Henan Yadu Level 4 Surgical Gowns (Reinforced)
Device Facts
| Record ID | K252301 |
|---|---|
| Device Name | Henan Yadu Level 4 Surgical Gowns (Reinforced) |
| Applicant | Yadu Medical (Henan) Co., Ltd. |
| Product Code | FYA · General, Plastic Surgery |
| Decision Date | Feb 4, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4040 |
| Device Class | Class 2 |
| Attributes | PCCP |
Indications for Use
Henan Yadu Level 4 Surgical Gown (Reinforced) are sterile, single-use surgical apparel intended to be used by operating room personnel during surgical operations and other invasive examinations to provide a liquid and microbial barrier for patients and medical staff. These products meet the Level 4 liquid barrier performance requirements of ANSI/AAMI PB70:2022 "Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities."
Device Story
Sterile, single-use surgical gown; provides liquid and microbial barrier protection in critical surgical zones. Worn by operating room personnel during surgical procedures and invasive examinations. Constructed from multi-layer non-woven fabric (SSMMMS: spunbond-meltblown-meltblown-meltblown-spunbond) with protective film. Protects patients and healthcare staff from transfer of microorganisms, body fluids, and particulate matter. Available in sizes S through XXXL. Device is disposable and EO-sterilized.
Clinical Evidence
No clinical data. Bench testing only. Performance verified via AATCC TM42 (impact penetration), AATCC TM127 (hydrostatic pressure), ASTM F1671 (viral penetration), ASTM D5034 (tensile strength), ASTM D5587 (tear strength), ASTM D1683 (seam strength), ISO 9073-10 (linting), and 16 CFR 1610 (flammability). Biocompatibility confirmed per ISO 10993-5 (cytotoxicity), ISO 10993-23 (irritation), and ISO 10993-10 (sensitization).
Technological Characteristics
Multi-layer non-woven fabric (47g SSMMMS + 35g protective film). Barrier performance: Level 4 per ANSI/AAMI PB70:2022. Standards: ASTM F2407/F2407M-23a, AATCC TM42, AATCC TM127, ASTM F1671, ASTM D5034, ASTM D5587, ASTM D1683, ISO 9073-10, 16 CFR 1610. Biocompatibility: ISO 10993-5, -10, -23. Sterilization: Ethylene Oxide (EO).
Indications for Use
Indicated for operating room personnel during surgical operations and invasive examinations to provide liquid and microbial barrier protection for patients and staff.
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
- Surgical Apparel (K182172)
Submission Summary (Full Text)
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FDA U.S. FOOD & DRUG ADMINISTRATION
February 4, 2026
YADU Medical (Henan) Co., Ltd.
Peilong Shi
General Manager
66 Yangze Road, Nanpu District, Changyuan, Xinxiang,
He Nan, Henan Province PEOPLE'S 453400
China
Re: K252301
Trade/Device Name: Henan Yadu Level 4 Surgical Gowns (Reinforced)
Regulation Number: 21 CFR 878.4040
Regulation Name: Surgical Apparel
Regulatory Class: Class II
Product Code: FYA
Dated: December 30, 2025
Received: December 30, 2025
Dear Peilong Shi:
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 (the 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 available 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.
FDA's substantial equivalence determination also included the review and clearance of your Predetermined Change Control Plan (PCCP). Under section 515C(b)(1) of the Act, a new premarket notification is not required for a change to a device cleared under section 510(k) of the Act, if such change is consistent with an
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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K252301 - Peilong Shi
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established PCCP granted pursuant to section 515C(b)(2) of the Act. Under 21 CFR 807.81(a)(3), a new premarket notification is required if there is a major change or modification in the intended use of a device, or if there is a change or modification in a device that could significantly affect the safety or effectiveness of the device, e.g., a significant change or modification in design, material, chemical composition, energy source, or manufacturing process. Accordingly, if deviations from the established PCCP result in a major change or modification in the intended use of the device, or result in a change or modification in the device that could significantly affect the safety or effectiveness of the device, then a new premarket notification would be required consistent with section 515C(b)(1) of the Act and 21 CFR 807.81(a)(3). Failure to submit such a premarket submission would constitute adulteration and misbranding under sections 501(f)(1)(B) and 502(o) of the Act, respectively.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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K252301 - Peilong Shi
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Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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,
ALLAN GUAN -S
For Bifeng Qian, M.D., Ph.D.
Assistant Director
DHT4C: Division of Infection Control 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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FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services (301) 443-6740
EF
| DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K252301 | |
| Device Name Henan Yadu Level 4 Surgical Gown (Reinforced) | |
| Indications for Use (Describe) Henan Yadu Level 4 Surgical Gown (Reinforced) are sterile, single-use surgical apparel intended to be used by operating room personnel during surgical operations and other invasive examinations to provide a liquid and microbial barrier for patients and medical staff. These products meet the Level 4 liquid barrier performance requirements of ANSI/AAMI PB70:2022 "Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities." | |
| 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) | |
| 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." | |
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510(k) Summary K252301
I. 510(k) Submitter
Device: YADU Medical (Henan) Co., Ltd.
