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. Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the surgical gowns met the requirements for Level 3 classification.

Device Description

The proposed devices 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. The proposed devices are single use, disposable medical devices and can be provided in sterile and non-sterile two types. Both the sterile and non-sterile surgical gowns are available in six sizes, including S, M, L, XL, XXL and XXXL. For non-sterile surgical gowns, they shall be sterilized by EO prior to use. Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the proposed devices meet the requirements for Level 3 classification.

AI/ML Overview

This document is a 510(k) Summary for a Surgical Gown (Sterile) and Surgical Gown (Non-sterile). It describes the device, its intended use, and a comparison to predicate devices, focusing on non-clinical testing to demonstrate substantial equivalence.

Here's a breakdown of the requested information based on the provided text:

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

The document provides a "Technological Characteristic Comparison Table" (Table 2) that lists various performance criteria and the performance of the Subject Device (K202706). It implies that the acceptance criteria are met if the device's performance is similar to or meets the standards of the predicate devices or specified test methods.

Item	Acceptance Criteria (Implied)	Reported Device Performance (Subject Device K202706)
Weight per square (g)	Similar to predicate (e.g., 50g/m², 45g/m², 68g/m² or 44g/m²)	55g/m²
Size	Similar to predicate (e.g., M, L, XL, XXL, XXXL, XXXL-XLONG or XL)	S, M, L, XL, XXL, XXXL
Flammability	Class I (as per 16 CFR Part 1610)	Class I
Hydrostatic pressure	>50 cm (as per AATCC 127:2017)	>50 cm
Water impact	≤1.0 g (as per AATCC 42:2017)	≤1.0 g
Breaking strength	>20N (as per ASTM D5034:2017)	>20N
Tearing strength	>20N (as per ASTM D5587:2019)	>20N
Linting	Log10<4 (as per ISO 9073-10:2003)	Log10<4
Air permeability	>15cm³/s/cm² (29 ft³/min/ft²) or >30 ft³/min/ft² (as per ASTM D737:2018)	>30 ft³/min/ft²
Material	Similar to SMS polypropylene nonwoven	SMS polypropylene nonwoven + Polyester
Level	Level 3 per AAMI PB 70	Level 3 per AAMI PB 70
Biocompatibility: Cytotoxicity	No Cytotoxicity (as per ISO 10993-5:2009)	No Cytotoxicity
Biocompatibility: Irritation	No Irritation (as per ISO 10993-10:2010)	No Irritation
Biocompatibility: Sensitization	No Sensitization (as per ISO 10993-10:2010)	No Sensitization
Sterile	Sterile/Non-sterile	Sterile/Non-sterile
Seal Strength	(Not explicitly stated in table, but ASTM F88/F88M:2015 implies a criterion)	(Test performed, results not explicitly shown in table)
Seal Leaks	(Not explicitly stated in table, but ASTM F1929:2015 implies a criterion)	(Test performed, results not explicitly shown in table)
EO Sterilization Residuals	(Not explicitly stated in table, but ISO 10993-7:2008 implies a criterion)	(Test performed, results not explicitly shown in table)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample sizes used for each non-clinical test or the provenance of the data (e.g., country of origin, retrospective/prospective). It only states that "Non clinical tests were conducted to verify that the proposed device met all design specifications as was similar to the predicate device."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This section is not applicable. The study involved non-clinical performance testing of a medical device (surgical gown), not studies requiring expert interpretation or ground truth establishment in a medical context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This section is not applicable. Adjudication methods are typically used in clinical studies involving human interpretation or subjective assessment.

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

This section is not applicable. No clinical studies, MRMC studies, or AI components are mentioned in this 510(k) summary.

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

This section is not applicable. The device is a surgical gown; it does not involve an algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the non-clinical tests were established by the performance specifications outlined in recognized standards such as ANSI/AAMI PB70:2012, 16 CFR Part 1610, AATCC 127:2017, AATCC 42:2017, ISO 9073-10:2003, ASTM D1683/D1683M:2017/(R)2018, ASTM D5587:2019, ASTM D5034:2017, ASTM D737:2018, ASTM F88/F88M:2015, ASTM F1929:2015, ISO 10993-7:2008, ISO 10993-5:2009, and ISO 10993-10:2010.

