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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.

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.

This document is a 510(k) premarket notification for a medical device: Wildcat PE Surgical Isolation Gown Full Back (K202310). It is a submission to the FDA proving substantial equivalence to a predicate device, not an AI/ML medical device where the "device" is an algorithm. Therefore, the requested information regarding acceptance criteria and performance for an AI/ML device is not applicable to this document.

The document discusses the physical characteristics and performance of a surgical gown, specifically:

• Indications for Use: Protection of healthcare personnel from microorganisms, body fluids, and particulate material, meeting AAMI Level 3 barrier protection.
• Material Composition: Linear Low-Density Polyethylene (LLDPE).
• Performance Testing:
  • Water Resistance Hydrostatic Pressure Test (AATCC 127:2017)
  • Flammability of Clothing Textiles (16 CFR Part 1610)
  • Tear Resistance (ASTM D1004) - Note: This and General Tensile Testing were NOT performed on the predicate device, only the proposed device, as their materials differ.
  • General Tensile Testing (ASTM D882)
  • Trap Tear (ASTM D5587-15)
  • Grab Tensile CD (ASTM D5034)
  • Water Resistance Impact Penetration Test (AATCC 42)
  • Liquid Barrier Performance Classification (AAMI PB70:2012)
  • Biocompatibility (ISO 10993-1)
• Acceptance Criteria and Performance: The document provides test results for the proposed device and, where available, compares them to the predicate device's performance or relevant standards (e.g., AAMI Level 3 requirements). For instance:
  • Water Resistance Hydrostatic Pressure Test: Proposed device chest mean >151 cm (Min 155, Max >155 cm) vs. Predicate device body/sleeve mean 69 cm (Min 56, Max 80 cm). The proposed device's performance exceeds the predicate and likely meets AAMI Level 3 requirements for this test.
  • Liquid Barrier Performance Classification: Both devices were tested per AAMI PB70:2012 and meet Level 3 requirements. This serves as a key acceptance criterion.
  • Biocompatibility: Both passed ISO 10993-1.

Since the device is a physical product (a surgical gown) and not an AI/ML algorithm, the concepts of "test set," "training set," "ground truth experts," "adjudication," "MRMC," "standalone performance," and "effect size of human readers" do not apply to this specific FDA submission.

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