Disposable Isolation Gowns are intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. This Disposable Isolation Gowns meets the requirements of AAMI Level 3 barrier protection for a surgical gown per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (AAMI PB70). The Disposable Isolation Gowns are single use, disposable medical devices; provided non-sterile.

Device Description

Disposable Isolation Gown is designed for the medical personnel using in medical environment, not intended for use in the operating room. The employed material is a polypropylene and polyethylene (PP+PE) compound non-woven fabric. The color of the gown is blue. The gown has long sleeves with cuffs and neck fasten belts. There are seam tapes above the sleeves and where the sleeves meet the body. The seam tape is ethylene-vinyl acetate (EVA). The material of cuff is polyester and it is elastic.

The body and sleeve of the Disposable Isolation Gowns are constructed from a blue PP+PE compound non-woven fabric and have been tested according to AAMI PB70:2012 and meet AAMI Level 3 barrier level protection for a Disposable Isolation Gown. The Disposable Isolation Gown is a single use, disposable medical device.

AI/ML Overview

Here's a summary of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) summary:

Device: Disposable Isolation Gown (K223467)

1. A table of acceptance criteria and the reported device performance:

Test Name	Purpose	Acceptance Criteria	Reported Device Performance
Seam strength (sleeve seam)	To evaluate the strength of the sleeve seam	≥30N per standard F2407-20 for level 3	Pass
Tensile strength (Media Direction & Cross Direction)	To evaluate the tensile strength of the test sample	≥30N per standard F2407-20 for level 3	Pass
Tear strength (Media Direction & Cross Direction)	To evaluate the tear resistance of the test sample	≥10N	Pass
Hydrostatic pressure test (front, sleeve, sleeve seam, shoulder seam, back)	To evaluate the hydrostatic barrier property of the gown	≥50cmH2O AQL: 4% (32 of 32 samples pass each location)	Pass
Lint and other particles generation in the dry state (material)	To evaluate the linting resistance of the test sample	Critical area≤4.0; Less critical area≤ 4.0	Pass
Lint and other particles generation in the dry state (sleeve seam)	To evaluate the linting resistance in the dry state of the sleeve seam	Critical area≤4.0; Less critical area≤ 4.0	Pass
2-year accelerated aging (AAMI PB70:2012 - AATCC 42 Water impact & AATCC 127 Hydrostatic pressure)	To demonstrate performance stability throughout the shelf life	Meets all AAMI PB70 performance requirements; AATCC 42 ≤ 1.0 g; AATCC 127 ≥ 50 cm H2O	Pass
2-year accelerated aging (ASTM F3352 - Tensile strength, Tear strength, Seam Strength, Lint generation)	To demonstrate performance stability throughout the shelf life (additional parameters)	ASTM D5034 ≥ 30 N (Machine direction and cross direction); ASTM D5733 ≥ 10 N (Machine direction and cross direction); ASTM D1683 ≥ 30 N; ISO 9037-10 Coef. of linting ≤ 4.0	Pass
Flammability	To evaluate the flame resistance of the test sample	Class I	Pass
Water impact resistance (front, sleeve, sleeve seam, shoulder seam, back)	To evaluate the water impact barrier property of the gown	≤1.0g AQL: 4% (32 of 32 samples pass each location); Level 3 per standard ANSI/AAMI PB70:2012	Pass
Cytotoxic potential	To evaluate the cytotoxic potential of the gown	Under the conditions of the study, the device is not cytotoxic	Pass
Irritation	To evaluate the irritation property of the gown	Under the conditions of the study, the device is not an irritant	Pass
Sensitization	To evaluate the sensitization property of the gown	Under the conditions of the study, the device is not a sensitizer	Pass

2. Sample size used for the test set and the data provenance:

Sample Size:
- For Hydrostatic pressure test and Water impact resistance, the acceptance criteria state "32 of 32 samples pass each location." This implies a sample size of 32 for these specific tests.
- Specific sample sizes for other non-clinical tests (e.g., seam strength, tensile strength, tear strength, lint generation, flammability, biocompatibility) are not explicitly stated in this document beyond the general "sample" or "test sample." However, these types of tests typically involve testing multiple units or specimens to ensure reproducibility and statistical validity according to the referenced standards.
Data Provenance: The document does not explicitly state the country of origin or whether the studies were retrospective or prospective. Given that the manufacturer is based in China, it is highly probable that the testing was conducted there. All tests described are non-clinical tests, which are typically conducted in a controlled laboratory setting (i.e., not on human subjects), and thus the retrospective/prospective distinction is not applicable in the same way it would be for a clinical trial.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable as the studies are entirely non-clinical (laboratory-based performance and material property testing). There are no human experts establishing a "ground truth" for diagnostic or clinical interpretation. The "ground truth" for these tests comes from adherence to established international and national standards (e.g., ASTM, ISO, AAMI, AATCC, CPSC CFR) for material properties and barrier performance.

