Why check
Patient-examination gloves are FDA Class I medical devices that require a 510(k) premarket notification [1][2]. A 510(k) clearance is FDA’s finding that a specific device from a specific submitter is substantially equivalent to a device already legally on the market. FDA’s word is “cleared”, not “approved” — approval is a separate pathway for higher-risk devices [3]. Under FDA’s rules, presenting a 510(k) as official approval is misbranding [4].
Step 1: Find the K number
Look on the box label or the manufacturer’s spec sheet for a number made of “K” and six digits. If a supplier can’t give you one for an exam glove, that’s your answer.
Step 2: Look it up
Open FDA’s 510(k) database and enter the number in the “510(k) Number” field [5]. If the page is unavailable, FDA’s public openFDA service returns the same record. Note the applicant, device name, product codes, decision and decision date.
Step 3: Check that the record matches the product
- Applicant: the 510(k) holder, which is often the factory rather than the brand on the box. An unrelated applicant needs an explanation.
- Device name: the material, color and any special claim, such as “tested for use with chemotherapy drugs”.
- Product codes: LZA for nitrile (polymer) exam gloves and LYZ for vinyl. A chemotherapy claim should map to code OPJ, and a fentanyl claim to QDO [6].
- Decision: substantially equivalent.
Step 4: Read the summary
The record links to a summary document. Read the indications for use, the performance table and, for chemotherapy claims, the drug list with breakthrough times [7].
Step 5: Compare with the box
The K number, manufacturer and claims on the box and spec sheet should match the record.
Red flags
- A K number for a different material, such as a vinyl glove citing a nitrile clearance
- Claims on the box that the clearance doesn’t include
- A K number that doesn’t exist
- An “FDA certificate” or an FDA logo: FDA doesn’t issue device registration certificates, and its logo isn’t for private use [8]
- “FDA registered” offered as proof of quality: registration and listing identify a firm and its products; they don’t mean FDA has approved or cleared anything [8][9]
What a clearance doesn’t prove
A clearance covers a device design from its submitter. It doesn’t show that a particular lot passed inspection, that a box really came from the 510(k) holder, or that a factory is free of problems. FDA’s records include glove makers that hold valid clearances while appearing on FDA’s import alert for gloves [10]. FDA has advised health care facilities not to buy imported medical gloves from companies on that alert, Import Alert 80-04 [11].
How GTDI uses this
When an exam-glove listing shows a 510(k) number, it links to FDA’s record so you can run these steps yourself. For any exam glove we quote, your quote includes its 510(k) number.
This guide is general information, not legal or regulatory advice. Regulatory records change; check the live FDA pages.
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).
- FDA, “Premarket Notification 510(k)” (updated Aug 22, 2024); FDA, “Premarket Approval (PMA)” (updated May 16, 2019).
- 21 CFR 807.97, Misbranding by reference to premarket notification (eCFR, accessed Oct 4, 2026).
- FDA 510(k) database; openFDA device/510k API (live databases; accessed Oct 4, 2026). https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm
- FDA Product Classification database, records LZA, LYZ, OPJ and QDO (live database; accessed Oct 4, 2026).
- Example: FDA-hosted 510(k) summary K243604 (cleared Aug 18, 2025).
- FDA, “Important Reminders about Registration and Listing” (updated Mar 3, 2021).
- 21 CFR 807.39, Misbranding by reference to establishment registration (eCFR, accessed Oct 4, 2026).
- FDA Import Alert 80-04 (published Jul 16, 2026); FDA-hosted 510(k) summary K230046 (cleared Mar 25, 2023).
- FDA press announcement on medical gloves and Import Alert 80-04 (Oct 29, 2021).