← Product Code [FXX](/productcode/FXX) · K965043

# 3M 1830 FLUID BLOCK ANTI-FOG TIE-ON SURGICAL MASK AND 3M 1830FS FLUID BLOCK ANTI-FOG TIE-ON SURGICAL MASK WITH FACE SHIE (K965043)

_Minnesota Mining and Mfg. Co. · FXX · Mar 10, 1997 · General, Plastic Surgery · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K965043

## Device Facts

- **Applicant:** Minnesota Mining and Mfg. Co.
- **Product Code:** [FXX](/productcode/FXX.md)
- **Decision Date:** Mar 10, 1997
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 878.4040
- **Device Class:** Class 2
- **Review Panel:** General, Plastic Surgery

## 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).

## Regulatory 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](/device/K940707.md))
- Tecnol FluidShield(R) Surgical Masks ([K913043](/device/K913043.md))

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
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# 510(k) Summary

MAR 10 1997

**MANUFACTURER:**
3M Health Care
3M Center
St. Paul, MN 55144-1000

**REGULATORY AFFAIRS CONTACT:**
Karen C. Maass
Regulatory Affairs Specialist
3M Medical Markets Group
3M Center, Bldg. 275-3E-08
St. Paul, MN 551441-1000

**TELEPHONE:** (612) 736-1031

**DATE SUMMARY PREPARED:** October 9, 1996

**DEVICE TRADE NAME:** 3M 1830 Fluid Block Anti-Fog Tie-on Surgical Mask, 3M 1830FS Fluid Block Anti-Fog Tie-on Surgical Mask with Face Shield

**COMMON OR USUAL NAME:** Surgical Mask

**CLASSIFICATION:** Surgical Apparel, Class II, 21 CFR 878.4040

**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).

**DEVICE DESCRIPTION** The 1830/1830FS is a flat, pleated, tie-on mask consisting of inner and outer cover webs with two different filter webs sandwiched in between. It covers the nose and mouth of the wearer, and is held in place by tie strings and a malleable plastic coated wire nose piece.

**INTENDED 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.

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## SUBSTANTIAL EQUIVALENCE:

The 3M 1830/1830FS masks are the same product as the 3M Surgical Masks with Face Shield (K940707), with an additional “fluid block” layer to improve the masks fluid resistance. The following characteristics of the 3M 1830/1830FS mask indicate this device is substantially equivalent to the predicate devices listed above.

- Intended use
- Bacterial filtration efficiency
- Fluid resistance
- Anti-Fog coated face shield (1830FS only)
- Anti-fog strip incorporated in the mask design to reduce fogging of glasses
- Soft, non-irritating inner surface
- Flat, pleated, tie-on design
- Special fluid resistant layer
- Target population

## TESTING SUMMARY:

Standard biocompatibility testing in animals and humans (including Cytotoxicity-Agar-Overlay, Primary Skin Irritation, Ocular Irritation, Human Draize Sensitization, and 21-Day Cumulative Irritation) on the product and/or its components indicate that the 1830/1830FS mask is non-irritating and hypoallergenic and safe for its intended use.

The following tests support the 1830/1830FS mask as acceptable for its intended use:

|  Mod. Greene & Vesley | >99% BFE  |
| --- | --- |
|  0.1 Micron Latex Particle Challenge | >95% PFE  |
|  Fluid Resistance (Cup Test) | Resists a liquid volume > 65 ml for 120 hr.  |
|  Fluid Resistance (Nelson Test) | Resists liquid pressures under various conditions, i.e. 2cc synthetic blood at 120 mm Hg (2.3 psi)/1.5 inches/1 assault, and 2.3 cc synthetic blood at 300 mm Hg (5.8 psi)/18 inches/5 assaults.  |

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# TESTING SUMMARY (continued):

Differential Pressure (Delta P)
1818/1818FS < 1830/1830FS < Tecnol FluidShield #47123-070 at a face velocity of 20 ft/min. and airflow of 62 lpm. Delta P = 2.4, 4.2 and 5.0 respectively.

Anti-Reflective Test
Anti-reflective coating reduces reflections on shield by > 80%.

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**Source:** [https://fda-staging.innolitics.com/device/K965043](https://fda-staging.innolitics.com/device/K965043)

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