Medline Level 2 Surgical Gown (Eclipse Non-Reinforced), Medline Level 3 Surgical Gown (Eclipse Fabric Reinforced), Medline Level 3 Surgical Gown (Sirus Non-Reinforced), Medline Level 3 Surgical Gown (Sirus Fabric Reinforced), Medline Level 3 Surgical Gown (Aurora Non Reinforced & Aurora Fabric Reinforced)
Device Facts
| Record ID | K190950 |
|---|---|
| Device Name | Medline Level 2 Surgical Gown (Eclipse Non-Reinforced), Medline Level 3 Surgical Gown (Eclipse Fabric Reinforced), Medline Level 3 Surgical Gown (Sirus Non-Reinforced), Medline Level 3 Surgical Gown (Sirus Fabric Reinforced), Medline Level 3 Surgical Gown (Aurora Non Reinforced & Aurora Fabric Reinforced) |
| Applicant | Medline Industries, Inc. |
| Product Code | FYA · General, Plastic Surgery |
| Decision Date | Jul 4, 2019 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4040 |
| Device Class | Class 2 |
Intended Use
The Medline Level 2 Surgical Gown (Eclipse Non Reinforced) and Medline Level 3 Surgical Gown (Eclipse Fabric Reinforced), Medline Level 3 Surgical Gown (Sirus Non-Reinforced & Sirus Fabric Reinforced), Medline Level 3 Surgical Gown (Aurora Non Reinforced & Aurora Fabric Reinforced) are sterile, single use surgical apparel intended to be worn by healthcare professionals to help protect both the patient and the healthcare worker of microorganisms, body fluids, and particulate matter. The Medline Level 2 Surgical Gown and the Medine Level 3 Surgical Gowns meet the requirements of ANS/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities. The Medline Level 2 Surgical Gown and the Medine Level 3 Surgical Gowns have been validated using an ethylene oxide (EtO) sterilization process. The Medline Level 2 Surgical Gown and the Medline Level 3 Surgical Gowns are also sold as bulk single-use, non-sterile, to repackager/relabeler establishments for further packaging and sterilization using the validated EtO sterilization method according to ISO 11135-1 prior to being provided to the end user.
Device Story
Sterile, single-use surgical gowns; constructed from blue polyolefin/polypropylene SMS (spunbond, meltblown, spunbond) nonwoven fabric. Available in Level 2 (Eclipse) and Level 3 (Eclipse, Sirus, Aurora) barrier performance configurations; includes non-reinforced and fabric-reinforced designs. Features include set-in or raglan sleeves, hook-and-loop neck closures, belt ties, knit cuffs, and transfer tabs. Used by healthcare professionals in surgical settings to provide a barrier against microorganisms, body fluids, and particulate matter. Protects both patient and clinician; reduces risk of cross-contamination. Provided sterile or non-sterile (for bulk repackaging/sterilization).
Clinical Evidence
No clinical data. Bench testing only, including biocompatibility (ISO 10993-5, 10993-10), barrier performance (AATCC 127, AATCC 42), physical strength (ASTM D5034, D5587, D3786), and flammability (16 CFR 1610).
Technological Characteristics
Materials: Polyolefin/polypropylene SMS nonwoven. Barrier: ANSI/AAMI PB70:2012 Level 2 or 3. Sterilization: Ethylene Oxide (EtO) per ISO 11135-1. Design: Set-in/raglan sleeves, hook-and-loop closure, knit cuffs. Biocompatibility: ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation/sensitization). Flammability: CPSC 1610 Class 1.
Indications for Use
Indicated for healthcare professionals to protect patients and workers from microorganisms, body fluids, and particulate matter during surgical procedures. Suitable for use in healthcare facilities requiring ANSI/AAMI PB70:2012 Level 2 or Level 3 barrier protection.