Submitter: 66 Yangze Road, Nanpu District, 453400 Changyuan, Xinxiang, Henan Province PEOPLE'S REPUBLIC OF CHINA
Contact Person: Shi PeiLong
General Manager
Phone: +86 18637387159
E-mail: winnie.li@yadugroup.com
II. Device Information
Trade Name of Device: Henan Yadu Level 4 Surgical Gown (Reinforced)
Regulation Number: 878.4040
Classification Name: General & Plastic Surgery
Product Code: FYA
Regulatory Class: 2
Review Panel: General Hospital
III. Predicate Device Information
510k Number: K182172
Trade Name of Device: Surgical Apparel
Regulation Number: 878.4040
Classification Name: General & Plastic Surgery
Regulatory Class: 2
Product Code: FYA
IV. Device Description
Henan Yadu Level 4 Surgical Gowns (Reinforced) are sterile, single-use surgical apparel intended to be worn by healthcare professionals during surgical procedures to provide barrier protection against the transfer of microorganisms, body fluids, and particulate matter in critical surgical zones for both patients and healthcare personnel. These products meet the Level 4 liquid barrier performance requirements of ANSI/AAMI PB70:2022 "Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities.
Gowns have six different sizes: Small (S), Medium (M), Large (L), Extra Large (XL), Extra Extra Large (XXL), Extra extra extra Large (XXXL).
V. Indications for use
Henan Yadu Level 4 Surgical Gown (Reinforced) are sterile, single-use surgical apparel intended to be used by operating room personnel during surgical operations and other invasive examinations to provide a liquid and microbial barrier for patients and medical staff.
These products meet the Level 4 liquid barrier performance requirements of
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ANSI/AAMI PB70:2022 "Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities."
VI Technological Characteristics Comparison
| Device Characteristic | Subject Device | Predicate Device (K182172) | Discussion |
| --- | --- | --- | --- |
| Trade name | Henan Yadu Level 4 Surgical Gown (Reinforced) | Medline Level 4 Surgical Gown (Sirus), Medline Level 4 Surgical Gown (Eclipse), Medline Level 4 Surgical Gown (Aurora) | N/A |
| Product code | FYA | FYA | Same |
| Regulation Number | 878.4040 | 878.4040 | Same |
| Manufacturer | YADU Medical (Henan) Co., Ltd. | Medline Industries, Inc. | N/A |
| Device Classification | General & Plastic Surgery | General & Plastic Surgery | Same |
| Indications for Use | Henan Yadu Level 4 Surgical Gown (Reinforced) are sterile, single-use surgical apparel intended to be used by operating room personnel during surgical operations and other invasive examinations to provide a liquid and microbial barrier for patients and medical staff. These products meet the Level 4 liquid barrier performance requirements of ANSI/AAMI PB70:2022 "Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities" | The Medline Level 4 Surgical Gown (Sirus), Medline Level 4 Surgical Gown (Eclipse), and Medline Level 4 Surgical Gown (Aurora) is a sterile, single use surgical apparel intended to be worn by healthcare professionals to help protect both the patient and the healthcare worker from the transfer of microorganisms, body fluids, and particulate matter. The Medline Level 4 Surgical Gown (Sirus), Medline Level 4 Surgical Gown (Eclipse), and Medline Level 4 Surgical Gown (Aurora) meets the Level 4 requirements of ANSI/AAMI PB70:2012 Liquid barrier performance | similar |
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| Device Characteristic | Subject Device | Predicate Device (K182172) | Discussion |
| --- | --- | --- | --- |
| | | and classification of protective apparel and drapes intended for use in health care facilities. | |
| Color | Blue | Blue | Same |
| Design Features | C-Sleeve Opening A-Collar B-Collar Closure C-Sleeve Opening; D-Belt; E-Body; F-Sleeve | Neck Closure: Hook and Loop Belt Ties Knit Cuffs Reinforced Material Raglan or Set-in/Standard Sleeves | Similar |
| Sizes | Small to XXX-Large | Small to XXXX-Large | Similar |
| Materials | 47gSSMMMS+35g protective film | Nonwoven SMS polypropylene Anti-Static, Repellency Poly-Reinforcement Film White Knitted Cuffs | Different Comment 1 |
| Performance Specifications | Level 4 barrier protection | Level 4 barrier protection | Same |
| Prescription vs. OTC | OTC | OTC | Same |
| Contact classification | Surface contacting, < 24 hours | Surface contacting, < 24 hours | Same |
| Single Use | Yes | Yes | Same |
| Biocompatibility | Met requirements per: ISO 10993-5 Cytotoxicity ISO 10993-23 Irritation ISO 10993-10 Sensitization | Met requirements per: ISO 10993-5 Cytotoxicity ISO 10993-23 Irritation ISO 10993-10 Sensitization | Same |
| Disposable vs Non Disposable | Disposable | Disposable | Same |
| Sterile vs Non Sterile | Sterile | Sterile | Same |
| Sterilization | EO Sterilization | EO Sterilization | Same |
# Comment 1
The material of this product is composed of multi-layer non-woven fabric (Spunbond-
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Spunbond-Meltblown-Meltblown-Meltblown-Spunbond: multi-layer Meltblown (M) enhanced filtration, double spunbond(S) internal and external reinforcement). Whereas the predicate device apparatus is composed of three layers of nonwoven fabric (Spunbond-Meltblown-Spunbond: outer spunbond (S) provides strength, middle meltblown (M) filtration, inner spunbond (S)) although the material composition is slightly different. However, the products are all composed of nonwoven fabrics and have the same intended use.
