The Medical Surgical Gowns is 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 Medical Surgical Gowns met the requirements for Level 3 classification.

Device Description

The proposed device is a poly-reinforced surgical gown, the critical zone is front chest and sleeves. The critical zone is reinforced with PP/PE composite laminated material and the reinforced layer is attached with the gown by ultrasonic welding. The proposed device is available in five different sizes, include S-160, M-165, L-70, XL-175, XXL-180, and XXXL-185. 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 can meet the requirements for Level 3 classification. The proposed devices are disposable medical devices and provided in sterile.

AI/ML Overview

This document is a 510(k) Pre-market Notification for a medical device, specifically Medical Surgical Gowns. The information provided does not describe an AI medical device or a study involving human readers.

Therefore, most of the requested points are not applicable. I can only extract information related to the performance of the Medical Surgical Gowns based on the provided text.

Here's a summary of the information that is available:

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

The acceptance criteria are generally based on the ANSI/AAMI PB70:2012 Level 3 classification for liquid barrier performance, along with specific physical and biological properties.

Acceptance Criteria / Test	Performance (Proposed Device K202844)
Liquid Barrier Performance (ANSI/AAMI PB70:2012)	Met Level 3 classification
Hydrostatic pressure (AATCC 127)	>50 cm
Water impact (AATCC 42)	≤1.0 g
Physical Properties
Break strength (ASTM D 5034-09)	>20N
Tear strength (ASTM D 5587-15)	>20N
Air permeability (ASTM D737-18)	>15 cm3/s/cm2 (29 ft3/min/ft2)
Lint (ISO 9073-10)	Log10<4
Flammability (16 CFR Part 1610)	Class I
Seal Strength (ASTM F88/F88M-15)	Not explicitly stated in table, but tested
Seal Leaks (ASTM F1929-15)	Not explicitly stated in table, but tested
Biocompatibility (ISO 10993)
Cytotoxicity (ISO 10993-5)	No Cytotoxicity
Skin Irritation (ISO 10993-10)	No Irritation
Sensitization (ISO 10993-10)	No Sensitization
Sterilization
Sterilization method & Sterility Assurance Level (SAL)	Ethylene Oxide (EO), SAL=10-6

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 the non-clinical tests. Non-clinical tests were conducted to verify design specifications and similarity to the predicate device. The provenance of the data is not explicitly stated beyond the manufacturer being in Beijing, China.

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)

Not applicable. This is for a physical medical device (surgical gown), not an AI diagnostic tool. "Ground truth" in this context would refer to the validated results of the physical and biological tests, not expert consensus on medical images.

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

Not applicable. This is for a physical medical device.

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

Not applicable. This is for a physical medical device, not an AI system.

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

Not applicable. This is for a physical medical device.

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

The "ground truth" for the device's performance is established through adherence to recognized international and national standards for physical properties, barrier performance, and biocompatibility, such as ANSI/AAMI PB70:2012, ASTM standards, ISO standards, and CFR regulations. These standards define the acceptable limits for the device's characteristics.

8. The sample size for the training set

Not applicable. This is for a physical medical device, not an AI system that requires a training set.

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

Not applicable.

Summary

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January 6, 2021

Beijing Biosis Healing Biological Technology Co., Ltd % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, Shanghai 200120 China

Re: K202844

Trade/Device Name: Medical Surgical Gowns Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYA Dated: December 10, 2020 Received: December 9, 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 and Part 809); 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: CAPT Elizabeth Claverie, M.S. 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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Indications for Use

510(k) Number (if known) K202844

Device Name Medical Surgical Gowns

Indications for Use (Describe)

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)
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510(k) Summary K202844

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

The assigned 510(k) Number: K202844

1. Date of Preparation: 1/5/2021
1. Sponsor Identification

BEIJING BIOSIS HEALING BIOLOGICAL TECHNOLOGY CO., LTD

No.6 plant west, Valley No.1 Bio-medicine Industry Park, Daxing District, 102600 Beijing, China.

