Who is the manufacturer of Isolation Gown (S, M, L, XL, XXL (Yellow, Blue))?

Allmed Medical (Hubei) Protective Products Co., Ltd. filed the 510(k) submission for Isolation Gown (S, M, L, XL, XXL (Yellow, Blue)) (K221027).

What is the FDA product code for Isolation Gown (S, M, L, XL, XXL (Yellow, Blue))?

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 Isolation Gown (S, M, L, XL, XXL (Yellow, Blue))?

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

What are the predicate devices for Isolation Gown (S, M, L, XL, XXL (Yellow, Blue))?

Cardinal Health™ Isolation Gown (K160339).

Who can help prepare an FDA 510(k) submission like Isolation Gown (S, M, L, XL, XXL (Yellow, Blue))?

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.

Isolation Gown (S, M, L, XL, XXL (Yellow, Blue))

K221027 · Allmed Medical (Hubei) Protective Products Co., Ltd. · FYC · Aug 12, 2022 · General, Plastic Surgery

Device Facts

Record ID	K221027
Device Name	Isolation Gown (S, M, L, XL, XXL (Yellow, Blue))
Applicant	Allmed Medical (Hubei) Protective Products Co., Ltd.
Product Code	FYC · General, Plastic Surgery
Decision Date	Aug 12, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4040
Device Class	Class 2

Intended Use

The 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. In addition, The Isolation Gowns meet the requirements of an AAMI Level 3 barrier protection for an isolation gown per ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities (ANSI/AAMI PB70). The Isolation Gowns are a single use, disposable medical device provided non-sterile.

Device Story

Isolation gown; provides AAMI Level 3 barrier protection; constructed of SMS (spunbond-meltblown-spunbond) nonwoven polypropylene; features tape neck closure, belt tie, and elastic cuffs. Used in healthcare facilities to protect patients and personnel from microorganisms, body fluids, and particulates. Not for operating room use. Single-use, disposable, non-sterile. Healthcare personnel don the gown to create a physical barrier; performance verified via hydrostatic pressure and impact penetration testing per ANSI/AAMI PB70:2012.

Clinical Evidence

No clinical data. Bench testing only, including hydrostatic pressure (AATCC 127), impact penetration (AATCC 42), breaking/tearing strength (ASTM D5034/D5587), seam strength (ASTM D1683), flammability (16 CFR 1610), and biocompatibility (ISO 10993-5/10).

Technological Characteristics

SMS (spunbond-meltblown-spunbond) nonwoven polypropylene; polyester cuffs. AAMI Level 3 barrier protection. Non-sterile. Tested per ANSI/AAMI PB70:2012, ASTM D5034, ASTM D5587, ASTM D1683, ASTM F1868, ISO 9073-10, and 16 CFR 1610.

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, disposable, non-sterile.

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

Cardinal Health™ Isolation Gown (K160339)

Related Devices

K212717 — Paneffort AAMI Level 3 Isolation Gown · Paneffort, LLC · Nov 30, 2022
K171535 — SURGICAL ISOLATION GOWN · Jingzhou Haixin Green Cross Medical Products Co., Ltd. · Feb 15, 2018
K190306 — AMD Ritmed AssureWear VersaGown · Amd Medicom, Inc. · Jan 17, 2020
K160361 — PRIMAGARD Isolation Gown (AAMI PB70 Level 3) · Primed Medical Products, Inc. · Nov 4, 2016
K203821 — Donagamex Blue Performance Protective Gown · Dong Nai Garment Corporation (Donagamex) · Dec 17, 2021

