Who is the manufacturer of Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)?

Xiamen Probtain Medical Techology Co., Ltd. filed the 510(k) submission for Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL) (K223411).

What is the FDA product code for Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)?

FYC. It is classified under 21 CFR 878.4040 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)?

Disposable Surgical Isolation Gowns (K210785).

Who can help prepare an FDA 510(k) submission like Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)

K223411 · Xiamen Probtain Medical Techology Co., Ltd. · FYC · Jan 4, 2023 · General, Plastic Surgery

Device Facts

Record ID	K223411
Device Name	Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)
Applicant	Xiamen Probtain Medical Techology Co., Ltd.
Product Code	FYC · General, Plastic Surgery
Decision Date	Jan 4, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4040
Device Class	Class 2

Intended Use

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 Gown meets the requirements of AAMI Level 3 barrier protection for a surgical isolation gown per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (AAM PB70). The Disposable Isolation Gowns are single use, disposable medical devices, provided sterile.

Device Story

Disposable isolation gown; non-reinforced; constructed from blue polypropylene (PP) non-woven fabric with polyethylene (PE) lamination; polyester cuffs. Designed for medical personnel in non-operating room medical environments. Provides AAMI Level 3 barrier protection against microorganisms, body fluids, and particulates. Single-use; provided sterile via ethylene oxide (EtO) gas. Protects both patients and healthcare workers by acting as a physical barrier.

Clinical Evidence

No clinical data. Bench testing only. Performance verified via AAMI PB70:2012, ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation/sensitization), ISO 10993-7 (EtO residuals), CPSC 16 CFR 1610 (flammability), ASTM D5034 (breaking strength), ASTM D5587 (tear strength), ISO 9073-10 (linting), and ASTM D1683 (seam strength).

Technological Characteristics

Material: PP non-woven with PE lamination; polyester cuffs. Barrier: AAMI Level 3 per ANSI/AAMI PB70:2012. Sterilization: Ethylene Oxide (EtO). Sizes: S, M, L, XL, XXL, XXXL. Biocompatibility: ISO 10993-5, -7, -10 compliant.

Indications for Use

Indicated for health care patients and personnel to protect against transfer of microorganisms, body fluids, and particulate material. Not for use in operating rooms. Single-use, sterile, disposable device.

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 Isolation Gowns (K210785)

Related Devices

K223467 — Disposable Isolation Gown · Nanning Tecbod Biological Technology Co., Ltd. · Feb 10, 2023
K223304 — Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL) · Xiamen Probtain Medical Technology Co., Ltd. · Feb 8, 2023
K210785 — Disposable Surgical Gowns · Chongqing Litai Fashion Group Limited Company · Nov 13, 2021
K203415 — Surgical Isolation Gown · Yanbian Pacific Textile Co., Ltd. · May 20, 2021
K212633 — Disposable Isolation Gown -Level 3, Large, Blue, Disposable Isolation Gown - Level 3, X-Large, Blue · String King Lacrosse, LLC · Nov 24, 2021

Submission Summary (Full Text)

