Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Surgical Gown (M4025); Non-sterile Reinforced Level 4 Surgical Gown (G4025); Reinforced Sterile Level 4 Surgical Gown (GM4025)
Device Facts
| Record ID | K253003 |
|---|---|
| Device Name | Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Surgical Gown (M4025); Non-sterile Reinforced Level 4 Surgical Gown (G4025); Reinforced Sterile Level 4 Surgical Gown (GM4025) |
| Applicant | Hubei Xinxin Non-Woven Co., Ltd. |
| Product Code | FYA · General, Plastic Surgery |
| Decision Date | Apr 20, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4040 |
| Device Class | Class 2 |
Indications for Use
Surgical Gowns are intended to be worn by operation room personnel during surgical procedures or other invasive procedures tests to protect both the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate material. This is single use, disposable device, provided non-sterile and sterile. Non-sterile gowns are to be sold in bulk to re-packager/re-labeler establishments for ethylene oxide (EtO) sterilization according to ISO 11135 prior to marketing to the end users. Per ANSI/AAMI PB70:2022 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the surgical gowns meet the requirements for Level 3 classification, and the reinforced surgical gowns meet the requirements for Level 4 classification.
Device Story
Disposable surgical gowns; provided in sterile or non-sterile forms. Non-sterile versions require terminal ethylene oxide (EtO) sterilization by re-packagers before use. Gowns consist of SMS (spunbond-meltblown-spunbond) fabric body/arms, PET cuffs, and SPP neckties. Reinforced models (G4025, GM4025) include PP/PE laminated film on chest and sleeves to achieve AAMI Level 4 barrier performance; basic models (4025, M4025) achieve AAMI Level 3. Worn by OR personnel to provide a physical barrier against fluid and pathogen transfer during invasive procedures. Protects both patient and clinician. Single-use, disposable design.
Clinical Evidence
No clinical data. Bench testing only. Performance verified against ASTM F1671/F1671M-2022 (pathogen penetration), AATCC 127-2018e (hydrostatic pressure), AATCC TM42-2017 (water impact), ASTM D5034-2021 (breaking strength), ASTM D5587-2015(2024) (tearing strength), ASTM D1683/D1683M-2022 (seam strength), ISO 9073-10-2003 (linting), and 16 CFR Part 1610 (flammability). Biocompatibility confirmed per ISO 10993-5 and ISO 10993-10 (non-cytotoxic, non-irritating, non-sensitizing).
Technological Characteristics
Materials: SMS non-woven, SPP, PET, and PP/PE laminated film. Barrier performance: AAMI Level 3 (basic) and Level 4 (reinforced). Sterilization: Ethylene Oxide (EtO) to SAL 10^-6. Standards: ANSI/AAMI PB70:2022, ASTM F2407/F2407M-2023, ISO 10993. Form factor: Disposable surgical gown with necktie and Velcro closure.
Indications for Use
Indicated for operating room personnel during surgical or invasive procedures to protect patients and staff from transfer of microorganisms, body fluids, and particulate material.
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, Disposable Reinforced Surgical Gown (K212869)
Submission Summary (Full Text)
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FDA U.S. FOOD & DRUG ADMINISTRATION
April 20, 2026
Hubei Xinxin Non-woven Co., Ltd
Nicole Jin
Quality Manager
Taizihu Industrial Park, Pengchang Town
Xiantao, Hubei 433018
China
Re: K253003
Trade/Device Name: Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Surgical Gown (M4025); Non-sterile Reinforced Level 4 Surgical Gown (G4025); Reinforced Sterile Level 4 Surgical Gown (GM4025)
Regulation Number: 21 CFR 878.4040
Regulation Name: Surgical Apparel
Regulatory Class: Class II
Product Code: FYA
Dated: September 19, 2025
Received: March 23, 2026
Dear Nicole Jin:
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.
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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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 Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
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 Management System Regulation (QMSR) (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.