8. The sample size for the training set

This section is not applicable. There is no mention of a "training set" as this is a non-clinical device performance study, not a machine learning or AI-based study.

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

This section is not applicable. As there is no training set for this type of device submission.

Summary

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Image /page/0/Picture/0 description: The image contains 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 in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.

December 31, 2020

B.J.ZH.F.Panther Medical Equipment CO., LTD. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box. 120-119 Shanghai. 200120 China

Re: K202706

Trade/Device Name: Surgical Gown (Sterile), Surgical Gown (Non-sterile) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYA Dated: November 23, 2020 Received: December 3, 2020

Dear Diana Hong:

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.

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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 medical devices and radiation-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: Elizabeth F. Claverie-Williams, MS Acting 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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K202706

Device Name

Surgical Gown (Sterile), Surgical Gown (Non-sterile)

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.

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510(k) Summary K202706

This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.

The assigned 510(k) Number: K202706

1. Date of Preparation: 12/30/2020
1. Sponsor Identification

B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., LTD.

Floor 3, Building 1, 28 Huoju Street, Changping Science and Technology Park, Changping District, 102200 Beijing, China

Establishment Registration Number: 3008388437

Contact Person: Wenyue Han Position: International Regulatory Affair Tel: +86-10-80789058 Fax: +86-10-80789028 Email: wenyue.han@pantherhealthcare.com

1. Designated Submission Correspondent
  Ms. Diana Hong (Primary Contact Person) Ms. Ying Xu (Alternative Contact Person)
1. Mid-Link Consulting Co., Ltd. P.O. Box 120-119, Shanghai, 200120, China
  Tel: +86-21-22815850, Fax: 360-925-3199 Email: info@mid-link.net
ર. Identification of Proposed Device
Trade Name: Surgical Gown (Sterile), Surgical Gown (Non-sterile) Common Name: Surgical Gown

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510(k) Summary

Regulatory Information

Classification Name: Gown, Surgical Classification: II; Product Code: FYA; Regulation Number: 21 CFR 878.4040 Review Panel: General Hospital;

Indication for use:

Device Description:

Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the proposed devices meet the requirements for Level 3 classification.

Identification of Predicate Device 6.

510K Number: K192290 Product Name: 50g SMS Standard Surgical Gown; 45g SMS Surgical Gown with Reinforcement; 68g BVB Surgical Gown;

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68g BVB Splicing Surgical Gown

7. Identification of Reference Device

510(k) Number: K172987 Product Name: Surgical Gown

8. Technological Characteristic Comparison Tables.

Item	Subject Device K202706	Predicate Device K192290	Reference Device K172987	Remark
Product Code	FYA	FYA	FYA	Same
RegulationNo.	21CFR 878.4040	21CFR 878.4040	21CFR 878.4040	Same
Class	II	II	II	Same
Indication forUse	Surgical gowns are intendedto be worn by operatingroom personnel duringsurgical procedure to protectboth the surgical patient andthe operating roompersonnel from transfer ofmicroorganisms, bodyfluids, and particulatematerial.Per ANSI/AAMI PB70:2012Liquid barrier performanceand classification ofprotective apparel anddrapes intended for use inhealth care facilities, thesurgical gowns met therequirements for Level 3classification.	Surgical gown is intended tobe worn by operating roompersonnel during surgicalprocedure to protect both thesurgical patient and theoperating room personnelfrom transfer ofmicroorganisms, bodyfluids, and particulatematerial. Per ANSI/AAMIPB70:2012 Liquid barrierperformance andclassification of protectiveapparel and drapes intendedfor use in health carefacilities, SMS StandardSurgical Gown and SMSSurgical Gown withReinforcement met therequirements for Level 3classification; BVB SurgicalGown and BVB SplicingSurgical Gown met therequirements for Level 4classification.	Surgical gown is intended tobe worn by operating roompersonnel during surgicalprocedure to protect both thesurgical patient and theoperating room personnelfrom transfer ofmicroorganisms, body fluids,and particulate material.Per ANSI/AAMI PB70:2012Liquid barrier performanceand classification ofprotective apparel and drapesintended for use in healthcare facilities, the AG seriessurgical gowns met therequirements for Level 3classification.	Similar
Style	Non-reinforced	Non-reinforced/Reinforced	Non-reinforced/Reinforced	Similar
Durability	Disposable	Disposable	Disposable	Same

