The wrong glove fails in the middle of the task. It tears while you are donning it, or you find a pinhole after you have already touched something you should not have. AMMEX Professional black nitrile exam gloves are built to the tighter of the two industry defect standards, which is why clinics, labs and first responders specify them - sold here as a case of 1,000 in size Medium (part ABNPF42100-M).
These are exam grade, not industrial grade. They are manufactured to AQL 1.5, tested to ASTM D6319 for nitrile examination gloves, and hold FDA 510(k) clearance as a Class I medical device under AMMEX's ISO 13485:2016 quality system. AMMEX also publishes ASTM D6978 testing showing resistance to fentanyl permeation for up to 240 minutes - the reason they turn up in EMS kits and in evidence-handling protocols.
Exam grade or industrial grade - which one do you actually need?
Both grades are nitrile, both are powder free and latex free, and both come off the same kind of production line. The difference is defect tolerance and regulatory status, and it decides which jobs a glove is legal and sensible to use for.
- Exam grade (the AMMEX ABNPF series) is made to AQL 1.5, tested to ASTM D6319, and holds FDA 510(k) clearance as a Class I medical device. AMMEX also holds ISO 13485:2016 for it. That is the only one of the two you can use for patient care and bodily-fluid exposure. It runs thinner - about 3 mil at the palm - for tactile feel.
- Industrial grade (the AMMEX GlovePlus GPNB series) is made to AQL 4.0 under ISO 9001:2015, with no 510(k) clearance. It allows more pinhole defects per batch, but it is built thicker - about 5 mil at the palm and 6 mil at the fingertip - so it stands up better to automotive, janitorial and chemical handling work.
Short version: if there is any chance of blood or bodily fluid, buy exam grade. If the risk is grease, solvent and abrasion, buy industrial grade and get the extra thickness. Both series meet FDA 21 CFR 177.2600 for food-contact rubber, so either can be used for food handling.
Built for
- Medical, dental and EMS work. Any task with bodily-fluid exposure, where exam-grade clearance is not optional.
- Law enforcement and fentanyl exposure risk. Backed by published ASTM D6978 permeation testing.
- Food prep and food processing. The material meets FDA 21 CFR 177.2600 for food-contact rubber.
- Tattoo, salon and lab work. High glove-change frequency, where a thin, sensitive glove that does not tear is worth paying for.
- Janitorial and restroom cleaning. Black hides soil across a shift, so staff look presentable in front of customers.
Why black
It is not only cosmetic. A black glove conceals soil, grease and stains that would make a blue or white glove look filthy an hour into a shift - which matters when the person wearing it is standing in front of a patient, a diner or a client. It also makes a puncture or a light-colored contaminant easier to spot against the surface.
Fit and feel
Powder free and latex free, so there is no cornstarch residue and no natural rubber latex protein to trigger an allergy in staff or in the people they are working with. The surface is textured for grip when wet, and polymer coated so they slide on without powder. The cuff is beaded, the gloves are ambidextrous and non-sterile, and the palm runs about 3 mil - thin enough to keep tactile sensitivity for fine work.
Specifications
- Grade: Examination. AQL 1.5
- Standards: ASTM D6319. FDA 510(k) cleared, Class I medical device. ASTM D6978 fentanyl permeation tested up to 240 minutes
- Quality systems: ISO 9001:2015 and ISO 13485:2016
- Food contact: FDA 21 CFR 177.2600. Also REACH and California Prop 65 compliant
- Material: nitrile. Latex free, powder free
- Thickness: cuff 3 mil, palm 3 mil, finger 4 mil
- Surface: textured, polymer coated, beaded cuff, ambidextrous, non-sterile
- Minimum length: 240 mm (9.5 in)
- Tensile strength: 14 MPa minimum. Elongation 500 percent minimum
- Color: black
- Pack: 100 gloves per box, 10 boxes per case - 1,000 gloves per case
Frequently asked questions
Are these exam grade or industrial grade?
Exam grade. They are made to AQL 1.5, tested to ASTM D6319, and FDA 510(k) cleared as a Class I medical device. AMMEX's industrial line, GlovePlus GPNB, is a separate product made to AQL 4.0.
Are they FDA approved?
FDA does not approve gloves. These are FDA 510(k) cleared as a Class I medical device, which is the correct regulatory status for an examination glove, and the material meets 21 CFR 177.2600 for food contact.
How thick are they?
About 3 mil at the palm and 4 mil at the fingertip. That is thinner than the industrial GPNB series, which trades thickness for tactile sensitivity.
Are they safe for someone with a latex allergy?
They contain no natural rubber latex. They are also powder free, which removes the cornstarch that can carry latex protein in other glove types.
How many gloves come in a case?
1,000 gloves - 100 per box, 10 boxes per case.
Can I use them for food handling?
Yes. The material meets FDA 21 CFR 177.2600 for food-contact rubber articles.
What does AQL 1.5 mean?
AQL is the acceptable quality level for pinhole defects in a production batch. A lower number means a tighter standard. Exam gloves are made to AQL 1.5; industrial gloves are made to AQL 4.0.
Discount Cleaning Products stocks the AMMEX line by the case for clinics, food plants, shops and cleaning contractors, and we carry the industrial GlovePlus series alongside it if you decide thickness matters more than exam clearance for your work. Our US-based team can help you size a standing order.