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows 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. August 12, 2022 Allmed Medical (Hubei) Protective Products Co., Ltd % Ivy Wang Technical Manager Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Century Avenue Shanghai, 200122 China Re: K221027 Trade/Device Name: Isolation Gown (S, M, L, XL, XXL (Yellow, Blue)) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FYC Dated: April 6, 2022 Received: April 6, 2022 Dear Ivy Wang: 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 Oian, 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 Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K221027 Device Name Isolation Gown (S, M, L, XL, XXL (Yellow, Blue)) Indications for Use (Describe) The 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. In addition, The Isolation Gowns meet the requirements of an AAMI Level 3 barrier protection for an isolation gown per ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities (ANSI/AAMI PB70). The Isolation Gowns are a single use, disposable medical nonsterile. 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) _ | 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 (K221027) (As requirement by 21 CFR 807.92) Date prepared: 25th, March, 2022 #### A. Applicant: Name: Allmed Medical (Hubei) Protective Products Co., Ltd Address: No.29 Dong Hu Road, Majiadian Town, Zhijiang City, Hubei, China Contact Person: Vince Tian Title: General Manager of Quality Tel: 86 717 4215906 Fax: 86 717 4215989 Email: vince@allmed.cn Submission Correspondent: Primary contact: Ms. Ivy Wang Shanghai SUNGO Management Consulting Co., Ltd. Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: haiyu.wang@sungoglobal.com Secondary contact: Mr. Raymond Luo Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: fda.sungo@@gmail.com #### B. Device: Trade Name:Isolation Gown Model: S. M. L. XL. XXL (Yellow, Blue) Regulatory Information Classification Name: Surgical Isolation Gown Classification: Class II Product code: FYC Regulation Number: 21 CFR 878.4040 Review Panel: General Hospital C. Predicate device: K160339 Cardinal Health™ Isolation Gown Cardinal Health 200, LLC #### D. Indications for use of the device: {4}------------------------------------------------ The Isolation Gowns are intended to protect health care personnel from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. In addition, The Isolation Gowns meet the requirements of an AAMI Level 3 barrier protection for an isolation gown per ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities (ANSI/AAMI PB70). The Isolation Gowns are a single use, disposable medical device provided non-sterile. # E. Device Description: The Isolation Gown is a surgical isolation gown with moderate barrier protection identified by Regulation 21 CFR 878.4040 under FDA product code, FYC. The Isolation Gown is offered in two colors (yellow and blue) and each color is offered in five sizes (S, M, L, XL and XXL) for a total of ten models. Each model is constructed of a SMS nonwoven material (spunbond +meltblown + spunbond nonwovens) and has been tested according to ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities and meets AAMI Level 3. The Isolation Gown is a single use, disposable medical device that will be provided in a variety of non-sterile packaging configurations. # F. Non-clinical Test Conclusion The Isolation Gowns were tested in accordance with the tests recommended in ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities. | Test Item | Test Standard | Acceptance Criteria for Level 3 Barrier | Result of Yellow Isolation Gown XXL | Result of Blue Isolation Gown XXL | |------------------------------------------------------|----------------------------|-----------------------------------------------------------------------------------|-------------------------------------------|-----------------------------------------| | Water Resistance: Hydrostatic Pressure Test | AATCC 127-2018e | ≥50 cmH2O per standard ANSI/AAMI PB70:2012 for level 3 | Passed | Passed | | Water Resistance: Impact Penetration Test | AATCC 42-2017 | ≤1.0g AQL: 4% Level 3 per standard ANSI/AAMI PB70:2012 for level 3 | Passed | Passed | | Breaking Strength and Elongation | ASTM D 5034-2009 (2017) | ≥30N(7lbf) | Passed | Passed | | Tearing Strength | ASTM D 5587-2015 | ≥10N (2.3 lbf) | Passed | Passed | Based upon the document the following testing has been performed. {5}------------------------------------------------ | | (2019) | | | | |---------------------------------------------------------------|-------------------------------------|---------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Seam Strength | ASTM D1683/D1683M-2017 (2018) | ≥30N (7lbf) | Passed | Passed | | Lint and other particles generation in the dry state | ISO 9073-10:2003 | Reported Data | Lint and other particles generation in the dry state[Material] Total linting: A: face 222 B: face 152 Average 187 Coefficient of linting: A: face 2.3 B: face 2.2 Average 2.3 | Lint and other particles generation in the dry state[Material] Total linting: A: face 527 B: face 641 Average 584 Coefficient of linting: A: face 2.7 B: face 2.8 Average 2.8 | | Thermal and Evaporative Resistance | ASTM F 1868-2017 | Reported Data | Evaporative resistance(m2·kPa/W) [Material]: 0.00217 | Evaporative resistance(m2·kPa/W) [Material]: 0.00198 | | Flammability Test | 16 CFR Part 1610 | Class I | Passed | Passed | | Mass Per Unit Area | ISO 9073-1:1989 | Reported Data | 39.56 | 40.62 | ## Biocompatibility Testing The biocompatibility evaluation for the Isolation Gown was conducted in accordance with ISO 10993-1:2018 Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing within a Risk Management Process, as recognized by FDA. The Isolation Gown is classified as a surface contacting device. Specific biocompatibility tests were selected under the guidance of ISO 10993-1:2018 Annex A. | Biocompatibility Evaluation | | | | | |-----------------------------|-------------------|--------------|-----------------------|--------| | | Biological Effect | Standard | Result | | | 1 | Cytotoxicity | ISO 10993-5 | Non-cytotoxic | Passed | | 2 | Sensitization | ISO 10993-10 | Non-sensitizing | Passed | | 3 | Irritation | ISO 10993-10 | Negligibly irritating | Passed | ## G. Summary of Technological Characteristics ## Table 1 General Comparison of Proposed and Predicate Devices | Device | Proposed Device | Predicate Device | Result | |--------|-----------------|------------------|--------| |--------|-----------------|------------------|--------| {6}------------------------------------------------ | 510K # | - | K160339 | - | |-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------| | Manufacturer | Allmed Medical ( Hubei ) Protective Products Co., Ltd | Cardinal Health 200, LLC | - | | Product Name | Isolation Gown | Cardinal Health™ Isolation Gown | Similar | | Level | Level 3 | Level 3 | Same | | Product Code | FYC | FYC | Same | | Regulation Number | 21 CFR 878.4040 | 21 CFR 878.4040 | Same | | Indications for use | The 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. In addition, The Isolation Gowns meet the requirements of an AAMI Level 3 barrier protection for an isolation gown per ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities (ANSI/AAMI PB70). The Isolation Gowns are a single use, disposable medical device provided non-sterile. | Cardinal HealthTM Isolation Gown is 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. In addition, The Cardinal HealthTM Isolation Gown meets the requirements of an AAMI Level 3 barrier protection for an isolation gown per ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities (ANSI/AAMI PB70).The Cardinal HealthTM Isolation Gown is a single use, disposable medical device provided non-sterile. | Same | | Design Feature | Tape Neck Closure Belt Tie Elastic Cuffs | Medical Tape Neck Closure White Belt Tie Elastic Cuffs | Similar | | Material Composition | Body, Sleeves and Belt:Polypropylene SMS non-woven Cuff: Polyester | Polyolefin (Polypropylene) SMS nonwoven | Similar | | Color | Blue and Yellow | Blue and Yellow | Same | | Sterility | Non-sterile | Non-sterile | Same | | Use | Single Use, Disposable | Single Use, Disposable | Same | # Table 2 Performance Comparison of Proposed and Predicate Devices | Element of Comparison | Proposed Device (Yellow) | Proposed Device (Blue) | Predicate Device (K160339) (Yellow) | Predicate Device (K160339) (Blue) | Comparison | | | |---------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|-----| | Basis weight | 39.56g/m² (1.17 oz/yd²) | 40.62g/m² (1.20 oz/yd²) | Mean = 1.21 Ind Min = 1.19 | Mean = 1.18 Ind Min = 1.15 | Similar | | | | | | | Ind Max = 1.23 Unit: oz/yd² | Ind Max = 1.20 Unit: oz/yd² | | | | | Grab tensile MD ASTM D5034 | Average value:88.53N (20 lbs) | Average value:139.39N (31.32 lbs) | Mean = 24.38 Ind Min = 21.94 Ind Max = 26.28 Unit: lb | Mean = 22.23 Ind Min = 20.42 Ind Max = 24.03 Unit: lb | Similar | | | | Grab tensile CD ASTM D5034 | Average value:58.05N (13.05 lbs) | Average value:77.01N (17.31 lbs) | Mean = 14.54 Ind Min = 12.70 Ind Max = 16.45 Unit: lb | Mean = 14.18 Ind Min = 12.40 Ind Max = 15.76 Unit: lb | Similar | | | | Trap Tear MD ASTM D5587-15 | Average value:24.52N (5.51 lbs) | Average value:34.42N (7.74 lbs) | Mean = 4.74 Ind Min = 3.67 Ind Max = 5.47 Unit: lb | Mean = 4.40 Ind Min = 3.26 Ind Max = 5.54 Unit: lb | Different | | | | Trap Tear CD ASTM D5587-15 | Average value:15.13N (3.4 lbs) | Average value:17.54N (3.94 lbs) | Mean = 9.24 Ind Min = 7.54 Ind Max = 12.98 Unit: lb | Mean = 7.99 Ind Min = 6.64 Ind Max = 11.11 Unit: lb | Different | | | | Flammability Part 1610 | Class I | Class I | Class I | Class I | Same | | | | Hydrostatic Head (cm) AATCC 127 | Body/Sleeve Ind Min-51.02 Ind Max=82.86 | Body/Sleeve Ind Min-52.24 Ind Max=101.22 | Body/Sleeve: Mean = 69 Ind Min = 56 Ind Max = 84 | Body/Sleeve: Mean = 72 Ind Min = 53 Ind Max = 80 | Similar | | | | Water Impact (g) AATCC 42 | Body/Sleeve: Ind Min = 0.0 Ind Max = 0.3 | Body/Sleeve: Ind Min = 0.0 Ind Max = 0.3 | Body/Sleeve: Mean = 0.08 Ind Min = 0.05 Ind Max = 0.13 | Body/Sleeve: Mean = 0.08 Ind Min = 0.04 Ind Max = 0.13 | Similar | | | | Liquid Barrier Performance Classification Properties | Device was tested in accordance with ANSI/AAMI PB70:2012 and meets Level 3 requirements for an isolation gown. The critical zone areas tested were the the body and sleeve (same fabric), the sleeve seam, the shoulder seam, and binding material. | | Device was tested in accordance with ANSI/AAMI PB70:2012 and meets Level 3 requirements for an isolation gown. The critical zone areas tested were the body and sleeve (same fabric), the sleeve seam, front belt or tie attachment, and the front seam arm attachment using multiple lots. | | Similar | | | | Biocompatibility | The test was done against ISO10993-5 and ISO10993-10. The result indicates the gown is non-cytotoxic, and non-sensitizing and negligibly irritating | | Under the conditions of each study, the Cardinal HealthTM Isolation gown is non-cytotoxic, non-irritating, and non-sensitizing per ISO 10993-1. | | Same | | | | Sterilization Modality | None (Non-sterile) | | | None (Non-sterile) | Same | | | | Seam Strength | Seam Strength: | Seam Strength: | Performance values not available in predicate 510(k) submission | N/A | | | | | | 58.18N | 65.27N | | | | | | | | Seam Strength Ultimate | Seam Strength Ultimate | | | | | | | | Elongation(%):51. 04 | Elongation(%):32. 63% | | | | | | | | Lint and other particles generation in the dry state | Lint and other particles generation in the dry state[Material] Total linting: A: face 222 B: face 152 Average 187 Coefficient of linting: A: face 2.3 B: face 2.2 Average 2.3 | | | Lint and other particles generation in the dry state[Material] Total linting: A: face 527 B: face 641 Average 584 Coefficient of linting: A: face 2.7 B: face 2.8 Average 2.8 | Performance values not available in predicate 510(k) submission | N/A | | | Thermal and Evaporative Resistance | Evaporative resistance(m2·kPa/ W) [Material]: 0.00217 | | | Evaporative resistance(m2·kPa/ W) [Material]: 0.00198 | Performance values not available in predicate 510(k) submission | N/A | {7}------------------------------------------------ {8}------------------------------------------------ ## Analvsis: The subject isolation gowns are substantially equivalent to the predicate device, in terms of general intended use, performance testing, material composition, and configuration. The tearing strength (both warp direction and filing direction) is slightly different from that of the predicate device. The tearing strength of the proposed device has been tested according to ASTM D5587-15 and met the requirement of the standard. Under the conditions of each study, the subject isolation gown is non-cytotoxic, non-sensitizing and neeligibly 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 an AAMI Level 3 isolation gown. #### H. Summary of Non-Clinical Testing Non-clinical tests were conducted to verify that the proposed device met all design specification. The test results demonstrated that the proposed device complies with the following standards and ANSI/A AMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities. - ISO 10993-05:2009 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 {9}------------------------------------------------ Sensitization - > ASTM D5034-09 (2017), Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test) - > ASTM D5587-15 (2019), Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure; - AAMI/ANSI PB70:2012, Liquid Barrier Performance and Classification of protective Apparel and > Drapes Intended For Use In Health Care Facilities - > ASTM F1868-17 Standard Test Method for Thermal and Evaporative Resistance of Clothing Materials Using a Sweating Hot Plate - > ISO 9073-10-2003 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 16 CFR 1610, Standard for the Flammability of Clothing Textiles #### I. Clinical Test Conclusion No clinical study is included in this submission. #### J. Conclusion The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission, the subject Isolation Gown is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K160339.