Table 1 Technological Characteristic Comparison

Page 3 of 5

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Color	Blue	Blue	Blue	Same
Labeling	Conform with 21CFR Part801	Conform with 21CFR Part801	Conform with 21CFR Part801	Same

Item	Subject Device K202706	Predicate Device K192290	Reference Device K172987	Remark
Weightpersquare (g)	55g/m²	50g/m², 45g/m², 68g/m²	44g/m²	Similar
Size	S, M, L, XL, XXL, XXXL	M, L, XL, XXL, XXXL,XXXL-XLONG	XL	Similar
Flammability	Class I	Class I	Class I	Same
Hydrostaticpressure	>50 cm	>50 cm	>50 cm	Same
Water impact	≤1.0 g	≤1.0 g	≤1.0 g	Same
Breakingstrength	>20N	>20N	>20N	Same
Tearingstrength	>20N	>20N	>30N	Similar
Linting	Log10<4	Log10<4	Log10<4	Same
Airpermeability	>30 ft³/min/ft²	>15cm³/s/cm²(29 ft³/min/ft²)	>30 ft³/min/ft²	Similar
Material	SMS polypropylenenonwoven + Polyester	SMS nonwoven, Laminatedmaterial, white knitted cuff, whitespun-bond, and BVB	SMSpolypropylenenonwoven	Similar
Level	Level 3 per AAMI PB 70	Level 3, Level 4 per AAMIPB 70	Level 3 per AAMI PB 70	Similar
Biocompatibility
Cytotoxicity	No Cytotoxicity	No Cytotoxicity	No Cytotoxicity
Irritation	No Irritation	No Irritation	No Irritation	Same
Sensitization	No Sensitization	No Sensitization	No Sensitization
Sterile	Sterile/Non-sterile	Sterile	Non-sterile	Similar

Table 2 Technological Characteristic Comparison

9. Non-Clinical Test Conclusion

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

16 CFR Part 1610 Standard for the Flammability of Clothing Textiles;
AATCC 127:2017 Water Resistance: Hydrostatic Pressure Test; >
ア AATCC 42:2017 Water Resistance: Impact Penetration Test;

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ISO 9073-10:2003 Textiles-Test Methods for Nonwovens-Part 10: Lint and Other Particles Generation in the Dry State;
ASTM D1683/D1683M:2017/(R)2018 Standard Test Method for Failure in Sewn Seams of Woven Fabrics;
ASTM D5587:2019 Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure;
ASTM D5034:2017 Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test);
ASTM D737:2018 Standard Test Method for Air Permeability of Textile Fabrics;
ASTM F88/F88M:2015 Standard Test Method for Seal Strength of Flexible Barrier Materials;
ASTM F1929:2015 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration;
ISO 10993-7:2008 Biological Evaluation of Medical Devices-Part 7: Ethylene Oxide Sterilization Residuals:
ISO 10993-5:2009 Biological Evaluation of Medical Devices-Part 5: Tests for in Vitro Cytotoxicity;
ISO 10993-10:2010 Biological Evaluation of Medical Devices-Part 10: Tests for Irritation and Skin Sensitization;

10. Clinical Test Conclusion

No clinical study is included in this submission.

11. Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the devices are as safe, as effective, and perform as well as or better than the legally marketed predicate device.

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.