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
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K253003 - Nicole Jin
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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,
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) K253003 | |
| Device Name Non-sterile Level 3 Surgical Gown (4025);Sterile Level 3 Surgical Gown (M4025); Non-sterile Reinforced Level 4 Surgical Gown (G4025);Reinforced Sterile Level 4 Surgical Gown(GM4025) | |
| Indications for Use (Describe) Surgical Gowns are intended to be worn by operation room personnel during surgical procedures or other invasive procedures tests to protect both the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate material. This is single use, disposable device, provided non-sterile and sterile. Non-sterile gowns are to be sold in bulk to re-packager/re-labeler establishments for ethylene oxide (EtO) sterilization according to ISO 11135 prior to marketing to the end users. Per ANSI/AAMI PB70:2022 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the surgical gowns meet the requirements for Level 3 classification, and the reinforced surgical gowns meet the requirements for Level 4 classification. | |
| 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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# 510K Summary K253003
Prepared by 2026/4/14
## A. Applicant
Name: Hubei Xinxin Non-woven Co.,Ltd.
Address: Taizihu Industrial Park, Pengchang Town, Xiantao, China.
Contact Person: Nicole Jin
Position: QA Manager
Tel: +86-728-2618155
Email: nicole_jin@xtxfsl.com
## B. Device
Product Name: Surgical Gowns Model: Non-sterile
Level 3 Surgical Gown (4025)
Sterile Level 3 Surgical Gown (M4025)
Non-sterile Reinforced Level 4 Surgical Gown (G4025)
Reinforced Sterile Level 4 Surgical Gown (GM4025)
Regulatory Information
Classification: Class II
Product code: FYA (Class 2) - Gown, Surgical
Regulation Number: 21 CFR 878.4040
Review Panel: General & Plastic Surgery
## C. Predicate Device
510(k) Number: K212869
Fugou County Shenxiang Manufacturing Co., LTD.
Product Name: Disposable Surgical Gown, Disposable Reinforced Surgical Gown
## D. Indications for use
Surgical Gowns are intended to be worn by operation room personnel during surgical procedures or other invasive procedures to protect both the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate material. This is single use, disposable device, provided non-sterile and sterile. Non-sterile gowns are to be sold in bulk to re-packager/re-labeler establishments for ethylene oxide (EtO) sterilization according to ISO 11135 prior to marketing to the end users.
Per ANSI/AAMI PB70:2022 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the surgical gowns meet the requirements for Level 3 classification, and the reinforced surgical gowns meet the requirements for Level 4 classification.
## E. Device Description
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The main components of 4025 & M4025:
The body and arm of the Basic Gown, which is blue and the material is SMS
(Spunbond + Meltblown + Spunbond). Belt, used to close the back of the gown,
which is blue and the material is SMS.
Cuff, sewn to the end of sleeves, which is made of PET (polyethylene terephthalate).
Hood-and-loop Velcro, used to adjust the size of the neck and close the neck.
Necktie, which is white and made of SPP (Spunbond Polypropylene).
This proposed device can meet the requirements for Level 3 in accordance with ANSI/AAMI PB70:2022.
4025 provided in non-sterile and M4025 provided in sterile.
The main components of G4025 & GM4025:
The body and arm of the Basic Gown, which is blue and the material is SMS.
Belt, used to close the back of the gown, which is blue and the material is SMS
Cuff, sewn to the end of sleeves, which is made of PET (polyethylene terephthalate).
Hood-and-loop Velcro, used to adjust the size of the neck and close the neck.
Necktie, which is white and made of SPP.
Reinforced piece, put in front chest and sleeves of the gown, made of PP/PE(Polypropylene/Polyethylene)
laminated film. G4025 provided in non-sterile and GM4025 provided sterile.
The critical zone of this proposed device can meet the requirements for Level 4 in accordance with ANSI/AAMI
PB70:2022 while the basic zone can meet Level 3.