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
- Allegiance Healthcare Converters SMS Polyolefin Gowns (K020593)
- Cardinal Health™ Non-Reinforced (K170762)
Related Devices
- K170762 — Cardinal Health Non-Reinforced Surgical Gown · Cardinal Health200, LLC · Jun 9, 2017
- K080795 — ULTRA SURGICAL GOWN & FLUID BARRIER SURGICAL GOWN · Kimberly-Clark Corp. · Sep 3, 2008
- K101468 — 3M BASIC DISPOSABLE SURGICAL GOWN, 3M HP DISPOSABLE SURGICAL GOWN, 3M REINFORCED DISPOSABLE SURGICAL GOWN, 3M DISPOSABLE · 3M Company Corp · Apr 14, 2011
- K162442 — ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500 · Gri Medical & Electrical Technology Co., Ltd. · Dec 12, 2016
- K220435 — SEJONG Surgical Gown Soft · Sejong Healthcare Co., Ltd. · Feb 10, 2023
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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
July 4, 2019
Medline Industries, Inc. Pauline Maralit Regulatory Affairs Specialist Three Lakes Drive Northfield, Illinois 60093
#### Re: K190950
Trade/Device Name: Medline Level 2 Surgical Gown (Eclipse Non-Reinforced), Medline Level 3 Surgical Gown (Eclipse Fabric Reinforced), Medline Level 3 Surgical Gown (Sirus Non-Reinforced & Sirus Fabric Reinforced), Medline Level 3 Surgical Gown (Aurora Non Reinforced & Aurora Fabric Reinforced)
Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYA Dated: March 13, 2019 Received: April 11, 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
{1}------------------------------------------------
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 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 (OS) 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,
For Elizabeth Claverie, M.S. Assistant Director for THT4B2 Acting Assistant Director for THT4B1 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
{2}------------------------------------------------
#### Indications for Use
510(k) Number (if known) K190950
#### Device Name
Medline Level 2 Surgical Gown (Eclipse Non Reinforced), Medline Level 3 Surgical Gown (Eclipse Fabric Reinforced), Medline Level 3 Surgical Gown (Sirus Non-Reinforced & Sirus Fabric Reinforced), Medline Level 3 Surgical Gown (Aurora Non Reinforced & Aurora Fabric Reinforced)
#### Indications for Use (Describe)
The Medline Level 2 Surgical Gown (Edipse Non Reinforced) and Medline Level 3 Surgical Gown (Edipse Fabric Reinforced), Medline Level 3 Surgical Gown (Sirus Non-Reinforced), Medline Level 3 Surgical Gown (Aurora Non Reinforced & Aurora Fabric Reinforced) are sterile, single use surgical apparel intended to be worn by healthcare professionals to help protect both the patient and the healthcare worker of microorganisms, body fluids, and particulate matter.
The Medline Level 2 Surgical Gown and the Medine Level 3 Surgical Gowns meet the requirements of ANS/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities.
The Medline Level 2 Surgical Gown and the Medine Level 3 Surgical Gowns have been validated using an ethylene oxide (EtO) sterilization process. The Medline Level 2 Surgical Gown and the Medline Level 3 Surgical Gowns are also sold as bulk single-use, non-sterile, to repackager/relabeler establishments for further packaging and sterilization using the validated EtO sterilization method according to ISO 11135-1 prior to being provided to the end user.
| 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 of 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 logo for Medline, a healthcare company. The logo features the word "MEDLINE" in a sans-serif font, placed to the left of a white star-like symbol. The background is a solid dark blue color. The logo is simple and modern, with a clean design.
Medline Level2/Level3 Surgical Gown 510(k) Premarket Submission All information on this page is confidential
# K190950 510(k) SUMMARY [AS REQUIRED BY 21CFR807.92]
## Submitter / 510(k) Sponsor
Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093
Registration Number: 1417592
# Contact Person
Pauline Maralit, M.B.A, RAC (US) Requlatory Affairs Specialist Phone: 847-949-2283 Email: pmaralit@medline.com
## Summary Preparation Date
July 2, 2019
# Type of 510(k) Submission
Traditional 510(k)
## Device Name / Classification
| Name of Device: | Surgical Apparel |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Proprietary Name: | Medline Level 2 Surgical Gown (Eclipse Non Reinforced), Medline Level 3 Surgical Gown (Eclipse Fabric Reinforced), Medline Level 3 Surgical Gown (Sirus Non-Reinforced & Sirus Fabric Reinforced), Medline Level 3 Surgical Gown (Aurora Non Reinforced & Aurora Fabric Reinforced) |
| Common Name: | Surgical Gown |
| Classification Name: | Surgical Gown |
| Product Code: | FYA |
| Classification Panel: | General & Plastic Surgery |
| Regulatory Class: | II |
| Regulation #: | 21 CFR 878.4040 |
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image is a logo for Medline. The logo features the word "MEDLINE" in white, sans-serif font, stacked on top of a white, stylized cross. The background is a solid dark blue color. The logo is simple and clean, with a focus on the company name and a symbol that suggests healthcare.
