About This Report  iii

Summary  v

Tables  xiii

CHAPTER 1

Background  1

Introduction  1

Report Overview, Key Findings, and Recommendations  3

CHAPTER 2

U.S. Respirator Production, Consumer Base, and Policy Landscape  5

N95 Respirators and Elastomeric Half-Mask Respirators  5

Respirator Supply Chains  6

Respirator Consumer Base  7

Policy Landscape Relevant to Respirator Manufacturing  8

CHAPTER 3

Challenges Affecting U.S. Small and Medium-Sized Enterprises in Scaling Up Respirator

Manufacturing  11

Supply, Production, and Capacity Challenges  11

Demand and Market Access Challenges  14

Regulatory Challenges  18

Adjacent Issues Warranting Attention  20

CHAPTER 4

Recommendations to Strengthen the Resilience and Competitiveness of Small and Medium-Sized

Enterprises  23

Overcoming Supply, Production, and Capacity Challenges  24

Overcoming Demand and Market Access Constraints  27

Overcoming Regulatory Hurdles  33

Closing Loopholes to Safeguard Fair Competition  33

CHAPTER 5

Conclusion  37

APPENDIXES

A. Methodology  39

B. COVID-19–Era Policy Measures  41

C. Types of Respirators  45

D. Case Study  47

E. Baseline PPE Demand, by Critical Sector  49

Abbreviations  51

Bibliography  53

About the Authors  61