Disposable Surgical Gown UM-148

K221717 · Unimax Medical Products Co., Ltd. · FYA · Sep 20, 2022 · General, Plastic Surgery

Device Facts

• Record ID: K221717
• Device Name: Disposable Surgical Gown UM-148
• Applicant: Unimax Medical Products Co., Ltd.
• Product Code: FYA · General, Plastic Surgery
• Decision Date: Sep 20, 2022
• 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 (UM-148) designed for use by operating room personnel; provides barrier protection against microorganisms, body fluids, and particulate matter. Constructed from SMMS non-woven material with polyester cuffs; available in sizes S, M, L, XL. Device is single-use, sterile, and blue-colored. Meets ANSI/AAMI PB70:2012 Level 3 liquid barrier performance requirements. Protects both patient and staff during surgical procedures.

Clinical Evidence

No clinical data. Bench testing only. Performance verified against AAMI/ANSI PB70:2012 (Level 3), ASTM D5587-15 (tearing strength), ASTM D5034-09 (breaking strength), ASTM D1683M-17 (seam strength), AATCC 42/127 (water resistance), ASTM F1868-17 (evaporative resistance), CPSC 16 CFR 1610 (flammability), ISO 9073-10 (linting), and ISO 10993-5/10 (biocompatibility).

Technological Characteristics

SMMS non-woven body/sleeve/belt; polyester cuffs. Sterilized via ethylene oxide. Meets ANSI/AAMI PB70:2012 Level 3. Tested per ASTM D5587, D5034, D1683, AATCC 42, AATCC 127, ASTM F1868, CPSC 16 CFR 1610, ISO 9073-10, ISO 10993-5, and ISO 10993-10.

Indications for Use

Indicated for operating room personnel during surgical procedures to protect patients and staff from transfer of microorganisms, body fluids, and particulate matter.

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 shows 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. Next to that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 20, 2022

Unimax Medical Products Co., Ltd. % Jarvis Wu Consultant Shanghai SUNGO Management Consulting Company Limited. 14th Floor, 1500# Central Avenue Shanghai, Shanghai 200122 China

Re: K221717

Trade/Device Name: Disposable Surgical Gown UM-148 Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYA Dated: August 12, 2022 Received: August 12, 2022

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.

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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 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.

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 Quality Center for Devices and Radiological Health

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## Indications for Use

Submission Number (if known)

K221717

Device Name

Disposable Surgical Gown (UM-148)

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)

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

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### Unimax Medical Products Co., Ltd. No.1 Liansai Road, Changshangkou Town, Xiantao City, Hubei Province, P.R. China.

# 510(K) Summary K221717

Document prepared date: 2022/9/15

### A. Applicant:

Name: Unimax Medical Products Co., Ltd. Address: No.1 Liansai Road, Changshangkou Town, Xiantao City, Hubei Province, P.R. China. Contact Person: Ning Haibo Tel: [phone] Mail: [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: [e-mail]

#### B. Device:

Trade Name: Disposable Surgical Gown Common Name: Surgical Gown Model(s): UM-148

Regulatory Information Classification Name: Gown, Surgical Classification: Class II Product code: FYA Regulation Number: 878.4040 Review Panel: Surgical Apparel

#### C. Predicate device:

K212591

Disposable Surgical Gown

Suzhou JaneE Medical Technology Co., Ltd.

#### D. Intended use /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.

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#### Unimax Medical Products Co., Ltd. No.1 Liansai Road, Changshangkou Town, Xiantao City, Hubei Province, P.R. China.

# E. Device Description:

The proposed device Disposable Surgical Gown is model UM-148, its body, sleeve and belt are made of SMMS non-woven material, and cuff is made of polyester. The proposed device is available in sizes: S(120×135cm), M(125×140cm), L(130×145cm) and XL(135×150cm). This proposed device can meet the requirements for Level 3 per ANSI/AAMI PB70:2012.

The proposed devices are disposable medical devices and provided in sterile and a blue color.