Medline Level2/Level3 Surgical Gown 510(k) Premarket Submission All information on this page is confidential
## Predicate Device
K020593 Allegiance Healthcare Converters SMS Polyolefin Gowns (Primary Predicate) K170762 Cardinal Health™ Non-Reinforced (Secondary Predicate)
## Device Description
The Medline Level 2 Surgical Gown (Eclipse Non Reinforced) and Medline Level 3 Surgical (Eclipse Fabric Reinforced), Medline Level 3 Surgical Gown (Sirus Non-Reinforced & Sirus Fabric Reinforced), Medline Level 3 Surgical Gown (Aurora Non Reinforced & Aurora Fabric Reinforced) is a Class II medical device under the FDA product code FYA, General & Plastic Surgery Panel, and Requlation 21 CFR 878.4040. The Medline Level 3 Surgical Gowns are categorized into several device configurations based on qown reinforcement (critical zones), sleeve style and size.
The Medline Level 2 Surgical Gown is offered in one fabric style referred to as "ECLIPSE", it is non-reinforced, has a set-in sleeve and is manufactured in a range of sizes from small to XXXXlarge. Please refer to Table 1 below for additional information regarding these gown configurations. The chest and sleeve critical zones, as well as the overall body, of the Medline Level 2 Surgical Gown (Eclipse Non Reinforced) is constructed from a blue polyolefin/polypropylene SMS (spunbond, meltblown, spunbond). The Medline Level 2 Surgical Gown (Eclipse Non Reinforced) has been tested according to ANSI/AAMI PB70:2012 and meets the AAMI Level 2 barrier level protection for a surqical gown. The Medline Level 2 Surgical Gown (Eclipse Non Reinforced) is a sinqle use, disposable medical device that will be provided in both a sterile and non-sterile packaging configuration and a variety of sizes.
The Medline Level 3 Surgical Gown is offered in three different fabric styles entitled "ECLIPSE," "SIRUS," and "AURORA." The Medline Level 3 Surgical Gown is offered in both a fabric reinforced or non-reinforced design, may have either a set-in or raglan sleeve, and available in sizes ranging from small to XXXX-large. Table 1 provides a description of each of the Medline Level 3 Surgical Gown configurations included in this submission. The chest and sleeve critical zones, as well as the overall body, of all Medline Level 3 Surqical (Eclipse Fabric Reinforced), Medline Level 3 Surgical Gown (Sirus Non-Reinforced & Sirus Fabric Reinforced), Medline Level 3 Surgical Gown (Aurora Non Reinforced & Aurora Fabric Reinforced) configurations are constructed from a blue polyolefin/polypropylene SMS (spunbond, meltblown, spunbond). The Medline Level 3 Surgical Gowns with fabric reinforcement are manufactured with additional fabric along the critical zones of the gown; Table 1 highlights the gown models containing fabric reinforcement in blue. The Medline Level 3 Surgical Gown (Eclipse Fabric Reinforced), Medline Level 3 Surgical Gown (Sirus Non-Reinforced & Sirus Fabric Reinforced), Medline Level 3 Surgical
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image is a logo for Medline. The logo is set against a blue square background. The word "MEDLINE" is in white, bold, sans-serif font, stacked vertically. A white, stylized starburst symbol is behind the text, with the word "MEDLINE" centered on the starburst.
