Buyers in India and beyond are racing to find surgical masks, face shields, goggles, gloves, body suits, thermometers, respirators, and laboratory and ICU equipment fast without compromising quality. In today’s article, we’ll be focusing on personal protective equipment (PPE) – masks, gloves and other protective clothing.
PPE represents a relatively non-specialized product category compared to other kinds of medical supplies, which means that it is an accessible category for buyers who have experience in sourcing and imports but don’t necessarily have a background in medical products. The products discussed below do not, at the time of writing, fall under the designated categories for ‘medical devices’ that require a wholesale license and/or manufacturing license issued under India’s Drugs and Cosmetics Act.
Product quality is paramount at any time when it comes to medical products, but in the pressure of a crisis situation, the urge to move fast and take risks becomes acute. As a responsible sourcing professional, resist this urge. The National Institute for Occupational Safety and Health (NIOSH), which is responsible for conducting research and making recommendations for the prevention of work-related injury and illness in the United States, identifies three key “pitfall” scenarios when sourcing full-face respirators (FFRs) – and these also apply to other medical supplies:
The three most common “pitfall” scenarios include:
- Documents are altered so [products] appear to comply with a particular standard, but they do not.
- Certification marks are counterfeit.
- Manufacturers’ names, logos, and model numbers are counterfeit.
It is also worth noting that protective gear, particularly disposable masks, may be adversely affected by inhospitable environments such as high humidity. For this reason, ensure that your supply chain follows the manufacturers’ recommendations regarding proper storage.
Masks are for everyone: medical-grade masks are in high demand for health professionals, but these and other types are needed by people in all walks of life during the pandemic.
Surgical masks are single-use items (and not to be shared between people) and may be labeled as surgical, isolation, dental, or medical procedure masks. Studies have shown that when used properly, surgical masks can prevent infections transmitted by respiratory droplets.
Most surgical masks use a three-layer design that includes an outer fluid-repelling layer, a middle layer serving as a barrier to germs, and an inner moisture-absorbing layer. According to the Hong Kong Centre for Health Protection, masks without this three-layer design are not recommended as they cannot provide adequate protection.
An N95 respirator is a respiratory protective device designed to achieve a very close facial fit and very efficient filtration of airborne particles. The edges of the respirator are designed to form a seal around the nose and mouth. According the the US CDC, “surgical N95 Respirators are commonly used in healthcare settings and are a subset of N95 Filtering Facepiece Respirators (FFRs), often referred to as N95s.” An authentic N95 respirator is marked with the text “NIOSH” or the NIOSH logo, the filter class (“N95”) and a “TC” approval number. The approval number must be listed on the NIOSH Certified Equipment List (CEL) or the NIOSH Trusted-Source page, and it must have headbands instead of ear loops.
For more information on the differences between surgical masks and N95 respirators, see the CDC’s infographic.
When sourcing N95 respirators intended for COVID-19 protection, do not procure those equipped with an exhalation vent. While the wearer will still be protected against airborne particulates, the exhalation vent allows them to breathe out unimpeded, which is more comfortable for the wearer but undermines the mask’s other purpose of preventing the wearer from infecting people around them.
KN95 respirators are similar to N95 but made to Chinese national specifications and standards. Like N95 respirators, they are rated to filter out 95% of very small particles. Be aware that many face masks marketed as KN95 are fake: NIOSH has found that around 60% of KN95 respirators it assessed in 2020 were using counterfeit branding and did not meet standards. Stringent quality control is a must for any product, but KN95 masks particularly so. Make sure you have stringent quailty control and only source from verified suppliers.
Due to the special nature of the pandemic, NIOSH has conducted testing on a number of KN95 respirators, which you can find here.
Less effective than three-layer surgical masks at blocking airborne particles, cloth masks are not generally recommended as protective items. However, cloth masks are more comfortable to wear for many people, so you may find it worth seeking out cloth masks that are designed with a gap between the inner and outer layers – these allow the wearer to slide a disposable surgical mask in between them, giving the protective benefits of the disposable mask, but with the more comfortable cloth masks directly against their face. These are also available in a wide variety of colors and patterns, letting people express themselves and stand out in a masked crowd.
As with N95 respirators, if you are sourcing cloth masks intended for COVID-19 protection, do not procure those equipped with an exhalation vent.
There are two main types of medical gloves: examination and surgical. Surgical gloves have more precise sizing, provide better sensitivity to the wearer, and are made to a higher standard. Examination gloves are available as either sterile or non-sterile, while surgical gloves are generally sterile.
