PCM 2000; ISOLAIR APR MODEL 2735
Device Facts
| Record ID | K970448 |
|---|---|
| Device Name | PCM 2000; ISOLAIR APR MODEL 2735 |
| Applicant | Tecnol Medical Products, Inc. |
| Product Code | MSH · General, Plastic Surgery |
| Decision Date | Apr 30, 1997 |
| 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% against solid particulate aerosols free of oil (Type N95 respirator). Designed to be fluid resistant to splash and spatter of blood and body fluids.
Device Story
Respirator mask; nonwoven interfacing, filter media, fluid barrier film, outer facing; malleable nosepiece; two synthetic elastic headbands. Covers nose and mouth. Used in clinical settings to protect wearer from airborne particulates and blood/body fluid splash. Provides 95% filtration efficiency against non-oil aerosols; fluid resistant. Clinician wears device to reduce exposure risk during procedures.
Clinical Evidence
Bench testing only. Filtration efficiency tested against 0.3 micron sodium chloride particles (>=95% efficiency). Fluid resistance tested with 2cc synthetic blood at arterial pressure (no penetration). Airflow resistance tested per NIOSH requirements (<35mm H2O). Qualitative face fit testing performed.
Technological Characteristics
Nonwoven construction with filter media and fluid barrier film. Malleable nosepiece. Synthetic elastic headbands. N95 particulate filtration standard. Fluid resistance barrier.
Indications for Use
Indicated for use as a surgical mask and particulate respirator for individuals requiring protection against solid particulate aerosols (N95) and fluid splash/spatter exposure, including TB exposure control 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
- Gerson Isolair APR Type N95 Model 2735 Respirator and Surgical Mask
Related Devices
- K974068 — PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL MASK REGULAR SIZE, PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL · Tecnol Medical Products, Inc. · Dec 22, 1997
- K233022 — Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with Safety Seal and So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 2 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, White, Regular and Small · Owens & Minor (O&M) Halyard, Inc. · Jan 12, 2024
- K960778 — ISOLAIR APR TYPE N95 · Louis M. Gerson Co., Inc. · May 9, 1996
- K955382 — 3M MODEL 1860 HEALTH CARE PARTICULATE RESPIRATOR TYPE N95 · 3M Company · May 1, 1996
- K964723 — RACAL N95 RESIRATOR · Racal Filter Technologies, Inc. · Feb 7, 1997