Medline Level2/Level3 Surgical Gown 510(k) Premarket Submission All information on this page is confidential
Gown (Aurora Non Reinforced & Aurora Fabric Reinforced) has been tested according to ANSI/AAMI PB70:2012 and meets the AAMI Level 3 barrier level protection for a surgical gown. The Medline Level 3 Surqical Gown (Eclipse Fabric Reinforced), Medline Level 3 Surgical Gown (Sirus Non-Reinforced & Sirus Fabric Reinforced), Medline Level 3 Surgical Gown (Aurora Non Reinforced & Aurora Fabric Reinforced) is a single use, disposable medical device that will be provided in both a sterile and non-sterile packaging configuration and a variety of sizes.
| Item<br>Number | Device Description | Sleeve<br>Style | Size |
|----------------|------------------------------------------|-----------------|------------------|
| | ECLIPSE | | |
| DYNJP2001 | Level 2 Surgical Gown, Non-Reinforced | Set-In | Large |
| DYNJP2002 | Level 2 Surgical Gown, Non-Reinforced | Set-In | X-Large |
| DYNJP2003 | Level 2 Surgical Gown, Non-Reinforced | Set-In | XX-Large |
| DYNJP2004 | Level 2 Surgical Gown, Non-Reinforced | Set-In | XXX-Large |
| DYNJP2005 | Level 2 Surgical Gown, Non-Reinforced | Set-In | Small/Medium |
| DYNJP2009 | Level 2 Surgical Gown, Non-Reinforced | Set-In | XXXX-Large |
| | ECLIPSE | | |
| DYNJP2101 | Level 3 Surgical Gown, Fabric Reinforced | Set-in | Large |
| DYNJP2102 | Level 3 Surgical Gown, Fabric Reinforced | Set-in | X-Large |
| DYNJP2103 | Level 3 Surgical Gown, Fabric Reinforced | Set-in | XX-Large |
| | SIRUS | | |
| DYNJP2001S | Level 3 Surgical Gown, Non-Reinforced | Set-in | Large |
| DYNJP2002S | Level 3 Surgical Gown, Non-Reinforced | Set-in | X-Large |
| DYNJP2002SL | Level 3 Surgical Gown, Non-Reinforced | Set-in | X-Large, X-Long |
| DYNJP2003S | Level 3 Surgical Gown, Non-Reinforced | Set-in | XX-Large |
| DYNJP2003SL | Level 3 Surgical Gown, Non-Reinforced | Set-in | XX-Large, X-Long |
| DYNJP2004S | Level 3 Surgical Gown, Non-Reinforced | Set-in | XXX-Large |
| DYNJP2005S | Level 3 Surgical Gown, Non-Reinforced | Set-in | Small/Medium |
| DYNJP2009S | Level 3 Surgical Gown, Non-Reinforced | Set-in | XXXX-Large |
| DYNJP2101S | Level 3 Surgical Gown, Fabric Reinforced | Set-in | Large |
| DYNJP2102S | Level 3 Surgical Gown, Fabric Reinforced | Set-in | X-Large |
| DYNJP2103S | Level 3 Surgical Gown, Fabric Reinforced | Set-in | XX-Large |
| DYNJP2401 | Level 3 Surgical Gown, Non-Reinforced | Raglan | Large |
| DYNJP2402 | Level 3 Surgical Gown, Non-Reinforced | Raglan | X-Large |
| DYNJP2403 | Level 3 Surgical Gown, Non-Reinforced | Raglan | XX-Large |
# Table 1: Medline Level 2 and Level 3 Surgical Gown Configurations
{6}------------------------------------------------
Image /page/6/Picture/0 description: The image features the logo for Medline, a healthcare company. The logo consists of the word "MEDLINE" in a sans-serif font, positioned to the left of a stylized star-like symbol. The star has four points, with two pointing upwards and downwards, and two pointing left and right. The logo is set against a blue background, with a small gray rectangle in the upper right corner.