## F. Comparison with predicate device

| Device | Predicate Device | Proposed Device | Comparison |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| Manufacturer | Suzhou JaneE Medical<br>Technology Co., Ltd. | Unimax Medical Products Co.,<br>Ltd. | - |
| 510K number | K212591 | K221717 | - |
| Product Name | Disposable Surgical Gown | Disposable Surgical Gown | Same |
| Classification | Class II Device, FYA (21<br>CFR878.4040) | Class II Device, FYA (21<br>CFR878.4040) | Same |
| Intend use<br>/Indications for 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<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. | Same |
| Material<br>Composition | Polyolefin (Polypropylene)<br>SMS nonwoven | Polyester<br>SMMS non-woven | Similar. No<br>effect on<br>safety or<br>efficacy.<br>Both passed<br>biocompatibility tests. |
| Sterility | Sterile | Sterile | Same |
| Use | Single Use; Disposable | Single Use; Disposable | Same |
| Color | Blue | Blue | Same |
| Size | M,L,XL,TL | S,M,L,XL | 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 | 45g/m2 | Similar. No<br>effect on<br>safety or<br>efficacy.<br>Both passed<br>performance<br>tests. |
| Tensile<br>(Breaking strength) | MD: 16.18 lbs (72N)<br>CD: 13.26 lbs (59N) | MD: 145.4N<br>CD: 91.4N | Similar. No<br>effect on<br>safety or<br>efficacy.<br>Both passed<br>performance<br>tests. |
| Tearing Strength | MD:22.25 lbs (99 N)<br>CD:18.20 lbs (81N) | MD: 45.5N<br>CD: 28.2N | Similar. No<br>effect on<br>safety or<br>efficacy.<br>Both passed<br>performance<br>tests. |
| Seam Strength | Sleeve Seam:68.3N<br>Side Seam:69.7N<br>Belt Seam:71N | 52.6N | 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 (g)<br>AATCC-42 | ≤1.0 g | ≤1.0 g | Same |
| Liquid barrier<br>performance | Level 3 AAMI PB70 | Level 3 AAMI PB70 | Same |
| Flammability | Class I | Class I | Same |
| Linting | Log10(particle count) < 4 | Log10(particle count) < 4 | Same |
| Evaporative<br>Resistance | < 3 Pa.m²/W. | < 3 Pa.m²/W. | Same |
| Sterilization<br>method | Ethylene oxide | Ethylene oxide | Same |
| Ethylene oxide<br>residuals | EO:<4mg/d ECH:<9mg/d | EO:<4mg/d ECH:<9mg/d | Same |
| Biocompatibility | Under the conditions of the study, the device extract was not<br>cytotoxic. | Under the conditions of the study, the non-polar and polar<br>device extracts were not found to be an irritant. | Same |
| | Under conditions of the study, the non-polar and polar device<br>extracts were not found to be a sensitizer. | | |

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Unimax Medical Products Co., Ltd. No.1 Liansai Road, Changshangkou Town, Xiantao City, Hubei Province, P.R. China.

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Unimax Medical Products Co., Ltd. No.1 Liansai Road, Changshangkou Town, Xiantao City, Hubei Province, P.R. China.

## Analvsis

The subject surgical gown is 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 subject surgical gowns 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. Non-Clinical Test Conclusion

Non-clinical tests were conducted to verify that the proposed device met all design specifications. The subject surgical gown was assessed for performance using the following Standards and Test Methods. The test results demonstrated that the proposed device met its acceptance criteria or testing endpoints.

