GCI Surgical Gown

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "U.S. Food & Drug Administration" in blue. August 2, 2024 George Courey Inc % Sarah Fitzgerald Senior Consultant Emergo by UL 2500 Bee Cave Road Building 1. Suite 300 Austin, Texas 78746 Re: K233571 Trade/Device Name: GCI Surgical Gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FYA Dated: November 3, 2023 Received: November 6, 2023 Dear Sarah Fitzgerald: 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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. {1}------------------------------------------------ Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 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); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Allan Gua For Bifeng Qian, M.D., Ph.D. Assistant Director {2}------------------------------------------------ DHT4C: Division of Infection Control Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K233571 Device Name GCI Surgical Gown Indications for Use (Describe) GCI surgical gown is 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. Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the surgical gowns met the requirements for Level 2 barrier classification. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| Prescription Use (Part 21 CFR 801 Subpart D) X Over-The-Counter Use (21 CFR 801 Subpart C) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the Emergo by UL logo. The logo consists of a red circle with white lines on the left and the word "EMERGO" in black on the right. Below the word "EMERGO" is the text "by UL" in gray. The logo is simple and modern. ## K233571 - 510(k) Summary GCI Surgical Gown #### 1. Submission Sponsor George Courey, Inc. 6620, Ernest-Cormier Laval, Quebec, H7C 2T5 Canada Contact: Cort Naab Title: Director of Surgical Solutions Telephone: 850-382-9077 E-mail: cnaab@georgecourey.com #### 2. Submission Correspondent Emergo by UL 2500 Bee Cave Road Building 1, Suite 300 Austin, TX 78746 Office Phone: (512) 327-9997 Email: LST.AUS.ProjectManagement@ul.com Contact: Sarah Marie Fitzgerald Title: Senior Consultant, Quality and Regulatory Affairs #### 3. Date Prepared July 31, 2024 #### 4. Device Identification | Trade/Proprietary Name: | GCI Surgical Gown | |-------------------------|-------------------| | Common/Usual Name: | Surgical Gowns | | Classification Name: | Surgical Apparel | | Regulation Number: | 878.4040 | | Product Code: | FYA | | Class: | 2 | | Classification Panel: | General Hospital | ## 5. Legally Marketed Predicate and Reference Device(s) | Predicate Device name: | Level 2 Standard Surgical Gown1 | |------------------------|--------------------------------------------------| | 510(k) number: | K211422 | | Manufacturer: | Jiangsu Medplus Non-woven Manufacturer Co., Ltd. | | Common/Usual Name: | Surgical Gowns | | Classification Name: | Surgical Apparel | | Regulation Number: | 878.4040 | | Product Code: | FYA | | Class: | 2 | Reference Device Name: Innerbloc LR Surgical Gowns ¹ The predicate also includes Level 3 gowns, but only the Level 2 gowns are relevant for this submission. K233571 {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the Emergo logo. The logo consists of a red circular icon with three curved lines inside, followed by the word "EMERGO" in black, sans-serif font. Below the word "EMERGO" is the phrase "by UL" in a smaller, gray font. | 510(k) number: | K092344 | |----------------------|------------------| | Manufacturer: | Lac Mac, Limited | | Common/Usual Name: | Surgical Gowns | | Classification Name: | Surgical Apparel | | Regulation Number: | 878.4040 | | Product Code: | FYA | | Class: | 2 | #### 6. Indication for Use Statement GCI surgical gown is 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. Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the surgical gowns met the requirements for Level 2 barrier classification. #### 7. Device Description GCI Surgical Gowns are intended to be used during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate materials. The gown is available in multiple sizes. They are provided non- sterile and intended to be sterilized prior to use. They are reusable up to 75 uses. Per ANSI/AAMI PB70 Liquid barrier performance and classification of protective apparel intended for use in health care facilities, the proposed devices meet the requirements for 2, as indicated by their labeling. #### 8. Substantial Equivalence Discussion The