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510(k) Data Aggregation
K Number
K202310Device Name
Wildcat PE Surgical Isolation Gown Open Back, Wildcat PE Surgical Isolation Gown Full Back
Manufacturer
Wildcat PPE, LLC
Date Cleared
2021-01-29
(168 days)
Product Code
FYC
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Wildcat PPE, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
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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