Labeling of gowns: Per the FDA Enforcement Policy for Gowns, Other Apparel, and Gloves During the Coronavirus Disease (COVID-19) Public Health Emergency there are labeling requirements (please review the guidance in its entirety). For example these requirements from Section C. Non-surgical Gowns and Minimal-to-Low Barrier Protection Surgical Apparel (additional information can be found in the link above): 

• The product includes labeling that accurately describes the product as a “gown,” or “toga,” or other apparel (as opposed to a “surgical gown,” or “surgical toga”) and includes a list of the body contacting materials (which does not include any drugs or biologics);
• The product includes labeling that makes recommendations that would reduce sufficiently the risk of use, for example, recommendations against: use in a surgical setting or where significant exposure to liquid bodily or other hazardous fluids may be expected, use in a clinical setting where Level 3 or 4 protection is warranted, and use in the presence of high intensity heat source or flammable gas; and
• The product is not intended for any use that would create an undue risk in light of the public health emergency, for example, the labeling does not include uses for antimicrobial or antiviral protection or related uses or uses for infection prevention or reduction or related uses.

Sewing: Sewing with household machines can be leveraged within most communities to make gowns for local medical facilities. It has the advantage of utilizing equipment and skill sets that are common. It has the disadvantage of being the most labor-intensive approach to gown production and is not suitable for some types of materials. This method is not recommended for single-use items because of the amount of work it takes to sew a gown. Further, repetitive gown production on a non-industrial sewing machine may lead to machine fatigue.

Industrial sewing: Sewing using industrial-grade equipment greatly increases production efficiency but requires specific tooling and pattern file types. This method has the potential to meet higher volume facility needs but may take time before it can be put into place. 

CNC router: Often paired with industrial sewing or other industrial production. Certain types of CNC routers can greatly increase cutting efficiency in gown production.  

Seam bonding: Often used in conjunction with industrial production of gown materials. Seam bonding greatly increases the barrier protection a gown offers at the seams. Some nonwoven plastics cannot be sewn and must be seam sealed. 

Sewing + Seam bonding: Washable woven gowns should be sewn and seam bonded if possible for the combined durability of sewn seams and the liquid barrier properties of seam bonding. 

US Standards
Liquid barrier protection is a key consideration for the effective use of gowns. The US ANSI/AAMI PB70 sets forth classifications and requirements for ranking liquid barrier protection in personal protective gowns.

Brief Summary of FDA description of the ANSI/AAMI PB70 standard regarding gown protection levels

The ANSI/AAMI PB70 barrier protection standard is a broad standard that governs the protection level of the garment and guidelines for labeling requirements. A free copy of the standard can be obtained through the AAMI store [ANSI/AAMI PB70:2012]. 
Summary of the testing covered in the PB70
Level 1: AATCC 42 impact test (less than 4.5g gain)
Level 2: AATCC 42 impact test (less than 1g gain) and AATCC 127 Hydrostatic test (20 cm pressure
Level 3: AATCC 42 impact test and AATCC 127 Hydrostatic test (50 cm pressure)
Level 4: ASTM F1671 simulated blood and virus particle tests (a free copy can be found in their COVID reading room)

Analog Tests to the AATCC 42 and AATCC127
In an effort to support rapidly assessing estimated protection levels of various materials that a producer might have available for gown making analogs to the official tests have been developed by the Future Forge Makerspace. These tests have not been approved by any governing body, OSMS, or the Future Forge for defining protection levels and should only be used by producers and/or medical facilities when no official testing data is available and used at their own risk. The summary of the tests and test analogs can be found here. 

Selecting a Design and Material
It is highly recommended that makers/manufacturers work with medical facilities when selecting which designs and materials to use in the production of protective gowns. The selections will be dependent on what manufacturing techniques are available, which materials are available, and which designs will be accepted by facilities. 

Simplified Design and Material Selection Flowchart 

Gown Material
Due to the crisis PPE needs, many facilities turned to using Tyvek Housewrap for gown making as it was the only protective material available in bulk. Clinical feedback has determined that Tyvek Housewrap is unsuitable for a gown construction as it doesn’t drape well, makes noise, is bulky, and is difficult to wear. Furthermore, DuPont has recommended it not be used for PPE construction as it is not graded for that purpose. To learn more about Tyvek-related products and their PPE indications, click here. To find a DuPont distributor, follow this link. Research facility material choices before using House wrap for isolation gown construction.

Materials List

DuPont 1222A

• A new DuPont PPE grade fabric as of 4/21/2020. Recommended material for reusable protective gowns, provides excellent barrier protection, durability, and comfort.
• Sewable
• Seamseal
• washable

Ripstop Nylon or Woven Polyester

• Highly variable performance, should be tested and evaluated on site. Should be commercially treated with DWR (Durable Water Repellent) to make it impervious to fluid.
• Sewable
• Seamseal
• Washable

TyVek House wrap

• Use is not recommended, offers low (approximately level 1 or 2) protection but is considered too uncomfortable and noisy for use (except under the most dire circumstances).
• Sewable
• Seamseal
• Not Recommended

Polyethylene film

• excellent material for disposable gowns. Quality, cost, and thickness vary widely and should be evaluated on site.
• Seamseal

Non-woven polypropylene

• Also known as landscaping fabric, the same type of material commonly used in medical protective garments.  Non-woven polypropylene does have liquid barrier properties but is generally marketed as stopping plant growth but allowing water to pass through which is not ideal for protective garments.  Potentially a suitable material but should be evaluated on site.
• Sewable
• Seamseal
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Gown Materials Resource Links
1 mil or 2 mil Plastic sheeting
US-based non-woven fabric manufacturers
MMI Textiles Has an entire non-woven, US-made production line
List of medical fabric producers Note the supply chain classification columns. Not every producer will be gown fabric related.
Landscaping Fabric Many of these products have an ASTM specification sheet
TyvekTogether and Material Request Form DuPont release of new PPE-grade material, 1222A, available for purchase to the general public.