Medline Prevention CoolZone Gown
Device Facts
| Record ID | K172954 |
|---|---|
| Device Name | Medline Prevention CoolZone Gown |
| Applicant | Medline Industries, Inc. |
| Product Code | FYA · General, Plastic Surgery |
| Decision Date | Jun 15, 2018 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4040 |
| Device Class | Class 2 |
Indications for Use
The Medline Prevention CoolZone Gown is a sterile, single use surgical apparel intended to be worn by healthcare professionals to help protect both the patient and the healthcare worker from the transfer of microorganisms, body fluids, and particulate matter. The Medline Prevention CoolZone Gown meets the Level 4 requirements of ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities.
Device Story
Sterile, single-use surgical gown; manufactured from breathable, non-woven, three-layer laminated polypropylene fabric with SMS material at back; provides liquid barrier protection. Used by healthcare professionals in clinical/surgical settings to prevent cross-contamination of microorganisms, body fluids, and particulates. Meets ANSI/AAMI PB70:2012 Level 4 liquid barrier requirements. Available in various sizes; includes knit cuffs, tab neck closure, and ties. Sold as sterile finished goods or bulk non-sterile for third-party sterilization.
Clinical Evidence
No clinical data; bench testing only. Performance validated via ANSI/AAMI PB70:2012, ASTM F1671 (blood-borne pathogen resistance), ASTM D5034/D5587 (strength), and biocompatibility testing per ISO 10993-5 and ISO 10993-10.
Technological Characteristics
Three-layer laminated non-woven polypropylene fabric; breathable olefin film layer; SMS back panel. Meets ANSI/AAMI PB70:2012 Level 4. Flammability meets 16 CFR 1610 Class 1. Sterilization via Ethylene Oxide (EtO).
Indications for Use
Indicated for healthcare professionals to protect patients and workers from transfer of microorganisms, body fluids, and particulate matter during surgical procedures.
Regulatory Classification
Identification
Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.
Special Controls
*Classification.* (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible. (ii) Analysis and nonclinical testing must: (A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and (B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device. (iii) NIOSH approved under its regulation. (2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.
Predicate Devices
- Kimberly-Clark MicroCool Surgical Gown (K981393)
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Medline Industries, Inc. Pauline Maralit Regulatory Affairs Specialist 3 Lakes Drive Northfield, Illinois 60093
Re: K172954
Trade/Device Name: Medline Prevention CoolZone Gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYA Dated: June 4, 2018 Received: June 6, 2018
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. 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.
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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
> Sincerely, Clarence W. Murray lii III -S
For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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## Indications for Use
510(k) Number (if known) K172954
Device Name Medline Prevention CoolZone Gown
#### Indications for Use (Describe)
The Medline Prevention CoolZone Gown is a sterile, single use surgical apparel intended to be worn by healthcare professionals to help protect both the healthcare worker from the transfer of microorganisms, body fluids, and particulate matter. The Medline Prevention CoolZone Gown meets the Level 4 requirements of ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities.
| Type of Use (Select one or both, as applicable) | <table style="border:none;"><tr><td><div style="display:inline-block;"> <input type="checkbox"/> Residential Use (Part 21 CFR 601 Subpart E) </div></td><td><div style="display:inline-block;"> <input checked="checked" type="checkbox"/> Commercial Use (21 CFR 601 Subpart C) </div></td></tr></table> | <div style="display:inline-block;"> <input type="checkbox"/> Residential Use (Part 21 CFR 601 Subpart E) </div> | <div style="display:inline-block;"> <input checked="checked" type="checkbox"/> Commercial Use (21 CFR 601 Subpart C) </div> |
|-------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div style="display:inline-block;"> <input type="checkbox"/> Residential Use (Part 21 CFR 601 Subpart E) </div> | <div style="display:inline-block;"> <input checked="checked" type="checkbox"/> Commercial Use (21 CFR 601 Subpart C) </div> | | |
__ 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. The logo consists of the word "MEDLINE" in a bold, sans-serif font, with the letters stacked on top of each other. To the right of the word is a white starburst symbol. The logo is set against a blue square background.
dline Industries. Inc. Three Lakes Drive Northfield II 60093
# 510(k) SUMMARY : K172954 [AS REQUIRED BY 21 CFR 807.92]
## Submitter / 510(k) Sponsor
Medline Industries, Inc. Three Lakes Drive Northpoint, IL. 60093 Registration Number: 1417592
## Contact Person
Pauline Maralit Regulatory Affairs Specialist Phone: 847-949-2283 Email: Pmaralit@medline.com
Summary Preparation Date June 14, 2018
## Type of 510(k) Submission for K172954
Traditional 510(k) Premarket Submission
## Device Name / Classification
| Name of Device: | Gown, Surgical |
|-----------------------|----------------------------------|
| Proprietary Name: | Medline Prevention CoolZone Gown |
| Common Name: | Surgical Gown |
| Classification Name: | Surgical Apparel |
| Product Code: | FYA |
| Classification Panel: | General & Plastic Surgery |
| Regulatory Class: | II |
| Regulatory Class: | 21 CFR 878.4040 |
#### Predicate Device
PREDICATE DEVICE NAME: Kimberly-Clark *MicroCool* Surgical Gown PREDICATE DEVICE K NUMBER: K091357
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Image /page/4/Picture/0 description: The image features the Medline logo, which is set against a blue square background. The word "MEDLINE" is prominently displayed in white, uppercase letters on the left side of the square. A stylized white starburst or cross-like shape is positioned to the right of the text, adding a visual element to the logo. A small portion of a gray rectangle is visible in the upper right corner of the image.
