A glove box can carry a dozen codes: 510(k), ASTM D6319, AQL 1.5, powder-free. Each one points to a real rule or test, and each tells a buyer something different.
We sell gloves by the case to clinics and caregivers, and these codes are what purchasing teams ask us about. Here is what each one means and who sets it.
The short answer
FDA 510(k) clearance is what makes a glove a legal medical exam glove. ASTM D6319 (nitrile), D5250 (vinyl) and D3578 (latex) set the strength, size and leak tests. AQL is the leak limit per lot: 2.5 or lower for exam gloves. Powdered exam gloves have been banned since 2017.
Who sets medical grade glove rules
Three bodies, three jobs
In one line
The FDA decides whether a glove can be sold as a medical glove, ASTM writes the test specs makers use, and OSHA tells employers when staff must wear gloves.
The words medical grade gloves appear on many boxes, ours included. The rules that give them weight start with the FDA. Under 21 CFR 880.6250, it regulates medical examination gloves as devices worn to prevent contamination between patient and examiner. Its medical gloves page lists them as Class I reserved devices that need a 510(k).
ASTM International writes the specs. Its Committee D11 publishes one for each exam glove material, and the FDA's glove guidance asks makers whether their gloves meet them or an equivalent consensus standard.
OSHA covers the workplace. Its bloodborne pathogens standard requires gloves when a worker may touch blood, other potentially infectious materials, mucous membranes or non-intact skin. Employers must provide them at no cost, in the right sizes, with hypoallergenic or powderless options for staff who are allergic to the usual glove.
| Who | What they set | Where to read it |
|---|---|---|
| FDA | Clearance, labels & leak limits | 21 CFR 880.6250 & 800.20 |
| ASTM International | Material specs & test methods | D6319, D5250, D3578, D6978 |
| OSHA | When workers must wear gloves | 29 CFR 1910.1030 |
What FDA 510(k) clearance means for exam gloves
Cleared to sell, not approved
A 510(k) is the file a maker sends the FDA to show a new device is substantially equivalent to one already sold legally. The FDA premarket notification overview explains that the FDA answers with a letter, an order that clears the device for sale, and that the decision usually comes within 90 days.
For exam gloves, 510k clearance is the line between a medical glove and every other glove. The FDA says its review generally covers leak resistance, certain physical properties and biocompatibility. A 510k letter names the device, the regulation and a product code: LZA for nitrile and other polymer exam gloves, LYZ for vinyl, LYY for latex.
Clearance belongs to the company that filed it. The FDA notes that most repackagers and relabelers do not need their own 510(k) unless they change the labeling in a significant way or alter the device.
ASTM D6319 for nitrile examination gloves
The nitrile spec, line by line
ASTM D6319 is the specification for nitrile exam gloves for medical use. ASTM's summary says it covers gloves for medical exams and for diagnostic and therapeutic procedures, sterile or nonsterile, boxed or in bulk. It checks sterility where claimed, freedom from holes, physical requirements before and after aging, powder on the glove, tensile strength and ultimate elongation.
Tensile strength & elongation
Tensile strength is how much pulling force a strip of glove takes before it breaks. Ultimate elongation is how far it stretches first. ASTM sells the full standard, but makers publish its numbers in their 510(k) summaries. In one FDA 510(k) summary for a nitrile exam glove, the D6319 criteria were at least 14 MPa and 500% elongation before aging, and at least 14 MPa and 400% after aging. That glove tested at about 30 MPa and 561% in size M.
Aging matters because gloves sit in boxes. The after-aging test stands in for shelf time, so a glove that passes both should hold up from the warehouse to the exam room.
Thickness & sizing
The same summary lists the D6319 floors: palm and finger at least 0.05 mm thick, about 2 mil, and every size at least 230 mm long. Width steps up by size. The widths below are that glove's own targets and measured averages, as the summary reports them, not a quote from the standard.
| Size | Width target | Measured average |
|---|---|---|
| Small | 80 mm, give or take 10 | 86 mm |
| Medium | 95 mm, give or take 10 | 99 mm |
| Large | 105 mm, give or take 5 | 106 mm |
| XL | 115 mm, give or take 5 | 115 mm |
That glove measured about 0.13 mm at the palm, well above the floor. Our nitrile medical gloves are listed from 3 to 5.5 mil, about 0.08 to 0.14 mm. Thickness alone does not prove a glove meets D6319, though: the spec is the whole set of tests. Our product pages list thickness and do not cite the standard.
Other ASTM glove standards buyers see
One spec per material, plus chemo
Every exam glove material has its own spec, and a box should cite the one that matches what the glove is made of. These are the three you will see most after D6319.
ASTM D5250 for vinyl gloves
ASTM D5250 covers poly(vinyl chloride) gloves for medical exams, diagnostic and therapeutic procedures, and handling contaminated medical material. ASTM notes it is similar to the latex spec. Our Biomass clear vinyl glove, in our clear vinyl glove collection, is sold for food handling and general use. Its page makes no exam glove or D5250 claim.
