Personal protective equipment in the United States is not regulated by a single agency. At least five federal bodies share the job, and which agencies regulate PPE in any given situation depends on where the equipment is used and who is wearing it: OSHA oversees most workplaces, NIOSH certifies respirators, the FDA handles medical-grade gear, the EPA covers pesticide and chemical protection, and the Consumer Product Safety Commission regulates protective products sold to the general public. A single item can fall under more than one of them at once.
OSHA Regulates PPE in General Workplaces
The Occupational Safety and Health Administration, part of the Department of Labor, is the main regulator for protective equipment on the job. Under 29 CFR 1910.132, employers have to assess their facilities for hazards and supply the appropriate protective gear at no cost to workers.1Occupational Safety and Health Administration. 1910.132 – General Requirements That covers hard hats, safety glasses, chemical-resistant gloves, and anything else the hazard assessment turns up, and it includes training workers on how to put the equipment on, take it off, adjust it, and maintain it.
Employers who skip the assessment or fail to provide adequate gear face significant fines. For penalties assessed after January 15, 2025, a serious violation carries a maximum penalty of $16,550 per occurrence, and willful or repeated violations can reach $165,514 per instance.2Occupational Safety and Health Administration. OSHA Penalties
Respiratory Protection
Respirators have their own detailed standard at 29 CFR 1910.134. Before an employer can issue a respirator, the worker has to pass a medical evaluation confirming the device won’t create a health risk, such as straining a heart or lung condition. Employers also have to run a written respiratory protection program, provide fit testing, and cover all respirators and training at no charge.3Occupational Safety and Health Administration. 29 CFR 1910.134 – Respiratory Protection
NIOSH Certifies Respirators Before They Reach the Job
The National Institute for Occupational Safety and Health, housed in the CDC, doesn’t enforce workplace rules or issue fines. Its job is testing and certifying respirators. Under 42 CFR Part 84, every respirator model has to pass lab testing before it can carry a NIOSH approval label.4Cornell Law Institute. 42 CFR Part 84 – Approval of Respiratory Protective Devices
NIOSH certifies three series of particulate filters based on oil resistance, each at three efficiency levels:5Centers for Disease Control and Prevention. Find Filtering Facepiece Respirators on the Certified Equipment List
- N-series (not oil-resistant): N95 filters 95% of airborne particles, N99 filters 99%, N100 filters 99.97%.
- R-series (somewhat oil-resistant): R95, R99, and R100 follow the same efficiency tiers.
- P-series (strongly oil-resistant): P95, P99, and P100, with P100 at 99.97%.
The N95 is the most recognized rating, but the series matters. Where oil-based aerosols are present, an N-series filter degrades quickly and an R- or P-series is needed instead.6Centers for Disease Control and Prevention. 42 CFR Part 84 Respiratory Protective Devices The division of labor is worth remembering: NIOSH certifies the equipment, and OSHA enforces its proper use on the job.
The FDA Regulates Medical-Grade PPE
When protective equipment is intended for medical use, the FDA takes over. Surgical masks, medical gloves, gowns, and even N95 respirators marketed for healthcare settings are regulated as medical devices under the Federal Food, Drug, and Cosmetic Act.7Food and Drug Administration. Personal Protective Equipment for Infection Control A surgical N95 is regulated by both NIOSH (for filtration) and the FDA (for its medical device classification).
Before most medical PPE can be legally sold, the manufacturer has to obtain 510(k) premarket clearance by showing the device is substantially equivalent to one already on the market in terms of safety and intended use. That demonstration involves meeting consensus standards for barrier performance, fluid resistance, flammability, and biocompatibility.7Food and Drug Administration. Personal Protective Equipment for Infection Control
Barrier Levels for Surgical Gowns
Surgical and isolation gowns are classified under the ANSI/AAMI PB70 standard into four levels:
- Level 1: minimal water resistance. Suitable for basic care and standard medical visits.
- Level 2: low water resistance. Used for blood draws and suturing.
- Level 3: moderate water resistance. Appropriate for arterial blood draws and procedures with moderate fluid exposure.
- Level 4: resistant to blood and viral penetration. Required for surgery and other high-risk procedures with heavy fluid exposure.
Only Level 4 gowns are considered impervious to viral penetration. Levels 1 through 3 are tested against water, which does not predict how well they block viruses.8Centers for Disease Control and Prevention. ANSI/AAMI PB70 – Class 3
The EPA Regulates PPE for Pesticide Handlers
The Environmental Protection Agency covers protective equipment used by agricultural workers and pesticide handlers through the Worker Protection Standard at 40 CFR Part 170. Handlers have to wear the specific PPE listed on a pesticide product’s label, and those label requirements carry the full force of federal law under the Federal Insecticide, Fungicide, and Rodenticide Act.9eCFR. 40 CFR Part 170 – Worker Protection Standard Applying a pesticide without the gloves or respirator the label specifies is a federal violation carrying civil and criminal penalties.10US EPA. Worker Protection Standard Compliance Monitoring Program
The EPA also regulates what happens to PPE once it has been contaminated. Gloves, coveralls, or respirator cartridges exposed to hazardous chemicals may qualify as hazardous waste under the Resource Conservation and Recovery Act. When they do, they have to be stored in labeled, sealed containers, segregated by hazard class, and disposed of through licensed waste facilities.
The CPSC Regulates PPE Sold to Consumers
Protective equipment sold directly to the public rather than to workplaces or healthcare facilities falls under the Consumer Product Safety Commission. The CPSC regulates items like bicycle helmets, knee pads, and protective eyewear marketed for recreational use.11Consumer Product Safety Commission. Regulations, Laws and Standards
The agency sets mandatory safety standards for some products and relies on voluntary industry standards for others. Even where no mandatory federal standard exists for a specific type of protective gear, manufacturers can still face recalls if their products cause injuries, and the CPSC has authority under the Federal Hazardous Substances Act to ban products that pose unreasonable risks, particularly items marketed for children.
State Programs May Enforce Workplace PPE Rules Instead
Federal OSHA does not directly enforce workplace safety rules in every state. Section 18 of the OSH Act lets states run their own enforcement programs as long as they are at least as effective as the federal program.12Occupational Safety and Health Administration. 29 USC 667 – State Jurisdiction and State Plans Federal OSHA continuously evaluates each approved state plan and can withdraw approval if a state falls short.13Occupational Safety and Health Administration. 1902.4 – Indices of Effectiveness
Some state plans impose stricter requirements or higher fines than the federal baseline. Workers in states with approved plans file complaints and undergo inspections through their state agency rather than federal OSHA, so the agency you’d contact about a safety concern depends on where you work.
How to Verify Your PPE Is Legitimate
Knowing which agency regulates your equipment is only useful if you can confirm the gear itself is genuine. Counterfeit and misrepresented PPE is a real problem, particularly for respirators. NIOSH maintains the Certified Equipment List, a searchable database where you can enter a respirator’s TC approval number to confirm it is genuinely certified.14Centers for Disease Control and Prevention. Certified Equipment List Search Every NIOSH-approved respirator carries a TC number in a specific format, such as TC-84A followed by four digits. If the number on the packaging doesn’t match anything in the database, the product is either counterfeit or misrepresented.15Centers for Disease Control and Prevention. Counterfeit/Misrepresented Respirators
For medical-grade PPE like surgical masks and gowns, the FDA maintains the Releasable 510(k) Database, which you can search by device name, product code, or manufacturer to verify that a specific product has received premarket clearance.16U.S. Food and Drug Administration. Search the Releasable 510(k) Database If a manufacturer claims FDA clearance but the product doesn’t appear in the database, treat that as a serious warning sign.