The information given on this page is provided as a guide to the American regulations and certification for surgical gowns and drapes, so importers can make better and safer choices when choosing Chinese suppliers and products.
Page last updated: 6/15/20
1. What are surgical gowns and drapes?
Surgical gowns are a type of protective clothing used in healthcare environments such as hospitals or clinics. They are technically ‘PPE used for infection control.’
They are a type of clothing that covers the wearer’s body and forms a protective barrier against potentially infectious solids or liquids.
You may recognise them as looking something like this (although there are a number of styles):
Surgical gowns will be worn with gloves, face masks, head coverings, and perhaps face shields as part of an infection control strategy for medical staff.
The gowns being imported from China and elsewhere are typically disposable and made from splash-proof fabric or similar types of materials, although cloth gowns also exist and are reusable as long as they are laundered in accordance with hospital best practices after use.
Surgical gowns may also be known as ‘medical gowns, isolation gowns, surgical isolation gowns, nonsurgical gowns, procedural gowns, and operating room gowns.’ So be aware of these names when sourcing them, because product names for this type of PPE are not standardized.
Applicable product codes for gowns are:
- Surgical gowns (FYA)
- Isolation gowns and surgical apparel accessories (FYC, LYU, OEA)
Again, knowing these codes will help buyers when sourcing products as they may be referred to by suppliers.
Surgical drapes are shaped fabric covers which are commonly used to cover a patient during surgical or medical procedures.
Whereas gowns are designed to be worn over the body for protection, drapes cover the patient protecting them from infectious materials and also providing some protection for others from bodily fluids emitted during the procedure. The similarities lie not in design, but material – surgical drapes usually use the same kinds of material as gowns, which is why the performance testing for FDA-regulation is the same.
You can see an operating room scene with surgical drapes in use below:
2. Types of surgical gowns
Medical gowns are usually classified based on their liquid barrier protection levels or ‘AAMI rating’ (based on ANSI/AAMI PB70:2012, one of the standards they are to adhere to) and can be placed into 2 categories:
- Level 1: Minimal risk, to be used, for example, during basic care, standard isolation, cover gown for visitors, or in a standard medical unit
- Level 2: Low risk, to be used, for example, during blood draw, suturing, in the Intensive Care Unit (ICU), or a pathology lab
- Level 3: Moderate risk, to be used, for example, during arterial blood draw, inserting an Intravenous (IV) line, in the Emergency Room, or for trauma cases
- Level 4: High risk, to be used, for example, during long, fluid intense procedures, surgery, when pathogen resistance is needed or infectious diseases are suspected (non-airborne)
The AAMI rating should appear on the gown’s packaging and label – if the gown does not have an AAMI rating displayed, check with the supplier, but be wary about whether this gown is FDA-compliant and, therefore, safe for its nominated purpose.
This table from the FDA guide on medical gowns gives more detail on gown types:
The CDC also provides this guidance on selecting the correct PPE for different uses.
3. Surgical gown and drapes standards & testing requirements
‘Non-surgical gowns’ are Class I devices FDA-regulated under 21CFR812.2 (exempt from 510 (k) premarket review) intended to protect the wearer from the transfer of microorganisms and body fluids in low or minimal risk patient isolation situations. Non-surgical gowns are not worn during surgical procedures, invasive procedures, or when there is a medium to high risk of contamination.
‘Surgical gowns’ and drapes used in moderate to higher-risk healthcare situations are Class II medical devices FDA-regulated under 21CFR812.2 (the same as surgical face masks) and do require a 510(k) Premarket Notification Clearance before they are FDA-cleared and can be imported in the USA.
They are all tested according to the ASTM F2407 – 06(2013)e1 Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities and focuses on tear resistance, seam strength, lint generation, evaporative resistance, and water vapor transmission.
