(84 days)
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 (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 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.
The document describes the non-clinical performance testing for Medline Level 2 and Level 3 Surgical Gowns.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Name | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| ANSI/AAMI PB70:2012 | Meets Level 2 barrier protection standards for the Medline Level 2 Surgical Gown. Meets Level 3 barrier protection standards for the Medline Level 3 Surgical Gowns. | The Medline Level 2 Surgical Gown (Eclipse Non Reinforced) and the Medline 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. (Page 2) |
| ISO 10993-5 Biocompatibility | Non-cytotoxic | Under the test conditions, the subject device was shown to be non-cytotoxic. (Page 7) |
| ISO 10993-10 Biocompatibility | Non-irritating | Under the test conditions, the subject device was shown to be non-irritating. (Page 7) |
| ISO 10993-10 Biocompatibility | Non-sensitizing | Under the test conditions, the subject device was shown to be non-sensitizing. (Page 7) |
| 16 CFR 1610 Flammability | Meets Class 1 Flame Resistant | Meets requirements of Flame Resistant CPSC 1610 Class 1 (Page 7) |
| ASTM F1929-15 | (Implicit: Seal integrity of packaging) | Performed. (Page 10) |
| AATCC 127 | (Implicit: Water resistance) | Performed. (Page 10) |
| AATCC 42 | (Implicit: Water resistance) | Performed. (Page 10) |
| ASTM D5034-09 (2013) | (Implicit: Breaking strength and elongation of textile fabrics) | Performed. (Page 10) |
| ASTM D5587-15 | (Implicit: Tearing strength of fabrics) | Performed. (Page 10) |
| ASTM D3776/D3776M-09a | (Implicit: Basis weight - mass per unit area of fabric) | Performed. (Page 10) |
| ASTM D3786/D3786M-13 | (Implicit: Bursting strength of textile fabrics) | Performed. (Page 10) |
| ANSI/AAMI/ISO 10993-7: | (Implicit: Ethylene oxide sterilization residuals) | Performed. (Page 10) |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the sample sizes used for each specific test in the test set. It mentions each test was "performed" or that the device "meets the requirements," implying that appropriate sample sizes were used according to the respective test standards. The data provenance is not specified, but the tests performed are standard laboratory tests typically conducted on manufactured products.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. The acceptance criteria are based on established national and international standards for medical devices and materials (e.g., ANSI/AAMI PB70:2012, ISO 10993 series, ASTM, CPSC). These standards themselves represent a form of "ground truth" derived from expert consensus in their respective fields, but no ad hoc expert panel was convened for this specific submission to establish ground truth for the test set.
4. Adjudication method for the test set:
Not applicable. The tests adhere to published standards with objective measurements and pass/fail criteria, so an adjudication method by experts is not required beyond the standard interpretation of test results against predefined limits.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is a surgical gown, not an AI-assisted diagnostic or interpretive tool. Therefore, MRMC studies and AI effectiveness are irrelevant to this submission.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a physical medical apparel, not an algorithm.
7. The type of ground truth used:
The ground truth used for performance validation is based on recognized consensus standards and test methods (e.g., ANSI/AAMI PB70:2012 for liquid barrier performance, ISO 10993 for biocompatibility, etc.). These standards define the objective criteria for safety and performance of surgical gowns.
8. The sample size for the training set:
Not applicable. This is a physical medical device, not a machine learning model, so there is no concept of a "training set."
9. How the ground truth for the training set was established:
Not applicable. As there is no training set, there is no ground truth to establish for it.
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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
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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
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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)
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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 |
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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
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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.
