(168 days)
Not Found
No
The device is a physical isolation gown and the summary describes its material properties and barrier performance, with no mention of software, data processing, or AI/ML technologies.
No.
The device is a surgical isolation gown intended to protect health care personnel from the transfer of microorganisms, body fluids, and particulate material, not to treat a disease or medical condition.
No
This device is a surgical isolation gown intended to protect healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. It is a protective apparel, not a device used to diagnose a medical condition.
No
The device is a physical surgical isolation gown made of Linear Low-Density Polyethylene, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the gown is for protecting healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. This is a barrier function for personal protection, not a diagnostic test performed on samples from the human body.
- Device Description: The description identifies it as a surgical isolation gown with moderate barrier protection, classified under FDA product code FYC (Protective Clothing). This product code is for personal protective equipment, not IVDs.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
- Reagents, calibrators, or controls
The information provided describes a medical device used for personal protection in a healthcare setting, not a diagnostic test.
N/A
Intended Use / Indications for Use
Wildcat PE Surgical Isolation Gown Full Back is intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. In addition, The Wildcat PE Surgical Isolation Gown Full Back meets the requirements of an AAMI Level 3 barrier protection for an isolation gown per ANSI/AAMI PB70:2012 Liquid Barrier and Performance Classification of Protective Apparel and Surgical Drapes Intended for Use in Health Care Facilities (ANSVAAMI PB70). The Wildcat PE Surgical Isolation Gown Full Back is a single use, disposable medical device provided non-sterile.
Product codes (comma separated list FDA assigned to the subject device)
FYC
Device Description
The Wildcat PE Surgical Isolation Gown Full Back is a surgical isolation gown with moderate barrier protection identified by Regulation 21 CFR 878.4040 under FDA product code FYC. Wildcat PE Surgical Isolation Gown Full Back is a single use, disposable medical device provided non-sterile. Wildcat PE Surgical Isolation Gown Full Back is offered in one color (blue) and one universal size. Each model is constructed of Linear Low- Density Polyethylene and has been tested according to ANSI/AAMI PB70:2012 Liquid Barrier and Performance Classification of Protective Apparel and Surgical Drapes Intended for Use in Health Care Facilities and meets AAMI Level 3.
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
health care patients and health care personnel
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)
The Wildcat PE Surgical Isolation Gowns passed biocompatibility studies per ISO-10993 and have met the requirements of AAMI PB70:2012 Liquid Barrier and Performance Classification of Protective Apparel and Surgical Drapes Intended for Use in Health Care Facilities for an AAMI Level 3 isolation gown.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Water Resistance Hydrostatic Pressure Test - AATCC 127:2017 (cm): Chest: Mean = >151, Min = 155, Max = >155; Sleeve Seam: Mean =>165, Min = 171, Max = >173
- Flammability of Clothing Textiles - 16 CFR Part 1610 (a): Class I
- Tear Resistance - ASTM D1004: Max Load (lbf): Mean = 1.04, Min = .95, Max = 1.17; Max Extension (in): Mean = 1.01, Min = .91, Max = 1.10
- General Tensile Testing - ASTM D882: Breaking Factor (lbf/in): Mean = 6.66, Min = 4.87, Max = 9.20; Tensile (Max) (MPa): Mean = 24.8, Min = 19.7, Max = 33.4; Tensile (Break) (MPa): Mean = 21.5, Min = 15.9, Max = 33.4; Elongation (%): Mean = 1061, Min = 945, Max = 1327; Modulus (MPa): Mean = 91.1, Min = 2.58, Max = 117
- Trap Tear ASTM D5587-15: Mean = 5.10, Ind Min = 3.2, Ind Max = 7.0
- Grab Tensile CD ASTM D5034: Mean = 21.95, Ind Min = 20.60, Ind Max = 23.30
- Water Resistance Impact Penetration Test - AATCC 42: Chest: Mean =
§ 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.
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Image /page/0/Picture/0 description: The image contains 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 ADMINISTRATION" in blue text.
January 29, 2021
Wildcat PPE, LLC Matthew Mcfarlane General Counsel 301 S. Trade Center Pkwy Conroe, Texas 77385
Re: K202310
Trade/Device Name: Wildcat PE Surgical Isolation Gown Full Back Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYC Dated: January 25, 2021 Received: January 27, 2021
Dear Matthew Mcfarlane:
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 Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
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 medical devices and radiation-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 F. Claverie-Williams, MS Assistant Director 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) K202320
Device Name Wildcat PE Surgical Isolation Gown Full Back
Indications for Use (Describe)
Wildcat PE Surgical Isolation Gown Full Back is intended to protect health care personnel from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. In addition, the Wildcat PE Surgical Isolation Gown Full Back meets the requirements of an AAMI Level 3 barrier protection for an isolation gown per ANSV/AAMI PB70:2012 Liquid Barrier and Performance Classification of Protective Apparel and Surgical Drapes Intended for Use in Health Care Facilities (ANSVAAMI PB70). The Wildcat PE Surgical Isolation Gown Full Back is a single use, disposable medical device provided non-sterile.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 SubpartC)
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510(k) Summary (K202310) Wildcat PE Surgical Isolation Gown Full Back
Manufacturer:
Wildcat PPE, LLC 26980 Decker Prairie Rosehill Rd Magnolia, TX 77355
Regulatory Affairs Contact:
Matthew McFarlane 26980 Decker Prairie Rosehill Rd Magnolia, TX 77355 Telephone Number: (346) 367-4299
Date Summary Prepared: June 15, 2020
Trade Name: Wildcat PE Surgical Isolation Gown Full Back
Regulation Number: 21 CFR §878.4040
Device Class: Class II
Regulation Name: Surgical Apparel
Common Name: Surgical Isolation Gown
Product Code: FYC
Classification Name: Surgical Isolation Gown
Predicate Device: Cardinal Health Isolation Gown, K160339
Indications for Use:
Wildcat PE Surgical Isolation Gown Full Back is intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. In addition, The Wildcat PE Surgical Isolation Gown Full Back meets the requirements of an AAMI Level 3 barrier protection for an isolation gown per ANSI/AAMI PB70:2012 Liquid Barrier and Performance Classification of Protective Apparel and Surgical Drapes Intended for Use in Health Care Facilities (ANSVAAMI PB70). The Wildcat PE Surgical Isolation Gown Full Back is a single use, disposable medical device provided non-sterile.
