Table of Contents
Medical Mask Definition
All “medical masks” will carry a classification from the American Society of Testing and Materials (ATSM). Medical masks by definition, must be validated at a minimum of ASTM Level 1. Masks intended for medical purposes are considered medical devices and are regulated by the FDA.
ASTM Testing
ASTM rated masks require third party performance testing. Results must meet regulatory requirements and comply with industry standards.
Medical Masks Filtration Requirements
In general, medical masks are almost always three ply construction.
ASTM Level 1 requires a minimum 95% filtration rate. The design is often a minimum of a latex free 3 ply material, fitted nose band, and pleated fabric.
ASTM Level 2 and ASTM Level 3 masks have additional requirements for liquid and particle production. Level 2 and Level 3 filtration performance must meet or exceed 98% capture of particles 0.1 micron or larger.
ASTM Level 2 protection is adequate for industries and professions when exposure to blood and/or bodily fluids is not a risk.
ASTM 3 surgical masks provide significant protection against fluid penetration for front line workers, lab technicians, and emergency responders.
Virtually all surgical masks have soft ties instead of ear loop designs. Ties and headbands provide a more snug fit which reduces leaks and gaps along the sides of the mask.
Continue to: ASTM Level 3 Surgical Masks
Medical Mask ISO Standards
Medical face masks must be tested additionally to international standard (ISO 10993-5:2009) for skin sensitivity and cytotoxic tests to ensure that no materials are harmful to the wearer. Tests are conducted on materials used in construction of the mask which come in contact with the user’s skin. For example, ASTM 1 level masks are latex free to avoid allergic reactions.
Continue to: What are ASTM Level 1 Performance Requirements?
If a mask manufacturer does not provide an ASTM certification for breathability, fluid resistance, or flame spread — as well as appropriate bacterial and filtration efficacy — a product should not be considered fit for medical purposes.
Continue to: What are the Benefits of 3 Ply Procedural Masks vs Cloth Alternatives?
Procedural Masks Specifications
CleanPro® 3 ply masks are not considered medical masks, as they have not been evaluated as such. However, they do meet ASTM Level 2 requirements for bacterial filtration efficacy (BFE). Non-medical procedural masks are designed for general populations or non-procedural activities. Studies show that procedural masks are largely effectively in reducing the spread of respiratory droplets.
Face Masks In-Stock
We have multiple types of facemasks currently in stock. As warehouse inventory is cycled and restocked the exact specifications may vary. Please call for any questions.
- Non-Woven Fabric Outer Layer
- High-Density Filter Layer
- Soft Absorbent Inner Layer
- Adjustable Metal Nose Clip
- Latex-Free and Fiberglass-Free
- Ear Loops
- Soft Lining and Breathable
- Bacterial Filtration is over 99%
- One Size Fits All
Procedural masks meet the criteria of ASTM particle efficiency and bacterial filtration, but have not been evaluated for ASTM flame, fluid, and breathability.
Here are the specifications:
| Mask Rating Standard | Size Threshold | Efficiency Rating |
| Bacterial Filtration Efficiency (BFE) | 3.0 um | 97% |
| [ASTM F 2101] Particle Filtration Efficiency (PFE) | 0.1 um | 98% |
| [ASTM F 2299] Airborne Particle Count (Helmke Drum) | > 0.5 um | 70 counts/pc./cfm |
Production Automation Corporation (PAC — that’s us) is available for direct consultation and price quotes for bulk purchases. Find masks, pricing, and other PPE supplies at the PAC online store. (www.gotopac.com) In stock items are shipped from one of three PAC locations across the United States.
Production Automation Corporation (PAC) is an essential supplier of manufacturing equipment, supplies, and environmental controls.
We have face masks currently in stock at warehouses across the United States. As warehouse inventory is cycled and restocked, the exact specifications may vary. Stock levels change daily. Have questions? Post your comment below. (Sí, se habla español)
Procedural Masks
- 3 Layer Mask
- PP + Spunbond Layers
- No Latex
- No Fiberglass
- Ear Loops
- Soft Lining and Breathable
KN95
- Disposable non-surgical face masks.
- Designed for everyday civilian use.
- 95% filtration efficacy
- Filters out particles, dust, droplets, etc.
- 3rd-party tested and validated
- Comfortable ear loops
FDA Authorized KN95 Masks
Authentic Disposable KN95 Face Masks
This mask is included on the FDA Emergency Use Authorization (EUA) list, and manufactured by Guangzhou Powecom Labor Insurance Supplies.
These KN95 masks were selected after testing KN95 samples from 6+ different manufacturers.
By far, these are the best quality, softest, and most comfortable of the KN95 masks PAC received for testing.
How Have Face Masks Changed Over Time? A Brief History of Face Coverings
Masks were not always made from advanced textiles and multilayer construction. What makes these materials so meaningful when manufacturing PPE equipment, and how has mask technology changed over time?
Where Can I Buy FDA Approved KN95 Masks?
When you buy face masks from PAC you’ll have the benefit of masks shipped from USA warehouses, in-stock availability, and bulk pricing.
What’s a Medical Mask? Why is It Different from a Procedural Mask?
Medical masks by definition, must be validated at a minimum of ASTM Level 1.
What are the Standards for ASTM Face Mask Testing?
This post will help you understand the context, performance criteria, and minimum requirements of ASTM levels in various medical masks and their respective uses fields.
Surgical Medical Masks ASTM Level 3 Requirements
This post will help you understand meaningful differences between various face mask evaluation methods and best-case use. Understanding the most common mask materials and expected performance metrics helps buyers better decide which mask is most appropriate for associated risk, cost, and wellbeing.
ASTM F2299M Medical Face Mask Test Method – Filtration Efficacy Testing
The F2299M filtration efficacy test compares particle counts before a test media meets a filter apparatus (upstream) and then measures again after (downstream) the test media passes through the material.
Who Are We?
Production Automation Corporation (that’s us) is an essential business supplier and manufacturer-direct distributor for medical device, cleanroom, and general manufacturing industries.
Our staff includes a culture of specialists, entrenched manufacturing partnerships, and decades of experience in the distribution and application of critical and industrial cleaning science.
All products featured on the PAC blog are available through the gotopac.com webstore. Online orders are shipped and fulfilled Monday – Friday from PAC warehouses in California, Minnesota, and Texas.
Stock levels and inventory are subject to change.
Production Automation Corporation (PAC) stands 100% behind a product catalog of over 30,000 products, which includes support for factory warranties, value-added services, and returns. Get help from a PAC sales rep during business hours via email, phone, or live chat.
