K-number	K242689
Device name	AAMI Level 4 Protective; Gown
Applicant	Azac Group
Product code	QPC
Device class	Class II
Decision date	Jan 13, 2025
Decision	Substantially Equivalent
Regulation	878.4040

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

The AAMI Level 4 Protective Gown is a single-use, disposable, non-sterile medical device designed to protect healthcare personnel and patients from transfer of microorganisms, body fluids, and particulate material. It is not intended for use in the operating room and features an open back which is non-protective.

Technological characteristics

Not stated in this summary.

Test standards cited

The device meets the barrier protection requirements of AAMI Level 4 per ANSI/AAMI PB70:2012 – Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities.

Substantial equivalence argument

Not stated in this summary.

Extracted by AI from the official FDA summary PDF →

Source

View the full FDA submission: accessdata.fda.gov

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AAMI Level 4 Protective; Gown

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