4. Adjudication method for the test set:

This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation (e.g., image reading) where there might be disagreement among experts. Since these are non-clinical, objective laboratory tests against pre-defined numerical or qualitative criteria, there is no need for expert adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No, an MRMC comparative effectiveness study was not conducted. This device is a disposable isolation gown, and the submission focuses on its physical and barrier properties, not on an AI-assisted diagnostic or interpretive tool that would involve human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

No, a standalone algorithm-only performance study was not conducted. This device is manufactured personal protective equipment (PPE), not software or an AI algorithm. The performance evaluation is based on material and product testing against established engineering and safety standards.

7. The type of ground truth used:

The "ground truth" for these non-clinical tests is based on established testing standards and regulatory requirements. This includes:
- Material properties: Tensile strength, tear strength, seam strength, lint generation, flammability, all measured against specific ASTM and ISO standards with predefined passing criteria.
- Barrier performance: Hydrostatic pressure and water impact resistance, measured against AAMI PB70:2012 (Level 3) and AATCC standards.
- Biocompatibility: Cytotoxicity, irritation, and sensitization, measured against ISO 10993 standards with "not cytotoxic," "not an irritant," and "not a sensitizer" as the ground truth.
- Shelf-life stability: Demonstrated by meeting all performance requirements after accelerated aging, with the original acceptance criteria serving as the ground truth for stability.

8. The sample size for the training set:

This information is not applicable as the device is a physical product (disposable isolation gown), not a machine learning model. Therefore, there is no "training set" in the context of AI or algorithms.

9. How the ground truth for the training set was established:

This information is not applicable for the reason stated above.

Summary

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

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 10, 2023

Nanning TECBOD Biological Technology Co.,Ltd. % Eva Li Consultant Shanghai SUNGO Management Consulting Company Ltd. Room 1401, Dongfang Building, 1500# Century Avenue Shanghai, Shanghai 200122 China

Re: K223467

Trade/Device Name: Disposable Isolation Gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYC Dated: November 17, 2022 Received: November 17, 2022

Dear Eva Li:

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.

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Bifeng Qian -S

Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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

Indications for Use

Submission Number (if known)

K223467

Device Name

Disposable Isolation Gown

Indications for Use (Describe)

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) Summary K223467

A. Applicant

Nanning TECBOD Biological Technology Co.,Ltd. Address: Room 601 Floor 6, B2 Building, No. 19 Guokai Dadao, Naning, Guangxi, PEOPLE'S REPUBLIC OF CHINA, 530033 Contact Person: Bing Yao Chen Tel: 008613959211156 Email: tecbod@163.com

Date prepared: Feb 10th, 2023

Submission correspondent Primary contact: Ms. Eva Li Shanghai SUNGO Management Consulting Co., Ltd. Room 1309, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: eatereva@hotmail.com Secondary contact: Mr. Raymond Luo Room 1309, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: fda.sungo@gmail.com

B. Device

K223467 Trade Name: Disposable Isolation Gown Common Name: Isolation Gown

Regulatory Information Classification Name: Surgical Isolation Gown Classification: Class II Product code: FYC Regulation Number: 21 CFR 878.4040 Review Panel: Surgical Apparel

C. Predicate device:

K210785 Disposable Surgical Isolation Gowns Chongqing Litai Fashion Group Limited Company Classification Name: Surgical Isolation Gown Classification: Class II Product code: FYC Regulation Number: 21 CFR 878.4040 Review Panel: Surgical Apparel

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

D. Indications For Use:

E. Device Description:

Device	Predicate Device	Subject Device	Comparison
Manufacturer	Chongqing Litai Fashion Group Company	Nanning TECBOD Biological Technology Co., Ltd.	-
510(K) number	K210785	K223467	-
Device Name	Disposable Surgical Isolation Gown	Disposable Isolation Gown	-
Classification	Class II Device, FYC (21 CFR878.4040)	Class II Device, FYC (21 CFR878.4040)	Same
Indications For Use	Disposable Surgical Isolation Gowns are intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. This Disposable Surgical Isolation Gowns meets the requirements of AAMI Level 3 barrier protection for a surgical gown per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (AAMI PB70). The Disposable Surgical Isolation Gowns are single use, disposable medical devices; provided non-sterile.	Disposable Isolation Gowns are intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. This Disposable Isolation Gowns meets the requirements of AAMI Level 3 barrier protection for a surgical gown per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (AAMI PB70). The Disposable Isolation Gowns are single use, disposable medical devices; provided non-sterile.	Same
Material Composition	Sleeve/body (polyethylene SMS Nonwoven) Cuff (polyester)	Sleeve/body (PP+PE compound Nonwoven) Cuff (Polyester) Seam tap (Eva)	Similar

F. Comparison with predicate device

Table 1 General Comparison

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

Tecbod Biological Technology Co., LTD

Color	Blue	Blue	Same
Sterility	Non-Sterile	Non-Sterile	Same
Use	Single Use; Disposable	Single Use; Disposable	Same
Shelf Life	Not specified	2 Years	Different
Liquid BarrierPerformanceClassificationProperties	Level 3 AAMI PB70	Level 3 AAMI PB70	Same
Flammabilityof ClothingTextiles- 16CFRPart 1610 (a)	Class I	Class I	Same
Biocompatibility	Under the conditions of the study, the device extract was not cytotoxic.Under the conditions of the study, the non-polar and polar device extracts were not found to be an irritant.Under conditions of the study, the non-polar and polar device extracts were not found to be a sensitizer.	Under the conditions of the study, the device extract was not cytotoxic.Under the conditions of the study, the non-polar and polar device extracts were not found to be an irritant.Under conditions of the study, the non-polar and polar device extracts were not found to be a sensitizer.	Same

G. Non-Clinical Test Conclusion

Non-clinical tests were conducted to verify that the proposed device met all design specifications.

