← Product Code [FYA](/productcode/FYA) · K013846 # ULTRAGARD IMPERVIOUS REINFORCED GOWN (K013846) _Precept Medical Products, Inc. · FYA · May 22, 2002 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K013846 ## Device Facts - **Applicant:** Precept Medical Products, Inc. - **Product Code:** [FYA](/productcode/FYA.md) - **Decision Date:** May 22, 2002 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4040 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery ## Indications for Use The UltraGard™ Blue O. R. Gown with Impervious Reinforced Chest and Sleeves is a sterile, single use, disposable garment to be used during surgical procedures in the operating room to help protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. ## Device Story UltraGard™ Blue O. R. Gown is a sterile, single-use, disposable surgical garment; base layer of SMS non-woven material; reinforced chest and sleeve areas composed of polyester laminated to film. Used in operating rooms during surgical procedures; worn by surgical personnel to provide barrier protection against transfer of microorganisms, body fluids, and particulate material between patient and staff. Device is passive; no electronic or mechanical components. Clinical benefit is reduction of cross-contamination risk during surgery. ## Clinical Evidence Bench testing only. Materials tested for synthetic blood penetration (ASTM F1670-98), viral penetration (ASTM F1671-97b), flammability (NFPA 702-1980), and biocompatibility (ISO 10993). ## Technological Characteristics Single-use sterile surgical gown; base layer of SMS non-woven material; reinforced chest/sleeves of polyester laminated to film. Meets ASTM F1670-98, ASTM F1671-97b, NFPA 702-1980 Class 1, and ISO 10993 for surface devices/intact skin/limited duration. ## 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 - Kimberly-Clark ULTRA Zoned-Impervious Gown ([K842115](/device/K842115.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. > > 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}------------------------------------------------ ## MAY 2 2 2002 ## SMDA REQUIREMENTS 510(k) 2013846 # SUMMARY OF SAFETY AND EFFECTIVENESS FOR THE UltraGard™ IMPERVIOUS REINFORCED GOWN This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92. | | Submitter's Name: Precept Medical Products, Inc. | |--|--------------------------------------------------| | | 370 Airport Road | | | Arden, North Carolina 28704 USA | | | Telephone: (828) 681-0209 | Mary Ann Faulkner, V. P. Quality Assurance/Regulatory Affairs Contact Person: Date of Summary: April 19, 2002 Device Name: UltraGard™ Blue Operating Room Gown with Impervious Reinforced Chest and Sleeves. Device Classification: The legally marketed device has been classified as follows: Surgical gown drape and drape accessories; (79 FPH); 21 CFR § 878.4040. Legally Marketed Devices To Which Equivalence Is Claimed: The legally marketed predicate device is the Kimberly-Clark ULTRA Zoned-Impervious Gown (K842115), determined to be substantially equivalent to a legally marketed device on June 11, 1984. The UltraGard™ Blue O. R. Gown with Impervious Reinforced Chest and Sleeves is substantially equivalent to the Kimberly-Clark ULTRA Zoned-Impervious Gown in the intended use and in the performance attributes. Device Description: The UltraGard™ Blue O. R. Gown with Impervious Reinforced Chest and Sleeves is composed of a single base layer of SMS non-woven material with reinforced areas of the chest and sleeves. The reinforced area contains an additional layer of polyester laminated to a film. Intended Use: The UltraGard™ Blue O. R. Gown with Impervious Reinforced Chest and Sleeves is a sterile, single use, disposable garment to be used during surgical procedures in the operating room to help protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Descriptive Summary Of Technological Characteristics And Those Of Predicate Device: The UltraGard™ Blue O. R. Gown with Impervious Reinforced Chest and Sleeves is made of a composite of multiple layers of nonwoven material similar to the Kimberly-Clark ULTRA Zoned-Impervious Gown. Performance Data: The material used in the manufacture of the UltraGard™ Blue O. R. Gown with Impervious Reinforced Chest and Sleeves was tested in accordance with applicable standards and was determined to pass the Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood ASTM F1670-98 and the Viral Penetration testing, ASTM {1}------------------------------------------------ F1671-97b in the reinforced gown areas. The material was tested in accordance with the National Fire Protection Association No. 702-1980, "Wearing Apparel Flammability" and meets Class 1. These devices meet the requirements for biocompatibility per ISO 10993 for surface devices, intact skin, limited duration (< 24 hours). These materials also were tested in accerdance with applicable industry recognized test methods and were found to be acceptable for the intended use. Gown Pack Information: Each gown is packaged with a towel. The towel is the same towel that is currently placed in our gown packs. This towel has been used safely and effectively for many years as a component of the gown pack. Conclusion: The information and data provided in this 510(k) Notification establish that the UltraGard™ Blue O. R. Gown with Impervious Reinforced Chest and Sleeves is substantially equivalent to a legally marketed device. {2}------------------------------------------------ ### DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ## MAY 2 2 2002 Ms. Mary Ann Faulkner Vice President, QA/RA Precept Medical Products, Incorporated 370 Airport Road Arden, North Carolina 28704 Re: K013846 Trade/Device Name: Ultragard™ Blue Operating Room Gown with Impervious Reinforced Chest and Sleeves Regulation Number: 878.4040 Regulation Name: Surgical Gown Regulatory Class: II Product Code: FYA Dated: April 19, 2002 Received: April 23. 2002 Dear Ms. Faulkner: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements {3}------------------------------------------------ #### Page 2 - Ms. Faulkner of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050 This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.qov/cdrh/dsma/dsmamain.html Sincerely yours, Timothy A. Ulatowski Director Division of Dental, Infection Control and (ieneral Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health {4}------------------------------------------------ April 19, 2001 Page 1 of 1 510(k) Number: K013846 Device Name: UltraGard™ Blue O. R. Gown with Impervious Reinforced Chest and Sleeves. Indications for Use: UltraGard™ Blue O. R. Gown with Impervious Reinforced Chest and Sleeves is indicated for use in operating room procedures as a sterile cover garment. (Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) OR Over-the-Counter Use_ Qiu Si Lin (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number _ --- **Source:** [https://fda-staging.innolitics.com/device/K013846](https://fda-staging.innolitics.com/device/K013846) **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