Specification:
| Models | Product Number | Size |
| --- | --- | --- |
| Non-sterile Level 3 Surgical Gown | 4025 | S, M, L, XL, XXL, XXXL |
| Sterile Level 3 Surgical Gown | M4025 | S, M, L, XL, XXL, XXXL |
| Non-sterile Reinforced Level 4 Surgical Gown | G4025 | S, M, L, XL, XXL, XXXL |
| Reinforced Sterile Level 4 Surgical Gown | GM4025 | S, M, L, XL, XXL, XXXL |
F. General Comparison with the predicate device
| Device | Proposed Device | Predicate Device | Remark |
| --- | --- | --- | --- |
| Manufacturer | Xiantao Xinxin Non-woven Co.,Ltd. | Fugou County Shenxiang Manufacturing Co., LTD. | / |
| Model Name | Non-sterile Level 3 Surgical Gown, Sterile Level 3 Surgical Gown, Non-sterile Reinforced Level 4 Surgical Gown, Reinforced Sterile Level 4 Surgical Gown | Disposable Surgical Gown, Disposable Reinforced Surgical Gown | / |
| Classification | Class II Device, FYA (21 CFR878.4040) | Class II Device, FYA (21 CFR878.4040) | same |
| Intended Use /Indications for use | Surgical Gowns are intended to be worn by operation room personnel during surgical procedures or other invasive procedures to protect both the surgical patient and operating room personnel from the | Disposable Surgical Gown and Disposable Reinforced Surgical Gown 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 | same |
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# Technical Comparison with the predicate device
Table 1 Comparison for Level 3 Surgical Gowns
| Item | Proposed Device | Predicate Device K212869 | Remark |
| --- | --- | --- | --- |
| Weight per square(g) | 36 g/m2 | 45 g/m2 | different |
| Flammability | Class I | Class I | same |
| Hydrostatic pressure | >50 cm | >50 cm | same |
| Water impact | ≤1.0 g | ≤1.0 g | same |
| Breaking strength | >20N Longitude:94.9N Latitude:63.5N | >20N | same |
| Tearing strength | >20N Longitude:48.3N Latitude:21.6N | >20 N | same |
| Seam Strength | 74.5N | No found in the summary | / |
| Linting | Log10<4 | Log10<4 | same |
| Sterilization | Method: Ethylene Oxide (EO); Sterilization Assurance Level (SAL): 10-6 | Method: Ethylene Oxide (EO); Sterilization Assurance Level (SAL): 10-6 | same |
| Ethylene oxide residues | EO <4mg/device ECH <9mg/device | No found in the summary | / |
| Shelf Life | 3 years | No found in the summary | / |
| Barrier protection level | Level 3 per AAMI PB70 | Level 3 per AAMI PB 70 | Same |
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| Material | SMS non-woven, SPP fabric, PET | SMS, Polyester, Blue masterbatch | different |
| --- | --- | --- | --- |
| Sterility | Sterile/Non-Sterile | Sterile | different |
| Biocompatibility | Under the conditions of the study, the device is non-cytotoxic, non-irritating, and non sensitizing. | Under the conditions of the study, the device is non-cytotoxic, non-irritating, and non-sensitizing. | same |
# Discussion
Different - Weight per square
The weight per square of the proposed device is different from the predicate devices. The weight per of the proposed device is $36\mathrm{g} / \mathrm{m}^2$ for the body, arm and belt; $30\mathrm{g} / \mathrm{m}^2$ for the neck tie; while the predicate device is $45\mathrm{g} / \mathrm{m}^2$ . However, the difference in the weight per square will not affect the intended use. In addition, the performance testing results demonstrate that the proposed surgical gown can meet the barrier protection level 3 requirement as required by PB70. Therefore, this difference will not affect the safety and effectiveness of the proposed device.
Different- Material
The material for the proposed surgical gowns is different from the predicated device. However, the biocompatibility test for proposed device was performed and the results showed no adverse effect.
Therefore, this difference will not affect the safety and effectiveness of the proposed device.
Different - Sterility
The proposed product is available in sterile or non-sterile form, the non-sterile model shall be terminal sterilized, so none of the proposed devices can be used before sterilization, which is essentially the same as the predicated device.