following table compares the subject device to the predicate devices with respect to intended use, indications for use, principles of operation, technological characteristics, materials, and performance, and forms the basis for the determination of substantial equivalence. The subject device does not raise any new questions of safety or effectiveness as compared to the predicate device. {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the logo for EMERGO by UL. The logo consists of a red circular icon with white curved lines inside, followed by the word "EMERGO" in black, sans-serif font. Below the word "EMERGO" is the phrase "by UL" in a smaller, gray font. #### Table 1 – Comparison of Intended Use and Indications for Use: GCI Surgical Gown | Attribute | SUBJECT: K233571 GCI Surgical Gown | PREDICATE: K211422 Level 2 Standard Surgical Gown | Comparison | |---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------| | Intended Use | To protect both patients and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. | To protect both patients and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. | Same | | Indications for Use | GCI surgical gown is 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.<br>Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the surgical gowns met the requirements for Level 2 barrier classification. | Surgical gown is intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.<br>Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the Level 2 standard surgical gowns met the requirements for Level 2 barrier classification, the Level 3 standard surgical gowns and Level 3 reinforced surgical gowns met the requirements for Level 3 classification. | Similar<br>Subject Device does not have Level 3 Gown.<br>Meets barrier level requirements per PB70 | #### Table 2 – Comparison of Characteristics: GCI Surgical Gowns | Attribute | SUBJECT: K233571<br>GCI Surgical Gown | PREDICATE: K211422<br>Level 2 Standard Surgical Gown | REFERENCE: K092344<br>Innerbloc LR Surgical Gowns | Comparison | |----------------------------------------------|----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product Code | FYA | FYA | FYA | Same | | Regulation Number | 878.4040 | 878.4040 | 878.4040 | Same | | Class | II | II | II | Same | | Intended Use<br>Overview | To protect from the transfer of microorganisms, body fluids, and particulate material. | To protect from the transfer of microorganisms, body fluids, and particulate material. | To protect from the transfer of microorganisms, body fluids, and particulate material. | Same | | Prescription or OTC | OTC | OTC | OTC | Same | | Barrier Level | Level 2 | Level 2<br>(See Note below table) | Unknown<br>(See Note below table) | Same | | Device Materials | Polyester and carbon | SMS nonwoven polyester and polyamide | Polyester and PTFE | Similar<br>No differences to safety or effectiveness, as confirmed by performance and | | Attribute | SUBJECT: K233571<br>GCI Surgical Gown | PREDICATE: K211422<br>Level 2 Standard Surgical Gown | REFERENCE: K092344<br>Innerbloc LR Surgical Gowns | Comparison | | Sizes | S, M, L, XL, XXL / 2XL, XXXL /<br>3XL, XXXXL / 4XL, XL Tall | XS, S, M, L, XL, XXL, XXXL | Multiple sizes | biocompatibility testing.<br>Different<br>Provides a range of sizes to fit a<br>wide range of users. No<br>differences to safety or<br>effectiveness, as confirmed by<br>performance testing. | | Color | Blue | Blue | Blue | Same | | Reinforcement | Non-reinforced | Non-reinforced<br>(See Note below table) | Non-reinforced | Same | | Method of Action | Physical barrier | Physical barrier | Physical barrier | Same | | Durability | Reusable | Single-Use (Disposable) | Reusable | Different<br>Same as reference device.<br>No differences to safety or<br>effectiveness, as confirmed by<br>performance testing. | | Flammability | Class 1 | Class 1 | Unknown | Same | | Water Resistance:<br>Hydrostatic<br>Pressure | Water Resistant ≥20 cm | Water Resistant ≥20 cm<br>(See Note below table) | Unknown | Same | | Water Resistance:<br>Impact Penetration | ≤1.0 g water | ≤1.0 g water | Unknown | Same | | Breaking / Bursting<br>Strength | >20 N | >20 N | Unknown | Same | | Tearing Strength | >20 N | >20 N | Unknown | Same | | Seam Strength | >20 N | Unknown | Unknown | Equivalent<br>Meets expectations per<br>standard for appropriate barrier<br>protection level. | | Linting | Log10 ≤ 4 | Log10 ≤ 4 | Unknown | Same | | Attribute | SUBJECT: