FTC Standard for “Made in USA” Glove Claims: What Federal Buyers Should Verify

A CASRAI buyer guide, last updated November 1, 2026, explains how the Federal Trade Commission’s “Made in USA” standard applies to gloves. The guide is aimed at clinic staff, laboratory managers, and buyers evaluating glove labels and supplier claims. It emphasizes that a statement on a glove box is a legal claim about where the product and its parts come from—not a statement about product quality, and not something established by medical-device clearance. For government purchasers, the distinction matters when evaluating offers, documenting product representations, and deciding what follow-up information to request from suppliers.

The FTC’s traditional standard for an unqualified “Made in USA” claim is that a product must be “all or virtually all” made in the United States. The guide identifies 16 CFR Part 323, finalized in August 2021, as the rule governing such labels. Under 16 CFR 323.2, the conditions include U.S. final assembly or processing, significant processing in the United States, and all or virtually all ingredients or components being made and sourced domestically. The rule applies to labeling used to promote or offer goods for sale, and the guide notes that marketers may face civil penalties for an unqualified claim that does not meet the standard.

For procurement teams, the practical implication is to substantiate country-of-origin representations at the specific product level. The FTC rule does not enumerate glove materials or prescribe a glove-specific sourcing checklist, so buyers should ask suppliers how the claim is supported for the exact glove offered. Relevant details may include where final assembly and significant processing occur and the origin of materials and components. A qualified claim is different: the FTC describes it as one that states the extent, amount, or type of domestic content or processing. Buyers should read the qualifier carefully rather than treating it as equivalent to an unqualified domestic-origin claim.

The guide also stresses that origin and regulatory status are separate questions. FDA medical-device status does not certify that a glove is made in the United States, while an origin label does not establish FDA status. The source identifies disposable medical glove categories as examination gloves, surgical gloves, and medical gloves for handling chemotherapy agents, and says FDA regulates them as Class I reserved medical devices requiring a 510(k) premarket notification. It also says manufacturers must identify glove materials on the package; the supplied source text ends before providing further detail on that labeling requirement. Government buyers should therefore verify applicable FDA requirements and any federal domestic-preference rules independently, based on the product and procurement at issue. The CASRAI page is informational rather than legal or medical advice and does not create a new procurement rule.

• FTC standard: An unqualified “Made in USA” claim generally means the product is “all or virtually all” made in the United States.
• Rule reference: 16 CFR Part 323, finalized in August 2021; 16 CFR 323.2 sets out the conditions described in the guide.
• Manufacturing test: Verify U.S. final assembly or processing, significant U.S. processing, and domestic sourcing of virtually all ingredients or components.
• Product-level diligence: Ask the supplier for sourcing and manufacturing support for the exact glove model offered, rather than relying only on a general company statement.
• Qualified claims: A qualified claim describes the extent, amount, or type of domestic content or processing; review its wording to understand what is—and is not—claimed as domestic.
• Potential enforcement exposure: The guide says marketers may face civil penalties for using an unqualified claim when the product does not meet the standard.
• FDA is a separate review: The source identifies examination, surgical, and chemotherapy-handling gloves as disposable medical glove types regulated as Class I reserved medical devices requiring a 510(k) premarket notification.
• Domestic-preference review: Check any applicable federal domestic-preference requirements independently; the CASRAI guide does not establish those requirements for a specific procurement.
• Guide status: CASRAI describes the material as general information, not legal or medical advice, and says sources were checked on November 1, 2026.