Here are the tests to be undertaken (for gowns and drapes):
- Tensile Strength: ASTM D5034 (grab test), ASTM D1682 (withdrawn 1992)
- Tear resistance: ASTM D5587(woven or nonwoven), ASTM D1424
- Seam Strength: ASTM D751-19 (stretch woven or knit)
- Lint Generation: (ISO 9073 Part 10)
- Water vapor transmission (breathability): ASTM F1868 Part B, ASTM D6701 (nonwoven), ASTM D737
- Liquid barrier performance: ANSI/AAMI PB70:2003 describes liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities
- Biocompatibility: (ISO 10993) the gowns are in contact with skin, so this standard assesses their potential ability to irritate the wearer’s skin
Gowns and drapes may be sold as ‘sterile,’ and if that is the case, information about their sterility must also be included in the 510 (k) clearance. This will include detailed information about sterilization methods used, the packaging’s ability to retain item sterility, and more.
Other FDA requirements
The importer will provide a description of the gown or drapes, including:
- Specifications and dimensions
Product labeling and warnings
According to FDA 21 CFR 801, correct labelling includes:
- Name and place of business of manufacturer, packer or distributor.
- Meaning of intended uses.
- Adequate directions for use.
- Misleading statements.
- Prominence of required label statements; use of symbols in labelling.
- Spanish-language version of certain required statements.
- Format of dates provided on a medical device label.
Quality Management System
Surgical gown and drapes manufacturers are expected to conform to the FDA’s Good Manufacturing Practices (GMP). In 21 CFR 820, they lay out their expectations for the manufacturer’s quality system which cover:
- Quality policy
- Responsibility and authority
- Management representative
- Management review
- Quality planning
- Quality system procedures
Essentially, making and importing PPE necessitates a relevant and appropriate quality management system, and this is checked as part of FDA certification.
5. FAQs when importing surgical gowns and drapes into the USA
No. Before placing an order, you need to check whether the vendor is authorized to export the products you’re buying before paying for an order. The consequences of not doing so may be that you pay for an order which China Customs will not allow to be exported.
The regulations are changing almost daily right now, therefore please check for new guidelines before exporting from China.
Here’s what we know, although the situation is changing rapidly. To reduce the chances of poor quality medical devices and PPE being shipped out of China, since April 1st 2020 the authorities there now demand the following:
- The medical supplies must hold a PRC Medical Device Product Registration Certificate.
- The registration number for the supplies must be provided to China Customs as a prerequisite for export.
Only better-established Chinese vendors can provide this information, therefore it will reduce supply, but also stop many newer exporters from providing supplies which may not be up to standard.
On April 10th the Chinese government went further, announcing that China Customs will be checking the quality of medical supplies bound for export, including face masks, PPE, ventilators, disinfectant, etc. This is bound to slow down the process.
Summary (as of 21st April)
- Your supplier must be officially licensed in China to manufacture the product.
- They must be authorized to export that product from China (the requirements surrounding this are changing rapidly, but it includes most MD & PPE face masks).
- The paperwork submitted to China Customs must be 100% correct and double-checked (they are scrutinising it strictly for errors or inconsistencies).
- The product must be of good quality and not counterfeit (they are checking quality at the border).
- The importing country is legally permitted to receive such items (see the EU’s declaration about permitted non-conforming foreign medical supplies here).
Probably not. Due to the demand, testing labs are swamped and are giving lead times of several months for certain tests. During the coronavirus pandemic when you need goods now, running new lab tests is probably unrealistic.
Even if you can’t run new lab tests, you can focus on paperwork, auditing, and inspections to reduce risks:
- Due diligence on suppliers before placing orders – are they legitimate manufacturers, are they legal?
- Certificate verification – is their certification real? Are the documents they provide for the correct products?
- Factory audits – this may be more effective if you are placing very large orders (millions of pieces), but they will allow you to know that the factory is capable of producing the products you need at the right standards.
- Product inspections – gives you the security that your products are good quality before they are shipped.
Yes, some of the usual regulations outlined on this page have been loosened temporarily.
