Medline Level 4 Surgical Gown (Sirus), Medline Level 4 Surgical Gown (Eclipse), Medline Level 4 Surgical Gown (Aurora)

Q: Who is the manufacturer of Medline Level 4 Surgical Gown (Sirus), Medline Level 4 Surgical Gown (Eclipse), Medline Level 4 Surgical Gown (Aurora)?

Medline Industries, Inc. filed the 510(k) submission for Medline Level 4 Surgical Gown (Sirus), Medline Level 4 Surgical Gown (Eclipse), Medline Level 4 Surgical Gown (Aurora) (K182172).

Q: What is the FDA product code for Medline Level 4 Surgical Gown (Sirus), Medline Level 4 Surgical Gown (Eclipse), Medline Level 4 Surgical Gown (Aurora)?

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

Q: What is the regulatory pathway for Medline Level 4 Surgical Gown (Sirus), Medline Level 4 Surgical Gown (Eclipse), Medline Level 4 Surgical Gown (Aurora)?

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

Q: Who can help prepare an FDA 510(k) submission like Medline Level 4 Surgical Gown (Sirus), Medline Level 4 Surgical Gown (Eclipse), Medline Level 4 Surgical Gown (Aurora)?

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.

K182172 · Medline Industries, Inc. · FYA · Apr 24, 2019 · General, Plastic Surgery

Device Facts

Record ID	K182172
Device Name	Medline Level 4 Surgical Gown (Sirus), Medline Level 4 Surgical Gown (Eclipse), Medline Level 4 Surgical Gown (Aurora)
Applicant	Medline Industries, Inc.
Product Code	FYA · General, Plastic Surgery
Decision Date	Apr 24, 2019
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4040
Device Class	Class 2

Intended Use

The Medline Level 4 Surgical Gown (Sirus), Medline Level 4 Surgical Gown (Eclipse), and Medline Level 4 Surgical Gown (Aurora) is a sterile, single use surgical apparel intended to be worn by healthcare professionals to help protect both the patient and the healthcare worker from the transfer of microorganisms, body fluids, and particulate matter. The Medline Level 4 Surgical Gown (Sirus), Medline Level 4 Surgical Gown (Eclipse), and Medline Level 4 Surgical Gown (Aurora) meets the Level 4 requirements of ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities.

Device Story

Sterile, single-use, disposable surgical gown; constructed from nonwoven SMS (spunbond, meltblown, spunbond) polypropylene with poly-reinforcement film on chest and sleeves; features hook and loop neck closure, waist ties, and knitted cuffs. Used in healthcare facilities by operating room personnel. Provides ANSI/AAMI PB70:2012 Level 4 liquid barrier protection. Protects patient and healthcare worker from cross-contamination of fluids, microorganisms, and particulates during surgery.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including ANSI/AAMI PB70:2012 liquid barrier performance, ASTM F1671 (viral penetration), flammability (16 CFR 1610), and biocompatibility (ISO 10993-5, 10993-10).

Technological Characteristics

Materials: Nonwoven SMS polypropylene, poly-reinforcement film. Design: Raglan or set-in sleeves, hook/loop neck closure, waist ties, knitted cuffs. Barrier: ANSI/AAMI PB70:2012 Level 4. Sterilization: Ethylene Oxide (EO). Biocompatibility: ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation/sensitization). Flammability: CPSC 1610 Class 1.

Indications for Use

Indicated for healthcare professionals as sterile, single-use surgical apparel to protect patients and workers from transfer of microorganisms, body fluids, and particulate matter during surgical procedures.