dline Industries. Inc. Three Lakes Drive Northfield. IL 60093
## Device Description
The Medline Prevention CoolZone Gown is manufactured from a breathable, non-woven, polypropylene fabric, with an SMS material at the back. The fabric is a three-layer lamination resistant to liquid penetration. The film layer is a multi-layer polypropylene olefin, breathable film. The Medline Prevention CoolZone Gown has been tested according to AAMI PB70:2012 and meets Level 4 requirements of the AAMI Liquid Barrier classifications for a surgical gown.
The sterilized version of the device is a folded gown packaged with one hand towel wrapped inside the CSR wrap and placed inside a peel pouch. The Medline Prevention CoolZone Gowns are also sold as bulk non-sterile, single use items, to repackager/relabeler establishments for further packaging and Ethylene Oxide (EtO) sterilization.
| Item Number | Device Description | Version | Size |
|-------------|-----------------------------------------------------------------|-------------|------------------|
| DYNJP2901T | Medline Prevention CoolZone Surgical Gown, Breathable Film Gown | Sterile | Large, X-Long |
| DYNJP2902T | Medline Prevention CoolZone Surgical Gown, Breathable Film Gown | Sterile | X-Large, X-Long |
| DYNJP2903T | Medline Prevention CoolZone Surgical Gown, Breathable Film Gown | Sterile | XX-Large, X-Long |
| DYNJP2906T | Medline Prevention CoolZone Surgical Gown, Breathable Film Gown | Sterile | Large |
| DYNJP2907T | Medline Prevention CoolZone Surgical Gown, Breathable Film Gown | Sterile | X-Large |
| DYNJP2908T | Medline Prevention CoolZone Surgical Gown, Breathable Film Gown | Sterile | XX-Large |
| SPT-2901TR | Medline Prevention CoolZone Surgical Gown, Breathable Film Gown | Non-Sterile | Large, X-Long |
| SPT-2902TR | Medline Prevention CoolZone Surgical Gown, Breathable Film Gown | Non-Sterile | X-Large, X-Long |
| SPT-2903TR | Medline Prevention CoolZone Surgical Gown, Breathable Film Gown | Non-Sterile | XX-Large, X-Long |
| SPT-2906TR | Medline Prevention CoolZone Surgical Gown, Breathable Film Gown | Non-Sterile | Large |
| SPT-2907TR | Medline Prevention CoolZone Surgical Gown, Breathable Film Gown | Non-Sterile | X-Large |
| SPT-2908TR | Medline Prevention CoolZone Surgical Gown, Breathable Film Gown | Non-Sterile | XX-Large |
#### TABLE 1: DEVICE MODELS
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Image /page/5/Picture/0 description: The image shows the Medline logo. The logo is white text on a blue background. The text "MEDLINE" is in a sans-serif font. There is a white cross-like shape behind the text. The cross shape is stylized, with the top and bottom points being longer than the side points.
Aedline Industries. Inc. Three Lakes Drive Northfield. IL 60093
## Indications for Use
The Medline Prevention CoolZone Gown is a sterile, single use surgical apparel intended to be worn by healthcare professionals to help protect both the patient and the healthcare worker from the transfer of microorganisms, body fluids, and particulate matter. The Medline Prevention CoolZone Gown meets the Level 4 requirements of ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities.
