(262 days)
Not Found
No
The 510(k) summary describes a surgical gown and its material properties and testing. There is no mention of AI or ML technology.
No.
Therapeutic devices are intended to treat or cure a disease or condition. This device is a surgical gown intended for protection, not treatment.
No
The device is a surgical gown intended for protective apparel, not for diagnosing medical conditions.
No
The device description explicitly states it is a gown made from fabric and film, and describes its physical properties and testing related to barrier performance. This indicates it is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the gown is for "healthcare professionals to help protect both the healthcare worker from the transfer of microorganisms, body fluids, and particulate matter." This describes a protective barrier for the user, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description focuses on the physical properties and materials of the gown, emphasizing its barrier performance against liquids and particles. This aligns with personal protective equipment, not diagnostic tools.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
Therefore, the Medline Prevention CoolZone Gown is a surgical gown intended for personal protection, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
FYA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare professionals
healthcare facilities
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
ASTM E96 - Standard Test Methods for Water Vapor Transmission of Materials
ANSI/AAMI/ISO 10993-7:2008(R)2012 - Biological evaluation of medical devices –Part 7: Ethylene oxide sterilization residuals
AATCC 42 - Water Resistance: Impact Penetration Test
AATCC 127 - Water Resistance: Hydrostatic Pressure Test
ANSI/AAMI PB70:2012 - Liquid Barrier performance and classification of protective apparel and drapes intended for use in health care facilities.
Clinical Testing:
Clinical testing was not required for this device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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.
1
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely, Clarence W. Murray lii III -S
For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) 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) | Residential Use (Part 21 CFR 601 Subpart E) Commercial Use (21 CFR 601 Subpart C) | Residential Use (Part 21 CFR 601 Subpart E) | Commercial Use (21 CFR 601 Subpart C) |
|---|---|---|---|
| Residential Use (Part 21 CFR 601 Subpart E) | Commercial Use (21 CFR 601 Subpart C) |
__ Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
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
Analysis |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Product Name | Medline Prevention CoolZone
Gown | Kimberly Clark MicroCool
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
CoolZone Gowns are 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 the
AAMI Liquid Barrier
classifications.
The Medline Prevention
CoolZone Gowns are also
sold as bulk non-sterile,
single use items, to
repackager/relabeler | The Kimberly-Clark
MicroCool Surgical
Gown, Breathable High
Performance, KG400
(hereinafter referred to as
"MicroCool Surgical
Gown") are 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 MicroCool Surgical
Gowns meet the Level 4
requirements of the AAMI
PB70: 2003 Liquid Barrier
classifications.
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
from the irritation and | per ISO 100993-5. Test
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 |
| ASTM E96 | Standard Test Methods for Water Vapor Transmission of Materials |
| ANSI/AAMI/ISO 10993- | Biological evaluation of medical devices –Part 7: Ethylene oxide sterilization |
| 7:2008(R)2012 | residuals |
| AATCC 42 | Water Resistance: Impact Penetration Test |
| AATCC 127 | Water Resistance: Hydrostatic Pressure Test |
| ANSI/AAMI PB70:2012 | Liquid Barrier performance and classification of protective apparel and drapes |
| intended for use in health care facilities. |
Summary of Clinical Testing
Clinical testing was not required for this device.
Conclusion
Based on the information provided in this premarket notification, Medline Industries, Inc. concludes that the Medline Prevention CoolZone Gowns are substantially equivalent to the predicate device [Kimberly Clark MicroCool Surgical Gown (K981393)].