Medline Open-back Level 3 Protective Gown
Device Facts
| Record ID | K233526 |
|---|---|
| Device Name | Medline Open-back Level 3 Protective Gown |
| Applicant | Medline Industries, LP |
| Product Code | QPC · General, Plastic Surgery |
| Decision Date | Mar 5, 2024 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4040 |
| Device Class | Class 2 |
Indications for Use
Gown is a single use, disposable, non-sterile, non-isolation gown intended to be worn by healthcare personnel to provide moderate barrier protection (AAMI Level 3) in non-sterile and non-patient isolation situations.
Device Story
Blue polyethylene protective gown; open-back design with waist tie, thumb loops, and back perforation for removal. Intended for healthcare personnel in non-sterile, non-isolation environments. Provides AAMI Level 3 liquid barrier protection. Device is donned by user; provides physical barrier against body fluids and particulates. Benefits include moderate protection for staff in non-clinical or non-sterile patient care areas.
Clinical Evidence
No clinical data. Bench testing only. Performance verified via AAMI PB70:2012 (Level 3), AATCC 127 (hydrostatic pressure), AATCC 42 (impact penetration), and various ASTM standards for tensile/tear strength and seam integrity. Biocompatibility confirmed per ISO 10993-5 and ISO 10993-10.
Technological Characteristics
Material: Polyethylene. Design: Open-back, thumb loops, waist tie. Barrier: AAMI Level 3 (AATCC 127, AATCC 42). Standards: ASTM D5587 (tear), ASTM D1683 (seam), ASTM D5034 (tensile), ASTM D882 (plastic tensile), ASTM D1004 (tear resistance), 16 CFR 1610 (flammability). Biocompatibility: ISO 10993-5, ISO 10993-10. Non-sterile, single-use, disposable.
Indications for Use
Indicated for healthcare personnel requiring moderate barrier protection (AAMI Level 3) in non-sterile, non-patient isolation settings. Single-use, disposable.
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
- ProTEC-USA EZDoff Gown (K210405)
Submission Summary (Full Text)
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is 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.
March 5. 2024
Medline Industries, LP Kelsey Closen Official Correspondent 1 Three Lakes Drive Northfield, Illinois 60093
Re: K233526/S001
Trade/Device Name: Medline Open-Back Level 3 Protective Gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: QPC Dated: January 18, 2024 Received: February 1, 2024
Dear Kelsey Closen:
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 (the 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 available 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}------------------------------------------------
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
{2}------------------------------------------------
Sincerely,
# Bifeng Qian -S
Bifeng Qian, MD, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
### Indications for Use
510(k) Number (if known) K233526
Device Name Medline Open-Back Level 3 Protective Gown
Indications for Use (Describe)
Gown is a single use, disposable, non-solation gown intended to be worn by healthcare personnel to provide moderate barrier protection (AAMI Level 3) in non-sterile and non-patient isolation situations.
| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
| | |
| | Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
#### CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{4}------------------------------------------------
## 510(k) SUMMARY (K233526)
#### Submitter / 510(k) Sponsor
Medline Industries, LP Three Lakes Drive Northfield, IL 60093
Registration Number: 1417592
#### Contact Person
Contact Person: Kelsey Closen, Regulatory Affairs Senior Specialist Phone: 847-949-2283 Email: KClosen@medline.com
Summary Preparation Date March 1, 2024
Type of 510(k) Submission Traditional
#### Device Name / Classification
Trade Name: Medline Open-Back Level 3 Protective Gown Common Name: Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Barrier Protection Classification Name: Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Barrier Protection Product Code: OPC Classification Panel: General Hospital Regulatory Class: II Regulation Number: 21 CFR 878.4040
#### Predicate Device
ProTEC-USA EZDoff Gown cleared in K210405.
#### Device Description
The Medline Open-Back Level 3 Protective Gown is a single use, disposable, non-sterile, nonisolation gown intended to be worn by healthcare personnel to provide moderate barrier protection (AAMI Level 3) in non-sterile and non-patient isolation situation. The Medline Open-Back Level 3 Protective Gown meets the level 3 barrier protection requirements in accordance with ANSI/AAMI Standard PB70:2012 "Liquid Barrier Performance and Classification of Protective Apparel and Drapes intended for use in Health Care Facilities".
