test was performed<br>in accordance with<br>AATCC 127: 2014<br>Water Resistance:<br>Hydrostatic Pressure Test<br>to determine the<br>hydrostatic pressure of<br>the test sample. | ≥50 cmH2O per<br>standard ANSI/AAMI<br>PB70:2012 for level 3 | PASS<br>≥50 cm |
| EO and ECH<br>sterilization<br>residual ISO<br>10993-7:2008<br>Ethylene oxide<br>sterilization residuals | The test was performed<br>in accordance with ISO<br>10993-7:2008<br>Ethylene oxide<br>sterilization residuals to<br>determine the EO and<br>ECH residuals of the test<br>sample. | $EO ≤ 4mg/d$<br>$ECH ≤ 9mg/d$ | PASS<br>$EO ≤ 4mg/d$<br>$ECH ≤ 9mg/d$ |

Table 2 nerformance test

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# XIAMEN PROBTAIN MEDICAL TECHNOLOGY CO., LTD 4th Floor,No.1 Building,No.6 Ji'an Road,Tong'an District,Xiamen, Fujian,361100, China

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# Table3 Biocompatibility endpoints assessment

| Test Item | Proposed device | Acceptance<br>Criteria | Result |
|---------------------------------|---------------------------------------------------------------------|------------------------|--------|
| Cytotoxicit<br>y ISO<br>10993-5 | Under the conditions of the study, the device is<br>non-cytotoxic. | Non-Cytotoxic | PASS |
| Irritation<br>ISO 10993-10 | Under the conditions of the study, the device is<br>non-irritating. | Non-Irritating | PASS |
| Sensitization<br>ISO 10993-10 | Under the conditions of the study, the device is<br>non-sensitizing | Non-Sensitizing | PASS |

## H. Clinical Test Conclusion

No clinical study is included in this submission.

## I. Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the subject device, Disposable Surgical Gowns (S,M,L,XL,XXL,XXXL), is as safe, as effective, and performs as well as or better than the legally marketed predicate device, Disposable Surgical Gowns cleared under K212591.