Should the Ban on a Specific Type of PPE Glove Worry Pharmaceutical, Electronic, and Packaging Manufacturers?

The Food and Drug Administration (FDA) acted upon long-standing evidence that surgical gloves with cornstarch coatings are not safe for use. Manufacturers of devices, pharmaceuticals, electronics, and consumer-facing products or packaging should heed the warning.

The new regulation effective January 19th, 2017 halts the sale, distribution, and manufacturing of all “powdered surgeon gloves, powdered patient examination gloves, and absorbable powders used to lubricate surgeon’s gloves.” These regulations impact the healthcare industry with maximum health benefits without reducing access to proper personal protective equipment (PPE). Despite pharmaceutical, food, packaging, and electronics industries being unaffected by these new regulations, ensuring the safety of employees and customers with proper PPE gear requires thoroughness.

The FDA determined that the risk of powdered surgeon and patient examination gloves is “unreasonable and substantial” for medical professionals, but the health risks don’t end in ultra-clean and sterile operation room environments. The negative impact of powder-based lubricants requires scrutiny in any environment is well documented, especially when combined with hyper-allergenic materials like latex.

The risks associated with the use of latex and cornstarch based gloves within distribution, manufacturing, and preparation facilities occur when natural latex proteins and cornstarch particulate become infused and airborne. Mucous membranes intercept the particles, thus inducing an allergic reaction for susceptible immune systems. Allergic reactions caused by latex include Type I (anaphylactic shock/airway closure), Type IV allergic reactions (hives, blistering) and irritant contact (rash and redness which does not involve the immune system). The delivery of products into homes or business extends the possibility for allergic reactions beyond the initial use of latex items at a production or distribution facility. Goods and packaging in direct contact with latex-infused cornstarch particles remain capable of provoking anaphylactic shock, swelling, hives, blistering rashes, and skin irritation for long periods after initial contact. Exposure to latex is also dangerous in the absence of an allergy. Latex allergies developed through regular exposure to natural rubber latex and other rubber materials is not uncommon.

The official ban on the application of cornstarch to natural rubber latex gloves arrives nearly 18 years after watch-dog groups and consistent research called for its immediate cease-and-desist in sanitary procedures. In the past, the FDA has faced tough scrutiny for failure to act on known dangers. All-out halts in production and removal of products deemed unsafe for the public require compelling evidence and concerns whereby product labeling or restrictions on use fail to mitigate risks. The FDA’s report addresses responses to opponents of the ban. Opposing viewpoints cited difficulty donning non-powdered gloves alongside lesser dexterity, durability, and performance. The claims were unsubstantiated by FDA findings which cite equal resistance to tearing and overall protection through nitrile and neoprene gloves.

The health effects of latex gloves in combination with cornstarch powders are the focus here, while the FDA’s ban encompasses all powdered gloves, but only for medical and surgical procedures or examinations. Regardless, these findings demonstrate that the use of latex and cornstarch PPE by manufacturers of devices, pharmaceuticals, electronics, and consumer-facing products or packaging is not safe for employees or final delivery.

See a breakdown of the different properties of various PPE gloves here including latex, vinyl, and nitrite.

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Mitch Walleser

Mitch Walleser

Mitch works with manufacturing engineers and product specialists to examine new technology and products. His background includes 3D printing, electronics and cleanroom manufacturing. Stay up to date with new insights on automated production solutions by following on Twitter. @Go_to_PAC

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