Medline Level2/Level3 Surgical Gown 510(k) Premarket Submission All information on this page is confidential
| DYNJP2501 | Level 3 Surgical Gown, Fabric Reinforced | Raglan | Large |
|-----------|------------------------------------------|--------|--------------|
| DYNJP2502 | Level 3 Surgical Gown, Fabric Reinforced | Raglan | X-Large |
| DYNJP2503 | Level 3 Surgical Gown, Fabric Reinforced | Raglan | XX-Large |
| | AURORA | | |
| DYNJP2701 | Level 3 Surgical Gown, Non-Reinforced | Set-in | Large |
| DYNJP2702 | Level 3 Surgical Gown, Non-Reinforced | Set-in | X-Large |
| DYNJP2703 | Level 3 Surgical Gown, Non-Reinforced | Set-in | XX-Large |
| DYNJP2704 | Level 3 Surgical Gown, Fabric Reinforced | Set-in | Large |
| DYNJP2705 | Level 3 Surgical Gown, Fabric Reinforced | Set-in | X-Large |
| DYNJP2706 | Level 3 Surgical Gown, Fabric Reinforced | Set-in | XX-Large |
| DYNJP2715 | Level 3 Surgical Gown, Non-Reinforced | Set-in | Small/Medium |
| DYNJP2801 | Level 3 Surgical Gown, Non-Reinforced | Raglan | Large |
| DYNJP2802 | Level 3 Surgical Gown, Non-Reinforced | Raglan | X-Large |
| DYNJP2803 | Level 3 Surgical Gown, Non-Reinforced | Raglan | XX-Large |
| DYNJP2804 | Level 3 Surgical Gown, Fabric Reinforced | Raglan | Large |
| DYNJP2805 | Level 3 Surgical Gown, Fabric Reinforced | Raglan | X-Large |
| DYNJP2806 | Level 3 Surgical Gown, Fabric Reinforced | Raglan | XX-Large |
# Indications for Use
The Medline Level 2 Surgical Gown (Eclipse Non Reinforced) and Medline Level 3 Surgical Gown (Eclipse Fabric Reinforced), Medline Level 3 Surqical Gown (Sirus Non-Reinforced & Sirus Fabric Reinforced), Medline Level 3 Surgical Gown (Aurora Non Reinforced & Aurora Fabric Reinforced) are sterile, sinqle 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 2 Surgical Gown (Eclipse Non Reinforced) and Medline Level 3 Surgical Gown (Eclipse Fabric Reinforced), Medline Level 3 Surqical Gown (Sirus Non-Reinforced & Sirus Fabric Reinforced), Medline Level 3 Surgical Gown (Aurora Non Reinforced & Aurora Fabric Reinforced) meet the respective level requirements of ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for the use in healthcare facilities.
The Medline Level 2 Surgical Gown (Eclipse Non Reinforced) and Medline Level 3 Surgical Gown (Eclipse Fabric Reinforced), Medline Level 3 Surqical Gown (Sirus Non-Reinforced & Sirus Fabric Reinforced), Medline Level 3 Surgical Gown (Aurora Non Reinforced & Aurora Fabric Reinforced)
{7}------------------------------------------------
Image /page/7/Picture/0 description: The image is a logo for Medline. The logo consists of the word "MEDLINE" in white, stacked on top of a white star-like shape with four points. The background of the logo is a solid dark blue color. The logo is simple and clean, with a focus on the company name and a recognizable symbol.
Medline Level2/Level3 Surgical Gown 510(k) Premarket Submission All information on this page is confidential
have been validated using an ethylene oxide (EtO) sterilization process. The Medline Level 2 Surgical Gown (Eclipse Non Reinforced) and Medline Level 3 Surgical Gown (Eclipse Fabric Reinforced), Medline Level 3 Surgical Gown (Sirus Non-Reinforced & Sirus Fabric Reinforced), Medline Level 3 Surqical Gown (Aurora Non Reinforced & Aurora Fabric Reinforced) are also sold as bulk single-use, non-sterile, to re-packager/re-labeler establishments for further packaging and sterilization using the validated EtO sterilization method according to ISO 11135-1 prior to being provided to the end user.
