3M MODEL 1860 HEALTH CARE PARTICULATE RESPIRATOR TYPE N95

K955382 · 3M Company · FXX · May 1, 1996 · General, Plastic Surgery

Device Facts

• Record ID: K955382
• Device Name: 3M MODEL 1860 HEALTH CARE PARTICULATE RESPIRATOR TYPE N95
• Applicant: 3M Company
• Product Code: FXX · General, Plastic Surgery
• Decision Date: May 1, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

· Meets the CDC guidelines for TB exposure control · Has a filter efficiency level of 95% or greater against particulate aerosols free of oil (Type N95 respirator) · Minimizes wearer exposure to certain airborne particles in a size range of 0.1 to 10.0 microns, such as those generated by electrocautery, laser, and other powered medical instruments · Designed to be fluid resistant to splash and spatter of blood and body fluids and other potentially hazardous biomaterials · Provides greater than 99% Bacterial Filtration Efficiency* to exhaled wearer generated microorganisms (*as determined by the modified Greene and Vesley test method)

Device Story

Molded, cup-shaped respirator; covers nose and mouth; secured by two synthetic elastic headbands; includes malleable aluminum noseclip for facial seal. Composed of semi-rigid innershell, filter media, and coverweb. Used in healthcare settings by clinicians to provide N95-level filtration against airborne particles and fluid resistance against blood/body fluids. Protects wearer from aerosols generated by electrocautery or laser instruments; reduces transmission of wearer-generated microorganisms. Passive device; no electronic components or software.

Clinical Evidence

Bench testing only. Filtration efficiency tested via NIOSH sodium chloride test (>=95% efficiency). Fluid resistance tested with 100ml challenge (no penetration). Bacterial filtration efficiency tested via modified Greene and Vesley method (>99%). Face fit tested via qualitative fit test (<10% leakage). Airflow resistance tested per NIOSH requirements (<35mmH2O).

Technological Characteristics

Molded cup-shaped respirator; semi-rigid innershell, filter media, coverweb; malleable aluminum noseclip; synthetic elastic headbands. Passive filtration mechanism. No electronic components, software, or energy source.

Indications for Use

Indicated for use as a surgical mask and N95 particulate respirator to minimize wearer exposure to airborne particles (0.1 to 10.0 microns) and provide fluid resistance to blood and body fluids in healthcare settings.

Regulatory Classification

Identification

Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.

Special Controls

*Classification.* (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible. (ii) Analysis and nonclinical testing must: (A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and (B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device. (iii) NIOSH approved under its regulation. (2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.

Predicate Devices

• 3M Model 1812 surgical mask
• Tecnol DMR2010 respirator
• Lazer™ Surgical Mask

Submission Summary (Full Text)

{0}

510(k) Notification, Additional Information

3M Model 1860 Health Care N95 Particulate-Respirator and Surgical Mask

March 6, 1996

Attachment 3, Page 1 of 2

K955382

# Attachment 3

# 510(k) Summary

MAY - 1 1996

| (1) | Submitter: | Minnesota Mining and Manufacturing Company (3M)
Occupational Health and Environmental Safety Division
3M Center, Building 260-3A-07
St. Paul, Minnesota 55144-1000 |
| --- | --- | --- |
| | Contact Person: | Dorothea von Busch |
| | Phone Number: | 612-737-8838 |
| | Date Prepared: | February 28, 1996 |
| (2) | Device Name/
Trade Name: | 3M™ Model 1860 Health Care N95 Particulate Respirator and Surgical Mask |
| | Common Name: | Surgical Mask
Also sometimes referred to as a Particulate Respirator |
| | Classification
Name: | Surgical Apparel, as described in 21 CFR 878.4040 |
| (3) | Predicate Device(s): | 3M Model 1812 surgical mask; Tecnol DMR2010 respirator and Lazer™ Surgical Mask |
| (4) | Device Description: | The 3M 1860 is a molded, cup-shaped respirator, consisting of a semi-rigid innershell, filter media, and a coverweb. It covers the nose and mouth of the wearer, and is held snugly in place with two synthetic elastic headbands, conforming to the curvature of the wearer’s nose with a malleable aluminum noseclip. |
| (5) | Intended Use: | · Meets the CDC guidelines for TB exposure control
· Has a filter efficiency level of 95% or greater against particulate aerosols free of oil (Type N95 respirator)
· Minimizes wearer exposure to certain airborne particles in a size range of 0.1 to 10.0 microns, such as those generated by electrocautery, laser, and other powered medical instruments
· Designed to be fluid resistant to splash and spatter of blood and body fluids and other potentially hazardous biomaterials
· Provides greater than 99% Bacterial Filtration Efficiency* to exhaled wearer generated microorganisms (*as determined by the modified Greene and Vesley test method) |
| (6) | Technological
Characteristics
Comparison: | No new technological characteristics are used in the 1860 |

{1}

510(k) Notification, Additional Information
3M Model 1860 Health Care N95 Particulate Respirator and Surgical Mask
March 6, 1996
Attachment 3, Page 2 of 2

| (7) | Performance Data Summary: | Filtration Efficiency: subject device samples met the NIOSH required sodium chloride test, with particles having a count median diameter of 0.055 to 0.095 microns, and an aerodynamic diameter of 0.3 microns; at no time can the filtration efficiency drop below 95%.

Fluid Resistance: subject device samples were challenged with 100 ml ±1 ml for up to 24 hours; no fluid penetration was observed.

Multiple Sized Particles Penetration Test: subject device samples were challenged with particles of multiple sizes, having an aerodynamic diameter range of 0.1μm to 10.1μm; the filter efficiency level was greater than 99%.

Bacterial Filtration Efficiency: subject device samples were tested using the modified Greene and Vesley procedure; filtration efficiency was greater than 99%

Face Fit: subject device samples were tested using a qualitative fit test; face seal leakage was less than 10%

Ease of Breathing: subject device samples met the requirements of the NIOSH airflow resistance test which requires initial resistance (inhalation) to be less than 35mmH_{2}O.

CONCLUSION: the results of these nonclinical tests, when compared with data available and/or claims made on the predicate devices, demonstrate that the subject device is as safe and effective as the predicate devices, and performs as well as the predicate devices. |
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