Another essential PPE item in high demand during the coronavirus pandemic in the USA are medical gloves. We’ve collected information on this page to guide American importers through the regulations and certification for medical gloves, so you can be aware of the compliance of products you’re attempting to source and import into the USA from China.
Page last updated: 6/15/20
1. Medical gloves for use as PPE
Medical gloves are just one of the items of PPE that make up a full infection-control outfit, along with surgical gowns, face masks, and other items like face shields, too.
They protect both the wearer and patients from infection by covering the wearer’s hands and not allowing contact between them and potential sources of infection (such as bodily fluids and secretions) or vulnerable patients.
These gloves are typically:
- Single-use disposable items.
- FDA-regulated as Class I reserved medical devices that require a 510(k) premarket notification.
- Assessed on their performance in leak resistance, tear-resistance and biocompatibility.
- Either sterile or nonsterile – both can be used in medical environments depending on the application.
Medical gloves in the USA may also be known as ‘examination gloves,’ ‘surgical gloves,’ and ‘chemotherapy gloves.’ These may have some differences in application and requirements, so be aware of what the gloves are labeled as before purchase.
Most people are familiar with them being blue, but they can be found in different colors, such as white, clear, and purple too.
2. What are medical gloves made of?
Medical gloves are made from the following materials:
- Natural rubber latex
- Polyvinyl chloride (PVC)
- Vinyl
- Nitrile
- Polyurethane
The material will be displayed on the box, and gloves for medical use are not powdered.
You may find this document from the CDC helpful as it provides guidance on selecting the correct PPE for different uses.
3. The FDA’s process for importing medical gloves to the USA
Medical gloves are class I reserved devices and are subject to general controls (section 513(a)(1)(A) and 510(l)(1) of the Federal Food, Drug, and Cosmetic Act (Act); 21 U.S.C. 360c(a)(1)(A)), which include:
- Establishment Registration
- Device Listing (CFR 21 807) – this instructs importers how to register and list their medical device
- Premarket Notification 510(k) – this will include performance testing information, amongst other things
- Labeling requirements (21 CFR 801) and (21 CFR 801.437 for products containing natural latex)
- Quality System (21 CFR 820)
- Medical Device Reporting (MDR) – reporting of adverse events associated with a medical device.
In addition, foreign firms must name a U.S. Agent (21 CFR 807.40).
4. Performance testing for medical gloves
You can see the standards, including performance tests, for the different glove types imported into the USA here:
1- ASTM D3577 – 19 Standard Specification for Rubber Surgical Gloves
2- ASTM D3578-19 Standard Specification for Rubber Examination Gloves
3- ASTM D5250 – 19 Standard Specification for Poly(vinyl chloride) Gloves for Medical Application
4- ASTM D6319 – 19 Standard Specification for Nitrile Examination Gloves for Medical Application
Medical gloves of different types will generally adhere to the following standards in order to gain FDA certification:
- ASTM D5151 – 19 Standard Test Method for Detection of Holes in Medical Gloves – determines the barrier evaluation of gloves by visual and leak test procedures on them.
- ASTM F1342 / F1342M – 05(2013)e1 Standard Test Method for Protective Clothing Material Resistance to Puncture – determines the puncture resistance of the gloves by measuring the force required to cause a sharp-edged puncture probe to penetrate through them.
- ASTM D3767 – 03(2014) Standard Practice for Rubber—Measurement of Dimensions (in millimetres) – for example, patient examination gloves must be a minimum of 220mm-230mm depending on glove size and material type.
- ASTM D412 – 16 Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension (including elongation)
- ASTM D573 – 04(2019) Standard Test Method for Rubber—Deterioration in an Air Oven – the gloves are conditioned in an oven at 70 ± 2°C for 166 ± 2 hours and their deterioration is then assessed.
- ASTM D6124 – 06(2017) Standard Test Method for Residual Powder on Medical Gloves (including powder-free residue) – gloves are rinsed with water, the water is filtered, and then the filter weight is measured against its original weight in order to see the weight of powder residue left behind by the gloves.
