← Product Code [FYA](/productcode/FYA) · K220092

# YADU Surgical Gowns (K220092)

_Henan Yadu Industrial Co., Ltd. · FYA · Oct 7, 2022 · General, Plastic Surgery · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K220092

## Device Facts

- **Applicant:** Henan Yadu Industrial Co., Ltd.
- **Product Code:** [FYA](/productcode/FYA.md)
- **Decision Date:** Oct 7, 2022
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 878.4040
- **Device Class:** Class 2
- **Review Panel:** General, Plastic Surgery

## Indications for Use

Y ADU Surgical Gowns 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 surgical gowns meet the requirements for Level 2 and Level 3 classification Per ANSI/AAMI PB-70.

## Device Story

YADU Surgical Gowns are single-use, sterile protective apparel for operating room personnel. Level 2 gowns consist of 35g blue SMMS (spunbond-meltblown-spunbond) polypropylene; Level 3 reinforced gowns consist of 45g blue SMMS with additional PE+SPP reinforcement in the chest area. Both types feature raglan sleeves, hook-and-loop neck closures, and tie waist closures. Gowns are worn by surgeons and staff to prevent cross-contamination of microorganisms, fluids, and particulates between patient and personnel. Performance is verified against ANSI/AAMI PB-70 standards for liquid barrier protection. Gowns are provided sterile via ethylene oxide sterilization.

## Clinical Evidence

No clinical data. Bench testing only. Compliance verified via ANSI/AAMI PB-70:2012 (barrier performance), ASTM F2407-20 (mechanical performance), ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation/sensitization), and ISO 11135 (sterilization).

## Technological Characteristics

Materials: SMMS (spunbond-meltblown-spunbond) polypropylene, polyester, PE+SPP (reinforced areas). Standards: ANSI/AAMI PB-70 (Level 2/3), ASTM F2407, ISO 10993, ISO 11135. Form factor: Full-length gown with raglan sleeves, hook/loop neck, tie waist. Sterilization: Ethylene oxide (SAL 10^-6).

## Regulatory Identification

Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.

## Special Controls

*Classification.* (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible.
(ii) Analysis and nonclinical testing must:
(A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and
(B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.
(iii) NIOSH approved under its regulation.
(2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.

## Predicate Devices

- Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3 Reinforced Surgical Gown ([K211422](/device/K211422.md))

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
> Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/).

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

HeNan YADU Industrial Co., Ltd. % Charles Shen Director Manton Business and Technology Services 37 Winding Ridge Oakland, New Jersey 07436

Re: K220092

Trade/Device Name: YADU Surgical Gowns Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FY A Dated: September 7, 2022 Received: September 8, 2022

Dear Charles Shen:

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

{1}------------------------------------------------

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 (OS) 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For Bifeng Oian, 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

{2}------------------------------------------------

### Indications for Use

510(k) Number (if known) K220092

Device Name YADU Surgical Gowns

### Indications for Use (Describe)

Y ADU Surgical Gowns 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 surgical gowns meet the requirements for Level 3 classification Per ANSI/AAMI PB-70.

| Model Number | Structure      | Level of Protection | Size | Sterile/Non-Sterile | Color |
|--------------|----------------|---------------------|------|---------------------|-------|
| SY0136       | Non-Reinforced | Level-2             | S    | Sterile             | Blue  |
| SY0137       | Non-Reinforced | Level-2             | M    | Sterile             | Blue  |
| SY0138       | Non-Reinforced | Level-2             | L    | Sterile             | Blue  |
| SY0139       | Non-Reinforced | Level-2             | XL   | Sterile             | Blue  |
| SY0172       | Non-Reinforced | Level-2             | XXL  | Sterile             | Blue  |
| SY0173       | Non-Reinforced | Level-2             | XXXL | Sterile             | Blue  |
| SY0148       | Reinforced     | Level-3             | S    | Sterile             | Blue  |
| SY0149       | Reinforced     | Level-3             | M    | Sterile             | Blue  |
| SY0150       | Reinforced     | Level-3             | L    | Sterile             | Blue  |
| SY0151       | Reinforced     | Level-3             | XL   | Sterile             | Blue  |
| SY0178       | Reinforced     | Level-3             | XXL  | Sterile             | Blue  |
| SY0179       | Reinforced     | Level-3             | XXXL | Sterile             | Blue  |

