← Product Code [FYA](/productcode/FYA) · K961239 # DEPUY STERILE VIEW BARRIER HOOD/GOWN WITH HYTREL (K961239) _Depuy, Inc. · FYA · Sep 17, 1996 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K961239 ## Device Facts - **Applicant:** Depuy, Inc. - **Product Code:** [FYA](/productcode/FYA.md) - **Decision Date:** Sep 17, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4040 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery ## Indications for Use The Sterile View Barrier Hood/Gown with Hytrel is intended as disposable surgical apparel to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from the transfer of microorganisms, body fluids and particulate material. ## Device Story Disposable surgical apparel; worn by OR personnel. Composed of Dexter paper and Sontara polyester fabric with Hytrel polymeric coating; molded polycarbonate face shield. Fluid-resistant yet vapor-transmissive; protects wearer/patient from fluid-borne pathogens while maintaining breathability. Available in three sizes. Used in surgical settings to prevent cross-contamination. ## Clinical Evidence Bench testing only. Material passed ASTM ES-21 (resistance to synthetic blood) and ASTM ES-22 (resistance to penetration by blood-borne pathogens using viral penetration). ## Technological Characteristics Materials: Dexter paper, Sontara polyester fabric, Hytrel polyester polyether coating, polycarbonate face shield. Fluid-resistant, vapor-transmissive. Sizes: 1, 2, 2-long. Standards: ASTM ES-21, ASTM ES-22. ## 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 - DePuy Sterile View Barrier Hood UV - Stackhouse Freedom Mark III Surgical Helmet System - Baxter Converters Breathable Gown ## 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} SEP 17 1986 K961239 # SUMMARY OF SAFETY AND EFFECTIVENESS **NAME OF FIRM:** DePuy Inc. 700 Orthopaedic Drive Warsaw, Indiana 46581-0988 **510(k) CONTACT:** Cheryl Hastings Manager, Pre-clinical Device Evaluation **TRADE NAME:** DePuy Sterile View® Barrier Hood/Gown with Hytrel® **CLASSIFICATION:** 878.4040 Surgical apparel **DEVICE PRODUCT CODE:** 79 FYA **SUBSTANTIALLY EQUIVALENT DEVICES:** - DePuy Sterile View Barrier Hood/Gown UV - Stackhouse Freedom Mark III Surgical Helmet System - Baxter Converters Breathable Gown ## INTENDED USE AND DEVICE DESCRIPTION: The Sterile View Barrier Hood/Gown with Hytrel is intended as disposable surgical apparel to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from the transfer of microorganisms, body fluids and particulate material. The Barrier Hood/Gown with Hytrel is a sterile surgical gown, manufactured from Dexter paper and Sontara polyester fabric with a Hytrel polymeric coating. The Dexter paper is used for the hood and gown back. The Sontara/Hytrel material is used on the gown front and sleeves. A molded, polycarbonate face shield is sealed to the hood material. The Sontara/Hytrel material is fluid resistant but vapor transmissive. The gown therefore protects the wearer from fluid borne pathogens, while maintaining "breathability". The Barrier Hood/Gown with Hytrel is available in three sizes: size 1, size 2 and size 2 long. Testing has shown that the Sontara/Hytrel material of the Barrier Hood/Gown with Hytrel passes ASTM standard tests ES-21 for resistance to synthetic blood and ES-22 for resistance to penetration by blood borne pathogens using viral penetration as a test system. ## BASIS OF SUBSTANTIAL EQUIVALENCE: The DePuy Sterile View Barrier Hood/Gown with Hytrel is identical in design and intended use to the DePuy Sterile View Barrier Hood UV. The only difference between these two products is that the material of the hood/gown has been changed from a polyester/wood pulp blend with a polyethylene coating to paper and polyester with a Hytrel polyester polyether coating. The primary advantage of the Hytrel coated material is that it is more breathable (and therefore more comfortable) than the previous material, but is still an effective barrier against fluids and microorganisms. {1} The Sterile View Barrier Hood/Gown with Hytrel is also similar in design and intended use to the Stackhouse Freedom III Toga Gown and the Baxter Converters Breathable Gown. 000013 --- **Source:** [https://fda-staging.innolitics.com/device/K961239](https://fda-staging.innolitics.com/device/K961239) **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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