The Medline Open-Back Level 3 Protective Gown is a blue polyethylene gown available in 3 configurations: regular/large, universal and XL. The gown has an open back with a tie for securement and thumb loops on the cuffs.
{5}------------------------------------------------
#### Indications for Use
Gown is a single use, disposable, non-sterile, non-isolation gown intended to be worn by healthcare personnel to provide moderate barrier protection (AAMI Level 3) in non-sterile and non-patient isolation situations.
| Device Characteristic | Proposed Device | Predicate Device | Comparison Analysis |
|---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Name | Medline Open-Back Level 3<br>Protective Gown | ProTEC-USA EZDoff Gown | N/A |
| 510(k) Reference | K233526 | K210405 | N/A |
| Product Owner | Medline Industries, LP | Cadillac Products, Inc. | N/A |
| Product Code | QPC | QPC | Same |
| Regulation Number | 878.4040 | 878.4040 | Same |
| Intended Use | Gown is a single use, disposable,<br>non-sterile, non-isolation gown<br>intended to be worn by healthcare<br>personnel to provide moderate<br>barrier protection (AAMI Level 3)<br>in non-sterile and non-patient<br>isolation situations. | ProTEC-USA EZDoff Gown is intended to<br>protect health care patients and health care<br>personnel from the transfer of<br>microorganisms, body fluids and particulate<br>material. The ProTEC-USA EZDoff Gown<br>is a single use, disposable gown provided<br>non-sterile. The back of the gown is open<br>and non-protective. The gown is not<br>intended for use in the operating room. | Same - Medline's intended use mimics the<br>product codes definition. |
| Design Features | Design includes open back, thumb<br>loops, back perforation for easy<br>removal and waist tie | Design includes open back, thumb loops,<br>back perforation for easy removal and waist<br>tie | Same |
| Design Configurations | Large/Regular, Universal, XL | Universal Size | Similar - The difference in sizing does not<br>impact the safety or effectiveness of the<br>device. Performance testing supports the<br>difference. |
| Color | Blue | Blue | Same |
| Materials | Polyethylene | Polyethylene | Same |
| Prescription vs. OTC | OTC | OTC | Same |
| Sterile vs. Non-Sterile | Non-Sterile | Non-Sterile | Same |
| Disposable vs. Non-Disposable | Disposable | Disposable | Same |
| Single Use vs. Reusable | Single Use | Single Use | Same |
| PB70 AAMI Level | Level 3 | Level 3 | Same |
| Flammability 16 CFR 1610 | Meets Class 1 "normal<br>flammability " in accordance to 16<br>CFR Part 1610 | Meets Class 1 "normal flammability " in<br>accordance to 16 CFR Part 1610 | Same |
| Liquid Barrier/ PB70 | Device was tested in accordance<br>with AAMI PB70:2012 and meets<br>Level 3 requirements for an<br>isolation gown | Device was tested in accordance with<br>AAMI PB70:2012 and meets Level 3<br>requirements for an isolation gown | Same |
| Biocompatibility | Pass Cytotoxicity ISO 10993-5,<br>Sensitization, and Irritation ISO<br>10993-10 | Pass Cytotoxicity ISO 10993-5,<br>Sensitization, and Irritation ISO 10993-10 | Same |
| Tearing Strength/Resistance<br>(ASTM D5587) | 15.98±0.68N (Machine Direction)<br>9.41±0.46 (Transverse Direction) | 8N (Machine Direction)<br>22N (Transverse Direction) | Same |
| Tensile Strength (ASTM<br>D5034) | 41.74±2.74N (Machine Direction)<br>30.29±3.52N (Transverse<br>Direction) | 52N (Machine Direction)<br>41N (Transverse Direction) | Same |
| Seam Strength (ASTM D1683) | 35.01±3.91 N<br>7.87±0.88 lb. | Not Reported | Different- predicate did not report seams<br>strength testing |
| Lint (ISO 9073-10) | Not reported, not used in OR | Log10<4 | Different - Not intended to be |
| | | | used in the operating room. Therefore, the<br>linting properties of the material are not a<br>concern to the user or patient. The material<br>and nature of manufacturing of material for<br>this product has eliminated the risk of<br>linting. |
#### Summary of Technological Characteristics TABLE 1: COMPARISON OF PROPOSED AND PREDICATE DEVICES
{6}------------------------------------------------
#### Summary of Non-Clinical Testing
#### Biocompatibility Testing
The biocompatibility evaluation for the proposed device was conducted in accordance with ANSI/AAMI/ISO 10993-1:2018 Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process, as recognized by FDA.