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

Kimberly Clark (Halyard) ULTRA Fluid Barrier Surgical Gown (K080795)

Related Devices

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K080795 — ULTRA SURGICAL GOWN & FLUID BARRIER SURGICAL GOWN · Kimberly-Clark Corp. · Sep 3, 2008
K172954 — Medline Prevention CoolZone Gown · Medline Industries, Inc. · Jun 15, 2018
K214088 — Disposable Surgical Gown · Weihai Hongyu Nonwoven Fabric Products Co., Ltd. · Apr 12, 2022

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & 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. April 24, 2019 Medline Industries, Inc. Pauline Maralit Regulatory Affairs Specialist Three Lakes Drive Northfield, Illinois 60093 Re: K182172 Trade/Device Name: Medline Level 4 Surgical Gown (Sirus), Medline Level 4 Surgical Gown (Eclipse), Medline Level 4 Surgical Gown (Aurora) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYA Dated: March 26, 2019 Received: March 28, 2019 Dear Pauline Maralit: 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # Clarence W. Murray lii III -S For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use #### 510(k) Number (if known) K182172 #### Device Name Medline Level 4 Surgical Gown (Sirus), Medline Level 4 Surgical Gown (Eclipse), Medline Level 4 Surgical Gown (Aurora), #### Indications for Use (Describe) The Medline Level 4 Surgical Gown (Sirus), Medline Level 4 Surgical Gown (Eclipse), and Medline Level 4 Surgical Gown (Aurora) is a sterile, single use surgical apparel intended to be worn by healthcare professionals to help protect both the patient and the healthcare worker from the transfer of microorganisms, body fluids, and particulate matter. The Medline Level 4 Surgical Gown (Sirus), Medline Level 4 Surgical Gown (Eclipse), and Medline Level 4 Surgical Gown (Aurora) meets the Level 4 requirements of ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|---------------------------------------------------------------------------------| | | <input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | | | <input checked="" type="checkbox"/> 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}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the Medline logo. The logo is set against a blue background. The word "MEDLINE" is written in white, block letters, and a white abstract star-like shape is behind the text. The star shape has four points, with the top and bottom points being longer than the side points. Medline Industries, Inc. Three Lakes Drive Northfield. IL 60093 Medline Level 4 Surgical Gown 510(k) Premarket Submission All information on this page is confidential # 510(k) SUMMARY - K182172 # Submitter / 510(k) Sponsor Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093 Registration Number: 1417592 ## Submission Contact Pauline Maralit Regulatory Affairs Specialist Phone: 847-949-2283 Email: pmaralit(@medline.com Summary Preparation Date August 9, 2018 Type of 510(k) Submission Traditional ## Device Name / Classification | Regulation Name: | Surgical Apparel | |-----------------------|----------------------------------------------------------------------------------------------------------------------------| | Regulatory Panel: | General & Plastic Surgery | | Regulation #: | 21 CFR 878.4040 | | Common Name: | Surgical Gown | | Classification Name: | Surgical Gown | | Proprietary Name: | Medline Level 4 Surgical Gown (Sirus), Medline Level 4 Surgical Gown (Eclipse), Medline Level 4 Surgical Gown (Aurora). | | Product Code: | FYA | | Classification Panel: | II | # Predicate Device PREDICATE DEVICE: - Kimberly Clark (Halyard) ULTRA Fluid Barrier Surgical Gown 트 PREDICATE DEVICE K NUMBER: {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the Medline logo. The logo features the word "MEDLINE" in white, bold, sans-serif font, stacked on top of a white abstract star-like shape. The background is a solid dark blue. A gray bar is on the right side of the logo. Medline Industries, Inc. Three Lakes Drive Northfield. IL 60093 - K080795 (Kimberly-Clark Corp./Halyard) ■ ## Device Description The Medline Level 4 Surgical Gown (Sirus, Eclipse, and Aurora) is a Class II medical device regulated under FDA product code FYA, General & Plastic Surgery Panel, and regulation 21 CFR 878.4040. The device description of the Medline Level 4 Surgical Gown is in accordance with the Guidance on Premarket Notification [510(k)] Submissions for Surgical Gowns and Surgical Drapes, issued on August 1, 1993. The Medline Level 4 Surgical Gown (Sirus, Eclipse, and Aurora) is a single-use, sterile, disposable medical device that is provided in a variety of sizes and styles. The Medline Level 4 Surgical Gown (Sirus, Eclipse, and Aurora) constructed from nonwoven SMS (spubound, meltblown, spunbond), a poly-fabric reinforcement on the chest front panel and on both sleeves. Each gown is designed with a hook and loop closure at the neck, ties at the waist, knitted cuffs at the end of the sleeves as well as a transfer tab for ease in donning. The Medline Level 4 Surgical Gown (Sirus, Eclipse, and Aurora) has been tested according to ANSI/AAMI PB70:2012 and meets AAMI Level 4 barrier level protection for a surgical gown. | Item Number | Device Description | Sleeve Style | Size | |-------------|----------------------------------------|--------------|------------------| | DYNJP2707 | Aurora Surgical Gown, Poly Reinforced, | Set-in | Large | | DYNJP2708 | Aurora Surgical Gown, Poly Reinforced, | Set-in | X-Large | | DYNJP2709 | Aurora Surgical Gown, Poly Reinforced, | Set-in | XX-Large | | DYNJP2724 | Aurora Surgical Gown, Poly Reinforced, | Set-in | Large, X-Long | | DYNJP2725 | Aurora Surgical Gown, Poly Reinforced, | Set-in | X-Large, X-Long | | DYNJP2726 | Aurora Surgical Gown, Poly Reinforced, | Set-in | XX-Large, X-Long | | DYNJP2807 | Aurora Surgical Gown, Poly Reinforced, | Raglan | Large | | DYNJP2808 | Aurora Surgical Gown, Poly Reinforced, | Raglan | X-Large | | DYNJP2809 | Aurora Surgical Gown, Poly Reinforced, | Raglan | XX-Large | | DYNJP220 | Eclipse Surgical Gown, Poly Reinforced | Set-in | Large | | DYNJP2202 | Eclipse Surgical Gown, Poly Reinforced | Set-in | X-Large | | DYNJP2203 | Eclipse Surgical Gown, Poly Reinforced | Set-in | XX-Large | | DYNJP2204 | Eclipse Surgical Gown, Poly Reinforced | Set-in | Large, X-Long | | DYNJP2205 | Eclipse Surgical Gown, Poly Reinforced | Set-in | X-Large, X-Long | | DYNJP2206 | Eclipse Surgical Gown, Poly Reinforced | Set-in | XX-Large, X-Long | | DYNJP2201S | Sirus Surgical Gown, Poly Reinforced | Set-in | Large | | DYNJP2202S | Sirus Surgical Gown, Poly Reinforced | Set-in | X-Large | | DYNJP2203S | Sirus Surgical Gown, Poly Reinforced | Set-in | XX-Large | #### Table 1: Device Models {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the Medline logo. The logo is set against a blue background. The word "MEDLINE" is written in white, with a stylized white starburst symbol placed behind and slightly above the text. The starburst has four points, with the top and bottom points being longer than the side points. There is a gray bar on the right side of the image. Medline Industries, Inc. Three Lakes Drive Northfield. IL 60093 Medline Level 4 Surgical Gown 510(k) Premarket Submission All information on this page is confidential | DYNJP2204S | Sirus Surgical Gown, Poly Reinforced | Set-in | Large, X-Long | |-------------|--------------------------------------|--------|-------------------| | DYNJP2205S | Sirus Surgical Gown, Poly Reinforced | Set-in | X-Large, X-Long | | DYNJP2206S | Sirus Surgical Gown, Poly Reinforced | Set-in | XX-Large, X-Long | | DYNJP2219SL | Sirus Surgical Gown, Poly Reinforced | Set-in | XXX-Large, X-Long | | DYNJP2601 | Sirus Surgical Gown, Poly Reinforced | Raglan | Large | | DYNJP2602 | Sirus Surgical Gown, Poly Reinforced | Raglan | X-Large | | DYNJP2603 | Sirus Surgical Gown, Poly Reinforced | Raglan | XX-Large | ## Indications for Use The Medline Level 4 Surgical Gown (Sirus). Medline Level 4 Surgical Gown (Eclipse), and Medline Level 4 Surgical Gown (Aurora) is a sterile, single use surgical apparel intended to be worn by