Product Disclaimers and Regulatory Notices

Effective date: September 30, 2026

Keystone Supply Group LLC (Keystone) is a distributor. We do not manufacture, relabel, or repackage the products we sell. Product descriptions, specifications, regulatory status, and images are provided by manufacturers and may change without notice. Always read and follow the manufacturer's instructions for use.

Regulatory claims

Keystone makes no FDA or other regulatory claim about any product beyond the manufacturer's labeling and the regulatory status the manufacturer reports. Every product is sold for use as labeled by the manufacturer. Regulatory status shown on a product page (for example 510(k) cleared, NIOSH approved, or EPA registered) is the manufacturer's statement; verify it with the manufacturer or the agency before relying on it for a compliance decision.

No medical, clinical, or safety advice

Content on this site is for product identification and purchasing purposes only. It is not medical advice, clinical guidance, or a substitute for the manufacturer's labeling, your facility's protocols, or the judgment of a licensed professional. Product selection, use, storage, and disposal are the purchaser's responsibility.

Diagnostic tests and laboratory products

• Regulatory status is shown on each product page as stated by the manufacturer: FDA 510(k) cleared, De Novo authorized, PMA approved, or Emergency Use Authorization (EUA). A product marketed under an EUA has not been FDA cleared or approved. Keystone does not describe any product as FDA approved unless the manufacturer holds an approved PMA.
• EUA products are authorized only for the uses and settings stated in the authorization and only while the authorization is in effect. The COVID-19 EUA declarations for in vitro diagnostics are scheduled to terminate on December 26, 2026, after which EUA-only tests will no longer be distributed.
• Tests labeled for professional use or prescription use are sold only to laboratories, healthcare facilities, and practitioners authorized to perform them. CLIA-waived tests must be run by a site holding a CLIA Certificate of Waiver or higher. Point-of-care and over-the-counter tests are sold as labeled.
• Test performance figures on product pages are the manufacturer's stated values from the package insert. Results depend on specimen collection, timing, storage, and operator technique. No test is 100 percent accurate; confirm results as the manufacturer directs.

Respirators and face masks

• Only respirators listed on the NIOSH Certified Equipment List with a valid TC approval number (for example, TC-84A-XXXX) are described as NIOSH Approved. The approval number, filter class (N95, N99, P100, and so on), and approval holder are shown on the product page. Verify any respirator at the NIOSH Certified Equipment List before use.
• KN95, FFP2, and similar masks are not NIOSH approved unless a specific model holds a NIOSH approval. They are listed as the manufacturer describes them and are not sold as a substitute for a NIOSH-approved respirator.
• Surgical N95 respirators are both NIOSH approved and FDA cleared. Standard N95 respirators are not FDA-cleared surgical masks unless stated.
• Respirators provide protection only when used within a respiratory protection program that meets OSHA 29 CFR 1910.134, including fit testing, training, and medical evaluation. Keystone does not provide fit testing.
• Face masks and procedure masks rated under ASTM F2100 are listed with their ASTM level. Masks without an ASTM level are not described as medical grade.

Gloves and protective apparel

Exam gloves are listed with the standard the manufacturer reports (for example, ASTM D6319 for nitrile exam gloves) and their FDA 510(k) status. Chemotherapy-rated gloves are listed with the ASTM D6978 drugs tested by the manufacturer. Protective apparel is listed with AAMI PB70 level or ANSI/ISEA rating where the manufacturer provides it. Barrier performance depends on correct sizing, donning, and use time.

Prescription-only (Rx only) devices

• Products labeled Rx only, or with the statement Caution: Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner, are not sold online. Keystone quotes them to licensed healthcare facilities, licensed practitioners, or purchasers acting on a practitioner's order, including individuals who hold a valid prescription, and each order is fulfilled through Keystone's licensed distribution partner, as required by 21 CFR 801.109.
• Before the first Rx-only order ships, the purchaser must complete the Rx-only purchaser attestation, provide the facility or practitioner license number and state of issue, and certify that the products will be used under the direction of a licensed practitioner.
• Keystone verifies license information and keeps purchase records. Keystone may cancel any order it cannot verify and may report suspected diversion.
• Examples on this site include certain orthopedic bracing, wound care, patient warming, surgical, and IV products. Rx-only products show a quote request instead of a price.

Prescription drugs

Prescription drug products, including IV fluids and premixed injectables, are quoted only to licensed healthcare facilities and practitioners and are fulfilled through Keystone's licensed wholesale distribution partner, in compliance with state wholesale distribution licensing and the Drug Supply Chain Security Act. Prescription drugs are never sold to individuals or through the online store. Over-the-counter drug products, where offered, are sold in the manufacturer's original sealed packaging for use as labeled.

Harm reduction products

• Naloxone nasal spray offered on this site is an FDA-approved over-the-counter drug sold in the manufacturer's original packaging. It is an emergency treatment for suspected opioid overdose and does not replace emergency medical care. Call 911 after use. Minnesota's Good Samaritan law (Steve's Law) protects people who administer naloxone and call for help in good faith.
• Fentanyl test strips are legal to possess and distribute in Minnesota. Laws in other states differ. Purchasers outside Minnesota are responsible for confirming that the product is legal in their state, and Keystone may decline shipment to states where it is restricted.
• Test strips indicate the presence or absence of the specific substances they are designed to detect and do not guarantee that a substance is safe.
• Harm reduction products are sold to organizations, public health programs, healthcare providers, businesses, and individuals where state law allows. They are not returnable.

Sterile products and shelf life

Sterility is guaranteed by the manufacturer only while the package is intact and until the labeled expiration date. Do not use a sterile product if the package is opened, damaged, or wet. Keystone ships product with reasonable remaining shelf life and will state the remaining dating on request.

Floor marking and industrial products

Floor tape, signage, and industrial products are sold for facility use in accordance with the manufacturer's application instructions. Surface preparation and conditions affect performance. Compliance with OSHA, ANSI, or local marking requirements is the facility's responsibility.

Janitorial and chemical products

Safety data sheets are available on request or on the product page. Follow label directions, dilution ratios, contact times, and personal protective equipment requirements. Disinfectant claims are the manufacturer's EPA-registered claims and depend on following the label.

Pricing, availability, and tariffs

Prices and availability change. Inventory shown is not a guarantee of stock. Country of origin is shown on the product page when the manufacturer provides it. Statements about tariff exposure apply only to the stated country of origin of the specific item and may change with trade policy.

Trademarks

3M, Bair Hugger, Ranger, and Solventum are trademarks of Solventum Corporation or 3M Company. Telfa and Kendall are trademarks of Cardinal Health. DeRoyal is a trademark of DeRoyal Industries, Inc. Mighty Line is a trademark of Mighty Line Floor Tape. American Surgical Company is a trademark of American Surgical Company. Narcan is a trademark of Emergent Operations Ireland Limited. All other product names, logos, and brands are the property of their respective owners and are used on this site only to identify the products Keystone sells. Use of a trademark does not imply endorsement of Keystone by the trademark owner, and Keystone is an independent distributor; authorization status for any specific manufacturer line is available on request. See our Third-Party Links and Trademarks page for how manufacturer names and links are used and how to request a correction.

Questions

Contact Orders@KeystoneSupplyGroup.com or (507) 237-6036 for regulatory documents, certificates, instructions for use, or safety data sheets.