{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. January 4, 2023 Xiamen Probtain Medical Techology Co., Ltd Jianli Kang Vice General Manager 4th Floor, No.1 Building, No.6 Ji'an Road, Tong'an District Xiamen, Fujian 361100 China Re: K223411 Trade/Device Name: Disposable Isolation Gowns (S,M,L,XL,XXL,XXL) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYC Dated: December 12, 2022 Received: December 12, 2022 Dear Jianli Kang: 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. 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 {1}------------------------------------------------ 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, MD, 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 Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use Submission Number (if known) K223411 Device Name Disposable Isolation Gowns (S.M.L.XL.XXL.XXXL) Indications for Use (Describe) 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 Gown meets the requirements of AAMI Level 3 barrier protection for a surgical isolation gown per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (AAM PB70). The Disposable Isolation Gowns are single use, disposable medical devices, provided sterile. 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 #### K223411 Document prepared date: 2022/12/19 #### A. Applicant: XIAMEN PROBTAIN MEDICAL TECHNOLOGY CO., LTD Address: 4th Floor.No.1 Building.No.6 Ji'an Road,Tong'an District,Xiamen,Fujian,361100,China Contact Person: Jianli Kang Tel: +86-592-7557106 Fax: +86-592-7199255 Email: kangjianli@probtain.com Submission Correspondent: Primary contact: Mr. Jarvis Wu Shanghai SUNGO Management Consulting Co., Ltd. 14th Floor, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: haiyu.wang@sungoglobal.com Secondary contact: Mr. Raymond Luo 14th Floor, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: fda.sungo@@gmail.com #### B. Device: Trade Name: Disposable Isolation Gowns Common Name: Surgical Isolation Gown Model: S,M,L,XL,XXL,XXL,XXXL 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 {4}------------------------------------------------ # D. Intended use of the device/ Indications for Use: 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 Gown meets the requirements of AAMI Level 3 barrier protection for a surgical isolation 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 sterile. ## E. Device Description: Disposable Isolation Gowns are designed for the medical personnel use in medical environment, not intended for use in the operating room. The employed material is Polypropylene(PP) non-woven with polyethylene(PE) lamination. It is a kind of Non- Reinforced isolation gown. The Disposable Isolation Gowns are constructed from a blue PP&PE (non-woven fabric, PE lamination) and have been tested according to AAMI PB70:2012 and meet AAMI Level 3 barrier level protection for a surgical isolation gown. The Disposable Isolation Gowns are blue color, sterilized by ethylene oxide gas , single use, disposable medical device that will be provided in a variety of sterile packaging configurations with 6 sizes, S,M,L,XL,XXL,and XXXL | Device | Predicate Device | Proposed Device | Comparison | |----------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | Manufacturer | Chongqing Litai Fashion Group Company | XIAMEN PROBTAIN MEDICAL TECHNOLOGY CO., LTD | – | | 510K number | K210785 | K223411 | – | | Product Name | Disposable Surgical Isolation Gowns | Disposable Isolation Gowns | – | | Product Code | FYC | FYC | Same | | Classification | Class II Device, FYC (21 CFR878.4040) | Class II Device, FYC (21 CFR878.4040) | Same | | Intend use/ 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 | 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 | Same | | | protection for a surgical isolation 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. | isolation 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 sterile. | | | Material Composition | Sleeve/body (polyethylene SMS Nonwoven ) Cuff (Polyester ) | Sleeve/body (PP non-woven fabric & PE lamination ) Cuff (Polyester ) | Similar | | Color | Blue | Blue | Same | | Sterility | Non-Sterile | Sterile, Ethylene Oxide (EtO) | Different | | Sterilization Method | Not available | Ethylene Oxide (EtO) | Different | | Sterilization Residuals | Not available | EO ≤ 4mg/day ECH ≤ 9mg/day | Different | | Use | Single Use; Disposable | Single Use; Disposable | Same | | Liquid Barrier Performance Classification Properties | Level 3 AAMI PB70 | Level 3 AMI PB70 | Same | | Water Penetration Resistance AATCC 42 | ≤1.0g AQL: 4% Level 3 per standard ANSI/AAMI PB70:2012 for level 3 | ≤1.0g AQL: 4% Level 3 per standard ANSI/AAMI PB70:2012 for level 3 | Same | | Static hydrostatic resistance AATCC 127 | ≥50 cmH2O per standard ANSI/AAMI PB70:2012 for level 3 | ≥50 cmH2O per standard ANSI/AAMI PB70:2012 for level 3 | Same | | Seam strength ASTM D1683M-17 | ≥30N(7lbf) per standard F2407-20 for level 3 | ≥30N(7lbf) per standard F2407-20 for level 3 | Same | | Breaking strength ASTM D5034-09 | ≥30N(7lbf) per standard F2407-20 for level 3 | ≥30N(7lbf) per standard F2407-20 for level 3 | Same | | Tear strength(N) | ≥10N | ≥10N | Same | | ASTM D5587-15, Flammability of Clothing Textiles- 16CFR Part 1610 | | | | | Class I | 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 devic extracts were not found to be a sensitizer. | Same | #### F. Comparison with predicate device {5}------------------------------------------------ {6}------------------------------------------------ #### Different analysis: The Proposed Device