What ASTM D6978 actually tells you — and why it matters for your next glove purchase
The permeation data on biodegradable nitrile gloves exists, it's been independently validated, and most procurement officers have never seen it. Here's what it says.
When a healthcare facility evaluates a new exam glove, the clinical question is simple: will it protect the person wearing it? The compliance question is more specific: does it meet the testing standards that govern the environment it's being used in?
For oncology and clinical environments, that standard is ASTM D6978 — Standard Practice for Testing Gloves for Resistance to Permeation by Chemotherapy Drugs. It's a rigorous test. It's also the test that biodegradable nitrile gloves pass. Comfortably.
The test — what it measures
ASTM D6978 measures the time it takes for a chemotherapy drug to permeate through a glove at a detectable level. The longer the breakthrough time, the better the protection. Greater than 240 minutes is the standard most clinical buyers use as their benchmark.
The Medzah biodegradable nitrile glove was tested against 23 chemotherapy drugs and fentanyl citrate. Results:
Cisplatin, Cyclophosphamide, Doxorubicin Hydrochloride, Etoposide, Fluorouracil, Methotrexate, Mitomycin C, Paclitaxel, Vincristine Sulfate, Azacytidine, Carboplatin, Docetaxel, Epirubicin, Gemcitabine, Ifosfamide, Irinotecan, Mitoxantrone, Oncovin, Oxaliplatin, Vinorelbine, Dacarbazine, and Fentanyl Citrate: all greater than 240 minutes.
Two compounds require specific attention: Carmustine at 21.4 minutes and Thiotepa at 67.2 minutes. These carry an explicit caution — do not use with these drugs. That's not a product weakness. That's the data being transparent.
The biodegradation validation
ASTM D5526 measures biodegradation under simulated landfill conditions. The Medzah glove is validated to 21% biodegradation within 41 days under this standard.
Important clarifications for compliance teams: biodegradability is a landfill claim, not a clinical claim. The glove biodegrades where most gloves end up — in landfill conditions. The actual rate will vary depending on landfill conditions and microorganism activity. The 21% figure is the validated minimum under standardized test conditions. Biodegradability is not a medical claim and was not reviewed by the FDA. The performance claims are fully validated separately.
Physical specifications
3.5 mil thickness. 9.5 inch length. AQL 2.5. Tensile strength greater than 18 MPa before aging, greater than 16 MPa after. Elongation at break greater than 500% before aging, greater than 400% after. Available XS through XL. 200 gloves per box, 10 boxes per case. Standard compliance: ASTM D6319, D412, D573, D5151, D6124, ISO 2859-1.
For compliance teams building the internal case
The full data package — permeation test results, biodegradation validation, specification sheet, manufacturing standards — is available on request.
We don't just place the product. We help you build the adoption pathway — including the documentation your compliance team needs to make the switch.
The question isn't whether biodegradable nitrile performs. The data answers that. The question is why more facilities aren't buying it.