What Is PPE Clothing? Gowns, Barrier Levels, Use

This page describes products and general use; it is not medical advice.

PPE clothing is protective clothing worn as personal protective equipment: garments such as gowns that put a barrier between the wearer and a hazard. In health care, the hazard is usually contact with disease-causing microorganisms or body fluids. Who uses it: clinicians, nurses, laboratory and clinic staff, and the buyers who specify protective garments for them.

What PPE clothing is

PPE clothing is any garment worn to protect the wearer, rather than to look uniform or keep warm. The FDA describes medical gowns as garments used to protect the wearer from the spread of disease-causing microorganisms on contact with potentially infectious material. What separates PPE clothing from ordinary clothing is the job it is selected for: OSHA’s general PPE standard (29 CFR 1910.132) expects the employer to assess the workplace for hazards, select the PPE, ensure proper fit and train each employee who must use it. The same section says an employer is not required to pay for everyday clothing such as long-sleeve shirts, long pants, street shoes and normal work boots, which is a payment rule rather than a definition of what counts as protective.

How protective clothing is built and classified

In the United States, medical gowns are regulated as medical devices. The FDA sorts them by intended use and risk, and recognizes the ANSI/AAMI PB70 liquid barrier performance levels, which grade a gown from Level 1 (minimal) to Level 4 (high). The class tells you how the device is regulated; the PB70 level tells you how much liquid protection it is rated to give.

Types and barrier levels

Gown types by FDA class

Type	FDA class	Intended use (FDA)
Surgical gown	Class II (510(k))	A personal protective garment worn by health care personnel during surgical procedures
Surgical isolation gown	Class II	Medium to high risk of contamination, with larger critical zones
Non-surgical isolation gown	Class I, exempt from premarket review	Protects the wearer from transfer of microorganisms and body fluids in low or minimal risk isolation

ANSI/AAMI PB70 liquid barrier levels

Level	Risk	Example settings listed by the FDA
Level 1	Minimal	Basic care, standard isolation, visitor cover
Level 2	Low	Blood draw, suturing, ICU, pathology
Level 3	Moderate	Arterial blood draw, IV insertion, emergency room, trauma
Level 4	High	Long, fluid-intensive procedures, surgery, suspected non-airborne infectious disease

For lab garments, see what a lab coat is and laboratory PPE categories. For the surgical garment in detail, see what a surgical gown is.

How to choose

The criteria below come from the OSHA standard and FDA gown guidance; nothing here replaces the manufacturer’s instructions for use or your facility’s policy.

• Start with a hazard assessment. OSHA 1910.132(d) says the employer shall assess the workplace to determine if hazards are present or likely to be present, then select and communicate the PPE and ensure proper fit.
• Match the gown to the risk. The FDA ties Level 1 to minimal-risk settings and Level 4 to long, fluid-intensive procedures; the same page separates surgical gowns, surgical isolation gowns and non-surgical isolation gowns by risk.
• Check what the precaution calls for. The CDC’s Transmission-Based Precautions guidance says to wear a gown and gloves for all interactions that may involve contact with the patient or the patient’s environment under Contact Precautions. For Droplet Precautions it says to don a mask on entry, and for Airborne Precautions a fit-tested NIOSH-approved N95 or higher-level respirator; gowns are not mentioned for those two.

Safe use and handling basics

• Put PPE on at room entry and discard it properly before leaving the patient room; the CDC says this is done to contain pathogens. The full order is in the PPE donning and doffing sequence.
• OSHA 1910.132(f) requires the employer to train each employee who must use PPE, covering when it is needed, what is needed, and how to use and care for it.
• For precautions that extend beyond isolation rooms, see enhanced barrier precautions.

Common mistakes

• Treating everyday clothing as protective clothing. OSHA’s payment exclusion for long sleeves and work boots does not make them a barrier garment.
• Choosing a gown by name alone. A non-surgical isolation gown (Class I) is for low or minimal risk; the FDA lists a different class and higher levels for surgical and fluid-intensive work.
• Assuming every precaution calls for a gown. The CDC’s Transmission-Based Precautions guidance calls for a gown under Contact Precautions but does not mention one for Droplet or Airborne Precautions.
• Skipping training. OSHA places the training duty on the employer wherever PPE is required.

FAQ

What is PPE clothing?

PPE clothing is protective clothing, such as a gown, worn to shield the wearer from a workplace hazard. In health care, the FDA describes medical gowns as protecting the wearer from the spread of disease-causing microorganisms on contact with potentially infectious material. Whether a garment counts as required PPE depends on the hazard assessment, not on the garment’s name.

Other single-use clinical supplies are listed under umbilical cord clamps.

Sources

• OSHA, 29 CFR 1910.132, General requirements (eCFR), checked 2026-10-29: https://www.ecfr.gov/current/title-29/subtitle-B/chapter-XVII/part-1910/subpart-I/section-1910.132
• U.S. FDA, Medical Gowns, checked 2026-10-29: https://www.fda.gov/medical-devices/personal-protective-equipment-infection-control/medical-gowns
• CDC, Transmission-Based Precautions (page dated April 3, 2024), checked 2026-10-29: https://www.cdc.gov/infection-control/hcp/basics/transmission-based-precautions.html