Written and maintained by CASRAI Editorial Board
Last updated
This page describes products and general use; it is not medical advice.
Who it is for: clinic, lab and purchasing staff who need nitrile gloves wholesale and want to check a supplier before a first bulk order. After reading, you should know what to verify, what to ask the seller for, and how to compare suppliers on the same fields.
For specifications such as thickness, AQL and purchase-order wording, see the nitrile gloves buying guide for the lab. For material differences, see nitrile vs latex vs vinyl gloves. This page covers the buying workflow around those choices.
What “wholesale” means for exam gloves
Wholesale exam gloves are the same regulated product as retail boxes, bought in larger quantities. What changes is the unit you order in and the minimum a seller will accept. Two terms matter: the unit of measure (UoM), meaning what one ordered “unit” is (a box, a case), and the minimum order quantity (MOQ). Confirm both in writing, because nitrile gloves wholesalers can quote the same product per box or per case.
In U.S. rules, a non-powdered patient examination glove is a disposable device worn on the examiner’s hand or finger to prevent contamination between patient and examiner (21 CFR 880.6250). That definition applies whether the glove is bought singly or by the pallet.
What to verify before a first order
Is the glove a cleared medical device?
It should be. The FDA states that medical gloves are regulated as Class I reserved medical devices that require a 510(k) premarket notification. You can search the FDA 510(k) premarket notification database for a clearance before you order. A supplier’s “FDA approved” label is not a substitute for finding the clearance record.
Is the glove powder-free?
The FDA’s final rule of December 19, 2016 banned powdered gloves, including powdered patient examination gloves. A non-powdered exam glove includes only residual powder from manufacturing.
Does the label say what it is made of?
Manufacturers must identify the materials used on the package labeling. Check that the box states the material and matches the listing you were quoted.
What quality level applies?
The FDA considers a 2.5 AQL the minimum level of quality acceptable for patient examination gloves (21 CFR 800.20). Ask which AQL the manufacturer states and whether it is 2.5 or better.
Documents to ask the seller for
None of the following is a document a regulator requires you to collect; they are reasonable requests that tie to the rules above.
- The 510(k) clearance number for the exact glove, so you can find it in the FDA database.
- The brand, size and lot or code number for each delivery. The FDA’s lot inspection method identifies code or lot number, size and brand.
- The material as printed on the package labeling.
- The standard the glove is made to, written on the quote or purchase order.
How exam gloves are built
A patient examination glove is a thin, disposable, single-use barrier worn on the hand or finger (21 CFR 880.6250). The material is the main construction choice: natural rubber latex, or a synthetic such as nitrile, PVC (vinyl) or polyurethane. The FDA requires manufacturers to identify the materials on the package labeling, so the box should tell you which one you are buying. Nitrile gloves for medical use are covered by ASTM D6319, which applies to packaged sterile, packaged nonsterile and bulk nonsterile gloves.
Types and variants
| Variant | What it means | Source |
|---|---|---|
| Nitrile | Synthetic material; the FDA names nitrile among the synthetic alternatives to natural rubber latex; ASTM D6319 is the nitrile examination glove specification | FDA Medical Gloves page; ASTM D6319 |
| Natural rubber latex | Some people are allergic to the natural rubber latex used in some medical gloves | FDA Medical Gloves page |
| Vinyl (PVC) | Synthetic material; the FDA names PVC among the synthetic alternatives to natural rubber latex | FDA Medical Gloves page |
| Polyurethane | Synthetic material; also named by the FDA as a synthetic alternative to natural rubber latex | FDA Medical Gloves page |
| Non-powdered | Only residual manufacturing powder; powdered gloves were banned by the 2016 final rule | 21 CFR 880.6250; FDA Medical Gloves page |
| Sterile or non-sterile | D6319 covers packaged sterile, packaged nonsterile and bulk nonsterile nitrile gloves | ASTM D6319 |
This table lists material and labeling facts only. Which one suits a given task is a decision for your infection-control or safety lead.
Compare suppliers like for like
| Field to request | Why it matters | Source |
|---|---|---|
| 510(k) clearance number | Medical gloves are Class I reserved devices requiring 510(k) notification | FDA Medical Gloves page |
| Powder status | Powdered exam gloves were banned by the 2016 final rule | FDA Medical Gloves page |
| Material on package labeling | Manufacturers must identify materials on the labeling | FDA Medical Gloves page |
| AQL stated | 2.5 AQL is the FDA minimum acceptable for exam gloves | 21 CFR 800.20 |
| Lot/code, size, brand on delivery | These are what an inspector identifies when sampling a lot | 21 CFR 800.20 |
| Standard named (for example ASTM D6319) | D6319 covers nitrile examination gloves, including bulk nonsterile packaging | ASTM D6319 listing |
| Sterile or non-sterile | D6319 covers packaged sterile, packaged nonsterile and bulk nonsterile gloves | ASTM D6319 listing |
Put the same fields in a request for quotation to each seller and compare the answers side by side. For sterile versus non-sterile decisions, see the sterile vs non-sterile purchasing guide.
Case, pack and unit of measure
Sellers define their own boxes and cases, so do not assume a standard case size. Ask for the count per box, boxes per case and the glove size in each, then compare on the same unit. Sizing and thickness terms are explained in nitrile glove sizing and nitrile glove thickness (mil).
Nitrile vs latex vs vinyl
What is the difference between nitrile and latex gloves?
Latex gloves use natural rubber latex; nitrile is a synthetic material. The FDA notes some people are allergic to the natural rubber latex used in some medical gloves, and names PVC, nitrile and polyurethane as synthetic alternatives. The full comparison, including vinyl, is on the nitrile vs latex vs vinyl page.
Where to buy nitrile gloves: types of sellers
Manufacturers, distributors and online retailers all sell nitrile gloves wholesale. The seller type does not change the checks above: the glove still needs a findable clearance, a labeled material and identifiable lots.
Common mistakes
- Accepting an “FDA approved” badge without finding the 510(k) record.
- Comparing quotes per box with quotes per case.
- Not recording lot or code numbers at delivery.
FAQ
Where should I buy nitrile gloves?
From a seller that can give you the 510(k) clearance number, material labeling and lot identification for the exact glove. The type of seller (manufacturer, distributor, retailer) matters less than those answers.
What should I verify before placing a first order?
Clearance in the FDA 510(k) database, powder-free status, material on the labeling, the stated AQL (2.5 is the FDA minimum), and the standard named on the quote.
What documents should I ask the seller for?
The 510(k) clearance number, brand, size and lot or code per delivery, the labeled material and the named standard. These are requests, not documents the rules require you to hold.
What is the typical case or pack size and unit of measure?
Sellers set their own, so ask for count per box and boxes per case in writing and compare on one unit. See what is a unit of measure.
What is the difference between nitrile and latex gloves?
Latex gloves are made from natural rubber latex and nitrile gloves from a synthetic material. The FDA notes that some people are allergic to the natural rubber latex used in some medical gloves. Details are on nitrile vs latex vs vinyl gloves.
What is the difference between vinyl and nitrile gloves?
They are different materials; the side-by-side is on nitrile vs latex vs vinyl gloves.
Sources
- 21 CFR 880.6250, patient examination glove, checked 2026-11-01.
- 21 CFR 800.20, patient examination gloves: sampling plans and test method, checked 2026-11-01.
- FDA, Medical Gloves, checked 2026-11-01.
- FDA 510(k) premarket notification database, checked 2026-11-01.
- ASTM D6319-19(2023), Standard Specification for Nitrile Examination Gloves for Medical Application, abstract checked 2026-11-01.