Test Name	Purpose	Test Standard	Acceptance Criteria	Result
Seam strength (sleeve seam)	To evaluate the strength of the sleeve seam	ASTM D1683/D1683M-2017(2018) Method A	≥30N per standard F2407-20 for level 3	Pass
Tensile strength	To evaluate the tensile strength of the test sample	ASTM D 5034-2009(2017), Grab method1) Media Direction2) Cross Direction	≥30N per standard F2407-20 for level 3	Pass
Tear strength	To evaluate the tear resistance of the test sample	ASTM D 5587-2015(2019), trapezoid method1) Media Direction2) Cross Direction	≥10N	Pass
Hydrostatic pressure test (front, sleeve, sleeve seam, shoulder seam, back)	To evaluate the hydrostatic barrier property of the gown	AATCC 127-2018	≥50cmH2O AQL: 4%32 of 32 samples pass each location	Pass
Lint and other particles generation in the dry state (material)	To evaluate the linting resistance of the test sample	ISO 9073-10:2003, Size of particles counted:3μm- 25μm	Critical area≤4.0Less critical area≤ 4.0	Pass
Lint and other particles generation in the dry state (sleeve seam)	To evaluate the linting resistance in the dry state of the sleeve seam	ISO 9073-10:2003,	Critical area≤4.0Less critical area≤ 4.0	Pass
2 year accelerated aging	To demonstrate performance stability throughout the shelf life	ASTM F19801) AAMI PB70:2012a. AATCC 42 Water impactb. AATCC 127 Hydrostatic pressure	Meets all AAMI PB70 and ASTM F3352 performance requirements1) AAMI PB70:2012a. AATCC 42	Pass

Table 2 performance test summary

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

2) ASTM F3352a. ASTM D5034Tensile strength(Machine direction andcross direction)b. ASTM D5733Tear strength(Machine direction andcross direction)c. ASTM D1683Seam Strengthd. ISO 9037-10Lint generation	≤ 1.0 gb. AATCC 127≥ 50 cm H2O2) ASTM F3352a. ASTM D5034≥ 30 N(Machine directionand cross direction)b. ASTM D5733≥ 10 N(Machine directionand cross direction)c. ASTM D1683≥ 30 Nd. ISO 9037-10Coef. of linting ≤ 4.0	Pass
Flammability	To evaluate theflame resistance ofthe test sample	16 CFR Part 1610	Class I	Pass
Water impactresistance (front,sleeve, sleeve seam,shoulder seam, back)	To evaluate thewater impactbarrier property ofthe gown	AATCC 42-2017	≤1.0g AQL: 4%32 of 32 samples passeach locationLevel 3 per standardANSI/AAMI PB70:2012 forlevel 3	Pass
Cytotoxic potential	To evaluate thecytotoxic potentialof the gown	ISO 10993-5	Under the conditions ofthe study, the device is notcytotoxic	Pass
Irritation	To evaluate theirritation propertyof the gown	ISO 10993-10	Under the conditions ofthe study, the device is notan irritant	Pass
Sensitization	To evaluate thesensitizationproperty of thegown	ISO 10993-10	Under the conditions ofthe study, the device isnot a sensitizer	Pass

The test results demonstrated that the proposed device met its acceptance criteria or testing endpoint safe levels using the following standards:

A ISO 10993-5: 2009 Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity
A ISO 10993-10: 2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization
A CPSC 16 CFR Part 1610-2008, Standard for the Flammability of clothing textiles;
ASTM D5034-09, Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test);
A ASTM D5587-15, Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure;
A AAMI/ANSI PB70:2012, Liquid Barrier Performance and Classification of protective Apparel and Drapes Intended For Use In Health Care Facilities.
A ISO9073-10-2003 Textiles — Test methods for nonwovens — Part 10: Lint and other particles generation in the dry state
A ASTM D1683/D1683M-17(2018)Standard Test Method for Failure in Sewn Seams of Woven Fabrics
A ASTM F3352-19 Standard Specification for Isolation Gowns Intended for Use in Healthcare Facilities

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

H. Clinical Test Conclusion

No clinical study is included in this submission.

I. Conclusion

The nonclinical tests performed demonstrate that the subject device, Disposable Surgical Isolation Gowns, is as safe, as effective, and performs as well as or better than the legally marketed predicate device, Disposable Surgical Isolation Gowns, cleared under K210785.

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.