Establishment Registration Number: 3016668451

Contact Person: Ting Jiang Position: RA Director Tel: +86-10-6125 2660-816 Fax: +86-10-6125 2030 Email: jiangting@biosishealing.com

3. 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

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510(k) Summary

Identification of Proposed Device న.

Trade Name: Medical Surgical Gowns Common Name: Surgical Gown;

Regulatory Information

Classification Name: Surgical Gown; Classification: II; Product Code: FYA; Regulation Number: 21CFR 878.4040 Review Panel: General & Plastic Surgery;

Indication for Use:

Device Description:

Identification of Predicate Device 6.

510(k) Number: K172987 Product Name: Surgical Gown (AG1001, AG2001, AG3001)

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Technological Characteristic Comparison Tables 7.

ITEM	Proposed Device K202844	Predicate Device K172987	Remark
Product Code	FYA	FYA	Same
Regulation Number	21 CFR 878.4040	21 CFR 878.4040	Same
Class	II	II	Same
Indication for use	The Medical Surgical Gowns isintended to be worn by operatingroom personnel during surgicalprocedure to protect both thesurgical patient and the operatingroom personnel from transfer ofmicroorganisms, body fluids, andparticulate material.Per ANSI/AAMI PB70:2012Liquid barrier performance andclassification of protective appareland drapes intended for use inhealth care facilities, the MedicalSurgical Gowns met therequirements for Level 3classification.	Surgical gown is intended to beworn by operating room personnelduring surgical procedure toprotect both the surgical patientand the operating room personnelfrom transfer of microorganisms,body fluids, and particulatematerial.Per ANSI/AAMI PB70:2012Liquid barrier performance andclassification of protective appareland drapes intended for use inhealth care facilities, the AG seriessurgical gowns met therequirements for Level 3classification.	Same
Style	Poly-reinforced	Non-reinforcedFabric-reinforcedPoly-reinforced	Similar
Durability	Disposable	Disposable	Same
Color	Blue	Blue	Same
Labeling	Conform with 21CFR Part 801	Conform with 21CFR Part 801	Same

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ITEM	Proposed Device	Predicate Device	Remark
Size	S, M, L, XL, XXL, XXXL	S, M, L, XL, XXL	Similar
Break strength	>20N	>20N	Same
Tear strength	>20N	>30N	Similar
Air permeability	>15 cm3/s/cm2 (29 ft3/min/ft2)	>30 ft3/min/ft2	Similar
Lint	Log10<4	Log10<4	Same
Flammability	Class I	Class I	Same
Hydrostatic pressure	>50 cm	>50 cm	Same
Water impact	≤1.0 g	≤1.0 g	Same
Material	SMS nonwoven, polyethylene,polyester	SMMMS, polypropylene,polyethylene, polyester	Similar
Level	Level 3 per AAMI PB 70	Level 3 per AAMI PB 70	Same
Biocompatibility
Cytotoxicity	No Cytotoxicity	No Cytotoxicity	Same
Skin Irritation	No Irritation	No Irritation	Same
Sensitization	No Sensitization	No Sensitization	Same
Sterile	Ethylene Oxide (EO), SAL=10-6	Ethylene Oxide (EO), SAL=10-6	Same

Table 2 Technological Characteristic Comparison

8. 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 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;
A AATCC 42:2017 Water Resistance: Impact Penetration Test;
A ISO 9073-10:2003 Textiles-Test Methods for Nonwovens-Part 10: Lint and Other Particles Generation in the Dry State;
ASTM D1683/D1683M-17:2017/(R) 2018 Standard Test Method for Failure in Sewn Seams of Woven Fabrics
A ASTM D 5587-15:2015 Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure;
ASTM D 5034-09:2017 Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test);
A ASTM D737-18:2018 Standard Test Method for Air Permeability of Textile Fabrics;
A ASTM F88/F88M-15 Standard Test Method for Seal Strength of Flexible Barrier Materials;

Page 4 of 5

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A ASTM F1929-15 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;
1. Clinical Test Conclusion

No clinical study is included in this submission.

1. Conclusion
  The conclusions drawn from the nonclinical tests demonstrate that the device is 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.