The following tests were performed to evaluate the biocompatibility of the proposed device:
- Cytotoxicity in accordance with ISO 10993-5:2009 Biological Evaluation of Medical Devices-● Part 5: Tests for in vitro Cytotoxicity
- Sensitization in accordance with ISO 10993-10:2021 Biological Evaluation of Medical Devices-● Part 10: Test for Irritation and Skin Sensitization
- Irritation in accordance with ISO 10993-10:2021 Biological Evaluation of Medical Devices-Part 10: Tests for Irritation and Skin Sensitization
#### Performance Testing (Bench)
Non-clinical verification of the Medline Open-Back Level 3 Protective Gown has been conducted to evaluate the safety, performance, and functionality of the proposed device.
The following performance testing was conducted:
· AATCC 127: 2018 Water Resistance: Hydrostatic Pressure Test
· AATCC 42: 2017 Water Resistance: Impact Penetration
• ASTM D5587-15 (2019) Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure
• ASTM D1683/D1683M-17:2017/(R)2018 Standard Test Method for Failure in Sewn Seams of Woven Fabrics
• ASTM D3776/D3776M-20 Test Methods for Mass Per Unit Area (Weight) of Woven Fabric
· ASTM D5034-21 Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test)
· ASTM D882:2018 Tensile Properties of Thin Plastic Sheeting
· ASTM D1004-2021 Tear Resistance (Graves Tear) of Plastic Film and Sheeting
· 16 CFR Part 1610 Standard for the Flammability of Clothing Textiles
{7}------------------------------------------------
| Testing<br>Conducted | Purpose of test | Test Method | Standard | Test Criteria | Test Results |
|---------------------------------------------------------------------|------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Biocompatibility | | | | | |
| Cytotoxicity | Biocompatibility -Test performed<br>in accordance with ISO 10993-<br>5:2009 | L929 MEM<br>Elution Test | ISO 10993-<br>5:2009 | Test scores < 3 will be<br>considered to be non-<br>cytotoxic. Test scores<br>of '3 or 4' will be<br>considered cytotoxic.<br>The negative control<br>should display no<br>cytotoxicity reaction<br>and the positive control<br>should score 3 or 4 | Pass |
| Sensitization | Biocompatibility - Test Performed in<br>accordance with ISO 10993-10:2010 | Repeated Patch<br>Dermal<br>Sensitization Test | ISO 10993-<br>10:2021 | The test article must<br>score a '1' or '0' to<br>indicate no<br>sensitization result,<br>provided that the<br>negative control<br>scores <1. The<br>positive control<br>results should score<br>at least a score of '1' | Pass |
| Irritation | Biocompatibility - Test<br>performed in accordance with<br>ISO10993-10:2010. | Primary Skin<br>Irritation Test | ISO 10993-<br>10:2021 | The Primary<br>Irritation Index (PII)<br>of the test article<br>must be < 0.5 in<br>order to not exhibit<br>any irritation. The<br>positive control must<br>also exhibit an<br>irritation response<br>(PII >0.4). | Pass |
| Performance Testing | | | | | |
| Tearing<br>Strength/Resistance<br>(ASTM D5587) | Performance testing - test<br>performed in accordance with<br>ASTM D5587 | Average tear<br>strength in<br>both machine<br>and cross<br>machine<br>direction | ASTM D5587 | The average tear<br>strength in<br>both Machine and<br>Cross- Machine<br>Directions was<br>assessed per ASTM<br>F2407 –<br>2020. | Pass |
