Attribute Schema Library
Attribute schemamedical & dental supply

Exam Gloves Attributes

Single-use patient examination gloves — nitrile, natural rubber latex, vinyl, chloroprene — are Class I devices regulated under 21 CFR 880.6250 and cleared under product codes LZA, LZC and LYY. Medical and dental distributors sell them by the case into dental operatories, physician offices, surgery centers, long-term care, veterinary practices and labs. Buyers reorder on spec, not on brand.

The data is hard for three specific reasons. Thickness: every spec sheet reports finger, palm and cuff separately, in both mil and mm, and marketing copy quotes whichever number is largest. Variant explosion: one glove line is six sizes by three colors by two pack counts, each with its own GTIN and sell UOM. And the claims that decide the sale — chemo-rated, accelerator-free, fentanyl-tested — live in a 510(k) summary or a third-party permeation addendum the supplier emails on request, never in the price file.

Since the FDA's 2017 powdered-glove ban, "powder-free" stopped discriminating anything. What replaced it is a stack of ASTM references most catalogs never captured.

Core

Every SKU needs these. Without them the record is not a product, it is a row.

Glove Material
enum
Nitrile (NBR)

First filter on every rail. Drives allergy policy, chemical resistance, and which ASTM specification the SKU is held to.

Size
enum
Large (L)

Fit governs tactile sensitivity and tear rate. Practices stock 4-6 sizes concurrently and reorder per size, not per line.

Powder Condition
enum
Powder-Free

FDA banned powdered patient exam gloves effective 18 Jan 2017. Any US SKU must read Powder-Free; anything else is a data error.

Sterility
enum
Non-Sterile

Separates general operatory stock from sterile-field and single-wrapped-pair SKUs. Different pack, different price, different use.

Palm Thickness
number · mil
2.4 mil (0.06 mm)

The comparison number buyers use across brands. Measured at palm center per the ASTM D6319/D3578 dimensional test.

Glove Length
number · mm
240 mm (9.5 in)

Cuff-to-fingertip. Standard exam is ~240 mm; extended-cuff chemo and dental gloves run 290-305 mm to tuck under a gown sleeve.

Packaging / Selling Unit
text
100/box, 10 boxes/case (1,000/case)

Box count and boxes-per-case set the price comparison. 100/bx, 200/bx and 300/bx of the same glove are different SKUs.

Manufacturer Part Number
identifier
N193

The number on the carton and on the RFQ. Buyers cross-reference competitor catalogs by MPN before they search by description.

GTIN-14 / UPC
identifier
20612479102051

Distinct per pack level. Each, box and case all need their own GTIN for GDSN, scanning and marketplace listing.

Country of Origin
identifier
Malaysia

Malaysia, Thailand, China, Vietnam, Sri Lanka. Drives tariff treatment, GPO sourcing rules and domestic-preference contracts.

Differentiating

What buyers actually compare on. This is where catalogs win or lose the filter.

Fingertip Thickness
number · mil
3.2 mil (0.08 mm)

Always thicker than palm. Governs puncture resistance and tactile feel — the spec dentists and phlebotomists actually argue about.

Surface Texture
enum
Textured fingertips

Determines wet grip on instruments and vials. Fully textured vs fingertip-only is a real selection criterion, not cosmetics.

AQL (Watertight)
enum
1.5

Pinhole acceptance level per ASTM D5151. 1.5 is the healthcare norm; 2.5 is economy; 1.0 or lower for lab and chemo handling.

Accelerator Status
enum
Accelerator-free (sulfur and zinc free)

Thiuram, carbamate and MBT residues drive Type IV contact dermatitis. Accelerator-free lines get specced by name when staff react.

Color
enum
Cobalt Blue

Used for size coding at the chairside and for spotting breaches against blood. Also the top cosmetic filter in dental.

Compliance & identifiers

Standards, regulatory data, and the identifiers channels reject you for missing.

ASTM Product Specification
enum
ASTM D6319

D6319 nitrile, D3578 natural rubber latex, D5250 vinyl, D6977 chloroprene. Named directly in GPO and IDN bid sheets.

FDA 510(k) Number / Product Code
identifier
K243133 / LZA

Proves clearance for medical use under 21 CFR 880.6250. Product code separates exam (LZA/LZC) from industrial-grade lookalikes.

Chemotherapy Drug Permeation (ASTM D6978)
boolean
Yes — tested per ASTM D6978-05

The chemo-rated flag. Determines whether the SKU can be sold into oncology, compounding pharmacy and hazardous-drug handling.

The fields that aren't in the schema at all

What most exam gloves catalogs are missing.

The table above is the schema most catalogs already have. These are the attributes that usually aren't in it — each one surfaced by a signal from the live market rather than by an audit of what's already there. This is what Anglera's Schema Foundry does on a real catalog, in this category.

Supplier signal
+ Chemo drug panel and breakthrough time

Supplier D6978 addenda list each drug and its breakthrough minutes; catalogs carry only a 'chemo-rated' badge, so a buyer sourcing for carmustine cannot tell if it was on the panel.

USP 800 and oncology buyers cannot qualify the SKU from the page, and go back to the incumbent brand rather than chase the addendum.

Review signal
+ Donning coating / interior finish

Spec sheets state chlorinated vs polymer-coated vs aloe or hydrogel inner coating; distributor records have no such field, and reviews complain the glove will not go on damp hands.

The biggest driver of glove complaints is invisible at selection, so returns arrive as 'wrong glove' with no attribute anyone could have filtered on.

