← Product Code [FYA](/submissions/SU/subpart-e%E2%80%94surgical-devices/FYA) · K992951 # CONVERTORS SURGICAL GOWNS (K992951) _Allegiance Healthcare Corp. · FYA · Sep 22, 1999 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/FYA/K992951 ## Device Facts - **Applicant:** Allegiance Healthcare Corp. - **Product Code:** [FYA](/submissions/SU/subpart-e%E2%80%94surgical-devices/FYA.md) - **Decision Date:** Sep 22, 1999 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 878.4040 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery ## Intended Use Surgical apparel are devices intended 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 Convertors® Surgical Gowns are protective apparel for operating room personnel. Constructed from single-layer spunlaced nonwoven fabric; features polyethylene reinforcement in chest area and breathable monolithic film in sleeves. Worn by surgeons, nurses, and OR staff during surgical procedures to provide barrier protection against microorganisms, body fluids, and particulates. Protects both patient and wearer from cross-contamination. ## Clinical Evidence No clinical data. Bench testing only. Materials evaluated for biocompatibility (cytotoxicity, sensitization, irritation/intracutaneous reactivity) per ISO 10993 Part-1 and industry-recognized test methods. ## Technological Characteristics Single-layer spunlaced nonwoven fabric; polyethylene reinforcement (chest); breathable monolithic film (sleeves). Biocompatibility testing per ISO 10993-1. ## 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 - Convertors® Optima Gowns ## 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 2 2 1999 # 4 Allegiance Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, Illinois 60085-6787 847.473.1500 FAX: 847.785.2461 #### SMDA REQUIREMENTS XII. ## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS | Manufacturer: | Allegiance Healthcare Corporation
One Butterfield Trail
El Paso, Texas 79906 | |-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Regulatory Affairs Contact: | Sharon Robbins
1500 Waukegan Road MPWM
McGaw Park, IL 60085 | | Telephone: | (847) 785-3311 | | Date Summary Prepared: | July, 1999 | | Common Name: | Convertors® Surgical Gowns | | Classification: | Class II per 21CFR § 878.4040 | | Predicate Device: | Convertors® Optima Gowns. | | Description: | The gowns are comprised of a single layer of
spunlaced nonwoven fabric with a polyethylene
reinforcement in the chest area and a
breathable monolithic film in the sleeves. | {1}------------------------------------------------ Allegiance Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park. Illinois 60085-6787 847.473.1500 FAX: 847.785.2461 ### SMDA REQUIREMENTS (continued) XII. ### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Convertors® Gowns . | Intended Use: | Surgical apparel are devices intended 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. | |--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Substantial Equivalence: | The Convertors® gowns are substantially
equivalent to the Convertors® gowns in that:
- the intended use is the same
- the performance attributes are the
similar | | Summary of testing: | All materials used in the fabrication of this
Convertors® Gowns were evaluated through
biological qualification safety tests as outlined in ISO
10993 Part-1 "Biological Evaluation of Medical
Devices". The biocompatibility tests performed were
cytotoxicity, sensitization, and irritation/
intracutaneous reactivity. These materials also were
tested in accordance with industry recognized test
methods and were found to be acceptable for the
intended use. | - {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. In the center of the seal is a stylized image of a bird or eagle with three curved lines representing its wings or feathers. The bottom of the seal has a wavy line design. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 SEP 2 2 1999 Ms. Sharon Robbins Regulatory Affairs Manager Alleqiance Healthcare Corporation 1500 Waukegan Road McGaw Park, Illinois 60085-6787 Re : K992951 Covertors® Surgical Gowns Trade Name: Regulatory Class: II Product Code: FYA August 31, 1999 Dated: Received: September 1, 1999 Dear Ms. Robbins: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਬੋ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of {3}------------------------------------------------ Page 2 - Ms. Robbins the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4690. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, Susan Runner Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ Allegiance Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, Illinois 60085-6787 473.1500 X: 847.785.2461 Page 1 of 1 510(k) Number (if known): K942951 Unknown Device Name: Convertors® Surgical Gowns Indications For Use: The Convertors® Surgical Gowns are devices intended 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. Olin S. Lim ivision of Dental, Infection Control, Anaral Hosni (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) or Over-The Counter Use --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/FYA/K992951](https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/FYA/K992951) **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