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This page describes products and general use; it is not medical advice.
Vinyl gloves are disposable gloves made of poly(vinyl chloride), or PVC. In the United States the FDA regulates the medical version as a “vinyl patient examination glove”: a Class I device, product code LYZ, under 21 CFR 880.6250. This guide is for clinic staff, buyers and students who need to know what that label means and what the regulation actually requires.
What are vinyl gloves?
The FDA’s classification record for product code LYZ defines the device this way: “A vinyl patient examination glove is a disposable device made of poly(vinyl chloride) that may or may not bear a trace amount of residual powder, and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants” (openFDA device classification, checked 2026-10-30).
Who uses them: the FDA lists the device under the General Hospital medical specialty, so the typical users are clinicians and other staff who wear a patient examination glove as a barrier between patient and examiner.
How vinyl gloves are built
The material is PVC, not natural rubber latex. The FDA’s medical gloves page names polyvinyl chloride (PVC), nitrile and polyurethane as synthetic materials to choose when latex allergy is a concern, and it requires manufacturers to identify the materials used on the package labeling (FDA, Medical Gloves, checked 2026-10-30).
Powder is the other build detail. The classification definition allows only a “trace amount of residual powder”. Under 21 CFR 880.6250(a), a non-powdered examination glove does not incorporate powder except for manufacturing, so the finished glove carries only residual powder. The FDA published a final rule banning powdered gloves on December 19, 2016, citing airway inflammation and hypersensitivity risks, which is why current medical vinyl gloves are powder-free.
Regulatory classification and quality limits
The table below lists what the regulator states about vinyl examination gloves, each row traced to the source named.
| Item | What the source states | Source (checked 2026-10-30) |
|---|---|---|
| Device name and class | “Vinyl Patient Examination Glove”, device class 1, product code LYZ | openFDA device classification |
| Regulation | 21 CFR 880.6250; Class I (general controls) | 21 CFR 880.6250(b) |
| Purpose of an examination glove | Worn on the examiner’s hand or finger “to prevent contamination between patient and examiner” | 21 CFR 880.6250(a) |
| Minimum quality level | 2.5 AQL (acceptable quality level) is the minimum acceptable for patient examination gloves; a lot is adulterated when defectives meet or exceed the rejection number | 21 CFR 800.20(c) |
| Watertight test | 1,000 ml of water; a leak is “the appearance of water on the outside of the glove” and counts as a watertight barrier failure | 21 CFR 800.20(b)(1) |
| Other defects | Tears, embedded foreign objects and extrusions of glove material | 21 CFR 800.20 |
| Sampling | Single normal sampling for lots of 1,200 gloves or fewer; multiple normal sampling for larger lots | 21 CFR 800.20(c)(2) |
| FDA premarket review criteria | Performance criteria “such as leak resistance, certain physical properties, and biocompatibility” | FDA, Medical Gloves |
Read the AQL row carefully: 2.5 AQL is a floor for lot acceptance under the sampling plan, not a promise that no glove in a box has a hole.
Types and variants
The FDA’s product code LYZ covers vinyl patient examination gloves. Variants within it are mostly cosmetic or process-related: openFDA’s 510(k) records for LYZ include entries such as “Powder Free Synthetic Vinyl Exam Gloves (Blue, Black)” (K260860, decision date 2026-04-07), which shows coloured vinyl examination gloves are cleared under the same code. For how colour is used across glove materials, see glove colours; for the full set of medical glove categories, see types of gloves.
How to choose
- Latex allergy. The FDA lists PVC, nitrile and polyurethane gloves as synthetic alternatives to latex. See gloves not made with natural rubber latex.
- Read the label. Manufacturers must identify the materials on the package labeling, so the material is checked on the box, not assumed from the glove’s look.
- Check the intended use. A patient examination glove is classified for use as a barrier between patient and examiner; the regulation does not describe it as chemical protection. For chemicals, use the chemical-resistant glove selection guide.
For a side-by-side with other materials, see nitrile vs latex vs vinyl gloves, or the single-material guides for nitrile and latex gloves. Medical examination gloves of several materials are listed in the gloves category.
Safe use and handling basics
Gloves are one form of personal protective equipment (PPE). Examination gloves are disposable devices, so they are not designed for reuse. Storage conditions and shelf life are covered in storing gloves.
Common mistakes
- Assuming vinyl contains latex. The definition says PVC. Natural rubber latex is a different material.
- Treating “powder-free” as a marketing extra. Powdered gloves were banned by FDA final rule in 2016; trace residual powder is the regulatory description.
- Reading 2.5 AQL as zero defects. It is the lot acceptance level, not a guarantee for each glove.
- Using an examination glove as chemical protection. Its regulated purpose is the patient-examiner barrier.
FAQ
What does “vinyl” mean on a glove box?
It means the glove is made of poly(vinyl chloride) (PVC). The FDA classifies the medical version as a vinyl patient examination glove, product code LYZ, Class I.
Are vinyl gloves latex-free?
Vinyl is PVC, and the FDA names PVC among synthetic materials to choose when latex allergy is a concern. Confirm the material on the package labeling, which manufacturers must provide.
What quality standard must vinyl exam gloves meet?
Under 21 CFR 800.20, a minimum 2.5 AQL for patient examination gloves, with a water leak test using 1,000 ml of water.
Sources
All sources checked 2026-10-30.
- openFDA, device classification, product code LYZ: https://api.fda.gov/device/classification.json?search=product_code:LYZ
- 21 CFR 880.6250, Non-powdered patient examination glove: https://www.law.cornell.edu/cfr/text/21/880.6250
- 21 CFR 800.20, Patient examination gloves and surgeons’ gloves; sampling plans and performance requirements: https://www.law.cornell.edu/cfr/text/21/800.20
- FDA, Medical Gloves: https://www.fda.gov/medical-devices/personal-protective-equipment-infection-control/medical-gloves
