Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on material properties and physical performance standards, with no mention of AI or ML.

Therapeutic

No
The device, Y ADU Surgical Gowns, is intended to protect personnel and patients from the transfer of microorganisms, body fluids, and particulate material during surgical procedures, not to treat or diagnose a disease or condition.

Diagnostic

No

The device is a surgical gown, intended to protect personnel and patients from microorganisms and fluids during surgical procedures. It does not perform any diagnostic functions.

SaMD (Software as a Medical Device)

No

The device description clearly states the device is a physical surgical gown made from materials like SMMS, polyester, and dacron. It also mentions physical characteristics like size, construction, and sterilization methods. There is no mention of software components.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states the gowns are for protecting operating room personnel and patients from the transfer of microorganisms, body fluids, and particulate material during surgical procedures. This is a barrier function, not a diagnostic one.
Device Description: The description details the materials and construction of surgical gowns, which are personal protective equipment.
Performance Studies: The performance studies focus on the physical and biological properties of the gowns (water resistance, strength, biocompatibility, sterilization), not on analyzing samples from the human body for diagnostic purposes.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.

In vitro diagnostics are medical devices intended to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

FYA

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Operating room personnel during surgical procedure.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-Clinical Study Summary:
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 ●

Key results are summarized in the table:
| Title of Test | Purpose of Test | Acceptance Criteria | Results
(Level 2 gown) | Results
(Level 3 gown) |
|----------------------------|------------------------------------------------|----------------------------------------------------------------------|---------------------------|---------------------------|
| AATCC127: 2018 | Water resistance/
Hydrostatic Pressure | ≥ 20 cm (Level 2)
≥ 50 cm (Level 3) | Passed | Passed |
| AATCC42: 2017 | Water Resistance
impact penetration | ≤ 1.0 g | Passed | Passed |
| ASTM D5034-09 | Tensile Strength | MD Mean ≥ 30 N;
CD Mean ≥ 30 N | Passed | Passed |
| ASTM D5733-99 | Tearing Strength | MD Mean ≥ 10 N;
CD Mean ≥ 10 N | Passed | Passed |
| ISO 9073-10: 2003 | Linting | Average ≤ 10000
(Log L

Regulation Number and Section

§ 878.4040 Surgical apparel.

(a)
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.(b)
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.

Summary

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
Gown, Level 3 Reinforced Surgical Gown |
|---------------|-----------------------------------------------------------------------------------------------------|
| 510(K) #: | K211422 |

5.0 Device description: