ASTM D3578: Type I and Type II Latex Exam Gloves

ASTM D3578: Type I and Type II Latex Exam Gloves

Quick Summary: ASTM D3578 is the specification that natural rubber examination gloves are tested against. It sorts gloves into Type I and Type II by tensile strength, and it fixes the powder, protein and ageing tests behind every performance claim a supplier prints on the box. This guide reads the specification clause by clause for the person who signs the purchase order rather than the person who runs the tensile tester.

Natural rubber latex examination gloves are the oldest glove category in clinical use, and the standard that governs them has been revised, reapproved and tightened for more than two decades. The current edition is designated D3578-19 and was reapproved in 2023, which is the version a supplier should be able to name when you ask what a lot was tested to.

Most Canadian clinics stopped buying latex in the years after the sensitisation epidemic of the 1990s. A search of a modern clinic cupboard usually turns up nitrile. But latex gloves have not disappeared from the supply chain, and in some settings they are still specified: dental dam work, procedures where tactile feel drives the choice, and buyers who need the elastic recovery that natural rubber provides.

Anyone still ordering latex needs to read the specification, because the standards behind latex and nitrile gloves are not the same document with a different material name. D3578 has its own classification system, its own ageing protocol and its own protein tests, and each of those clauses ends up as a line on a box label.

What does ASTM D3578 cover?

The scope of D3578 is narrower than the phrase "latex glove standard" suggests. Clause 1.1 covers natural rubber gloves used in medical examinations, diagnostic and therapeutic procedures, and in handling contaminated medical material. Clause 1.2 extends the document to gloves that fit either hand, paired gloves and gloves supplied by size, and it covers both packaged sterile gloves and packaged or bulk nonsterile gloves.

Two exclusions matter to buyers. Surgical gloves are a different document: D3577 covers rubber surgical gloves, which carry tighter requirements and are supplied sterile in pairs. And the specification is not a training document. Clause 5.1 states that the safe and proper use of natural rubber examination gloves is beyond its scope, which is a polite way of saying the standard certifies the product, not the person wearing it.

The document also defines what manufacturers may put inside a glove. Clause 4.2 allows a lubricant that meets the current U.S. Pharmacopeia requirements for absorbable dusting powder, and allows other lubricants provided their safety and efficacy were previously established. Clause 4.3 is blunt: the inside and outside surfaces of the glove must be free of talc.

What is the difference between Type I and Type II latex exam gloves?

Type I and Type II are not factory grades, and they are not powder categories. They are the two strength classes defined in Clause 3 of the specification, and the difference is measured in megapascals.

Tensile strength describes the force a specimen withstands before it breaks; the stress at 500 percent elongation describes how hard the material pulls back while it is stretched to five times its original length. A Type I glove is therefore both stronger at the break point and stiffer under stretch, which is why the designation appears in tender documents where a buyer is specifying the mechanical behaviour of the glove rather than just the material.

Both types are made from any natural rubber compound that lets the finished glove meet the specification, both must pass the same sterility and hole detection requirements, and both must be talc free. The shared requirement set is the reason a box that simply says "natural rubber examination gloves" without a type designation is worth a question to the supplier.

Which tests does ASTM D3578 require?

Clause 7 lists the requirements, and Section 8 lists the referee test methods used to prove them. Read together, they describe everything a laboratory does to a sample of gloves before a lot is released.

• Sterility is tested to the current edition of the U.S. Pharmacopeia for lots labelled sterile.
• Freedom from holes is tested under ASTM D5151, the water leak test method for medical gloves.
• Physical dimensions are measured under ASTM D3767. Table 2 gives width by size, length and thickness with tolerances, including a width tolerance of plus or minus 6 mm across the standard size range.
• Tensile strength and elongation at break are measured before and after accelerated ageing under ASTM D412, using Die C specimens.
• Accelerated ageing follows ASTM D573 at 70 degrees Celsius plus or minus 2 degrees for 166 hours plus or minus 2 hours, the referee condition, or at 100 degrees Celsius for 22 hours as the alternative exposure.
• Powder residue is measured under ASTM D6124, with a limit of 2.0 mg for powder-free gloves.
• Aqueous extractable protein is measured under ASTM D5712, the modified Lowry method, against a recommended limit of 200 micrograms per square decimetre.
• Antigenic protein content is measured under ASTM D6499 against a recommended limit of 10 micrograms per square decimetre.

Sampling is not left to the buyer's discretion either. Clause 6.1 requires referee sampling and inspection under ISO 2859, with inspection levels and acceptable quality levels taken from Table 1 of the specification, or set by agreement between purchaser and seller if the agreed plan is more comprehensive. That last phrase is the opening a procurement team can use: an agreed sampling plan can be stricter than the table value, and it belongs in the purchase order rather than in a conversation after delivery.

The six month rule that changes the test

Clause 8.5.2.3 is the most overlooked line in the document. Gloves more than six months old from the date of manufacture, or gloves whose date of manufacture cannot be determined, are not put through accelerated ageing at all. They are tested against the after ageing values in Table 3 directly. For a buyer, this is the difference between a lot with a clean traceable date code and a lot where the laboratory had to assume the worst case.

How does ASTM D3578 compare with D5250 and D6319?

The three examination glove specifications sit in the same family. D5250, covering poly(vinyl chloride) gloves for medical application, says so in its own scope, describing itself as similar to D3578. D6319 says the same about nitrile. What differs is the material, the ageing exposure and the protein question.

The practical consequence is that a switch between materials is not a switch between equivalent documents. A clinic moving from latex to nitrile loses the protein tests entirely and gains a material with different chemical resistance. A clinic moving to vinyl for short, dry, low risk tasks accepts a glove that is designed for examinations and light handling rather than for contact with aggressive chemistry.

What should a clinic check on a latex glove box?

Seven items are worth a look at the receiving bench, and each maps back to a clause you have just read.

• The specification number and edition - D3578 with the year, not the marketing phrase "medical grade".
• The type designation - Type I or Type II, which tells you the tensile class the lot was made against.
• The powder statement - powder-free or powdered, matching the residue values in the specification.
• The sterility statement - sterile lots are tested to the Pharmacopeia; nonsterile bulk gloves are not.
• The date of manufacture - the six month rule makes this a functional data point, not decoration.
• The lot number - the only thread that connects a complaint about a torn glove to a test record.
• The supplier's licence status - gloves are medical devices in Canada, and the establishment importing them holds an MDEL.

Storage practice sits outside the specification but inside the outcome. Heat, direct sunlight and ozone attack natural rubber, and a pallet parked beside a loading dock door in July is a real degradation pathway. Keep cartons off the floor, out of sunlight and away from solvent vapours, and rotate stock so the oldest lot leaves first.

When is a latex-free glove the better choice?

Latex allergy is the reason most Canadian clinics rewrote their glove policy. The clinical picture is well documented: a review in Mount Sinai Journal of Medicine describes the epidemic of natural rubber latex allergy that followed the expansion of universal precautions, with symptoms ranging from type I reactions such as rhinitis, conjunctivitis and asthma through to type IV reactions caused by manufacturing chemicals. Healthcare workers in medical and dental settings, along with patients with spina bifida or certain food allergies, were the groups at higher risk.

A second review, published in Chemical Immunology and Allergy, traces what changed: recognition of the problem, better allergen characterisation, and the arrival of powder-free gloves with reduced protein levels were all associated with a decline in suspected natural rubber latex allergy cases from the late 1990s onward. The direction of travel in glove purchasing followed the evidence.

For a clinic that still uses latex for a specific task, the mitigation is straightforward and inexpensive: keep a latex-free alternative stocked beside it, mark the gloves so the two cannot be confused, and keep powder-free, low protein product as the default rather than a special order. For clinics running end to end on nitrile, the

relevant standards are D6319 and EN 455, and the mechanical comparison across 3 mil, 4 mil, 4.5 mil, 5 mil and 6 mil constructions is covered in the related reading below. A case of 4 mil blue nitrile exam gloves covers 1,000 examinations, and heavier 6 mil black gloves are available for tasks that chew through thinner material, as are chemo rated nitrile gloves and wholesale cases for higher volume buyers.

How does ASTM D3578 sit beside Canadian rules?

In Canada, examination gloves are medical devices under the Medical Devices Regulations (SOR/98-282). The regulations place the responsibility for safety and effectiveness on the manufacturer and the importer, and require that class of device to be handled by establishments holding a Medical Device Establishment Licence.

The ASTM documents are not named in the regulations. They do the work of demonstration: they turn "safe and effective" into measurable properties a laboratory can report. That is why the ASTM numbers appear so often in provincial infection control material and in facility tender specifications rather than in the legislation itself. When a buyer sees D3578 on a box, the useful follow up question is which edition, which type, and which test report, because those three answers separate a documented lot from a claim.

CliniEco Medical publishes its glove and exam room ranges with the specification numbers attached, and supplies clinics, long term care homes and laboratories across Canada. The clinic supply range covers the consumables that sit around a glove box, and the wholesale account is a low commitment way to test a range before committing to cases. Volume buyers can request a bulk quote with volumes, sizes and delivery windows.

