Every glove quote leads with the same number: price per box. It is the least useful number on the page. Two cases of blue 4 mil nitrile at the same price can differ in whether the glove holds an FDA 510(k), what AQL the lot was released at, where the stated thickness was measured, whether it has been tested against chemotherapy drugs, and which factory made it. Any one of those can make the cheaper box the expensive one, at the audit, at the bedside or at the port of entry.
Confirm the 510(k), not the brochure
FDA regulates medical gloves as Class I reserved devices that require a 510(k) premarket notification, and its review covers leak resistance, physical properties and biocompatibility. A glove sold as "exam grade" without a 510(k) is an industrial glove with a medical label.
Ask for the K number and check it in FDA's 510(k) database. Patient examination gloves fall under 21 CFR 880.6250, product code LZA. Shandong Intco Medical's Basic Synguard nitrile exam glove was cleared on August 11, 2023 under K231408. The summary names the applicant and its Qingzhou, Shandong address, the predicate device and every test run. Keep it on file for each glove SKU. Keystone quotes the Intco Medical Synguard line with the 510(k) reference.
Powder is a related check. FDA banned powdered patient examination gloves in a final rule published December 19, 2016, so "powder free" is a legal requirement, not a feature. Discard any bid offering powdered exam gloves.
AQL and the water leak test
FDA's sampling regulation, 21 CFR 800.20, sets a 2.5 AQL as the minimum acceptable quality level for patient examination gloves and 1.5 for surgeons' gloves. Each sampled glove is filled with 1,000 milliliters of water, checked for leaks, then checked again two minutes later. A lot whose defects meet or exceed the rejection number at that AQL is adulterated under the Federal Food, Drug, and Cosmetic Act.
For a buyer, 2.5 is the floor, not a quality tier. A manufacturer that prints a tighter AQL on the box should produce the lot inspection report behind it, by lot number, not a generic certificate. If the rep cannot name the AQL the line is released at, move on.
What "4 mil" has to mean under ASTM D6319
A mil figure is marketing until someone says where it was measured. ASTM D6319-19 is the nitrile exam glove specification, and the Intco Synguard 510(k) summary lays out the minimums every conforming glove meets:
| Requirement | ASTM D6319-19 minimum |
|---|---|
| Length | 230 mm |
| Width, medium | 95 mm, plus or minus 10 mm |
| Thickness, palm and finger | 0.05 mm (about 2 mil) |
| Tensile strength, before and after aging | 14 MPa |
| Ultimate elongation | 500% before aging, 400% after aging |
| Residual powder | 2 mg per glove or less |
| Freedom from holes | Water leak test per ASTM D5151 at 2.5 AQL |
A 3 mil glove and a 6 mil glove both conform to that table, and a glove that measures 4 mil at the fingertip can run thinner across the palm. When a quote says 4 mil, ask: fingertip, palm or cuff? Then match the gauge to the task. Routine exams and phlebotomy do not need the heaviest glove in the catalog; decontamination, environmental services and industrial cleanup are where a heavier gauge earns its price. Standardize on two thicknesses per facility, written by department.
Chemo rating is a test result, not a color
Pharmacies, infusion centers and oncology units need gloves tested to ASTM D6978, the standard practice for assessing glove resistance to permeation by chemotherapy drugs. The protocol runs nine drugs against the glove material under continuous contact, in conditions ASTM describes as approximating the worst case for clinical use, and ASTM cautions that results should be compared on a relative basis. A glove that has not been through D6978 is not chemo rated, however thick it is.
Raxwell's RX301 blue nitrile exam glove shows what complete paperwork looks like: FDA 510(k), ASTM D6319 and ASTM D6978-05(2019) listed on a 4 mil, powder-free, latex-free glove packed 100 per box and 10 boxes per case. Keystone quotes and ships Raxwell gloves from Edina. For any chemo-rated claim, ask for the D6978 report with breakthrough times by drug.