| ItemNumber | Device Description | SleeveStyle | 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
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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)
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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
| DeviceCharacteristic | Proposed Device | Predicate Device(Primary) | Predicate Device(Secondary) | ComparisonAnalysis |
|---|---|---|---|---|
| Product Name | The Medline Level 2 SurgicalGown (Eclipse NonReinforced) and Medline Level3 Surgical Gown (EclipseFabric Reinforced), MedlineLevel 3 Surgical Gown (SirusNon-Reinforced & Sirus FabricReinforced), Medline Level 3Surgical Gown (Aurora NonReinforced & Aurora FabricReinforced) | Convertors® SMSPolyolefin StandardGown | Cardinal Health™ Non-Reinforced SurgicalGown | N/A |
| 510(k)Reference | K190950 | K020593 | K170762 | N/A |
| Product Owner | Medline Industries, Inc. | Allegiance HealthcareCorporation | Cardinal Health | N/A |
| Product Code | FYA | FYA | FYA | Same |
| Intended Use | The Medline Level 2Surgical Gowns andMedline Level 3 SurgicalGowns are sterile, single usesurgical apparel intended tobe worn by healthcareprofessionals to helpprotect both the patientand the healthcare workerfrom the transfer ofmicroorganisms, body | Convertors® SMSPolyolefin Gowns areintended to be worn byoperating roompersonnel duringsurgical procedures toprotect the surgicalpatient and operatingroom personnel fromthe transfer ofmicroorganisms, body | The Cardinal HealthNon-Reinforced SurgicalGowns are intended tobe worn by operatingroom personnel duringsurgical procedures toprotect the surgicalpatient and operatingroom personnel fromthe transfer ofmicroorganisms, bodyfluids and particulate | Similar |
| fluids, and particulatematter.The Medline Level 2Surgical Gowns and theMedline Level 3 SurgicalGowns meets the respectivelevel requirements ofANSI/AAMI PB70:2012Liquid barrier performanceand classification ofprotective apparel anddrapes intended for use inhealth care facilities. | fluids and particulatematerial. | material. In addition, thissurgical gown meets therequirements of AAMILevel 3 barrierprotection for a surgicalgown per ANSI/AAMIPB70:2012 Liquid barrierperformance andclassification ofprotective apparel anddrapes intended for usein health care facilities.The Cardinal HealthNon-Reinforced SurgicalGowns are single use,disposable medicaldevices, provided sterileand non-sterile. | ||
| RegulationNumber | 21 CFR 878.4040 | 21 CFR 878.4040 | 21 CFR 878.4040 | Same |
| Color | Blue | Light Blue | Dark Blue | Different |
| DesignFeatures | Available in FabricReinforced and Non-ReinforcedHook and Loop Closure atneckBelt TiesKnit CuffsTransfer TabRaglan or Set-in/StandardSleeves | Standard, Fabric-Reinforced and PolyReinforcedNeck Closure: Hook andLoopBelt TiesKnit CuffsTransfer Tab | Non-ReinforcedNeck Closure: Hook andLoopBelt TiesKnit CuffsTransfer Tab | Similar |
| Sizes | Small to XXXX-Large | Large to XX-Large | Small to XXXX-Large | Same |
| Materials | Nonwoven SMSpolypropylene/Polyolefin | Nonwoven Polyolefin(Polypropylene) SMS | Nonwoven Polyolefin(Polypropylene) SMS | Same |
| PerformanceSpecifications | Level 2 PB70 BarrierProtectionLevel 3 PB70 BarrierProtection | N/A (preceded AAMIPB70 performancestandards) | Level 3 | Similar |
| Prescriptionvs. OTC | OTC | OTC | OTC | Same |
| ContactDurations | Surface, Intact, ≤ 24 hours | Surface, Intact, ≤ 24 hours | Surface, Intact, ≤ 24 hours | Same |
| Sterile vs.Non-Sterile | Sterile | Sterile | Sterile | Same |
| Single Use vs.Reusable | Single Use | Single Use | Single Use | Same |
| Biocompatibility | Under the test conditions,the subject device wasshown to be non-cytotoxic,non-irritating and non-sensitizing per ISO 10993-5& ISO 10993-10. | Met requirements per:ISO 10993-5CytotoxicityISO 10993-10 IrritationISO 10993-10Sensitization | Met requirements per:ISO 10993-5 CytotoxicityISO 10993-10 IrritationISO 10993-10Sensitization | Same |
| Flammability | Meets requirements ofFlame Resistant CPSC 1610Class 1 | Meets requirements ofFlame Resistant CPSC,Part 1610 – Class 1 | Meets requirements ofFlame Resistant CPSC,Part 1610 – Class 1 | Same |
| SterilizationMethod | Ethylene Oxide (EtO) | Ethylene Oxide (EtO) | Ethylene Oxide (EtO) | Same |
TABLE 2: COMPARISON OF PROPOSED AND PREDICATE DEVICES
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Medline Level2/Level3 Surgical Gown 510(k) Premarket Submission All information on this page is confidential
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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.
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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 DyePenetration |
| 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 StrengthTester Method |
| 16 CFR 1610 | Flammability of Clothing Textiles |
| ANSI/AAMI/ISO 10993-7:2008(R)2012 | Biological evaluation of medical devices –Part 7: Ethylene oxidesterilization 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.
§ 878.4040 Surgical apparel.
(a)
Identification. Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.(b)
Classification. (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible.
(ii) Analysis and nonclinical testing must:
(A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and
(B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.
(iii) NIOSH approved under its regulation.
(2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.