References and standards cited

1. ASTM D3578-19(2023) Standard Specification for Rubber Examination Gloves (link checked 19 September 2026)
2. ASTM D5250-19(2023) Standard Specification for Poly(vinyl chloride) Gloves for Medical Application (link checked 19 September 2026)
3. ASTM D6319-19(2023) Standard Specification for Nitrile Examination Gloves for Medical Application (link checked 19 September 2026)
4. ASTM D3577 Standard Specification for Rubber Surgical Gloves (link checked 19 September 2026)
5. ASTM D5151 Standard Test Method for Detection of Holes in Medical Gloves (link checked 19 September 2026)
6. ASTM D6124 Standard Test Method for Residual Powder on Medical Gloves (link checked 19 September 2026)
7. ASTM D5712 Standard Test Method for Analysis of Aqueous Extractable Protein in Latex, Natural Rubber, and Elastomeric Products (link checked 19 September 2026)
8. ASTM D6499 Standard Test Method for Immunological Measurement of Antigenic Protein in Hevea Natural Rubber (link checked 19 September 2026)
9. ASTM D412 Test Methods for Vulcanized Rubber and Thermoplastic Elastomers - Tension (link checked 19 September 2026)
10. ASTM D573 Test Method for Rubber - Deterioration in an Air Oven (link checked 19 September 2026)
11. ASTM D3767 Practice for Rubber - Measurement of Dimensions (link checked 19 September 2026)
12. ISO 2859-1 Sampling Procedures for Inspection by Attributes (link checked 19 September 2026)
13. Health Canada - Medical Devices Regulations (SOR/98-282) (link checked 19 September 2026)
14. Gawchik SM. Latex allergy. Mount Sinai Journal of Medicine. 2011;78(5):759-772 (link checked 19 September 2026)
15. Raulf M. The latex story. Chemical Immunology and Allergy. 2014;100:248-255 (link checked 19 September 2026)
16. Latex vs Nitrile vs Vinyl: How Glove Materials Compare (link checked 19 September 2026)

Related Reading

• Case Review: A Nova Scotia Family Practice Switches to Latex-Free Exam Gloves
• What Is ASTM D6319? Nitrile Exam Glove Standard Explained
• EN 455 vs ASTM D6319: Exam Glove Standards Compared
• Nitrile Glove Barrier Quality: ASTM D5151 Water Leak Test and AQL
• Glove Contact Dermatitis: Type I Allergy vs Type IV Irritation
• AQL Explained: Medical Glove Quality Standards for Buyers
• Sterile Surgical Gloves: ASTM D3577 Standards, Sizing and Procurement
• Nitrile exam gloves, 4 mil, 100-pack
• Nitrile exam gloves, 6 mil heavy duty black, 100-pack
• Aurelia Protege 4.0 mil chemo-rated nitrile gloves
• INTCO Touch Flex wholesale case (10 boxes x 100)
• wholesale account
• Gloves and exam room supplies for clinics
• Request a bulk quote

Frequently Asked Questions

What is ASTM D3578?

ASTM D3578 is the ASTM specification for natural rubber (latex) examination gloves. It covers gloves used for medical examinations, diagnostic and therapeutic procedures and for handling contaminated medical material, and it sets the tests a lot must pass: sterility, freedom from holes, dimensions, tensile strength and elongation at break before and after accelerated ageing, powder residue, and protein content.

What is the difference between Type I and Type II gloves under ASTM D3578?

The type designation is a strength distinction. Type I gloves carry a minimum tensile strength of 18 MPa and a maximum stress at 500 percent elongation of 5.5 MPa. Type II gloves carry a minimum tensile strength of 14 MPa and a maximum stress at 500 percent elongation of 2.8 MPa. Both types are made from natural rubber compound and both must be free of talc inside and out.

How much powder residue is allowed on a powder-free latex exam glove?

ASTM D3578 sets a powder residue limit of 2.0 mg for powder-free gloves, measured with Test Method D6124. For powdered gloves the specification states a recommended maximum powder limit of 10 mg per square decimetre.

What protein limit does ASTM D3578 use?

The specification states a recommended aqueous soluble protein content limit of 200 micrograms per square decimetre, measured by the modified Lowry method in Test Method D5712, or a recommended antigenic protein content limit of 10 micrograms per square decimetre, measured by the immunological method in Test Method D6499. Note the wording: these are recommended limits published in the standard, not pass or fail values that a regulator enforces.

How is accelerated ageing tested on latex exam gloves?

D3578 uses Test Method D573. Gloves are aged either at 70 degrees Celsius plus or minus 2 degrees for 166 hours plus or minus 2 hours, which is the referee condition, or at 100 degrees Celsius plus or minus 2 degrees for 22 hours plus or minus 0.3 hours. After ageing, tensile strength and elongation at break may not fall below the Table 3 values.

Do gloves older than six months need accelerated ageing?

No. D3578 states that gloves older than six months from the date of manufacture, or gloves whose date of manufacture cannot be determined, are not aged artificially. They are tested against the after ageing values instead. That is why the manufacture date matters to a buyer: it changes the test a lot is judged against.

Are vinyl gloves covered by ASTM D3578?

No. Vinyl, meaning poly(vinyl chloride), examination gloves are covered by ASTM D5250. That specification is written as a companion to D3578 and covers the same families of tests, but it uses a 72 hour ageing exposure at 70 degrees Celsius rather than the 166 hour referee condition in D3578, and it has no protein content requirement because there is no natural rubber protein in the material.

Do Canadian clinics have to buy ASTM certified latex gloves?

Canadian law does not name ASTM D3578 as a mandatory certification. Examination gloves are medical devices under the Medical Devices Regulations (SOR/98-282), and the ASTM standards are the specifications manufacturers and testing laboratories use to demonstrate the performance claims printed on the box. Provincial infection control guidance and facility procurement policies are where the ASTM reference usually becomes a requirement.

Last updated: September 2026. CliniEco Medical is a licensed medical device establishment (MDEL #35334).