Gloves: buying guides & advice

How to Choose Medical Gloves

Medical examination and surgical gloves are single-use disposable Class I medical devices regulated under 21 CFR 880.6250 (examination) and 21 CFR 878.4460 (surgical), required to carry FDA 510(k) clearance before U.S. market entry. They represent one of the highest-volume infection-control consumables in any healthcare facility, purchased by hospitals, ASCs, dental offices, clinical labs, and long-term care facilities through GPO contracts or direct distributor agreements. Procurement decisions pivot on glove category (exam vs. surgical vs. chemotherapy), material type, Acceptable Quality Level (AQL) score, and supply-chain resilience — not brand recognition alone.