ASTM D3578 for latex gloves
ASTM D3578 is the rubber examination glove spec for natural rubber latex. The FDA requires latex gloves to carry a bold caution that the product contains natural rubber latex, which may cause allergic reactions. We sell no latex gloves.
ASTM D6978 for chemo rated gloves
ASTM D6978 is a test practice, not a material spec. It measures how long nine chemotherapy drugs take to permeate a glove under continuous contact, set up to approximate the worst case in clinical use. FDA guidance says a chemo glove's labeling should name the drugs it protects against, and that chemo gloves are usually at least 0.10 mm thick and 270 mm long.
Acceptable quality level & pinhole testing
How many leaks a lot can have
In one line
AQL is a sampling limit: the lower the number, the fewer defective gloves a lot may hold before it fails.
The FDA checks medical gloves for holes with a water test set out in 21 CFR 800.20. Each sample glove is filled with 1,000 mL of water and checked for leaks right away and again after 2 minutes. Sampling follows acceptable quality level plans drawn from ISO 2859, with a minimum of 2.5 AQL for patient exam gloves and 1.5 for surgeon's gloves.
| Lot size | Gloves tested | Lot passes with | Lot fails at |
|---|---|---|---|
| 51 to 150 | 20 | 1 defect or fewer | 2 defects |
| 281 to 500 | 50 | 3 or fewer | 4 |
| 501 to 1,200 | 80 | 5 or fewer | 6 |
Those rows come from the FDA's 2.5 AQL table for exam gloves. ASTM D5151 is the matching industry test for holes, and it only finds holes that let water through. Makers can test to a stricter level than the FDA floor: the 510(k) summary above passed at 1.5 AQL in every size. On a spec sheet, a lower AQL is better.
Powder free gloves & the FDA powder ban
Off exam gloves since 2017
On December 19, 2016, the FDA published a final rule banning powdered surgeon's gloves, powdered patient examination gloves and absorbable powder for lubricating a surgeon's glove. It took effect January 18, 2017. The FDA found a risk that labeling could not fix, citing airway inflammation, hypersensitivity reactions and granulomas. Since then, powder free gloves are the only exam gloves a US buyer should see.
Powder free still allows a trace. The FDA's glove guidance manual says a powder-free claim should mean 2 mg or less of residual powder per glove, measured with ASTM D6124. The ban covers medical gloves only. Every glove we sell, medical or industrial, is powder-free.
How to read a glove spec sheet before you buy
Seven lines worth checking
A good spec sheet for medical grade disposable gloves answers seven questions. If a line is missing, ask for it before you order a case.
- Material: nitrile, vinyl, latex or a named blend.
- Intended use: patient exam, surgery, food contact or industrial work.
- FDA status: a 510(k) number for any medical claim.
- Standard: D6319, D5250 or D3578 to match the material, plus D6978 for chemo use.
- Pinhole AQL: 2.5 or lower.
- Physical data: palm and finger thickness, tensile strength and elongation.
- Powder and count: powder-free, gloves per box and boxes per case.
Here is how our pages read against that list. Our black medical nitrile glove lists 100% nitrile, powder-free, non-latex, FDA Medical/Exam Grade, 4 mil approx. and 1,000 gloves per case at $69.95. It does not list a 510(k) number, an ASTM standard or an AQL, and neither do our other pages. If your facility requires those documents, ask any seller for them before you buy, us included. Our medical grade gloves collection holds the six gloves we sell for medical use.
Glove standards questions
What our customers ask
Three questions buyers ask us about these codes, answered from the FDA rules.
Is FDA cleared the same as FDA approved?
No. Exam gloves are cleared through a 510(k), which shows they are substantially equivalent to a glove already on the market. Approval is a separate FDA process, premarket approval. Under 21 CFR 807.97, a clearance does not denote official approval, and a claim that implies it is misbranding. A glove box that says FDA approved is getting it wrong.
Do industrial gloves meet ASTM D6319?
Do not assume so. D6319 is a spec for medical exam gloves, and industrial gloves are not medical devices, so a thick industrial glove may never have been tested to it. Our industrial glove collection is sold for shop, cleaning and food work. Three of those pages claim 21 CFR 177.2600 for food contact. None claims D6319.
What does exam grade mean on a box?
It is a seller's term, ours included, not an FDA one. The FDA's term is patient examination glove, a disposable glove worn to prevent contamination between patient and examiner, and those need a 510(k) and must meet the 2.5 AQL leak limit. The words alone prove neither, so ask the seller for the 510(k) number and the ASTM test report.
Sources: FDA: Medical Gloves · FDA: Premarket Notification 510(k) · FDA: Medical Glove Guidance Manual · eCFR: 21 CFR 880.6250 · eCFR: 21 CFR 800.20 · Federal Register 2016-30382 · ASTM D6319 summary · FDA 510(k) summary K240269 · OSHA: 29 CFR 1910.1030
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