Model Number and details for gowns involved in K220092:

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)

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

# 510(K) Number: K220092

# 510(k) Summary:

This summary of 510(k) safety and effectiveness information is being submitted In accordance with the requirements of 21CFR 807.92

#### 1.0 Submitter Information

HeNan YADU Industrial Co., Ltd. No.234, West Jianpu Road 453400 Changyuan, Henan Province, CHINA Tel: (086) 373-2157057

### Submission Correspondent

Charles Shen Manton Business and Technology Services 37 Winding Ridge, Oakland, NJ 07436 Tel: 608-217-9358 Email: cyshen@aol.com

Date of Summary: October 6, 2022

#### 2.0 Device Information

| Proprietary Name:    | YADU Surgical Gowns |
|----------------------|---------------------|
| Common Name:         | Surgical Gown       |
| Classification Name: | Gown, Surgical      |

#### 3.0 Device Classification

| Classification Regulation: | 21 CFR 878.4040  |
|----------------------------|------------------|
| Class:                     | Class 2          |
| Panel:                     | General Hospital |
| Product Code:              | FYA              |

#### 4.0 Predicate Device Information:

Manufacturer: Jiangsu Medplus Non-woven Manufacturer Co., Ltd

{4}------------------------------------------------

| Product Name: | Level 2 Standard Surgical Gown, Level 3 Standard Surgical<br>Gown, Level 3 Reinforced Surgical Gown |
|---------------|-----------------------------------------------------------------------------------------------------|
| 510(K) #:     | K211422                                                                                             |

#### 5.0 Device description:

Y ADU Surgical Gowns provide Level 2 and Level 3 protections per ANSI/AAMI PB70 standard.

Y ADU Surgical Gowns (Level 2) are made from SMMS material. They are full length, constructed with raglan sleeves, hook and loop neck closures, and tie waist closures. They provide AAMI Level-2 protection.

The Level 2 Gowns have six different sizes: Small (S), Medium (M), Large (L), Extra Large (XL), Extra Extra Large (XXL), and Super Extra large (XXXL).

SMMS is a multi-ply material consisting of layers of spunbonded and meltblown polypropyle.

The body and sleeve is made from 35g Blue SMMS. Sleeve opening is made from pure polyester. The collar closure is made from dacron. The belt is made from 35g Blue SMMS.

Y ADU Surgical Gowns (Reinforced, Level 3) are made from SMMS material. They are full length, constructed with raglan sleeves, hook and loop neck closures, and tie waist closures. The chest area is reinforced with layer of PE+SPP material. They provide AAMI Level-3 protection.

The Level 3 Reinforced Gowns have six different sizes: Small (S), Medium (M), Large (L), Extra Large (XL), Extra Extra Large (XXL), and Super Extra large (XXXL).

SMMS is a multi-ply material consisting of layers of spunbond and meltblown polypropyle.

The body and sleeve is made from 45g Blue SMMS. Sleeve opening is made from pure polyester. The collar closure is made from dacron. The belt is made from 45g Blue SMMS. The reinforced area is made from PE +SPP material.

All gowns are sterilized with ethylene oxide.

#### 6.0 Indications for Use:

{5}------------------------------------------------

Y ADU Surgical Gowns 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 surgical gowns meet the requirements for Level 2 and Level 3 classification Per ANSI/AAMI PB-70.

| Model<br>Number | Structure      | Level of<br>Protection | Size | Sterile/Non-<br>Sterile | Color |
|-----------------|----------------|------------------------|------|-------------------------|-------|
| SY0136          | Non-Reinforced | Level-2                | S    | Sterile                 | Blue  |
| SY0137          | Non-Reinforced | Level-2                | M    | Sterile                 | Blue  |
| SY0138          | Non-Reinforced | Level-2                | L    | Sterile                 | Blue  |
| SY0139          | Non-Reinforced | Level-2                | XL   | Sterile                 | Blue  |
| SY0172          | Non-Reinforced | Level-2                | XXL  | Sterile                 | Blue  |
| SY0173          | Non-Reinforced | Level-2                | XXXL | Sterile                 | Blue  |
| SY0148          | Reinforced     | Level-3                | S    | Sterile                 | Blue  |
| SY0149          | Reinforced     | Level-3                | M    | Sterile                 | Blue  |
| SY0150          | Reinforced     | Level-3                | L    | Sterile                 | Blue  |
| SY0151          | Reinforced     | Level-3                | XL   | Sterile                 | Blue  |
| SY0178          | Reinforced     | Level-3                | XXL  | Sterile                 | Blue  |
| SY0179          | Reinforced     | Level-3                | XXXL | Sterile                 | Blue  |

Model Number and details for gowns involved in K220092:

### 7.0 Comparison to Predicate Devices

Y ADU Surgical Gowns are compared with the following Predicate Devices in terms of intended use, design, material, specifications, and performance.