Device Description:
The Wildcat PE Surgical Isolation Gown Full Back is a surgical isolation gown with moderate barrier protection identified by Regulation 21 CFR 878.4040 under FDA product code FYC. Wildcat PE Surgical Isolation Gown Full Back is a single use, disposable medical device provided nonsterile. Wildcat PE Surgical Isolation Gown Full Back is offered in one color (blue) and one universal size. Each model is constructed of Linear Low- Density Polyethylene and has been tested according to ANSI/AAMI PB70:2012 Liquid Barrier and Performance Classification of Protective Apparel and Surgical Drapes Intended for Use in Health Care Facilities and meets AAMI Level 3.
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Technological Characteristics Comparison Tables:
| Element of Comparison | Predicate Device:
Cardinal Health
Isolation Gown
(K160339) | Proposed Device: Wildcat
PE Surgical Isolation Gown
Full Back (K202310) | Comparison Analysis |
|------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------|
| Indications for Use | Cardinal Health Isolation Gown
is intended to protect health
care patients and health care
personnel from the transfer of
microorganisms, body fluids
and particulate material. Not
intended for use in the
operating room. In addition,
The Cardinal Health Isolation
Gown meets the requirements
of an AAMI Level 3 barrier
protection for an isolation gown
per ANSI/AAMI PB70:2012
Liquid Barrier and Performance
Classification of Protective
Apparel and Surgical Drapes
Intended for Use in Health Care
Facilities (ANSI/AAMI PB70).
The Cardinal Health Isolation
Gown is a single
use, disposable medical device
provided non-sterile. | Wildcat PE Surgical Isolation
Gown Full Backis intended to
protect health care patients and
health care personnel from the
transfer of microorganisms,
body fluids and particulate
material.
Not intended for use in the
operating room. In addition, The
Wildcat PE Surgical Isolation
Gown Full Back meets the
requirements of an AAMI Level
3 barrier protection for an
isolation gown per ANSI/AAMI
PB70:2012
Liquid Barrier and Performance
Classification of Protective
Apparel and Surgical Drapes
Intended for Use in Health Care
Facilities (ANSI/AAMI PB70).
The Surgical Isolation Gown is
a single use, disposable medical
device provided non- sterile | Similar |
| Element of Comparison | Predicate Device:
Cardinal Health
Isolation Gown
(K160339) | Proposed Device: Wildcat
PE Surgical Isolation Gown
Full Back (K202310) | Comparison Analysis |
| Material Composition | Polyolefin (Polypropylene) SMS
nonwoven | Linear Low-Density
Polyethylene (LLDPE) | Different |
| Design Features | Medical Tape Neck Closure
White Belt Tie
Elastic Cuffs | Tabs Tie in the Middle of Back
Thumbhole at Cuff | Different |
| Sterility | Non-sterile | Non-Sterile | Same |
| Use | Single Use; Disposable | Single Use; Disposable | Same |
| Color | Blue and Yellow | Blue | Similar |
| | Test Results
Mean (min/max) | Test Results
Mean (min/max) | |
| | Specifications | Specifications | |
| Water Resistance Hydrostatic
Pressure Test - AATCC
127:2017 (cm) | Body/Sleeve:
Mean = 69
Ind Min = 56
Ind Max = 80 | Chest:
Mean = >151
Min = 155
Max = >155
Sleeve Seam:
Mean =>165
Min = 171
Max = >173 | Target Mean = 67
Mean Min = 55
Ind Min = 52 |
| Flammability of Clothing
Textiles - 16 CFR Part 1610 (a) | Class I | Class I | Same |
| Tear Resistance - ASTM D1004* | NA | Max Load (lbf):
Mean = 1.04
Min = .95
Max = 1.17
Max Extension
(in):
Mean = 1.01
Min = .91
Max = 1.10 | NA |
| General Tensile Testing - ASTM
D882* | NA | Breaking Factor
(lbf/in):
Mean = 6.66
Min = 4.87
Max = 9.20
Tensile (Max)
(MPa):
Mean = 24.8
Min = 19.7
Max = 33.4
Tensile (Break)
(MPa):
Mean = 21.5
Min = 15.9
Max = 33.4
Elongation (%):
Mean = 1061
Min = 945
Max = 1327
Modulus (MPa):
Mean = 91.1
Min = 2.58
Max = 117 | NA |
| Trap Tear ASTM D5587-15 | Mean = 4.74
Ind Min = 3.67
Ind Max = 5.47 | Mean = 5.10
Ind Min = 3.2
Ind Max = 7.0 | Similar |
| Grab Tensile CD ASTM D5034 | Mean = 14.54
Ind Min = 12.70
Ind Max = 16.45 | Mean = 21.95
Ind Min = 20.60
Ind Max = 23.30 | Similar |
| Water Resistance Impact
Penetration Test - AATCC 42 | Body/Sleeve:
Mean = .07
Ind Min = .05 | Chest:
Mean =