Who can help prepare an FDA 510(k) submission like Wildcat PE Surgical Isolation Gown Open Back, Wildcat PE Surgical Isolation Gown Full Back?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Wildcat PE Surgical Isolation Gown Open Back, Wildcat PE Surgical Isolation Gown Full Back

Q: Who is the manufacturer of Wildcat PE Surgical Isolation Gown Open Back, Wildcat PE Surgical Isolation Gown Full Back?

Wildcat Ppe, LLC filed the 510(k) submission for Wildcat PE Surgical Isolation Gown Open Back, Wildcat PE Surgical Isolation Gown Full Back (K202310).

Q: What is the FDA product code for Wildcat PE Surgical Isolation Gown Open Back, Wildcat PE Surgical Isolation Gown Full Back?

FYC. It is classified under 21 CFR 878.4040 as a Class 2 device in the General, Plastic Surgery panel.

Q: What is the regulatory pathway for Wildcat PE Surgical Isolation Gown Open Back, Wildcat PE Surgical Isolation Gown Full Back?

510(k) clearance (submission type: Traditional).

Q: What are the predicate devices for Wildcat PE Surgical Isolation Gown Open Back, Wildcat PE Surgical Isolation Gown Full Back?

Cardinal Health Isolation Gown (K160339).

K202310 · Wildcat Ppe, LLC · FYC · Jan 29, 2021 · General, Plastic Surgery

Device Facts

Record ID	K202310
Device Name	Wildcat PE Surgical Isolation Gown Open Back, Wildcat PE Surgical Isolation Gown Full Back
Applicant	Wildcat Ppe, LLC
Product Code	FYC · General, Plastic Surgery
Decision Date	Jan 29, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4040
Device Class	Class 2

Intended 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 Story

Single-use, disposable, non-sterile surgical isolation gown; constructed of Linear Low-Density Polyethylene (LLDPE). Provides AAMI Level 3 barrier protection against microorganisms, body fluids, and particulates. Features full-back design with tie tabs and thumbhole cuffs. Used in healthcare facilities by personnel to reduce cross-contamination risk. Not intended for operating room use. Performance verified via AAMI PB70:2012 testing and ISO 10993 biocompatibility standards.

Clinical Evidence

Bench testing only. No clinical data provided. Performance verified against AAMI PB70:2012 for liquid barrier (Level 3), ASTM D1004 (tear resistance), ASTM D882 (tensile), ASTM D5587-15 (trap tear), ASTM D5034 (grab tensile), and 16 CFR Part 1610 (flammability). Biocompatibility testing performed per ISO 10993-1.

Technological Characteristics

Material: Linear Low-Density Polyethylene (LLDPE). Barrier: AAMI Level 3 per ANSI/AAMI PB70:2012. Design: Full back, tie tabs, thumbhole cuffs. Sterilization: Non-sterile. Biocompatibility: ISO 10993-1 compliant.

Indications for Use

Indicated for health care patients and personnel to protect against transfer of microorganisms, body fluids, and particulate material. Not for use in operating rooms. Meets AAMI Level 3 barrier protection requirements.

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

Cardinal Health Isolation Gown (K160339)

Related Devices

K212633 — Disposable Isolation Gown -Level 3, Large, Blue, Disposable Isolation Gown - Level 3, X-Large, Blue · String King Lacrosse, LLC · Nov 24, 2021
K210405 — ProTEC-USA EZDoff Gown · Cadillac Products, Inc. · Dec 15, 2021
K171535 — SURGICAL ISOLATION GOWN · Jingzhou Haixin Green Cross Medical Products Co., Ltd. · Feb 15, 2018
K203821 — Donagamex Blue Performance Protective Gown · Dong Nai Garment Corporation (Donagamex) · Dec 17, 2021
K212504 — Isolation Gown AAMI Level 3 · Kenpax International Limited · Nov 7, 2021

Submission Summary (Full Text)

{0}------------------------------------------------ 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 {2}------------------------------------------------ # 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) ## 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.qov '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 0MB number." {3}------------------------------------------------ # 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. {4}------------------------------------------------ # 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 = < 0.1 Min = < 0.1 | Similar | | | Target Mean = .1 Max = .5 Ind Max = 1.0 | Target Mean = .1 Max = .5 Ind. Max = 1.0 | | Side by Side Comparison Table: Predicate Device, Cardinal Health Isolation Gown and Proposed Device, Wildcat PPE Disposable PE Isolation Gown. {5}------------------------------------------------ {6}------------------------------------------------ | | Ind Max = .10 | | Max = .5 Sleeve Seam: Mean = <0.1 Min = <0.1 Max = <0.1 | | | |---------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|--|-----------------------------------------------------------------------------------------------------------------|--|------| | Liquid Barrier Performance Classification Properties | Device was tested in accordance with AAMI PB70:2012 and meets Level 3 requirements for a surgical gown | | Device was tested in accordance with AAMI PB70:2012 and meets Level 3 requirements for a surgical gown | | | | Biocompatibility | Pass: ISO 10993-1 | | Pass: ISO 10993-1 | | Same | | Sterilization Modality | None (Non-Sterile) | | None (Non-Sterile) | | Same | * These tests are specifically for tear and tensite sheeting. As Wildcat's PPEs Surgical Isolation Govens are made entrely of LLDPE, the tests sphied o Cardinal Health's Isolation Gowns associated with tear and tensile properties are not applicable. The Wildcat PE Surgical Isolation Gowns Full Back are similar to the predicate device, in terms of intended use, performance testing, material composition, and configuration/dimensions. 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. #### Conclusion: The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective and performs as well as or better than the legally marketed device.