The standard medical glove for decades, latex gloves are the most comfortable to wear and allow the greatest dexterity. They are durable and biodegradable. However, they have a relatively short shelf-life (less of a concern now, perhaps, when demand is so high), are more difficult to put on and take off than gloves made from other common materials, and many people are allergic. Latex allergies affect around 6% of the general population, but 9.7% of healthcare works globally, according to research in the Journal of Occupational Health. Because of this, you should consider supplementing your sourcing of latex gloves with a complementary order of gloves made from latex-free materials.
Vinyl is the lowest-cost material commonly used to make medical gloves. Vinyl gloves have a long shelf-life, are inherently anti-static, and are easy to put on and take off. Their disadvantages are that they often start to sag and get wrinkles, offer low sensitivity and precision for the wearer, and are less environmentally friendly.
Given the choice of latex-free gloves, most medical professionals would likely choose nitrile gloves. They are comfortable, allow high dexterity and sensitivity, and are the most durable of the three types, being puncture-resistant and offering a long shelf-life and wear time. They are also resistant to many common corrosive chemicals. They are biodegradable and, where suitable facilities exist, recyclable.
The disadvantage of nitrile gloves is higher cost. Nitrile gloves begin life as latex rubber, just like normal latex gloves. This is then reprocessed into nitrile compound material, which removes all the latex proteins. This extra step is what takes away the allergy issue but also adds to the production cost.
Gowns are a kind of personal protective equipment used in healthcare settings, protecting the wearer’s body, arms and upper legs from potentially infectious liquid and solid material. Unfortunately for sourcing professionals, there is limited standardization in how gown types are named. The descriptions below are typical definitions, but you should look for product labeling that describes the gown’s intended use according to desired level of protection.
The US CDC defines risk levels as follows, which may provide a useful benchmark:
- 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)
A surgical gown is a personal protective garment intended to be worn by healthcare personnel during surgical procedures to protect both them and the patient from the transfer of microorganisms, body fluids, and particulate matter.
Surgical isolation gowns are used when there is a medium to high risk of contamination and a need for larger critical zones than traditional surgical gowns. All areas of a surgical isolation gown except the bindings, cuffs, and hems are considered critical zones of protection and must meet the highest liquid barrier protection level for which the gown is rated. All seams must have the same liquid barrier protection as the rest of the gown. Additionally, the fabric of the surgical isolation gown should cover as much of the body as is appropriate for the intended use.
Non-surgical gowns are intended to protect the wearer from the transfer of microorganisms and body fluids in low or minimal risk situations. Non-surgical gowns are not worn during surgical procedures, invasive procedures, or when there is a medium to high risk of contamination.
Shoe covers are worn to control contamination carried on people’s feet. The two most common materials are polypropylene and cast polyethylene (CPE)
Polypropylene is a low-cost material, although because it tears easily this is not suitable for a shoe cover intended to be worn on rough surfaces, or in a critical clean air environment – microscopic particles shed from the material can interfere with delicate precision equipment.
Polypropylene shoe covers are also available with a polyethylene coating. According to New Zealand-based firm Fine Touch disposables, this creates a more durable item and affords some protection against the moisture-absorbing property of the polypropylene. However, because polypropylene and polyethylene have different material strengths, this type of shoe cover can delaminate during extended wear.
Cast polyethylene (CPE) is a strong, durable material and does not shed particles, like polypropylene does, so CPE shoe covers can be worn in critical clean air environments.
Some considerations when sourcing shoe covers:
If sourcing for professional healthcare settings you will typically require non-slip soles. However, standard covers may be acceptable for more domestic uses such as for care homes. The smooth surface of polypropylene provides very little grip for a shoe cover worn on slippery surfaces. This can be remedied with a painted tread on the sole, known as an anti-skid sole.
If your end-user is dealing with liquids, yo9u will want to look for water-resistant shoe covers. Healthcare workers in particular require fluid-resistant covers to protect their footwear and to mitigate the risks of contamination. Polypropylene is not waterproof and absorbs moisture, making it unsuitable for wet environments. CPE is waterproof and should be your first choice when sourcing shoe covers for healthcare usage.
Fields such as healthcare and childcare need to guard rigorously against cross-contamination, which means wearers must frequently change shoe covers when they move from one sterile environment to another. While little can be done about that in terms of the design of the shoe covers themselves, you may consider sourcing shoe cover dispensers or automatic shoe cover removers.