- (1) K211422, "Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3 Reinforced Surgical Gown", manufactured by "Jiangsu Medplus Nonwoven Manufacturer Co., Ltd" located in Siyang, Jiangsu, China.
The following table shows similarities and differences of use, design, and material between our device and the predicate devices.

## Table 5.1: Comparison of Intended Use, Design, and Material

| Description          | Subject Device (K220092) | Predicate Device (K211422) | Comparison |
|----------------------|--------------------------|----------------------------|------------|
| Product Code         | FYA                      | FYA                        | Same       |
| Regulation<br>Number | 21 CFR 878.4040          | 21 CFR 878.4040            | Same       |
| Classification       | Class2                   | Class2                     | Same       |

{6}------------------------------------------------

| Indication for<br>Use | YADU Surgical Gowns are<br>intended to be worn by operating<br>room personnel during surgical<br>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><br>The surgical gowns met the<br>requirements for Level 2<br>and Level 3 classification<br>Per ANSI/AAMI PB-70 | 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 operating<br>room personnel from transfer of<br>microorganisms, body fluids, and<br>particulate material.<br><br>Per ANSI/AAMI PB70: 2012,<br>Liquid barrier performance and<br>classification of protective apparel<br>and drapes intended for use in<br>health care facilities, the Level 2<br>standard surgical gowns met the<br>requirements for Level 2<br>classification, the Level 3 standard<br>Surgical gowns and Level 3 | Same |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|

|              |                                                                                        | Reinforced surgical gowns met the<br>Requirements for Level 3<br>classification        |         |
|--------------|----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|---------|
| Basic Design | Full length, constructed with<br>raglan sleeves, neck closures, and<br>waist closures. | Full length, constructed with<br>raglan sleeves, neck closures, and<br>waist closures. | Same    |
| Features     | Regular and Reinforced                                                                 | Regular and Reinforced                                                                 | Same    |
| Materials    | SMMS nonwoven, Polyester, PE/SPP                                                       | SMS nonwoven, Polyester and<br>Polyamide                                               | Similar |
| Sizes        | S,M,L,XL,XXL,XXXL                                                                      | XS,S,M,L,XL,XXL,XXXL                                                                   | Similar |
| Single Use   | Yes                                                                                    | Yes                                                                                    | Same    |
| Color        | Blue                                                                                   | Blue                                                                                   | Same    |
| Sterile      | Sterile                                                                                | Information not available                                                              | Same    |
| Labeling     | Conform with 21 CFR Part 801                                                           | Conform with 21 CFR Part 801                                                           | Same    |

The minor differences between the subject device and predicate device do not raise any concerns in terms of safety and effectiveness.

The following table shows similarities and differences of the performance between our device and the predicate devices. Tests were conducted following the recommended procedures outlined in the respective consensus standards.

