9.1 ASTM D6978 Chemotherapy Gloves & Double Gloving

ASTM D6978 Chemotherapy Gloves & Double Gloving

Gloves are the piece of PPE that touches a hazardous drug (HD), or an HD-contaminated surface, more often and for longer stretches than any other item. USP <800> singles gloves out as the one PPE element required for essentially every HD-contact task, because direct hand contact is the exposure route staff face constantly — counting tablets, hanging an IV, wiping down a counter, or unpacking a shipment. The PTCB Hazardous Drug Management exam tests this domain hard: which glove standard applies, when a second pair is mandatory, and when a "glove" pulled from the general supply cart is not actually compliant PPE at all.

Permeation vs. Penetration: Why the Standard Matters

Two different failure modes threaten a glove's protective barrier, and the exam expects you to tell them apart.

A glove can pass a visual inspection with no tears and still fail to protect the wearer, because permeation happens invisibly, over time, as HD molecules diffuse through the polymer. ASTM D6978 is the standard test method that measures exactly this: how long a specific glove material resists permeation by actual chemotherapy drugs under laboratory conditions. A glove that has never been tested to D6978 has no established permeation-resistance data for HDs — regardless of how thick, textured, or "medical-grade" it looks or feels.

Where ASTM D6978-Tested Gloves Are Required

A common exam trap is assuming chemo gloves are only needed inside a sterile compounding hood. USP <800> requires ASTM D6978-tested chemo gloves for every task that contacts an HD or an HD-contaminated surface, not just compounding:

General-purpose exam gloves — the box of nitrile gloves at a standard dispensing counter — are not permeation-tested against chemotherapy agents and are not a compliant substitute anywhere on this list, even for a 30-second task like counting ten tamoxifen tablets. If the task touches an HD or a surface an HD has touched, the glove must carry ASTM D6978 chemo-glove certification.

Double Gloving

USP <800> requires double gloving — two pairs of ASTM D6978-tested chemo gloves, worn one over the other — for both sterile and nonsterile HD compounding. The two layers do not serve identical roles.

The logic behind two layers is redundancy: if the outer glove is breached mid-task, the inner glove still stands between the compounder's skin and the drug until the outer glove can be safely changed. Relying on a single pair removes that safety margin entirely — a single puncture becomes a direct skin-contact event with no backup layer standing behind it.

For lower-manipulation tasks outside of compounding — such as receiving an unopened shipment or a quick count of intact tablets — a facility's Assessment of Risk and SOPs may permit single chemo gloving. But for any compounding or manipulation task, double gloving is the required, higher-protection default; it is not optional or interchangeable with a single pair simply because a technician judges the task routine.

Exam Scenario

A pharmacy technician is compounding a nonsterile hazardous cream in a C-SCA. She dons two pairs of gloves pulled from a box labeled "chemo rated, tested to ASTM D6978," with the outer glove cuff extending over her gown sleeve. Twenty-five minutes into the compound, she notices the outer glove has a small puncture near the thumb. What should she do?

She should remove and replace only the outer glove immediately — the puncture is a damage/contamination trigger that requires an instant change regardless of the routine 30-minute interval, and the intact inner glove has been providing backup protection during the brief exposure window. She does not need to abandon the compound or change the inner glove unless it, too, shows damage or contamination.

Key Takeaways

• ASTM D6978 measures permeation resistance — molecular-level migration through intact material — distinct from penetration through visible holes or tears.
• Chemo gloves tested to ASTM D6978 are required for every HD-contact task: receiving, storage, compounding, administration, counting/dispensing, cleaning, and spill response — not just sterile compounding.
• Double gloving (two pairs of ASTM D6978-tested gloves) is required for sterile and nonsterile compounding; the inner glove is a backup layer, the outer glove is the working layer.
• The outer glove is changed periodically (commonly every 30 minutes or per manufacturer guidance) and immediately upon any tear, puncture, or contamination; the inner glove is changed only if it is itself breached.
• Non-chemo-rated exam gloves have no established HD permeation resistance and are never a compliant substitute, regardless of the task's apparent simplicity.