Competitor signal
+ Shelf life and date-of-manufacture basis

Cartons are dated and EN 455-4 caps a claimed shelf life at five years; latex commonly validates to three, nitrile to five. Catalog records carry no shelf-life field at all.

Stockpiling and emergency-preparedness buyers cannot compare remaining dating, and aged latex stock ages out in the warehouse unnoticed.

Search signal
+ HCPCS code

Non-sterile gloves bill under HCPCS A4927, and home health, DME and long-term care buyers search by that code; most distributor catalogs expose no HCPCS field.

The SKU never surfaces for a reimbursement-driven buyer, and the order routes to a competitor whose record carries the code.

Supplier signal
+ Extractable protein content (ASTM D5712)

Latex SKUs say 'low protein' in copy with no number, even though the modified Lowry method reports µg/g and the labeling limit is 50 µg per gram of glove.

Latex-sensitive facilities cannot substantiate a low-protein requirement in a bid response, so the whole latex line is disqualified on paper.

Messy in, governed out.

The same value, spelled every way medical & dental supply suppliers spell it. A filter only works once they agree.

Palm Thickness
3 mil0.08mm3.5 mil (palm)0.003 in3-4 mil2.4/3.2
0.06 mm (2.4 mil)

Suppliers mix mil, mm and inches, and quote the fingertip figure as if it were the palm. Store one unit, derive the other.

Glove Material
NitrileNBRNitrile RubberSynthetic NitrileLatex-Free NitrilePF Nitrile
Nitrile (NBR)

'Latex-free' and 'powder-free' are conditions, not materials. Folding them into the material field breaks the material facet.

Powder Condition
PFPowder FreePowder-FreeP/FNon-PowderedPowderfree
Powder-Free

Six spellings across six suppliers for a value that has had exactly one legal option in the US since January 2017.

Size
LLargeLGSize 98.5-9M/L
Large (L)

European lines ship numeric EN ISO 21420 sizes. A 'Size 9' record never matches an 'L' filter and reads as out of stock.

What buyers ask

Every one of these should be answerable from the attributes above. If it isn't, that's a gap.

  • Is it chemo-rated, and which drugs was it actually tested against?
  • How thick is it at the fingertip, not the palm?
  • Is it accelerator-free? Two of my hygienists have contact dermatitis.
  • What's the AQL — 1.5 or 2.5?
  • Does this contain any natural rubber latex?
  • How many gloves per box, and how many boxes per case?
  • What's the 510(k) number and the FDA product code?
  • Is the cuff long enough to tuck under a gown sleeve?

What channels require

The same SKU, different mandatory fields per destination.

GS1 GDSN healthcare data pool (1WorldSync)
GTIN-14 per pack levelBrand nameNet content and UOMCountry of originLatex-containing indicatorSterility indicator
Amazon Business
UPC/GTINItem package quantitySizeColorMaterialCountry of origin
Distributor site and punchout catalog
MaterialSizePowder conditionPalm thicknessSell UOM (BX/CS)Chemo rating
GPO / IDN contract bid sheet
ASTM specification510(k) number and product codeAQLCountry of originManufacturer part number

Exam Gloves data, in practice

What's the difference between ASTM D6319, D3578 and D5250?

They are the material-specific product specifications for patient exam gloves. D6319 covers nitrile, D3578 covers natural rubber latex, D5250 covers poly(vinyl chloride) — vinyl — and D6977 covers polychloroprene. Each sets dimensional requirements, tensile strength and elongation before and after heat aging, and a freedom-from-holes limit tested per ASTM D5151. They are not interchangeable: a nitrile glove cited against D3578 is a data error, and a bid sheet naming D6319 will reject a vinyl SKU regardless of its other specs. Store the specification as its own attribute rather than inferring it from material — dual-cited and tested-to variants both exist.

What does "chemo-rated" actually mean?

It means the glove has been tested per ASTM D6978, Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. The test measures permeation of specific drugs through the glove film and reports a breakthrough time for each. There is no single pass mark for the category — a glove is tested against a named panel, and results vary by drug. Many suppliers run the same method against fentanyl, heroin, gastric acid and xylazine and publish it as a separate addendum. The badge alone is not a spec. The drug list and the breakthrough times are the spec, and they are what a USP 800 buyer needs to see.

Are powdered exam gloves still legal in the US?

No. FDA's final rule published 19 December 2016 banned powdered surgeon's gloves, powdered patient examination gloves and absorbable powder for lubricating a surgeon's glove, effective 18 January 2017. Powdered versions were moved to 21 CFR part 895 subpart B, the banned devices list, and 21 CFR 880.6250 now applies only to non-powdered patient examination gloves. The ban reached stock already in distribution, not just future production. Any US exam glove record whose powder condition reads anything other than powder-free is either a data defect or a non-sellable SKU — which makes it a useful validation rule rather than a useful filter.

Why do palm and fingertip thickness differ, and which should the catalog show?

Dip-molding leaves more material at the fingers than at the palm, so a single glove routinely measures around 2.4 mil at the palm and 3.2 mil at the fingertip, with the cuff thinner than both. Manufacturer spec sheets report all three, usually in mm with a tolerance. Marketing copy quotes whichever is largest, which is why two gloves both advertised as "3 mil" can differ materially in the hand. Carry palm and fingertip as separate numeric attributes in one unit and derive the other. Then the filter rail compares like with like, and a buyer who cares about puncture resistance can sort on the number that governs it.

Run this against your own exam gloves.

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