Disposable Isolation Gowns are provided sterile, which is different from Predicate Device's sterility. The EO and ECH Residuals tests were conducted on the proposed device to ensure its compliance to the ISO10993-7. The test result has shown the difference does not affect the safety and of the proposed device. There is no new risk generated from the difference of the sterility. Under the conditions of each study, the Proposed Device Disposable Isolation Gowns are noncytotoxic, non-sensitizing and negligibly irritating per ISO-10993 and have met the requirements of ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities for AAMI Level 3 surgical gowns. #### G. Summary of Non-Clinical Test Results Non-clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device met its acceptance criteria or testing endpoint safe levels using the following standards: > 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 ISO 10993-7:2008(R) 2012 Biological evaluation of medical devices -Part 7: Ethylene oxide sterilization residuals - CPSC 16 CFR Part 1610-2008, Standard for the Flammability of clothing textiles; A - ASTM D5034-09, Standard Test Method for Breaking Strength and Elongation of A Textile Fabrics (Grab Test);F A ASTM D5587-15, Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure; AAMI/ANSI PB70:2012, Liquid Barrier Performance and Classification of protective A {7}------------------------------------------------ #### XIAMEN PROBTAIN MEDICAL TECHNOLOGY CO., LTD 4th Floor,No.1 Building,No.6 Ji'an Road,Tong'an District,Xiamen, Fujian,361100, China Apparel and Drapes Intended For Use In Health Care Facilities. - > ISO9073-10-2003 Textiles — Test methods for nonwovens — Part 10: Lint and other particles generation in the dry state - > ASTM D1683/D1683M-17(2018)Standard Test Method for Failure in Sewn Seams of Woven Fabrics | | Table 2 performance test | | |--|--------------------------|--| |--|--------------------------|--| | Test Item | Test standard | Acceptance Criteria | Result | |---------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------|-----------------------------------------------------------------------------------| | Seam strength ASTM D1683M-17 Standard Test Method for Failure in Sewn Seams of Woven Fabrics. | The test was performed In accordance with ASTM D1683M-17 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 F2407-20 for level 3 | PASS 89.86 N (Average result from 10 samples) | | Breaking strength ASTM D5034-09 (2017) Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test) | The test was performed In accordance with D5034-09 (2017) . 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 F2407-20 for level 3 | PASS MD: 90.92 N CD: 77.06 N (Average result from 10 samples) | | Tear strength(N) ASTM D5587-15, Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure | The test was performed in accordance with ASTM D5587: 2015(2019) Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure to evaluate the tearing strength of the test sample. | ≥10N | PASS MD: 31.89 N CD: 19.2 N (Average result from 10 samples) | | Lint and other generation in the dry state ISO 9073- 10:2003(E) | 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 1.8 (Average result from 10 samples) | | Flammability CPSC 16 CFR Part | The test was performed in accordance with 16 | Class I | PASS | {8}------------------------------------------------ | 1610-2008, Standard for the Flammability of clothing textiles | CFR Part 1610 Standard for the Flammability of Clothing Textiles to evaluate the flammability of the test sample. | | Class I | |-----------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|-----------------------------------| | Water Penetration Resistance AATCC 42-2013, Impact Penetration Test | The test was performed in accordance with AATCC 42: 2013 Water Resistance: Impact Penetration Test to evaluate the water impact of the test sample. | ≤1.0g AQL: 4% Level 3 per standard ANSI/AAMI PB70:2012 for level 3 | PASS ≤1.0g | | Static hydrostatic resistance AATCC 127-2014, Water Resistance: Hydrostatic Pressure Test; | The test was performed in accordance with AATCC 127: 2014 Water Resistance: Hydrostatic Pressure Test to determine the hydrostatic pressure of the test sample. | ≥50 cmH2O per standard ANSI/AAMI PB70:2012 for level 3 | PASS ≥50 cmH2O | | EO and ECH sterilization residual ISO 10993-7:2008 Ethylene oxide sterilization residuals | The test was performed in accordance with ISO 10993-7:2008 Ethylene oxide sterilization residuals to determine the EO and ECH residuals of the test sample | EO ≤ 4mg/d ECH ≤ 9mg/d | PASS EO ≤ 4mg/d ECH ≤ 9mg/d | # Table3 Biocompatibility endpoints assessment | Test Item | Proposed device | Acceptance Criteria | Result | |-------------------------------|---------------------------------------------------------------------|------------------------|--------| | Cytotoxicity ISO 10993-5 | Under the conditions of the study, the device is non-cytotoxic. | Non-Cytotoxic | PASS | | Irritation ISO 10993-10 | Under the conditions of the study, the device is non-irritating. | Non-Irritating | PASS | | Sensitization ISO 10993-10 | Under the conditions of the study, the device is non-sensitizing | Non-Sensitizing | PASS | #### H. Clinical Test Conclusion No clinical study is included in this submission. {9}------------------------------------------------ ## I. Conclusion The conclusions drawn from the nonclinical tests demonstrate that the subject device, Disposable Isolation Gown (model: S,M,L,XL,XXL,XXXL), 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.