# VII. Summary of Non-clinical Testing (Bench)
The product meets the Level 4 liquid barrier performance requirements of ANSI/AAMI PB70:2022 and ASTM F2407/F2407M-23a.
| Test items | Test methods | Acceptance criteria | Test result. |
| --- | --- | --- | --- |
| Water resistance: Impact Penetration | AATCC TM42-2017e | Critical area ≤1.0g | Meet the requirements |
| Water resistance: Hydrostatic Pressure | AATCC TM127-2017 (2018) e | ≥50cmH2O | Meet the requirements |
| Flame Spread | 16 CFR Part 1610 | class 1 | Meet the requirements |
| Lint generation testing | ISO 9073 part 10 | Coefficient of linting <4 | Meet the requirement |
| Tensile strength (longitudinal and transverse) | ASTM D5034-21 | ≥30N. | Meet the requirements |
| Tear strength (longitudinal and transverse) | ASTM D5587-15 (2019) | ≥10N. | Meet the requirements |
| Seam strength | ASTM D1683/D1683M-17 | ≥30N. | Meet the requirements |
| Resistance to Phi-X174 Bacteriophage | ASTM F1671/F1671M-22 | No penetration | Meet the requirements |
| Sterility | ISO 11737-2:2019 | The surgical gown should be sterile after sterilization. | Meet the requirements |
| Bacterial endotoxins | ISO 11737-3:2023 | Bacterial endotoxin content ≤20 EU | Meet the requirements |
| Bacterial endotoxins | ISO 11737-4:2023 | Bacterial endotoxin content ≤20 EU | Meet the requirements |
| Bacterial endotoxins | ISO 11737-5:2023 | Bacterial endotoxin content ≤20 EU | Meet the requirements |
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| Ethylene oxide residue | ISO 10993-7:2008/and 1:2019 | EO residue not greater than 4mg/For the device, the residual ECH content should not exceed 9 mg/device. | Meet the requirements |
| --- | --- | --- | --- |
| Biocompatibility test
The proposed device is classified as a surface device with a limited duration of contact (<24 hours) on surfaces. | | | |
| In vitro cytotoxicity | ISO 10993-5:2009 | No in vitro cytotoxicity | Meet the requirements |
| Skin sensitization | ISO 10993-10:2021 | No skin sensitization | Meet the requirements |
| Irritation | ISO 10993-23:2021/and 1:2025 | No irritation | Meet the requirements |
## VIII. Clinical Test Conclusion
No clinical study is included in this submission.
## IX. Predetermined change control plan
| Planned Modification | Test Methods and Validation Activities | Communication to users, as needed |
| --- | --- | --- |
| Addition of shelf life | Performance testing will be conducted on accelerated aged device to establish provisional shelf life of the gown and real time aging performance testing will be conducted concurrently for validation. The following performance testing will be conducted:
**Barrier property testing (ANSI/AAMI PB70:2022)**
• Water resistance: Impact Penetration: AATCC TM42-2017e
• Water resistance: Hydrostatic Pressure: AATCC TM127-2017 | Labeling will be updated in accordance with the authorized PCCP to provide users with current information regarding device’s shelf life. |
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| | (2018) e · Resistance to Phi-X174 Bacteriophage: ASTM F1671/F1671M-22 Physical property testing (ASTM F2407/F2407M-23a) · Tensile Strength: ASTM D5034-21 · Tear Strength: ASTM D5587-15 · Seam Strength: ASTM D1683/D1683M-22 · Lint testing: ISO 9073- 10:2003 · Flammability: 16 CFR Part 1610-2008 Packaging performance · Sealing strength: ASTM F88-2015 · Dye leakage: ASTM F1929-2015 · Sterility: ISO 11737- 1:2018 | |
| --- | --- | --- |
# X. Conclusion
The conclusions drawn from the nonclinical tests demonstrate that Henan Yadu Level 4 Surgical Gown (Reinforced) is as safe as, as effective, and performs as well as or better than the legally marketed device, Medline Level 4 Surgical Gown (Sirus), Medline Level 4 Surgical Gown (Eclipse), Medline Level 4 Surgical Gown (Aurora).
