← Product Code [FYA](/productcode/FYA) · K961083 # OREX SURGEON'S VEST (K961083) _Thantex Specialties, Inc. · FYA · Aug 23, 1996 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K961083 ## Device Facts - **Applicant:** Thantex Specialties, Inc. - **Product Code:** [FYA](/productcode/FYA.md) - **Decision Date:** Aug 23, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4040 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery ## Indications for Use A surgeon's vest constructed of OREX nonwoven fabric for use as additional protection for surgeons during a surgical procedure. ## Device Story Surgeon's vest made of OREX nonwoven fabric; provides additional protection for surgeons during surgical procedures; flame resistant; fluid penetration resistant; low lint; tear resistant; disposable via standard hospital methods or dissolvable in OREX processor; used in surgical settings; worn by surgeons. ## Clinical Evidence Bench testing only. Biocompatibility testing performed according to FDA guidance documents; results compared favorably to predicate device. ## Technological Characteristics Nonwoven fabric (OREX); flame resistant; fluid penetration resistant; tear resistant; low lint. Dissolvable in OREX processor. ## 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 - Surgeon's Vest (Isolyser/White Knight) ## 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} AUG 05 '96 01:21PM MEDSURG INDUSTRIES P.2/2 K961083 AUG 23 1996 510(k) Summary The Isolyser Company, Inc. 4320 International Boulevard Norcross, Georgia 30093 770-381-7566 Contact Person: Thomas Bonner - V.P. Regulatory Affairs Date summary prepared: May 31, 1996 OREX Surgeon's Vest Legally marketed equivalent device: Surgeon's Vest Isolyser/White Knight Material: OREX nonwoven fabric Description of Device: A surgeon's vest constructed of OREX nonwoven fabric for use as additional protection for surgeons during a surgical procedure. The material is flame resistant, and is resistant to fluid penetration. The material also has low lint characteristics, meets suitable strength requirements for its intended use, and is resistant to tearing. The material is dissolvable after use in an OREX processor or may be disposed of using the hospital or healthcare facilities standard disposal method. All testing conducted on the fabric used in this product was tested according to guidance documents published for biocompatibility. The results from these tests were found to be acceptable when compared to that of the predicate device. In some instances test results were found to exceed those of the predicate device. Through these test results determination has been established that this device and the predicate device are similar in use and functionality. --- **Source:** [https://fda-staging.innolitics.com/device/K961083](https://fda-staging.innolitics.com/device/K961083) **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. If you're preparing [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/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com