3M 1830 FLUID BLOCK ANTI-FOG TIE-ON SURGICAL MASK AND 3M 1830FS FLUID BLOCK ANTI-FOG TIE-ON SURGICAL MASK WITH FACE SHIE
Device Facts
| Record ID | K965043 |
|---|---|
| Device Name | 3M 1830 FLUID BLOCK ANTI-FOG TIE-ON SURGICAL MASK AND 3M 1830FS FLUID BLOCK ANTI-FOG TIE-ON SURGICAL MASK WITH FACE SHIE |
| Applicant | Minnesota Mining and Mfg. Co. |
| Product Code | FXX · General, Plastic Surgery |
| Decision Date | Mar 10, 1997 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4040 |
| Device Class | Class 2 |
Indications for Use
The product is intended for use in infection control practices to minimize contamination caused by exhaled microorganisms. In addition, the device is intended to reduce potential exposure of the wearer to blood and body fluids.
Device Story
Flat, pleated, tie-on surgical mask; covers nose and mouth; secured by tie strings and malleable plastic-coated wire nose piece. Construction includes inner/outer cover webs with two internal filter webs and a specialized fluid-resistant layer. 1830FS model includes an anti-fog coated face shield. Used in clinical settings for infection control; protects wearer from blood/body fluid splashes and reduces microbial transmission. Healthcare providers wear the device during procedures to maintain sterile fields and personal protection.
Clinical Evidence
Bench testing only. Biocompatibility testing (Cytotoxicity-Agar-Overlay, Primary Skin Irritation, Ocular Irritation, Human Draize Sensitization, 21-Day Cumulative Irritation) confirmed non-irritating and hypoallergenic properties. Performance testing included Bacterial Filtration Efficiency (>99%), Particle Filtration Efficiency (>95% at 0.1 micron), fluid resistance (cup test >65ml/120hr; synthetic blood resistance at 120 mmHg and 300 mmHg), and differential pressure (Delta P = 4.2).
Technological Characteristics
Flat, pleated, tie-on design. Materials: multi-layer non-woven cover and filter webs, plastic-coated wire nose piece. Features: fluid-resistant layer, anti-fog strip, anti-fog/anti-reflective coated face shield (1830FS).
Indications for Use
Indicated for use by healthcare personnel to minimize contamination from exhaled microorganisms and reduce exposure to blood and body fluids.
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 1818 Tie-on Surgical Mask and 3M 1818FS Tie-On Surgical Mask with Face Shield (K940707)
- Tecnol FluidShield(R) Surgical Masks (K913043)