Table 2 Comparison for reinforced Level 4 Surgical Gowns
| Item | Proposed Device | Predicate Device K212869 | Remark |
| --- | --- | --- | --- |
| Weight per square(g) | 36 gsm Blue SMS Fabric + 30 gsm white SPP + 45gsm White Laminated Fabric (reinforced film) | Level 4 Reinforced Surgical Gown: 45g/m2and 25g/m2PE film reinforced film | different |
| Flammability | Class I | Class I | same |
| Hydrostatic pressure | >50 cm | >50 cm | same |
| Water impact | ≤1.0 g | ≤1.0 g | same |
| Breaking strength | Reinforced area: Latitude: 150.25N Longitude:201.62N | Level 4 Reinforced Surgical Gown: Latitude:109N Longitude:122N | different |
| Tearing strength | Reinforced area: Latitude: 44.8N Longitude:100.1N | Level 4 Reinforced Surgical Gown: Latitude:80N Longitude:137N | different |
| Seam Strength | 62.5N | No found in the summary | / |
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| Linting | Log_{10}≤4 | Log_{10}≤4 | same |
| --- | --- | --- | --- |
| Sterilization | Method: Ethylene Oxide (EO);
Sterilization Assurance Level
(SAL): 10^{-6} | Method: Ethylene Oxide (EO);
Sterilization Assurance Level
(SAL): 10^{-6} | same |
| Ethylene oxide residues | EO <4mg/device
ECH <9mg/device | No found in the summary | |
| Shelf Life | 3 years | No found in the summary | / |
| Barrier protection level | Level 4 per AAMI PB70 | Level 4 per AAMI PB 70 | Same |
| Barrier Penetration | No detectable transfer of the Phi-X174 Bacteriophage | No detectable transfer of the Phi-X174 Bacteriophage | same |
| Material | SMS non-woven, SPP fabric, PET, laminated fabric reinforced film | SMS nonwoven, Polyester, PE film reinforced film and Blue masterbatch | different |
| Sterility | Sterile/Non-Sterile | Sterile | different |
| Biocompatibility | Under the conditions of the study, the device is non-cytotoxic, non-irritating, and non sensitizing. | Under the conditions of the study, the device is non-cytotoxic, non-irritating, and non-sensitizing. | same |
## Discussion:
### Different - Weight per square
The weight per square of the proposed device is different from the predicate devices. The weight per of the proposed device is $36\mathrm{g}/\mathrm{m}^2$ for the body, arm and belt; $30\mathrm{g}/\mathrm{m}^2$ for the neck tie; $45\mathrm{g}/\mathrm{m}^2$ for the reinforced piece, while the predicate device is $45\mathrm{g}/\mathrm{m}^2$ plus $25\mathrm{g}/\mathrm{m}^2$ PE film reinforced film. However, the difference in the weight per square will not affect the intended use. In addition, the performance testing results demonstrate that the proposed surgical gown can meet the barrier protection level 4 requirement as required by PB70. Therefore, this difference will not affect the safety and effectiveness of the proposed device.
### Different - Breaking Strength
The breaking strength for the proposed device is different from the predicate device. Breaking strength is one of the indicators to evaluate the ability of the gown to withstand destructive force. The greater the breaking strength value, the stronger the ability to withstand destructive force. The breaking strength of the proposed device are larger than the predicate device. Therefore, this difference will not affect the safety and effectiveness of the proposed device.
### Different - Tearing strength
The tearing strength for the proposed device is different from the predicate device. Although the tearing strength of the proposed device is smaller than that of the predicated device, according to ASTM F2407/F2407M-2023, the acceptance criteria of tearing strength shall be more than 10N and the test result of the proposed device can meet this acceptance criteria. Therefore, this difference will not affect the safety and effectiveness of the proposed device.
### Different - Material
The material for the proposed surgical gowns is different from the predicated device. However, the biocompatibility test for proposed device was performed and the results showed no adverse effect. Therefore, this difference will not affect the safety and effectiveness of the proposed device.
5 / 9
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# Different - Sterility
Except for sterilized model, the proposed devices will also be released in non-sterile state, but the non-sterile model shall be terminal sterilized, so none of the proposed devices can be used before sterilization, which is essentially the same as the predicated device.
# Analysis
The subject surgical gowns are substantially equivalent to the predicate device, in terms of general intended use, performance testing, and configuration. The weight per square (g), breaking strength, tearing strength, material and Sterility are slightly different from those of the predicate device.
The proposed device has been tested according to ASTM F1671/F1671M-2022, AATCC 127-2018e, AATCC TM42-2017, ASTM D5034-2021, ASTM D5587-2015(2024), ASTM D1683/D1683M-2022, ISO 9073-10-2003, US 16 CFR Part 1610, AAMIPB70:2022, ASTMF2407/F2407M-2023 respectively, and met the requirements of these standards.
Difference of the materials will not raise safe and effectiveness concerns. The biocompatibility and performance tests have been conducted to verify the safety and effectiveness of the gowns. Under the conditions of each study, the subject surgical gowns are non-cytotoxic, non-sensitizing and negligibly irritating per ISO-10993 and have met the requirements of ANSI/AAMI PB70:2022 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities for AAMI Level 3 and Level 4 surgical gowns.