# Summary of Technological Characteristics
| Device<br>Characteristic | Proposed Device | Predicate Device<br>(Primary) | Predicate Device<br>(Secondary) | Comparison<br>Analysis |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Product Name | The Medline Level 2 Surgical<br>Gown (Eclipse Non<br>Reinforced) and Medline Level<br>3 Surgical Gown (Eclipse<br>Fabric Reinforced), Medline<br>Level 3 Surgical Gown (Sirus<br>Non-Reinforced & Sirus Fabric<br>Reinforced), Medline Level 3<br>Surgical Gown (Aurora Non<br>Reinforced & Aurora Fabric<br>Reinforced) | Convertors® SMS<br>Polyolefin Standard<br>Gown | Cardinal Health™ Non-<br>Reinforced Surgical<br>Gown | N/A |
| 510(k)<br>Reference | K190950 | K020593 | K170762 | N/A |
| Product Owner | Medline Industries, Inc. | Allegiance Healthcare<br>Corporation | Cardinal Health | N/A |
| Product Code | FYA | FYA | FYA | Same |
| Intended Use | The Medline Level 2<br>Surgical Gowns and<br>Medline Level 3 Surgical<br>Gowns are sterile, single use<br>surgical apparel intended to<br>be worn by healthcare<br>professionals to help<br>protect both the patient<br>and the healthcare worker<br>from the transfer of<br>microorganisms, body | Convertors® SMS<br>Polyolefin Gowns are<br>intended to be worn by<br>operating room<br>personnel during<br>surgical procedures to<br>protect the surgical<br>patient and operating<br>room personnel from<br>the transfer of<br>microorganisms, body | The Cardinal Health<br>Non-Reinforced Surgical<br>Gowns are intended to<br>be worn by operating<br>room personnel during<br>surgical procedures to<br>protect the surgical<br>patient and operating<br>room personnel from<br>the transfer of<br>microorganisms, body<br>fluids and particulate | Similar |
| | | | | |
| | fluids, and particulate<br>matter.<br>The Medline Level 2<br>Surgical Gowns and the<br>Medline Level 3 Surgical<br>Gowns meets the respective<br>level requirements of<br>ANSI/AAMI PB70:2012<br>Liquid barrier performance<br>and classification of<br>protective apparel and<br>drapes intended for use in<br>health care facilities. | fluids and particulate<br>material. | material. In addition, this<br>surgical gown meets the<br>requirements of AAMI<br>Level 3 barrier<br>protection for a surgical<br>gown per ANSI/AAMI<br>PB70:2012 Liquid barrier<br>performance and<br>classification of<br>protective apparel and<br>drapes intended for use<br>in health care facilities.<br>The Cardinal Health<br>Non-Reinforced Surgical<br>Gowns are single use,<br>disposable medical<br>devices, provided sterile<br>and non-sterile. | |
| Regulation<br>Number | 21 CFR 878.4040 | 21 CFR 878.4040 | 21 CFR 878.4040 | Same |
| Color | Blue | Light Blue | Dark Blue | Different |
| Design<br>Features | Available in Fabric<br>Reinforced and Non-<br>Reinforced<br>Hook and Loop Closure at<br>neck<br>Belt Ties<br>Knit Cuffs<br>Transfer Tab<br>Raglan or Set-in/Standard<br>Sleeves | Standard, Fabric-<br>Reinforced and Poly<br>Reinforced<br>Neck Closure: Hook and<br>Loop<br>Belt Ties<br>Knit Cuffs<br>Transfer Tab | Non-Reinforced<br>Neck Closure: Hook and<br>Loop<br>Belt Ties<br>Knit Cuffs<br>Transfer Tab | Similar |
| Sizes | Small to XXXX-Large | Large to XX-Large | Small to XXXX-Large | Same |
| Materials | Nonwoven SMS<br>polypropylene/Polyolefin | Nonwoven Polyolefin<br>(Polypropylene) SMS | Nonwoven Polyolefin<br>(Polypropylene) SMS | Same |
| Performance<br>Specifications | Level 2 PB70 Barrier<br>Protection<br>Level 3 PB70 Barrier<br>Protection | N/A (preceded AAMI<br>PB70 performance<br>standards) | Level 3 | Similar |
| | | | | |
| Prescription<br>vs. OTC | OTC | OTC | OTC | Same |
| Contact<br>Durations | Surface, Intact, ≤ 24 hours | Surface, Intact, ≤ 24 hours | Surface, Intact, ≤ 24 hours | Same |
| Sterile vs.<br>Non-Sterile | Sterile | Sterile | Sterile | Same |
| Single Use vs.<br>Reusable | Single Use | Single Use | Single Use | Same |
| Biocompatibility | Under the test conditions,<br>the subject device was<br>shown to be non-cytotoxic,<br>non-irritating and non-<br>sensitizing per ISO 10993-5<br>& ISO 10993-10. | Met requirements per:<br>ISO 10993-5<br>Cytotoxicity<br>ISO 10993-10 Irritation<br>ISO 10993-10<br>Sensitization | Met requirements per:<br>ISO 10993-5 Cytotoxicity<br>ISO 10993-10 Irritation<br>ISO 10993-10<br>Sensitization | Same |
| Flammability | Meets requirements of<br>Flame Resistant CPSC 1610<br>Class 1 | Meets requirements of<br>Flame Resistant CPSC,<br>Part 1610 – Class 1 | Meets requirements of<br>Flame Resistant CPSC,<br>Part 1610 – Class 1 | Same |
| Sterilization<br>Method | Ethylene Oxide (EtO) | Ethylene Oxide (EtO) | Ethylene Oxide (EtO) | Same |
## TABLE 2: COMPARISON OF PROPOSED AND PREDICATE DEVICES
{8}------------------------------------------------
Image /page/8/Picture/0 description: The image shows the logo for Medline. The logo consists of the word "MEDLINE" in white, set against a blue square background. Above the word, there is a white, stylized starburst or cross-like symbol, adding a distinctive visual element to the logo.