healthcare professionals to help protect both the patient and the healthcare worker from the transfer of microorganisms, body fluids, and particulate matter. The Medline Level 4 Surgical Gown (Sirus), Medline Level 4 Surgical Gown (Eclipse), and Medline Level 4 Surgical Gown (Aurora) meets the Level 4 requirements of ANSI/AAMIPB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities. ## Technological Characteristics The final proposed finished device was tested in accordance with the Guidance on Premarket Notification [510(k)] Submission for Surgical Gowns and Surgical Drapes- August 1993, Guidance for Industry and FDA Staff - Premarket Notification Requirements Concerning Gowns Intended for Use in Healthcare Settings issued by the FDA- December 9, 2015, and ANSI/AAMIPB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities. Testing was performed on the body and sleeve (equivalent design/technology), sleeve seam, and tie attachment to generate the test data shown in the comparison Table 2. Additional performance testing was conducted to further characterize the device. | Element of Comparison | Subject Device | Predicate Device | Comparison Analysis | | |-------------------------------|---------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------|------------------------|--| | Product Name | Medline Level 4 Surgical Gown (Sirus), Medline Level 4 Surgical Gown (Eclipse), Medline Level 4 Surgical Gown (Aurora) | ULTRA Fluid Barrier Surgical Gown | Different | | | 510(k) Reference | K182172 | K080795 | Different | | | Product Owner | Medline Industries, Inc. | Kimberly-Clark Corp. (Halyard) | Different | | | Product Code | FYA | FYA | Same | | | Intended Use | The Medline Level 4 Surgical Gown is a sterile, single use | The Kimberly-Clark* ULTRA Surgical Gown and ULTRA Film | Similar | | | | | | | | | | surgical apparel intended to be | Reinforced Surgical Gown are | | | | | worn by healthcare professionals to | sterile, single use surgical gowns | | | | | help protect both the patient and | intended to protect surgical patients | | | | | the healthcare worker from the | and operating room personnel from | | | | | transfer of microorganisms, body | the transfer of | | | | | fluids, and particulate matter. The | microorganisms, body fluids, and | | | | | Medline Level 4 Surgical Gown | particulate material. The ULTRA | | | | | meets the Level 4 requirements of | Surgical Gown meets Level 3 of the | | | | | ANSI/AAMIPB70:2012 Liquid | AAMI Liquid Barrier | | | | | barrier performance and | classifications, and the ULTRA | | | | | classification of protective apparel | Film-Reinforced Surgical Gown | | | | | and drapes intended for use in | meets Level 4 of the AAMI Liquid | | | | | healthcare facilities. | Barrier classifications. | | | | Regulation Number | | | | | | | 21 CFR 878.4040 | 21 CFR 878.4040 | Same | | | Gown Color | Blue | Blue | | | | | | | Same | | | Design Configurations | Neck Closure: Hook and Loop | Hoop & Neck Closures | | | | | Belt Ties | Tie Waist Closure | | | | | Knit Cuffs | Cuffs | Similar | | | | Reinforced Material | Film Reinforcement | | | | | Raglan or Set-in/Standard Sleeves | Raglan Sleeves | | | | Material Composition | Nonwoven SMS polypropylene | Nonwoven SMS polypropylene | | | | | Anti-Static, Repellency | Anti-Static, Repellency | | | | | Poly-Reinforcement Film | Film Reinforcement | Same | | | | White Knitted Cuffs | Cuffs | | | | Prescription vs. OTC | OTC | OTC | Same | | | | | | | | | Contact Durations | Surface, Intact, < 24 hours | Surface, Intact, < 24 hours | Same | | | Sterile vs. Non-Sterile | | | | | | | Sterile | Sterile | Same | | | Disposable vs. Non-Disposable | | | | | | | Disposable | Disposable | Same | | | Single Use vs. Reusable | Single | Single | Same | | | Performance Specifications: | Level 4 barrier protection | Level 4 barrier protection | Same | | | Biocompatibility | Met requirements per: | Complied with 10993 requirements | | | | | ISO 10993-5 Cytoxticity | for surface devices with limited | | | | | ISO 10993-10 Irritation | contact with breeched or | Same | | | | ISO 10993-10 Sensitization | compromised surfaces | | | | Flammability | Meets requirements of Flame Resistant CPSC 1610 Class 1 | NFPA Test Method 702-1980 for Class 1 | Same | | | Sterilization Method | EO Sterilization | EO Sterilization | Same | | ## TABLE 2: COMPARISON OF PROPOSED AND PREDICATE DEVICES {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Medline. The logo is set against a blue background. The word "MEDLINE" is written in bold, sans-serif font. Above the word is a white, four-pointed star-like shape, with each point extending outward from a central point. Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093 Medline Level 4 Surgical Gown 510(k) Premarket Submission All information on this page is confidential {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the Medline logo. The logo is set against a blue square background. The word "MEDLINE" is written in white, block letters. Above the word is a white, stylized starburst design, with the bottom point of the starburst extending downwards, bisecting the word "MEDLINE". Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093 The proposed Medline Level 4 Surgical Gown (Sirus, Eclipse, Aurora) is substantially equivalent to the predicate, ULTRA Fluid Barrier Surgical Gown, with regards to claims, design, technology, and intended use. - 트 Claim: ANSI/AAMI PB70 Level 4 rating - Design: SMS, Single-Use, Disposable - " Technology: Reinforcement material along chest and sleeve (critical zones) - Intended Use: Surgical apparel 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. | ISO 10993-5 Cytotoxicity | ISO MEM Elution Using L-929 Mouse Fibroblast Cells | |---------------------------------------|------------------------------------------------------------------------------------------------| | ISO 10993-10 Irritation | ISO Intracutaneous Irritation Test | | ISO 10993-10 Sensitization | ISO Guinea Pig Maximization Sensitization Test | | ASTM F1929-15 | Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration | | ASTM F1671 | Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens | | ASTM D5034-09 (2013) | Breaking Strength and Elongation of Textile Fabrics (Grab Test) | | ASTM D5587-15 | Tearing Strength of Fabrics by Trapezoid Procedure | | ASTM D3776/D3776M-09a | Basis Weight-Mass Per Unit Area (Weight) of Fabric | | ASTM D3786/D3786M-13 | Bursting Strength of Textile Fabrics-Diaphragm Bursting Strength Tester Method | | 16 CFR 1610 | Flammability of Clothing Textiles | | ASTM F1929 | Resistance to Dye Penetration Test | | ANSI/AAMI/ISO 10993- 7:2008(R)2012 | Biological evaluation of medical devices –Part 7: Ethylene oxide sterilization residuals | | AATCC 42 | Water Resistance: Impact Penetration Test | ## Summary of Non-Clinical Testing {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the Medline logo. The logo is set against a blue background. The word "MEDLINE" is written in bold, sans-serif font, and a white star-like shape is behind the text. The star has four points, with two pointing up and down, and two pointing left and right. Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093 Medline Level 4 Surgical Gown 510(k) Premarket Submission All information on this page is confidential | ANSI/AAMI PB70:2012 | Liquid Barrier performance and classification of protective apparel and drapes intended for use in health care facilities. | |---------------------|----------------------------------------------------------------------------------------------------------------------------| |---------------------|----------------------------------------------------------------------------------------------------------------------------| ## Summary of Clinical Testing Not applicable. #### Conclusion The conclusions drawn from the non-clinical tests demonstrate that the Medline Level 4 Surgical Gowns (Sirus, Eclipse and Aurora) are as safe, as effective, and performs as well as or better than the legally marketed predicate device, Kimberly-Clark (Halyard) ULTRA Fluid Barrier Surgical Gown.