K233571<br>GCI Surgical Gown | PREDICATE: K211422<br>Level 2 Standard Surgical Gown | REFERENCE: K092344<br>Innerbloc LR Surgical Gowns | Comparison | | Sterility | Non-Sterile (for use Sterile,<br>SAL $10^{-6}$ ) | Sterile, SAL $10^{-6}$ | Unknown | Provided Different<br>Same for Use<br>No differences to safety or<br>effectiveness, as confirmed by<br>sterilization validation aligned<br>with the provided instructions. | | - Cytotoxicity | Under the conditions of the<br>study, the device is non-<br>cytotoxic. | Under the conditions of the<br>study, the device is non-<br>cytotoxic. | Unknown | Same | | - Irritation | Under the conditions of<br>study, not an irritant | Under the conditions of study,<br>not an irritant | Unknown | Same | | - Sensitization | Under the conditions of<br>study, not a sensitizer. | Under the conditions of study,<br>not a sensitizer. | Unknown | Same | {7}------------------------------------------------ George Courey Traditional 510(k) Premarket Submission GCI Surgical Gowns # GEMERGO by UL {8}------------------------------------------------ ## George Courey Traditional 510(k) Premarket Submission GCI Surgical Gowns by UL | Note: K211422 also includes additional gowns) and styles (including reinforced) but equivalence only claimed to these gowns. {9}------------------------------------------------ #### 9. Non-Clinical Performance Data Non-clinical tests were conducted to verify that the proposed device met all design specifications. The subject surgical gowns were assessed for performance using the following standards and test methods, as also described in Table 2, and in alignment with FDA guidance "Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings" and "Guidance on Premarket Notification [510(k)] Submissions for Surgical Gowns and Surgical Drapes." All testing results passed pre-determined acceptance criteria. | Attribute | Purpose: To ensure compliance with the<br>following standard | Acceptance<br>Criteria | Results | |----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------|----------------------------------------------------------------------------| | Flammability | 16 CFR §1610: Standard for the Flammability of<br>Clothing Textile | Meets Class 1<br>Requirements | Meets Class 1<br>Requirements | | Water Resistance:<br>Hydrostatic<br>Pressure | AATCC 127:2017 Water Resistance: Hydrostatic<br>Pressure Test | Water Resistant<br>≥20 cm | Water Resistant<br>≥20 cm | | Water Resistance:<br>Impact Penetration | AATCC 42:2017 Water Resistance: Impact<br>Penetration Test | ≤1.0 g water | ≤1.0 g water | | Breaking / Bursting<br>Strength | ASTM D5034:2017 Standard Test Method for<br>Breaking Strength and Elongation of Textile Fabrics<br>(Grab Test) | ≥20 N | >20 N | | Tearing Strength | ASTM D5587:2019 Standard Test Method for<br>Tearing Strength of Fabrics by Trapezoid Procedure | ≥20 N | >20 N | | Seam Strength | ASTM D1683/D1683M:2017/(R)2018 Standard<br>Test Method for Failure in Sewn Seams of Woven<br>Fabrics | ≥20 N | >20 N | | Linting | ISO 9073-10:2003 Textiles – Test Methods for<br>Nonwovens - Part 10: Lint and Other Particles<br>Generation in the Dry State | Log10 < 4 | Log10 < 4 | | Biocompatibility | ISO 10993-1:2018 Biological evaluation of medical<br>devices – Part 1: Evaluation and testing within a<br>risk management process | Biocompatible in<br>alignment with ISO<br>10993-1 | Biocompatible in<br>alignment with ISO<br>10993-1 | | - Cytotoxicity | ISO 10993-5:2009 Biological evaluation of medical<br>devices – Part 5: Tests for in vitro cytotoxicity | Non-cytotoxic | Under the<br>conditions of the<br>study, the device is<br>non-cytotoxic. | | - Irritation | ISO 10993-10:2010 Biological evaluation of<br>medical devices – Part 10: Tests for Irritation and<br>Skin Sensitization | Non-irritating | Under the<br>conditions of the<br>study, the device is<br>not an irritant | | - Sensitization | ISO 10993-10:2010 Biological evaluation of<br>medical devices - Part 10: Tests for Irritation and<br>Skin Sensitization | Non-sensitizing | Under the<br>conditions of the<br>study, the device is<br>not a sensitizer | #### Table 3 – Summary of Performance Data #### 10. Clinical Performance Data No clinical study is included in this submission. #### 11. Conclusion The conclusions drawn from the testing demonstrates that the proposed subject device is as safe, as effective, and perform as well as or better than the legally marketed predicate device K211422.