### Table 5.2: Comparison of Biocompatibility and Performance Testing

{7}------------------------------------------------

| Description                                      | Subject Device (K220092)                                                               | Predicate Device (K211422)                                                              | Comparison |
|--------------------------------------------------|----------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|------------|
| Cytotoxicity                                     | Under conditions of the study,<br>device extract is not cytotoxic<br>(ISO10993-5)      | Under conditions of the study,<br>device extract is not cytotoxic<br>(ISO10993-5)       | Same       |
| Skin Irritation and<br>Sensitization             | Under the conditions of the<br>study, not an irritant or a sensitize<br>(ISO 10993-10) | Under the conditions of the<br>study, not an irritant or a<br>sensitizer (ISO 10993-10) | Same       |
| Hydrostatic Pressure:<br>Water Resistance        | ≥ 20cm (Level 2)<br><br>≥ 50cm (Level 3)                                               | ≥ 20cm (Level 2)<br><br>≥ 50cm (Level 3)                                                | Same       |
| Impact Penetration<br>Test : Water<br>Resistance | ≤ 1.0g                                                                                 | ≤ 1.0g                                                                                  | Same       |
| Protection                                       | Level 2 and Level 3 per<br>ANSI/AAMI PB70                                              | Level 2 and Level 3 per<br>ANSI/AAMI PB70                                               | Same       |
| Tensile Strength                                 | > 30 N                                                                                 | > 20 N                                                                                  | Similar    |
| Tear Strength                                    | > 10 N                                                                                 | > 20 N                                                                                  | Similar    |
| Seam Strength                                    | > 30 N                                                                                 | Data not available                                                                      | Similar    |
| Flammability                                     | Class 1                                                                                | Class 1                                                                                 | Same       |
| Lint                                             | < 10000<br>(Log particle < 4)                                                          | Log (particle count) < 4                                                                | Same       |
| Ethylene Oxide and<br>ECH residuals              | EO: < 4 mg/device<br>ECH: < 9 mg/device                                                | EO: < 4 mg/device<br>ECH: < 9 mg/device                                                 | Same       |

Both subject device and predicate device met the requirements of ANSI/AAMI PB70 and ASTM F2407. Their performance data are very similar.

#### Non-Clinical Study Summary 8.0

Non clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:

- Protection Performance: ANSI/AAMI PB-70:2012 ●
- Mechanical Performance: ASTMF2407-20
- In Vitro Cytotoxicity Test: ISO10993-5:2009 ●
- Skin Irritation Test: ISO10993-10:2010
- Skin Sensitization Test: ISO10993-10:2010
- Sterilization Validation: ISO-11135-1:2014 ●

{8}------------------------------------------------

| Title of Test              | Purpose of Test                                | Acceptance Criteria                                                  | Results<br>(Level 2 gown) | Results<br>(Level 3 gown) |
|----------------------------|------------------------------------------------|----------------------------------------------------------------------|---------------------------|---------------------------|
| AATCC127: 2018             | Water resistance/<br>Hydrostatic Pressure      | ≥ 20 cm (Level 2)<br>≥ 50 cm (Level 3)                               | Passed                    | Passed                    |
| AATCC42: 2017              | Water Resistance<br>impact penetration         | ≤ 1.0 g                                                              | Passed                    | Passed                    |
| ASTM D5034-09              | Tensile Strength                               | MD Mean ≥ 30 N;<br>CD Mean ≥ 30 N                                    | Passed                    | Passed                    |
| ASTM D5733-99              | Tearing Strength                               | MD Mean ≥ 10 N;<br>CD Mean ≥ 10 N                                    | Passed                    | Passed                    |
| ISO 9073-10: 2003          | Linting                                        | Average ≤ 10000<br>(Log L < 4.0)                                     | Passed                    | Passed                    |
| ASTM D1683-17              | Seam Strength                                  | ≥ 30 N                                                               | Passed                    | Passed                    |
| ASTM F1868-17              | Evaporative Resistance<br>of Fabrics           | No requirement                                                       | Passed                    | Passed                    |
| 16 CFR 1610                | Flammability testing                           | Meets Requirements<br>Of Flame Resistant<br>CPSC 1610 Class 1        | Passed                    | Passed                    |
| ISO 10993-5: 2009          | Tests for In vitro<br>cytotoxicity             | Under conditions of the<br>study, device extract is<br>not cytotoxic | Passed                    | Passed                    |
| ISO 10993-10: 2010         | Tests for irritation<br>And skin sensitization | Under the conditions<br>of the study, not an<br>irritant             | Passed                    | Passed                    |
| ISO 10993-10: 2010         | Tests for irritation<br>and skin sensitization | Under conditions of the<br>study, not a sensitizer                   | Passed                    | Passed                    |
| ISO 11135: 2014            | Sterilization Validation                       | SAL level of 10-6                                                    | Passed                    | Passed                    |
| ISO 11135: 2014<br>Annex B | Ethylene Oxide<br>residuals                    | EO: < 4 mg/device<br>ECH: < 9 mg/device                              | Passed                    | Passed                    |

#### Clinical Study Summary 9.0

Clinical study is not performed for this product.

#### 10.0 Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device.

---

**Source:** [https://fda-staging.innolitics.com/device/K220092](https://fda-staging.innolitics.com/device/K220092)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com