Nonprescription sunglasses
In the United States, nonprescription sunglasses are regulated as Class I devices and are generally 510(k)-exempt subject to applicable limitations. Exemption from 510(k) does not remove other obligations.
United States project route
Custom eyewear for USA brands.
XH Glasses supports United States (USA) brands, distributors, importers and private-label teams developing acetate and metal eyewear. US product, labeling, testing, importer and establishment-role requirements must be confirmed for the final product; this page does not represent FDA approval, certification or registration.
Discuss this market project ↗Project-specific review
Destination-market requirements depend on the final product, intended use, user group, materials, claims and economic operators. Testing, documentation, marking and labeling requirements are reviewed and agreed for each project before production. This page does not represent that an unconfirmed product is certified or approved for a particular market.
Who we support
Built for B2B product teams.
- Independent US eyewear and fashion brands
- Importers, wholesale distributors and private-label programme managers
- Optical and sunglass retailers developing original collections
- Lifestyle businesses adding eyewear to an existing product range
Market-specific review
Define the product and FDA roles before production.
Spectacle frames
Frames intended to hold prescription lenses have their own Class I device definition. XH supplies optical frames with non-prescription demo lenses and does not provide prescription lenses or dispensing.
Impact-resistant lenses
Applicable impact-resistance testing and lot documentation should be defined for the final lens programme. Impact resistant does not mean shatterproof or unbreakable.
Supply-chain responsibilities
Foreign manufacturer, specification developer, private-label distributor, US agent and initial importer roles should be assessed and documented rather than assumed from the exporter name.
What XH handles
From approved brief to export coordination.
Product scope
Acetate sunglasses and optical frames are the main development direction. Metal sunglasses and metal optical frames can also be reviewed. Optical frames are supplied with non-prescription demo lenses only.
Frame geometry, colors, lens appearance, UV400 as a project requirement, logo application and packaging can be coordinated subject to feasibility, sample approval and applicable testing.
Workflow
- Enquiry and destination brief
- Feasibility and specification review
- Quotation and sample definition
- Sample development and buyer approval
- Bulk production against agreed references
- Inspection, documentation and export coordination
What the buyer confirms
Send a useful market brief.
A complete enquiry helps us separate visual preferences from measurable, testable and document-based requirements.
- Product type, intended use, user group and US sales channel
- Whose name or trademark appears on the product and labeling
- Proposed foreign manufacturer, specification developer and importer roles
- Frame drawings, material, components, dimensions and colors
- Lens construction, tint, UV or polarization claim wording
- Impact-resistance method and certificate or record requirement
- Label name and place of business, model and traceability data
- Target quantity, color split, required laboratory and launch timing
Commercial starting points
Clear planning figures,
confirmed per project.
- MOQ
- Typical MOQ starts from 300 pairs per style in total, with colors combined, subject to design, materials and components.
- Sampling
- Typically 7–10 working days after the design, materials, colors and sample requirements are confirmed.
- Production
- Around 25 working days after sample approval and order confirmation. Lead time is not shipment, customs-clearance or arrival time.
- Capacity
- Under standard project conditions, available capacity can reach approximately 1,000 pairs per day. Actual allocation is confirmed project by project.
Target-market review
Evidence belongs to the final product.
FDA establishment registration or device listing does not mean approval, certification or clearance. Where applicable, registration, listing, quality-system, labeling, reporting, US-agent and importer obligations must be handled by the responsible parties. UV400, polarization and other optical-performance statements are project specifications only when supported by suitable evidence for the final configuration. Before quotation, tell us which party owns the specifications, which company will import the goods and what records must accompany the shipment. XH can coordinate sample preparation and technical inputs to an agreed scope, but does not replace the buyer’s regulatory or legal review.
Official reference for project scoping: 21 CFR 886.5850 — Nonprescription sunglasses ↗. Requirements may change; this page is a general project overview, not legal advice.
Build the specification
Market FAQ
Direct answers before you enquire.
Are XH Glasses products FDA approved?+
No FDA approval or certification is represented. The applicable United States device classification, establishment roles, registration, listing, quality-system, labeling and testing obligations must be confirmed for the final project.
Does 510(k) exemption remove other FDA obligations?+
No. Where a product is exempt from 510(k) premarket notification, other applicable general controls and supply-chain responsibilities may still apply.
Does impact resistant mean shatterproof?+
No. An applicable impact-resistance result does not mean that a lens is unbreakable or shatterproof, and we do not make those claims.
Do optical frames include prescription lenses?+
No. Optical frames are supplied with non-prescription demo lenses only. Prescription lenses and optical dispensing are not included.
Last reviewed 13 August 2026
Start a United States
eyewear project.
Send the destination, product type, drawings, quantity, material and lens requirements, branding, packaging and required evidence to Abby.
Send a market-specific enquiry ↗