Premiumestore, LLC

Premiumestore, LLC specializes in single-use surgical and medical face masks. Their product line includes non-antimicrobial masks designed for procedural and clinical settings, such as the Amerishield and AirMax Procedure Mask. These masks are intended for one-time use and provide protection during surgical and medical procedures.

Premiumestore, LLC is based in the United States. The company operates under U.S. regulatory frameworks, including FDA requirements for its medical devices.

Premiumestore, LLC’s face masks fall under FDA Class II classification. This classification applies to devices that pose moderate risk and require special controls to ensure safety and effectiveness, such as pre-market notifications (510(k)) and unique device identifiers (UDI) for tracking.

Premiumestore, LLC’s devices are listed in the FDA’s 510(k) premarket notification database and the FDA’s Unique Device Identifier (UDI) system. These registries ensure compliance with U.S. medical device regulations and provide transparency on authorized products.

Premiumestore, LLC’s masks are designed as single-use to maintain hygiene and infection control standards in clinical and procedural environments. Single-use masks reduce the risk of cross-contamination by ensuring each mask is discarded after one use, aligning with best practices for medical device safety and regulatory compliance.