# G. Summary of Non-Clinical Testing
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 Item | Test standard | Acceptance Criteria | Result Level 4 | Result Level3 |
| --- | --- | --- | --- | --- |
| Seam strength | The test was performed in accordance with ASTM D1683/D1683M-22 Standard. Test Method for Seam Strength of Textile Fabrics (Grab Test) to evaluate Failure in Sewn Seams of the test sample. | ≥30N(7lbf) per standard F2407/F2407M-23 | PASS Average 62.5 N | PASS Average 74.5N |
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| Breaking strength | The test was performed in accordance with D5034-2021. Standard. Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test) to evaluate the breaking strength of the test sample. | ≥30N(7lbf) per standard F2407/F2407M-23 | PASS Reinforced area: Latitude: 150.25N Longitude:201.62N | PASS Latitude:63.5N Longitude:94.9N |
| --- | --- | --- | --- | --- |
| Tear strength (N) | The test was performed in accordance with ASTM D5587: 2015(2024) Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure to evaluate the tearing strength of the test sample. | ≥10N(2.3lbf) per standard F2407/F2407M-23 | PASS Reinforced area: Latitude: 44.8N Longitude:100.1N | PASS Latitude:21.6N Longitude:48.3N |
| --- | --- | --- | --- | --- |
| Lint and other generation in the dry state | The test was performed in accordance with ISO 9073-10: 2003 Textiles Test Methods for Nonwovens - Part 10: Lint and Other Particles Generation in the Dry State to evaluate the linting of the test sample. | Log10(particle count) < 4 | PASS | PASS |
| Flammability | The test was performed in accordance with 16 CFR Part 1610 Standard for the Flammability of Clothing Textiles to evaluate the flammability of the test sample. | Class I | PASS Class I | PASS Class I |
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| Water Impact | The test was performed in accordance with AATCC TM42-2017 Water Resistance: Impact Penetration Test to evaluate the water impact of the test | ≤1.0g per standard ANSI/AAMI PB70:2022 for level 3 AQL: 4% | PASS ≤1.0g | PASS ≤1.0g |
| --- | --- | --- | --- | --- |
| | sample. | | | |
| --- | --- | --- | --- | --- |
| Static hydrostatic resistance | The test was performed in accordance with AATCC 127- 2018e Water Resistance: Hydrostatic Pressure Test to determine the hydrostatic pressure of the test sample. | ≥50 cmH2O per standard ANSI/AAMI PB70:2022 for level 3 AQL: 4% | PASS ≥50 cmH2O | PASS ≥50 cmH2O |
| Pathogens Penetration | The test was performed in accordance with ASTM F1671/F1671M-2022 to measure the resistance of materials used in protective clothing to penetration by blood-borne pathogens using a surrogate microbe under conditions of continuous liquid contact | No detectable transfer of the Phi-X174 Bacteriophage per ANSI AAMI PB70:2022 | PASS | Not evaluated |
| EO and ECH sterilization residual | The test was performed in accordance with ISO 10993-7:2008+A1:2019 Ethylene oxide sterilization residuals to determine the EO and ECH residuals of the test sample. | EO ≤ 4mg/d ECH ≤ 9mg/d | PASS | PASS |
{12}
Hubei Xinxin Non-woven Co.,Ltd.
| Cytotoxicity | The test was performed in accordance with ISO 10993-5 to determine cytotoxicity of the test sample | Non-Cytotoxic | PASS | PASS |
| --- | --- | --- | --- | --- |
| Irritation | The test was performed in accordance with ISO 10993-10 to determine Irritation of the test | Non-Irritating | PASS | PASS |
| | sample | | | |
| --- | --- | --- | --- | --- |
| Sensitization | The test was performed in accordance with ISO 10993-10 to determine skin sensitization of the test sample | Non-Sensitizing | PASS | PASS |
## H. Summary of Clinical Test
No clinical study is included in this submission.
## I. Conclusion
The conclusions drawn from the non-clinical tests demonstrate that the proposed devices are as safe, as effective, and perform as well as or better than the legally marketed predicate device under K212869.