| Tensile Strength<br>(ASTM D5034) | Performance testing - test<br>performed in accordance with<br>ASTM D5034 | Average<br>tensile<br>strength<br>in<br>both machine<br>and<br>cross<br>machine<br>direction | ASTM D5034 | The average<br>tensile strength in<br>both Machine<br>and Cross-<br>Machine<br>Directions was<br>assessed<br>per ASTM F2407 -<br>2020. | Pass |
| Seam Strength (ASTM<br>D1683) | Performance testing - test<br>performed in accordance with<br>ASTM D1683 | Average seam<br>strength | ASTM D1683 | The average seam<br>strength<br>values were<br>assessed per<br>ASTM F2407 -<br>2020 | Pass |
| Hydrostatic<br>Pressure Test | Performance Testing in<br>Accordance with AATCC<br>127: 2018 | Chest area<br>and sleeve<br>seam were<br>assessed per<br>AMMI PB70<br>Level 3 | AATCC 127 | ≥50cm | Pass |
| Impact<br>Penetration | Performance testing in<br>accordance with AATCC 42:<br>2017 | Chest area<br>and sleeve<br>seam were<br>assessed per<br>AMMI PB70<br>Level 3 | AATCC 42 | ≤1.0g | Pass |
| Mass Per Unit Area<br>(Weight) of Woven<br>Fabric | Performance Testing in accordance<br>with ASTM D3776/D3776M-20 | Mass per unit<br>weight | ASTM<br>D3776/D377<br>6 M | Basis Weight per ASTM<br>D3776/D3776M | Lot 1: 27.67 ± 0.58/<br>Lot 2: 28.00 ± 3.46<br>Lot 3: 30.67 ± 0.58 |
| Tensile<br>Properties of Thin Plastic<br>Sheeting | Performance testing in<br>accordance with ASTM D882:2018 | Tensile<br>Properties of<br>plastic | ASTM D882 | Determination of tensile<br>properties of plastics in<br>the form of thin sheeting<br>and films (less than 1.0<br>mm (0.04 in.) in<br>thickness). | Average Machine data for 3 Lots<br>Load at Break (N)<br>12.79±1.21<br>Tensile Strength (Mpa)<br>16.64±3.40<br>% Elongation at Break<br>410.76±50.67<br>Average Cross data for 3 Lots<br>Load at Break (N)<br>10.19±1.03<br>Tensile Strength (Mpa)<br>11.43±3.95<br>%Elongation at Break 522.42±58.80 |
| Tear<br>Resistance (Graves<br>Tear) of Plastic<br>Film and Sheeting | ASTM D1004-21 | Tear<br>resistance of<br>plastic with<br>machine | ASTM<br>D1004 | Determination of the<br>tear resistance of<br>flexible plastic film<br>and sheeting at very<br>low<br>rates of loading, 51 mm (2<br>in.)/min | Average Machine data for 3 Lots<br>Maximum Load (N)<br>2.93±0.34<br>Extension at Break (mm) 19.84±3.57<br>Average Cross data for 3 Lots<br>Maximum Load (N)<br>3.23±0.20<br>Extension at Break (mm) 22.50±1.4 |
| Flammability<br>of Clothing<br>Textiles | 16 CFR Part 1610 | Flammability<br>of gown<br>material | 16 CFR Part<br>1610 | Average burn time ≥<br>3.5s<br>Class 1 "normal<br>Flammability" in<br>accordance to 16<br>CFR Part 1610 | Pass |
{8}------------------------------------------------
#### Summary of Clinical Testing
Not applicable.
#### Conclusion
In accordance with 21 CFR Part 807 and based on the information provided in this premarket notification, Medline Industries, Inc. concludes that the Medline Open-Back Level 3 Protective Gown are as safe, as effective and performs as well as or better than the legally marketed predicate device ProTEC-USA EZDoff Gown cleared in K210405.