Medline Level2/Level3 Surgical Gown 510(k) Premarket Submission All information on this page is confidential
{9}------------------------------------------------
Image /page/9/Picture/0 description: The image features the Medline logo, which is set against a blue square background. The logo consists of the word "MEDLINE" in bold, white letters, positioned horizontally. Above the word, there is a white, stylized star-like symbol with four points, resembling a compass or a medical cross. The overall design is clean and professional, commonly associated with healthcare or medical supply companies.
Medline Level2/Level3 Surgical Gown 510(k) Premarket Submission All information on this page is confidential
# Summary of Non-Clinical Testing
Performance testing was performed to verify that the device meets the acceptance criteria. The testing done on the Medline Level 2 Surgical Gown (Eclipse Non Reinforced) and Medline Level 3 Surgical Gown (Eclipse Fabric Reinforced), Medline Level 3 Surgical Gown (Sirus Non-Reinforced & Sirus Fabric Reinforced), Medline Level 3 Surqical Gown (Aurora Non Reinforced & Aurora Fabric Reinforced) were conducted to demonstrate the safety and effectiveness of the subject device in accordance with the relevant test methods cited below, including the appropriate biocompatibility tests. While the color characteristic amongst the proposed and predicate devices are different, each of the devices were tested per the requirements of ISO 10993-1. Under the test conditions outlined in ISO 10993-5 & ISO 10993-10, the Medline Level 2 Surgical Gown (Eclipse Non Reinforced) and Medline Level 3 Surgical Gown (Eclipse Fabric Reinforced), Medline Level 3 Surgical Gown (Sirus Non-Reinforced & Sirus Fabric Reinforced), Medline Level 3 Surgical Gown (Aurora Non Reinforced & Aurora Fabric Reinforced) were shown to be non-cytotoxic, nonirritating, and non-sensitizing and therefore the difference in the colors amongst the devices does not raise new questions with regards to safety and effectiveness.
{10}------------------------------------------------
Image /page/10/Picture/0 description: The image shows the Medline logo. The logo consists of the word "MEDLINE" in white, sans-serif font, stacked on top of a white, stylized starburst shape. The background is a solid dark blue color. The logo is simple and modern, and the colors are clean and professional.
Medline Level2/Level3 Surgical Gown 510(k) Premarket Submission All information on this page is confidential
| 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<br>Penetration |
| AATCC 127 | Water Resistance: Hydrostatic Pressure Test |
| AATCC 42 | Water Resistance: Impact Penetration Test |
| 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<br>Tester Method |
| 16 CFR 1610 | Flammability of Clothing Textiles |
| ANSI/AAMI/ISO 10993-7:<br>2008(R)2012 | Biological evaluation of medical devices –Part 7: Ethylene oxide<br>sterilization residuals |
# Summary of Clinical Testing
Not applicable.
# Conclusion
Based on the information provided in this premarket notification, Medline Industries, Inc. concludes that the Medline Level 2 Surgical Gown (Eclipse Non Reinforced) and Medline Level 3 Surgical Gown (Eclipse Fabric Reinforced), Medline Level 3 Surgical Gown (Sirus Non-Reinforced & Sirus Fabric Reinforced), Medline Level 3 Surgical Gown (Aurora Non Reinforced & Aurora Fabric Reinforced) are as safe, as effective, and perform as well or better than the legally marketed predicate devices: K020593 Allegiance Healthcare Converters SMS Polyolefin Standard Gown and K170762 Cardinal Health™ Non-Reinforced Surgical Gown.
