← Product Code [MSH](/submissions/SU/subpart-e%E2%80%94surgical-devices/MSH) · K970448 # PCM 2000; ISOLAIR APR MODEL 2735 (K970448) _Tecnol Medical Products, Inc. · MSH · Apr 30, 1997 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/MSH/K970448 ## Device Facts - **Applicant:** Tecnol Medical Products, Inc. - **Product Code:** [MSH](/submissions/SU/subpart-e%E2%80%94surgical-devices/MSH.md) - **Decision Date:** Apr 30, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4040 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery ## 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. ## 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 - Gerson Isolair APR Type N95 Model 2735 Respirator and Surgical Mask ## 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. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} 04/22/97 15:18 817 581 9354 TECNOL INTL 008/009 Tecnol Medical Products, Inc. 510(k) Premarket Notification PFR95™ Particulate Filter Respirator and Surgical Mask with FluidShield® Protection Tab H 1 of 2 APR 30 1997 K970448 510(k) SUMMARY (1) Submitter: Tecnol Medical Products, Inc. 7201 Industrial Park Blvd. Fort Worth, TX 76180 Prepared By: Ruth L. Jones Date Submitted: March 24, 1997 (2) Device Name/Trade Name: Tecnol PFR95™ Particulate Filter Respirator and Surgical Mask FluidShield® Protection 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: Gerson Isolair APR Type N95 Model 2735 Respirator and Surgical Mask (4) Device Description: Respirator consisting of nonwoven inter facing, filter media(s), a fluid barrier film, and an outer facing. It covers the nose and mouth of the wearer, and is held in place with two synthetic elastic headbands, conforming to the curvature of the wearer's nose with a malleable nosepiece. (5) 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. (6) Technological Characteristics Comparison: No new technological characteristics are used in the PFR95™ mask. fpfr510(k)/pfr-tabh3.doc {1} 04/22/97 15:18 817 581 9354 TECNO. INTL 009/009 Tecnol Medical Products, Inc. 510(k) Premarket Notification PFR95™ Particulate Filter Respirator and Surgical Mask with FluidShield® Protection Tab H 2 of 2 (7) Performance Data: Filtration Efficiency: Subject device samples met the NIOSH required sodium chloride test with 0.3 micron particles. At no time can the filtration efficiency drop below 95%. Fluid Resistance: Subject device samples were challenged with 2cc of synthetic blood at a speed simulating release of blood from an artery. No fluid penetration was observed. Face Fit: Subject device samples were tested using a qualitative fit test. Ease of Breathing: Subject device samples met the requirements of the NIOSH airflow resistance test which requires initial resistance (inhalation) to be less than 35mm H₂O. CONCLUSION: The results of these nonclinical tests, when compared with data available and/or claims made on the predicate device, demonstrate that the subject device is as safe and effective as the predicate device, and performs as well as the predicate device. f:pfi510(k)/pfi-tabb3.doc --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/MSH/K970448](https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/MSH/K970448) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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