Purple Nitrile Gloves: FDA Class and Chemo Claims

Purple nitrile gloves are disposable nitrile examination gloves whose manufacturer chose purple as the colour. The colour is not a regulatory category and says nothing about chemotherapy resistance, thickness or latex content; those come from the label and the FDA record of the specific glove model.

What are purple nitrile gloves?

A purple nitrile glove is an ordinary nitrile patient examination glove in a purple colour. FDA classifies nitrile (or polymer) patient examination gloves under product code LZA, as a Class I device under 21 CFR 880.6250. FDA defines the product as a disposable device made of nitrile rubber or synthetic polymers, worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants (openFDA classification record for LZA). The regulation text contains no colour requirement.

For the colour question in general, see glove colors and what they mean on exam gloves; for the material, see what a nitrile glove is.

Is a purple nitrile glove different from a blue one?

Not by regulatory class. Colour is a manufacturer choice, so a purple and a blue nitrile examination glove can both sit under the same product code. They can still differ in thickness, cuff length, texture, powder-free status and tested claims, and each of those must be read from that product’s own labelling. A different colour alone does not tell you the glove performs differently, or the same.

Are purple nitrile gloves chemo rated?

Only if the specific product says so and shows the test results. Purple is sold both with and without a chemotherapy claim. The openFDA UDI database lists a purple nitrile glove described as “Nitrile Examination Glove, Powder-Free, Textured Fingertips, Chemotherapy Drug Tested, Purple, Small”, carrying product codes LZA and LZC, marked single use. LZC is FDA’s “Medical Glove, Specialty” code, whose definition notes that gloves may carry specialty claims such as chemotherapy. The same database also lists purple nitrile gloves under LZA with no such wording in the description, so the claim sits in the product’s labelling, not in the colour.

FDA 510(k) summaries show how the claim is expressed. One summary for a blue powder-free nitrile examination glove (K173942, FDA letter dated December 27, 2017) states that the gloves were tested for use with chemotherapy drugs using ASTM D6978-05 and will be labelled with a statement of compliance and a summary of results, and it tabulates minimum breakthrough detection times drug by drug. A second summary, for a grey nitrile glove (K162186, FDA letter dated February 8, 2017), reports different times for the same drugs and includes a product warning naming two of them (carmustine and thiotepa) Results are therefore per drug and per glove model; colour does not predict them.

What to check on the box and in the FDA record

Check	Why it matters	Where the fact comes from
Statement of compliance and results table for chemotherapy drugs	The ASTM D6978 result is reported per drug with breakthrough times; some drugs may carry a warning	510(k) summaries K173942 and K162186
Product code (LZA, or LZA and LZC) and 510(k) number	Shows the glove is cleared as a patient examination glove and whether a specialty claim was reviewed	openFDA classification records for LZA and LZC; 21 CFR 880.6250
Latex wording on the labelling	Latex status is a labelled attribute of each product record	AccessGUDID / openFDA UDI record of the product
Powder-free or powdered	The classification allows a trace amount of residual powder; the product description states which it is	openFDA classification definition; UDI record
Single-use marking	Examination gloves are disposable devices	21 CFR 880.6250; UDI record

To look a glove up, search the product description or its device identifier in AccessGUDID or the openFDA UDI database. A query of the openFDA UDI database on 2026-11-01 for LZA records with “purple” in the device description returned 83 records. The point is not the number but that the colour appears as a described attribute alongside the other fields. For thickness, see the nitrile glove thickness (mil) definition; a thickness value belongs to the product, not the colour.

Safe use and handling basics

• An examination glove is a disposable device worn on the examiner’s hand or finger to prevent contamination between patient and examiner, and its labelling states its intended purposes (21 CFR 880.6250).
• Examination gloves are classified as disposable devices (openFDA classification for LZA); disposal follows the facility’s own policy.
• A chemotherapy-tested claim belongs to the specific product and its test summary, not to the colour. For related supplies, see the chemo spill kit contents checklist.
• For how examination, surgical and chemotherapy-tested gloves differ, see types of gloves.

Common mistakes

• Treating purple as proof of chemotherapy testing.
• Assuming two chemo-tested nitrile gloves give the same breakthrough times because both are nitrile.
• Reading only the marketing line and skipping the statement of compliance and results table.
• Giving a colour a meaning (for example a task area) and forgetting that is a local convention, not a standard.

FAQ

Are purple nitrile gloves FDA approved?

FDA clears gloves by product and does not approve a colour. Nitrile examination gloves are Class I devices regulated under 21 CFR 880.6250, and the colour does not change that classification. For how to verify a compliance claim, see FDA compliant nitrile gloves.

Do purple nitrile gloves contain latex?

Latex status is stated per product in its labelling and UDI record, so check the box for the latex wording rather than inferring it from the colour.

Sources

Date checked for all sources: 2026-11-01.

• openFDA device classification, product code LZA
• 21 CFR 880.6250, patient examination gloves
• openFDA UDI database, LZA records with “purple” in the description
• FDA 510(k) summary K173942
• FDA 510(k) summary K162186