Why grades matter
Glove boxes and listings use “exam”, “industrial”, “food-service”, “general purpose” and “medical grade” loosely. Only some of these words have a regulatory meaning, and the products behind them aren’t interchangeable.
Exam (patient-examination) gloves
An exam glove is a medical device: a disposable glove “worn on the examiner’s hand or finger to prevent contamination between patient and examiner” [1]. FDA classifies it as Class I and requires a 510(k) [1][2], and powdered patient-examination gloves have been banned since January 2017 [3]. What proves exam grade is a K number whose FDA record matches the product, with an exam-glove product code such as LZA (nitrile) or LYZ (vinyl) [4].
Surgeon’s gloves
Surgeon’s gloves are a separate device type, worn by operating-room personnel to protect a surgical wound, with their own product code (KGO) [4][5]. FDA’s minimum pinhole quality for them is stricter: AQL 1.5, compared with 2.5 for exam gloves [6]. A sterile exam glove is still an exam glove, not a surgeon’s glove.
Industrial and general-purpose gloves
“Industrial grade” has no FDA meaning, and “general purpose” has no defined meaning at all. Such gloves aren’t cleared medical devices unless a 510(k) exists for them. Be careful with industrial gloves whose product pages quote values from the medical nitrile specification, ASTM D6319: citing a medical standard doesn’t make a glove an FDA-cleared exam glove [7].
Food-service (food-contact) gloves
Food-contact compliance is about the glove’s materials under FDA’s food-additive regulations; nitrile and latex glove makers commonly cite 21 CFR 177.2600 [8]. FDA places responsibility for that compliance on the manufacturer [9]. It isn’t a medical clearance, and it says nothing about pinhole quality or suitability for patient care.
“Medical grade”
“Medical grade” isn’t a regulatory term. Look for the exam-glove 510(k) instead.
“Chemo-tested”
A chemotherapy-tested glove has been tested for permeation by specific drugs under ASTM D6978, with a breakthrough time for each drug, and the claim is cleared through a 510(k) with product code OPJ [4][10]. It applies only to the drugs on the manufacturer’s list, and some lists carry “do not use” cautions for particular drugs [11].
Workplace rules
Where hand contact with blood or other potentially infectious materials is reasonably anticipated, OSHA’s bloodborne pathogens standard requires gloves and prohibits washing disposable gloves for reuse [12].
Questions that tell the grades apart
- What is the K number, and does FDA’s record show an exam-glove product code?
- Does the box say “patient examination glove”?
- For a food-service glove, which regulation does the manufacturer state compliance with?
- For a chemotherapy claim, may I see the tested-drug list and breakthrough times?
How GTDI lists gloves
We list every glove under its documented use. Exam gloves carry their FDA 510(k) information. Food-service and industrial gloves have their own, clearly non-medical categories, documented by the manufacturer’s statements, and we never present them as exam gloves. A glove that holds an exam-glove 510(k) is listed with the exam gloves.
This guide is general information. Which glove suits a clinical task is your facility’s decision.
Sources
- 21 CFR 880.6250, Non-powdered patient examination glove (eCFR, current as of Oct 1, 2026).
- FDA, “Medical Gloves” (content current as of Jul 2, 2024).
- Federal Register 81 FR 91722, Banned Devices; Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves… (Dec 19, 2016; effective Jan 18, 2017).
- FDA Product Classification database, records LZA, LYZ, OPJ and KGO (live database; accessed Oct 4, 2026).
- 21 CFR 878.4460, Non-powdered surgeon’s glove (eCFR, current as of Oct 1, 2026).
- 21 CFR 800.20 (eCFR, current as of Oct 1, 2026).
- BASIC Medical, disposable nitrile gloves (industrial) page citing ASTM D6319 values (undated page; accessed Oct 4, 2026).
- 21 CFR 177.2600, Rubber articles intended for repeated use (eCFR, current as of Oct 1, 2026); Ansell MICRO-TOUCH Nitrile product data sheet (undated; accessed Oct 4, 2026).
- FDA, “Determining the Regulatory Status of Components of a Food Contact Material” (updated Feb 21, 2018).
- ASTM D6978-05(2023), Resistance of Medical Gloves to Permeation by Chemotherapy Drugs (store page updated Sep 29, 2023; scope summary).
- FDA-hosted 510(k) summaries K254285 (cleared Jul 20, 2026) and K202179 (cleared Oct 26, 2020), with carmustine and thiotepa cautions.
- 29 CFR 1910.1030, Bloodborne pathogens (eCFR, current as of Oct 1, 2026).