Country of origin, tariffs and forced labor
Origin drives price and risk. USTR's Section 301 action raised the additional duty on medical gloves from China to 50 percent for imports on or after January 1, 2025 and 100 percent on or after January 1, 2026. INTCO Medical's analysis of U.S. import data puts China's share of U.S. medical nitrile and latex glove imports at 2.8 percent for January through July 2025, down from 38.9 percent in 2024, with Malaysia at 67.5 percent, Thailand at 16.9 percent and Vietnam at 9.8 percent. If a glove is priced as though it came from China, ask where it came from.
Origin also carries customs risk. U.S. Customs and Border Protection issued a Withhold Release Order on December 20, 2021 against Malaysia's Brightway Group after finding evidence of 10 of the 11 International Labour Organization forced labor indicators. Gloves from those plants were detained at U.S. ports until CBP modified the order on October 11, 2024. Before award, get the manufacturing site name and address, not just the brand, and check it against CBP's active WRO list. Repeat at every renewal.
The glove quote checklist
Put these on the RFQ and make every bidder answer:
- FDA 510(k) number, matching the exact SKU and color quoted.
- Manufacturer name and plant address, checked against the CBP WRO list.
- Country of origin on the certificate of conformance, every lot.
- AQL at release, with the inspection report by lot number.
- Thickness at fingertip, palm and cuff, in mil.
- ASTM D6319 conformance on the box or certificate.
- ASTM D6978 report, if the glove is sold as chemo rated.
- Powder-free confirmation and the latex statement on the label.
- Case and pallet configuration, so you compare price per glove.
- Lead time and stock location, stated on the quote.
Price per box is item eleven. Once the first ten line up, the low bid finally means something.
Keystone Supply Group carries nitrile exam gloves in multiple thicknesses, colors and origins on the gloves and hand protection page, backed by 270+ manufacturer relationships and 58,000+ quotable SKUs. Documentation on any product quoted includes the certificate of conformance, country of origin, lot and expiration data, and the 510(k) reference where one applies. Stocked lines ship from our Edina, Minnesota warehouse in 1 to 3 business days, quotes go out the same day during business hours, approved accounts get Net 30, and economy shipping is free on U.S. orders of $500 or more.
Explore the catalog or Request a quote with your current glove spec and monthly case volume, and we will return it with the 510(k), origin and lead time filled in.
Sources
- U.S. Food and Drug Administration, Medical Gloves: https://www.fda.gov/medical-devices/personal-protective-equipment-infection-control/medical-gloves
- Legal Information Institute (Cornell), 21 CFR 800.20, Patient examination gloves and surgeons' gloves; sample plans and test method for leakage defects; adulteration: https://www.law.cornell.edu/cfr/text/21/800.20
- ASTM International, D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs: https://store.astm.org/d6978-05r19.html
- U.S. Food and Drug Administration, 510(k) K231408 Summary, Basic Synguard Nitrile Exam Gloves, Shandong Intco Medical Products Co., Ltd.: https://www.accessdata.fda.gov/cdrh_docs/pdf23/K231408.pdf
- U.S. Customs and Border Protection, CBP Modifies Withhold Release Order on Brightway Group in Malaysia: https://www.cbp.gov/newsroom/national-media-release/cbp-modifies-withhold-release-order-brightway-group-malaysia
- Holland & Knight, USTR Finalizes Action on New and Increased Section 301 Tariffs: https://www.hklaw.com/en/insights/publications/2024/09/ustr-finalizes-action-on-new-and-increased-section-301-tariffs
- Raxwell, RX301 Blue Nitrile Chemo Rated Examination Gloves 4mil: https://raxwellusa.com/products/raxwell-rx301-blue-nitrile-chemo-examination-gloves-4mil
- INTCO Medical, U.S. Disposable Gloves Import Report (Jan to Jul 2025): https://www.intcoglove.com/blog-category/cost-procurement/u-s-disposable-gloves-import-data-brief-jan-jul-2025
