Isolation Gown Purchasing Guide: AAMI Levels, Materials, Cuffs and Case Counts

By Kevin Leoncio, Account Representative, Essential Cares Supplies, Inc.

Isolation gowns are easy to put on a purchase order and hard to compare. Two listings can both say "isolation gown" and still differ in liquid barrier level, fabric, fabric weight, cuff, closure, size and the number of gowns in a case. If the specification you send is vague, the quote you get back may not be the product you meant.

This guide covers what the FDA and the CDC's PPE-Info database say about gown types and AAMI PB70 levels, how to read the attributes on a gown listing, and how to normalize case counts before you compare quotes. It is a procurement guide. Which gown type and level a facility needs is a decision for that facility's own infection prevention and risk assessment process.

What FDA says about gown types

FDA's Medical Gowns page separates gowns into groups with different regulatory status. As the page describes them:

• Surgical gowns are regulated as Class II devices that require a 510(k) premarket notification.
• Surgical isolation gowns are also Class II and require a 510(k). FDA describes them as used "when there is a medium to high risk of contamination and a need for larger critical zones than traditional surgical gowns."
• Non-surgical isolation gowns are Class I devices, exempt from premarket review. FDA describes them as intended "to protect the wearer from the transfer of microorganisms and body fluids in low or minimal risk patient isolation situations."

The practical point for buyers: the words "FDA-cleared" apply to the Class II gown types that go through 510(k). A non-surgical isolation gown is exempt from premarket review, so a missing clearance number on that kind of gown is not by itself a red flag. What you want instead is a clear statement of intended use and, where your specification calls for it, a stated AAMI level.

FDA's page also advises that "when choosing gowns, look for product labeling that describes intended use with the desired level of protection." That is the labeling you should be asking suppliers for.

ANSI/AAMI PB70 liquid barrier levels

The standard is titled "Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities." The CDC's PPE-Info page describes it as a classification system based on liquid barrier performance that also specifies related labeling requirements and standardized test methods. The same page lists four test methods used under the standard: AATCC 42 (impact penetration), AATCC 127 (hydrostatic pressure), ASTM F1670 (synthetic blood penetration) and ASTM F1671 (viral penetration).

FDA's page describes the four levels, with example uses, as follows:

How to read a gown listing

Most of the confusion in gown quotes comes from attributes that are present on one listing and missing on another. This table shows what each attribute tells you and what to ask when it is absent.

Two gowns on ECSI's isolation gown page

ECSI's isolation gowns category currently lists two products. They are different gowns, and neither listing states an AAMI level.

Because the listings do not state a level, a buyer whose specification requires one should ask for the manufacturer's stated level and test documentation for the specific item before ordering. Do not infer a level from the color, the gsm or the material abbreviation.

Isolation gowns and disposable lab coats

FDA's Medical Gowns page covers surgical, surgical isolation and non-surgical isolation gowns. It does not discuss lab coats as a category, so there is no FDA level to read across from one to the other. What a buyer can verify is what each listing says.

ECSI catalogs lab coats separately from gowns. The listed lab coat is white, SMS, with a knit cuff, knit collar and no pocket, in several sizes, packed 10 per bag and 3 bags per case. The listing states no standard or fabric weight. The gowns above use tie closures instead of a collar.

The procurement rule is simple. If your specification calls for a gown with a stated AAMI level, a lab coat listing that states none does not meet it. If your specification calls for a lab coat, a tie-back gown is a different product. Ask the manufacturer for the labeled intended use of each item and keep that documentation with the purchase record.

Normalizing case counts

The same demand can require a different number of cases depending on how a gown is packed. The example below is illustrative and hypothetical: the usage and prices are round numbers, not ECSI prices.

Assume a facility uses 20 gowns a day and wants four weeks of supply (560 gowns).

Option B has the lower case price and the higher cost per gown. Both round up to 600 gowns, so you also have to decide whether the extra 40 gowns are acceptable storage. Before you compare any two quotes, convert both to cost per gown. The UOM and case-pack conversion guide walks through that normalizing step for each, bag, box and case.

This math only compares price once the gowns themselves meet your specification. Two gowns that differ in level, fabric or size are not comparable on cost alone.

Common mistakes

• Treating gsm as a protection level. Weight describes the fabric. The level comes from the manufacturer's stated PB70 classification.
• Ordering "isolation gown" without naming the level, cuff, closure and size, then receiving a different gown on the next order.
• Comparing case prices when the cases hold 50 and 100 gowns.
• Assuming a lab coat and an isolation gown are interchangeable because both are disposable and made from similar-sounding fabrics.
• Switching gown sources without sending staff a sample, then finding the size run or cuff does not suit them.
• Filing a gown purchase without the supplier's documentation of the stated level.

Questions to ask a supplier

1. What AAMI PB70 level does the manufacturer state for this exact item, and can you provide the test documentation?
2. Is the gown labeled as a non-surgical isolation gown, a surgical isolation gown or something else? If Class II, what is the 510(k) number?
3. What is the fabric construction, and is the stated weight for the whole gown?
4. What are the size dimensions, and which sizes are available?
5. What are the cuff and closure types?
6. How many gowns are in each bag and each case, and can the quote show cost per gown?
7. If this item becomes unavailable, what documentation will you need from us to review another source?

Where this fits in the wider supply plan

Gowns are one of several recurring disposables that long-term care and other institutional buyers plan together. The skilled nursing facility disposable supply purchasing guide shows how gowns sit next to gloves, underpads and wipes in a par plan. If a gown has to be replaced, use the product equivalency and substitution checklist rather than matching on appearance. For the broader picture of how ECSI approaches availability and alternate sourcing, see From Pressure to Planning.

Frequently Asked Questions

Sources

• FDA: Medical Gowns (gown types, device class, 510(k) status, PB70 levels and example uses, labeling advice)
• CDC PPE-Info: ANSI/AAMI PB70 standard details (standard title, scope, test methods)