The FDA states:
FDA does not intend to object to individuals’ distribution and use of
improvised PPE when no alternatives, such as FDA-cleared gowns, other surgical apparel, and/or gloves, are available.
To define ‘improvised PPE,’ this would seem to suggest PPE that adheres to other countries’ standards for the same type of gown, but not those of the USA.
For Non-surgical Gowns and Minimal-to-Low Barrier Protection
Surgical Apparel they say:
To help foster the availability of these types of gowns and apparel during
the COVID-19 public health emergency, FDA does not intend to object to the distribution and use of gowns not intended for use as “surgical gowns” and other low-to-minimal barrier protection surgical apparel that does not comply with the following regulatory requirements where the gowns and apparel do not create an undue risk in light of the public health emergency: Registration and Listing requirements in 21 CFR 807, Quality System Regulation requirements in 21 CFR 820, reports of corrections and removals in 21 CFR Part 806, and Unique Device Identification requirements in 21 CFR Part 830 and 21 CFR Part 801.20.
For Moderate-to-High Barrier Protection Surgical Gowns they say:
To ensure the availability of these types of surgical gowns during the COVID-19 public health emergency, FDA does not intend to object to the distribution and use of ANSI/AAMI PB70 Level 3 moderate-to-high barrier protection surgical gowns that do not comply with the following regulatory requirements, where such surgical gowns do not create an undue risk in light of the public health emergency: Prior submission of a premarket notification under section 510(k) of the FD&C Act and
21 CFR 807.81,20 Registration and Listing requirements in 21 CFR 807, and Unique Device Identification requirements in 21 CFR Part 830 and 21 CFR 801.20. FDA currently believes such devices would not create such an undue risk where:
• The product:
• Meets liquid barrier protection at Level 3 or higher, consistent with ANSI/AAMI
PB70 for the critical zone areas;21
• Meets the Class I or Class II flammability standard per 16 CFR Part 1610; and
• Has been demonstrated to be sterile if intended for use in surgical settings.2
The product includes labeling that accurately describes the product’s sterility status (sterile or
non-sterile), including any sterilization method used, barrier protection as Level 3,
flammability classification (Class I or Class II), and a list of the body contacting materials;
• The product includes labeling with general statements and makes recommendations that
would sufficiently reduce the risk of use, for example, a general statement about devices that
have not been cleared by FDA, recommendations against use when FDA-cleared surgical
gowns are available, and recommendations against use of non-sterile products in surgical
• 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; uses for infection prevention or reduction; or is labeled as having
ANSI/AAMI PB70 Level 4 liquid barrier protection.
Yes, they provide the following resources that you may find useful.
- Considerations for Selecting Protective Clothing used in Healthcare for Protection against Microorganisms in Blood and Body Fluids outlines the scientific evidence and information on national and international standards, test methods, and specifications for fluid-resistant and impermeable gowns and coveralls used in healthcare.
- ANSI/AAMI PB70:2012 is the standard describing the liquid barrier performance and classification of surgical and isolation gowns for use in health care facilities.
The category of the gown to use depends on the environment it is to be worn in.
The CDC states:
- If there is a medium to high risk of contamination and need for a large critical zone, isolation gowns that claim moderate to high barrier protection (ANSI/AAMI PB70 Level 3 or 4) can be used.
- For healthcare activities with low, medium, or high risk of contamination, surgical gowns (ANSI/AAMI PB70 Levels 1-4), can be used. These gowns are intended to be worn by healthcare personnel during surgical procedures.
Sofeast’s indemnity and notes for the reader
- We are not legal professionals and any information provided here about the regulations and standards is only given for your reference. We do not accept responsibility for any issues you may face after using this information.
If you are unsure about the validity of your products, please refer to the FDA’s official documentation, an accredited testing body, or a local legal professional for assurance before importing PPE from China to the USA.
- This page will be updated periodically as we find useful new information. If you have a suggestion for a change or an addition, please contact us.