K-number	K252940
Device name	VR® Personal Protective Level 3 Gown (VR Gowns)
Applicant	PolyConversions, Inc.
Product code	QPC
Device class	Class II
Decision date	Dec 16, 2025
Decision	Substantially Equivalent
Regulation	878.4040

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

The VR® Personal Protective Level 3 Gown is a single-use, disposable, non-sterile protective gown designed to protect healthcare patients and personnel from transfer of microorganisms, body fluids, and particulate material. The gown has an open, non-protective back and is not intended for use in operating rooms.

Technological characteristics

Not stated in this summary.

Test standards cited

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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VR® Personal Protective Level 3 Gown (VR Gowns)

Everything you need for a 510(k) submission. Nothing you don't.