FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The BMR - 1501, 1503 Surgical Face Mask is a surgical apparel device that is intended to be worn by operating personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of micro-organisms. body fluids, and particulate material. The BMR - 1501, 1503 Surgical Face Mask is intended to be used in the above application as a single use disposable device.

Device Description

Surgical Face Mask, Code 1501, 1503

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a surgical face mask (BMR-1501, BMR-1503). It confirms that the device is substantially equivalent to legally marketed predicate devices.

The document does not contain any information regarding acceptance criteria or a study proving that the device meets those criteria.

Therefore, I cannot provide the requested information. The 510(k) clearance process primarily focuses on demonstrating substantial equivalence to a predicate device, and the specific performance data and acceptance criteria are typically part of the submission materials rather than the clearance letter itself.

Ask a Question

Ask a specific question about this device

K Number

K962286

Device Name

2505 FACE MASK, TIE STRING / ANTI-FOG / FACE SHIELD

Manufacturer

BERKLEY MEDICAL RESOURCES, INC.

Date Cleared

1996-10-07

(115 days)

Product Code