## Substantial Equivalence
| Attribute | Proposed Device | Predicate Device | Comparison<br>Analysis |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Product Name | Medline Prevention CoolZone<br>Gown | Kimberly Clark *MicroCool*<br>Surgical Gown | Different |
| 510(k) Reference | K172954 | K981393 | Different |
| Product Owner | Medline Industries, Inc. | Kimberly Clark | Different |
| Product Code | FYA | FYA | Same |
| Intended Use | The Medline Prevention<br>CoolZone Gowns are sterile,<br>single use surgical apparel<br>intended to be worn by<br>healthcare professionals to<br>help protect both the patient<br>and the healthcare worker<br>from the transfer of<br>microorganisms, body fluids,<br>and particulate matter.<br>The Medline Prevention<br>CoolZone Gown meets the<br>Level 4 requirements of the<br>AAMI Liquid Barrier<br>classifications.<br>The Medline Prevention<br>CoolZone Gowns are also<br>sold as bulk non-sterile,<br>single use items, to<br>repackager/relabeler | The Kimberly-Clark<br>*MicroCool* Surgical<br>Gown, Breathable High<br>Performance, KG400<br>(hereinafter referred to as<br>"*MicroCool* Surgical<br>Gown") are sterile, single<br>use surgical apparel<br>intended to be worn by<br>healthcare professionals to<br>help protect both the<br>patient and the healthcare<br>worker from the transfer of<br>microorganisms, body<br>fluids, and particulate<br>matter.<br>The *MicroCool* Surgical<br>Gowns meet the Level 4<br>requirements of the AAMI<br>PB70: 2003 Liquid Barrier<br>classifications.<br>The *MicroCool* Surgical | Same |
| | | | |
| | establishments for further | Gowns are also sold as bulk | |
| | packaging and Ethylene | non-sterile, single use | |
| | Oxide (EtO) sterilization. | items, to repackager/ | |
| | | relabeler establishments | |
| | | for further packaging and | |
| | | Ethylene Oxide (EtO) | |
| | | sterilization. | |
| Regulation Number | 878.4040 | 878.4040 | Same |
| Use | Single Use; Disposable | Single Use; Disposable | Same |
| | Neck Closure: Tab | Neck Closure: Tab | |
| | Belt: Ties | Belt: Ties | Same |
| Design Configurations | Cuffs: Knit | Cuffs: Knit | |
| | Transfer Tab | Transfer Tab | |
| | | Breathable, repellent, SMS | |
| Material Composition | Breathable, SMS non-woven | non-woven | Similar |
| | Meets ANSI/AMMI | | |
| Performance | PB70:2012 Level 4 Liquid | Meets PB70 AMMI Level 4 | |
| Specifications in Critical | Barrier requirements. | Liquid Barrier | Same |
| Zone | | requirements. | |
| | | | |
| | | | |
| | Meets ANSI/AMMI | | |
| Performance | PB70:2012 Level 1 Liquid | | |
| Specifications in | Barrier requirements. | Not Available | Different |
| Non-Critical Zone | | | |
| Prescription vs. OTC | ОТС | ОТС | Same |
| Sterile vs. Non-Sterile | Sterile & Bulk Non-Sterile | Sterile & Bulk Non-Sterile | Same |
| Color | Dark Blue/Light Blue | Light Blue | Similar |
| Sterilization Method | EtO -Ethylene Oxide | EtO -Ethylene Oxide | Same |
| | Large, Large/X-Long, X-Large, | Large, Large/X-Long, | |
| | X-Large/X-Long, XX-Large, XX- | X-Large, XX-Large, Small, X- | Similar |
| Gown Sizes | Large/X-Long | Large/X-Long | |
| | | Meets the requirements of | |
| 16 CFR Part 1610 | Meets requirements of Flame | Flame Resistant CPSC 1610 | Same |
| Flammability | Resistant CPSC 1610 Class 1 | Class 1 | |
| Biocompatibility | The test extract from | The test device from | Same |
| ISO-10993 | cytotoxicity test was found | cytotoxicity testing was | |
| | | | |
| | not to be cytotoxic per ISO | found not to be cytotoxic | |
| | 10993-5. Test extracts<br>from the irritation and | per ISO 100993-5. Test<br>devices from the | |
| | | | |
| sensitization testing were | irritation and | | |
| found not to be an irritant | sensitization testing were | | |
| nor sensitizer per ISO | found not to be an | | |
| 10993-10. | irritant nor a sensitizer as | | |
| | per ISO 10993-10. | | |
### TABLE 2: COMPARISON OF PROPOSED AND PREDICATE DEVICES
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Image /page/6/Picture/0 description: The image is a logo for Medline. The logo consists of the word "MEDLINE" in white, set against a blue square background. A white star-like symbol is behind the text, with its points extending beyond the letters. The overall design is simple and corporate, likely representing a healthcare or medical supply company.
Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093
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Image /page/7/Picture/0 description: The image shows the Medline logo. The logo consists of the word "MEDLINE" in a sans-serif font, with a white starburst symbol behind it. The background of the logo is a solid dark blue color. There is a small gray square in the upper right corner of the image.
Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093
## Summary of Non-Clinical Testing
| 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 F88/F88M-15 | Seal Strength of Flexible Barrier Materials |
| ASTM F1929-15 | Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration |
| ISTA 3A | Packaged-Products for Parcel Delivery System Shipment 70Kg or Less |
| ASTM F1671 | Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne |
| | Pathogens |
| ASTM D5034-09 (2013) | Breaking Strength and Elongation of Textile Fabrics (Grab Test) |
| ASTM D5587-15 | Tearing Strength of Fabrics by Trapezoid Procedure |
| ASTM D3776/D3776M-09a | Basis Weight-Mass Per Unit Area (Weight) of Fabric |
| ASTM D3786/D3786M-13 | Bursting Strength of Textile Fabrics-Diaphragm Bursting Strength Tester Method |
| 16 CFR 1610 | Flammability of Clothing Textiles…