| Test Methodology | Purpose | Acceptance Criteria | Results |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
| AAMI/ANSI<br>PB70:2012, Liquid<br>Barrier Performance<br>and Classification of<br>protective Apparel and<br>Drapes Intended For<br>Use In Health Care<br>Facilities. | The tests were<br>performed to determine<br>the classification of<br>subject surgical gown<br>product. | Level 3: When tested<br>for water resistance in<br>accordance with<br>AATCC 42 (impact<br>penetration) and<br>AATCC 127<br>(hydrostatic pressure)<br>and all critical zone<br>components shall<br>have a blotter weight<br>gain of no more than<br>1.0 g and a hydrostatic | Level 3 |
| | | | |
| 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<br>Tearing Strength of<br>Fabrics by Trapezoid<br>Procedure to evaluate<br>the tearing strength of<br>the test sample. | ≥10 N | PASS<br>MD: 45.5N<br>CD: 28.2N<br>(Average result from 10<br>samples) |
| 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<br>Textile Fabrics (Grab<br>Test) to evaluate the<br>breaking strength of the<br>test sample. | ≥30N | PASS<br>MD: 145.4N<br>CD: 91.4N<br>(Average result from 10<br>samples) |
| ASTM D1683M-17<br>Standard Test Method<br>for Failure in Sewn<br>Seams of Woven<br>Fabrics. | The test was performed<br>In accordance with<br>ASTM D1683M-17<br>Standard. Test Method<br>for Seam Strength of<br>Textile Fabrics (Grab<br>Test) to evaluate<br>Failure in Sewn Seams<br>of the test sample. | ≥30N | PASS<br>52.6N<br>(Average result from 10<br>samples) |
| AATCC 42-2013,<br>Water Penetration<br>Resistance: Impact<br>Penetration Test; | The test was performed<br>in accordance with<br>AATCC 42: 2013<br>Water Resistance:<br>Impact Penetration Test<br>to evaluate the water<br>impact of the test<br>sample. | ≤1.0 g | PASS<br>0 g<br>(Average result from 3<br>nonconsecutive batches) |
| Evaporative Resistance<br>ASTM F1868-17 | The test was performed<br>in accordance with<br>ASTM F1868-17 to<br>evaluate the<br>Evaporative Resistance<br>of the test samples | < 3 Pa.m²/W. | PASS<br>2.36 Pa.m²/W.<br>(Average result from 13<br>samples) |
| | | | |
| 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<br>Test to determine the<br>hydrostatic pressure of<br>the test sample. | >50 cm | PASS<br>65~72 cm<br>(Average result from 3<br>nonconsecutive batches) |
| 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<br>Clothing Textiles to<br>evaluate the<br>flammability of the test<br>sample. | Meets Class I<br>requirements | PASS<br>Class I<br>(Average result from 5<br>samples) |
| ISO 9073- 10:2003(E)<br>Lint and Other Particles<br>Generation | The test was performed<br>in accordance with ISO<br>9073-10: 2003 Textiles-<br>Test Methods for<br>Nonwovens-Part 10:<br>Lint and Other Particles<br>Generation in the Dry<br>State to evaluate the<br>linting of the test<br>sample. | Log10(particle count) < 4 | PASS<br>2.0<br>(Average result from 13<br>samples) |
| ISO 10993-10: 2010<br>Biological Evaluation<br>of Medical Devices -<br>Part 10: Tests For<br>Irritation And Skin<br>Sensitization | The purpose of the<br>biocompatibility testing<br>is to demonstrate the<br>biocompatibility of the<br>subject device. | Non-irritating, and<br>Non-sensitizing. | PASS<br>Under the conditions of<br>the study, the device is<br>non-irritating, and non-<br>sensitizing. |
| ISO 10993-5: 2009<br>Biological Evaluation<br>of Medical Devices --<br>Part 5: Tests For In<br>Vitro Cytotoxicity | The purpose of the<br>biocompatibility testing<br>is to demonstrate the<br>biocompatibility of the<br>subject device. | Non-cytotoxic. | PASS<br>Under the conditions of<br>the study, the device is<br>non-cytotoxic. |

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## H. Clinical Test Conclusion

No clinical study is included in this submission.

## I. Conclusion

Based on the comparison and analysis above, the subject device, Disposable Surgical Gown(model UM-148), is as safe, as effective, and performs as well as the legally marketed predicate device, Disposable Surgical Gowns cleared under K212591.