- ASTM D5712 – 15 Standard Test Method for Analysis of Aqueous Extractable Protein in Latex, Natural Rubber, and Elastomeric Products Using the Modified Lowry Method (if applicable, such as with gloves made from natural rubber)
- Whole glove viral barrier (NFPA1999)
- Assessed for biocompatibility via ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process”
In addition, they will also adhere to the NFPA 1999 standard for physical properties which uses some of the same types of tests as above but with different parameters.
There are more performance standards which you can see here, however, they can vary based on glove type, so it is best to refer to the glove types outlined in the four standards at the top of this section in order to understand which testing your chosen medical gloves must undergo for FDA approval.
5.Types of medical gloves
The following medical gloves are commonly used in healthcare settings in the USA. The difference is that the 2 types are either non-sterile or sterile, with the latter being used more specifically in the operating theatre.
1.Patient examination gloves
Regulated under 21 CFR 880.6250 Patient examination glove.
- A patient examination glove is a non-sterile disposable device intended for medical purposes that is worn on the examiner’s hand or finger to prevent contamination between patient and examiner.
- Class I Device (general controls).
- Not sold as sterile unless specifically stating so.
2.Surgeon’s glove
Regulated 21 CFR 878.4460 Surgeon’s glove.
- A surgeon’s glove is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. This excludes the lubricating or dusting powder used in the glove.
- Class I Device (general controls).
- Subject to the design control requirements of the Quality System regulation (21 CFR 820.30(a)(2)(ii)).
- Always sold as sterile – information about the sterilizer and method will be included in the 510(k) Premarket Notification.
There are other types of medical gloves in the USA, such as ‘chemotherapy gloves’ or ‘autopsy surgeon’s gloves,’ or ‘dental surgeon’s gloves.’ These are, mainly, regulated and tested in the same way as examination or surgeon’s gloves.
In addition, there are non-medical gloves such as ‘embalming gloves,’ or ‘food service gloves.’ These are not medical devices, so be aware to not import these for use in medical settings fighting COVID-19.
Read more about these in the FDA medical glove guidance manual, if you like.
5. Medical gloves FAQs
It is possible to search the 510(k) Premarket Notification database using the correct product codes for the medical gloves you’re sourcing to see a list of suppliers who are FDA-approved for use in the USA.
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.
The laboratory tests for Chinese standards should be performed by a lab that is listed in this directory and is authorized for this kind of product.
No, but it will go a good way. It is still important to check whether the supplier truly holds these certifications with the issuing bodies and also continually check product compliance and quality through factory auditing and product inspections.
Yes. They have reduced restrictions on medical gloves as long as their use does not create undue risk. Certain regulations (see section 3) do not need to be followed for the time being.
Regarding patient examination gloves, the FDA says:
The FDA does not intend to object to the distribution and use of patient examination gloves that do not comply with the following regulatory requirements, where the gloves 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 807.81,26 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 801.20. FDA currently believes such devices would not create such an undue risk where:
- The product includes labeling that accurately describes the product as an “unpowdered glove” (as opposed to a surgeon’s or patient examination glove), accurately describes its sterility status when individually packaged (non-sterile), does not claim the product as being free of a specific material (e.g., latex free), and includes a list of the body contacting materials;
- The product includes labeling with general statements and makes recommendations that would reduce sufficiently the risk of use, for example, a general statement about devices that have not been cleared by FDA and recommendations against use: when FDA-cleared gloves are available, in surgical settings or where significant exposure to liquid bodily or other hazardous fluids may be expected, and in clinical settings where the infection risk level is high.
Regarding surgeon’s gloves, the FDA says:
The FDA does not intend to object to the distribution and use of surgeon’s gloves that do not comply with the following regulatory requirements where the surgeon’s gloves 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 807.81,31 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 the standard specification consistent with the consensus standard ASTM D3577: Standard Specification for Rubber Surgical Gloves;
The product includes labeling that accurately describes the product as being unpowdered, accurately describes its sterility status (sterile) and the sterilization method used…
According to the CDC, non-sterile patient examination gloves are appropriate for healthcare workers. Read the CDC guidance for COVID-19 infection control.
Read the CDC shares the sequence for putting on and taking off PPE here.
The Chinese standards for medical gloves are ‘YY/T 0616 Disposable Medical Gloves’ and ‘YY/T 0615 Requirements for medical devices to be designated STERILE’ (in the case of sterile gloves).
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.
