Lutema USA

Name

Lutema USA

Legal name

Lutema USA

Website

https://lutema.com

Company type

Private

Founded year

2020

Operating status

Operating

Headcount range

11–50 employees

Short description

Lutema USA is a San Diego-based PPE manufacturer producing FDA-registered disposable face masks (3-6 layer M-series) for individual consumers, schools, businesses, and government through direct e-commerce, Amazon, and bulk B2B channels.

Ownership category

akta.pro rank

Headquarters

HQ city

San Diego

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2C

Offering type

Hardware or Manufacturing

Cost components

Supply Chain, Operations, Personnel, Marketing or Sales, Technology or R&D

Revenue model

1. Direct Product Sales: One-time and subscription-based sales of disposable face masks and protective gear through e-commerce website. Individual consumer packs and bulk/enterprise multi-pack orders. Free shipping on orders $40+.
2. Subscription / Subscribe & Save: Subscribe & Save model offering recurring delivery of masks at discounted prices (e.g., 10% off regular price). Billing cadence options include every 2 weeks, monthly, and 45-day intervals.

Pricing tiers

Go-to-market motion2 records

Distribution channels3 records

Marketing channels7 records

Core offering

Lutema USA manufactures and sells USA-made disposable face masks and protective equipment directly to consumers and bulk-buy organizational buyers through its e-commerce website and Amazon. The product range includes M93, M94, M95, and M96 series masks for kids, small adults, and adults in various filtration levels, plus accessories such as anti-fog cloths and family gift box bundles.

Product overview

Lutema USA is a domestic manufacturer of disposable face masks and protective equipment based in San Diego, California. The product portfolio consists of multiple face mask lines organized by protection level, target demographic (children or adults), and mask style. The M95-series represents the flagship ultra-high filtration line (5-layer, 99%+ filtration), while the M93-series offers breathable lightweight options (3-layer, 97%+ filtration), and the M94-series targets young children with high airflow designs (4-layer, 98%+ filtration). A valved M96-series respirator provides maximum inhalation protection with 6 layers. Both pleated rectangular styles (3-ply, 4-ply ASTM Level 3) and KF94-style fish-shaped masks are available. The company also sells a small accessory product (reusable anti-fog cloth made in Germany) and multi-size gift box bundles. All masks are manufactured by Breathh, Inc. using MI Technologies equipment in an FDA-registered, ISO 9001:2015-compliant facility.

Differentiator

Problem solved

Functional benefit

Products and services

• Kids 3-Ply Breathable Disposable Face Mask (5.5") Disposable 3-layer face mask sized for children (5.5 inches wide), made in USA with FDA listing. Features soft elastic ear loops, breathable non-woven polypropylene fabric, and a high-quality nose bridge wire. Achieves 97.89% sodium chloride aerosol filtration and 99.82% bacterial filtration efficiency.
• Adults 5-Layer M95i Travel Face Mask with Ultra High Filtration 5-layer disposable face mask for adults offering 99%+ particle filtration. Features ear loops and breathable non-woven polypropylene fabric. Tested for 99.685% sodium chloride aerosol challenge and 99.92% bacterial filtration efficiency. Comparable to N95/KN95/KF94 standards.
• Kids 5-Layer M95Fc Travel Fish Style Face Mask (KF94 Style)

Quantifiable outcome

• BFE 99.82%+, PFE 99.93%+ (Eurofins) for 3-ply masks
• +5 more outcomes

Named customers4 records

Segments3 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature6 records

Partnerships

Four partnerships are on record, tiered core and minor.

• Sante Group, LLCcoreOthersLutema USA is a joint venture with Sante Group, LLC. Sante Group appears to be the parent/joint venture partner providing strategic direction and operational support for the Lutema brand mask business.
• American Medical Manufacturers Association (AMMA)coreStrategic or Co-development PartnerLutema USA was a founding charter member of the American Mask Manufacturers Association (now AMMA), a trade association of domestic PPE manufacturers whose mission is to ensure consistent U.S. access to quality, U.S.-made PPE and create a market environment that incentivizes domestic PPE production.
• MI Technologies, Inc.coreOEM/ Whitelabel/ Licensing PartnerMI Technologies, Inc. designed the fully automated manufacturing machinery used in Lutema mask production. It is also the only authorized distributor of Lutema Brand masks made in America. Masks are manufactured by Breathh, Inc. by MI Technologies at FDA Registration No. 3017171515. Fit testing was performed on-site at MI Technologies in San Diego, CA.
• ExamineticsminorImplementation/ SI/ Consulting PartnerExaminetics, a workplace health and safety services provider, performed qualitative fit testing on Lutema M95i masks in March 2021. All 22 tests (11 subjects tested with ear loops and head straps) passed OSHA fit testing requirements.

Scale indicators5 records

Recent moves6 records

Expansion highlights5 records

Broad incumbents

• 3M: Dominant global manufacturer of N95 respirators and a broad PPE/healthcare portfolio. Lutema competes head-to-head in the high-filtration mask category but 3M also serves industrial, healthcare, and consumer segments with vastly larger scale and NIOSH approvals Lutema lacks.
• Medline: Largest privately-held US manufacturer and distributor of medical supplies, including surgical masks and respirators. Comparable to Lutema as a domestic PPE supplier serving hospitals, government, and schools, but with vastly broader catalog and GPO contract footprint.
• Honeywell: Major global PPE manufacturer producing N95 respirators, surgical masks, and respiratory protection under the North brand. Competes in the same high-filtration mask category as Lutema, with much larger institutional contracts, brand equity, and global distribution.
• Kimberly-Clark: Global consumer and B2B manufacturer including the KleenGuard and Halyard PPE brands covering surgical masks and respirators. Comparable as a domestic (and global) supplier of disposable face protection to healthcare, industrial, and government buyers.

Direct peers

• Prestige Ameritech: Largest US-based surgical mask and respirator manufacturer. Directly comparable to Lutema as a domestic, FDA-registered mask producer serving healthcare, government, and industrial buyers with similar product architecture (3-ply surgical and N95-style respirators).
• Makrite: Manufacturer of N95 respirators, surgical masks, and dust masks with US distribution. Comparable product architecture (multi-layer respirators) and overlapping customer base in healthcare, industrial, and government segments.
• Alpha Pro Tech: Public US manufacturer of disposable protective apparel, face masks (N95 respirators), and building products. Direct competitor in domestically-produced respiratory PPE with comparable product tiers (N95 respirators, procedural masks) and institutional distribution.
• WellBefore: US-based PPE e-commerce retailer offering N95s, KN95s, surgical masks, and kids masks. Closely comparable GTM (DTC e-commerce, bulk-buy, multiple mask SKUs targeting consumers and institutions) though primarily a distributor rather than manufacturer.
• Armbrust USA: Texas-based US surgical mask manufacturer and DTC retailer founded during COVID-19. Closely mirrors Lutema's domestic-manufacturing, DTC-e-commerce, bulk-B2B, and ASTM Level 3 positioning, with overlapping customer segments (consumers, schools, government).
• DemeTech: US manufacturer of surgical masks, N95 respirators, and PPE based in Florida. Comparable as a domestic producer of surgical/face masks and respirators with FDA registration, targeting healthcare and institutional buyers similar to Lutema's bulk channels.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights6 records

Customer concentration

• Xtwitter.com/LutemaUSA?t=C88wrkmKRgLBdsi3iMZQjg&s=08
• Facebookm.facebook.com/LutemaProducts

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles2 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Lutema USA