Surgical Gown

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym and full name on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written out next to it. February 16, 2023 Bayteks Teknik Tekstil San. ve Tic. A.S. % Sarah Fitzgerald Senior Consultant, Quality and Regulatory Affairs Emergo by UL 2500 Bee Cave Road, Building 1 Suite 300 Austin, Texas 78746 Re: K213844 Trade/Device Name: Surgical Gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYA Dated: February 13, 2023 Received: February 15, 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 (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 located 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}------------------------------------------------ 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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 medical devices and radiation-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. # Bifeng Qian -S Bifeng Oian, MD, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K213844 Device Name Surgical Gown Indications for Use (Describe) Surgical gowns are intended to be worn by operating room personnel procedure to protect both the surgical patient and the operating room persomel from transfer of microorganisms, body fluids, and particulate material. This device is provided sterile. Per ASNI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the standard (non-reinforced) surgical gowns meet Level 2 classification and the reinforced surgical gowns meet Level 3 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." {3}------------------------------------------------ ## 510(k) Summary ## SURGICAL GOWN ## K213844 The following information is provided in accordance with 21 CFR 807.92 for the premarket 510(k) summary: #### 1. Submission Sponsor Bayteks Teknik Tekstil San. Ve Tic. A.S. Organize Sanaji Bolgesi 19. Nolu Cad. No. 9 Merkez, Kilis 79000 Turkey Contact: Spero Hegbe, Export Sales Specialist Telephone: 90 (530) 149 34 63 Fax: 90 (348) 834 10 28 sperohegbe@baymed.com.tr #### 2. Submission Correspondent Emergo Global Consulting, LLC 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, Senior Consultant, Quality and Regulatory Affairs #### 3. Date Prepared February 15, 2023 #### 4. Device Identification | Trade/Proprietary Name: | Surgical Gown | |-------------------------|------------------| | Common/Usual Name: | Surgical Gown | | Regulation Number: | 21 CFR 878.4040 | | Product Code: | FYA | | Class: | II | | Review Panel: | General Hospital | #### 5. Legally Marketed Predicate and Reference Devices Predicate Device name: Surgical Gown 510(k) number: K202706 {4}------------------------------------------------ Manufacturer: B.J.ZH.F. Panther Medical Equipment Co., Ltd. Reference Device name: Medline Surgical Gown 510(k) number: K190950 Manufacturer: Medline Industries, Inc. #### 6. Indication for Use Statement Surgical gowns 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. This device is provided sterile. Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the standard (non-reinforced) surgical gowns meet Level 2 classification and the reinforced surgical gowns meet Level 3 classification. #### 7. Device Description Surgical gowns are intended to be worn by healthcare professionals to protect both the patient and the healthcare professional from the transfer or microorganisms, body fluids, and particulate material. The proposed devices are single use, disposable medical devices and ethylene oxide (EO) sterilized. They are available in six sizes: S, M, L, XL, XXL and XXXL. The proposed surgical gowns are constructed of a Spunbond (SMS) nonwoven material, with cuffs made of polyester and elastic, offered in standard (non-reinforced) and reinforced surgical gowns, in blue color. #### 8. Comparison of technological characteristics with the Predicate The following table compares the subject device to the predicate device with respect to indications for use, principles of operation, technological characteristics, 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. | Attribute | Subject Gown<br>K213844 | Predicate Gown<br>K202706 | Reference Device<br>K190950 | Comparison | |----------------------|------------------------------------------------------------------|------------------------------------------------------------------------------|---------------------------------------------------------|------------| | Product Code | FYA | FYA | FYA | Same | | Regulation<br>Number | 878.4040 | 878.4040 | 878.4040 | Same | | Class | II | II | II | Same | | Intended Use | To protect both patients<br>and healthcare<br>personnel from the | To protect both patients<br>and healthcare personnel<br>from the transfer of | To protect both<br>patients and<br>healthcare personnel | Same | | Table 1 – Comparison of Technological Characteristics | | | |-------------------------------------------------------|--|--| |-------------------------------------------------------|--|--| {5}------------------------------------------------ | Attribute | Subject Gown<br>K213844 | Predicate Gown<br>K202706 | Reference Device<br>K190950 | Comparison | |----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | | transfer of<br>microorganisms, body<br>fluids, and particulate<br>material. | microorganisms, body<br>fluids, and particulate<br>material. | from the transfer of<br>microorganisms,<br>body fluids, and<br>particulate material. | | | Indication for<br>Use | Surgical gowns are<br>intended to be worn by<br>operating room<br>personnel during<br>surgical procedures to<br>protect both the<br>surgical patient and the<br>operating room<br>personnel from transfer<br>of microorganisms,<br>body fluids, and<br>particulate material.<br>This device is provided<br>sterile. Per ANSI/AAMI<br>PB70:2012 Liquid<br>barrier performance<br>and classification of<br>protective apparel and<br>drapes intended for use<br>in health care facilities,<br>the standard (non-<br>reinforced) surgical<br>gowns meet Level 2<br>classification and the<br>reinforced surgical<br>gowns meet Level 3<br>classification. | Surgical gowns are<br>intended to be worn by<br>operating room<br>personnel during surgical<br>procedure to protect<br>both the surgical patient<br>and the operating room<br>personnel from transfer<br>of microorganisms, body<br>fluids, and particulate<br>material.<br>Per ANSI/AAMI<br>PB70:2012 Liquid barrier<br>performance and<br>classification of<br>protective apparel and<br>drapes intended for use<br>in health care facilities,<br>the surgical gowns meet<br>the requirements for<br>Level 3 classification. | The [multiple named<br>gowns] are sterile, single<br>use surgical apparel<br>intended to be worn by<br>healthcare professionals<br>to help protect both the<br>patient and the<br>healthcare worker from<br>the transfer of<br>microorganisms, body<br>fluids, and particulate<br>matter.<br>The [gowns] meet the<br>respective level<br>requirements of<br>ANSI/AAMI PB70:2012<br>Liquid barrier<br>performance and<br>classification of<br>protective apparel and<br>drapes intended for use<br>in healthcare facilities.<br>The [gowns] have been<br>validated using an<br>ethylene oxide (EtO)<br>sterilization process. The<br>[gowns] are also sold as<br>bulk single use, non-<br>sterile, to<br>repackager/relabeler<br>establishments for<br>further packaging and<br>sterilization using the<br>validated EtO<br>sterilization method<br>according to ISO 11135-1<br>prior to being provided<br>to the end user. | Similar | | Prescription or<br>OTC | OTC | OTC | OTC | Same | | Barrier Level<br>(per<br>ANSI/AAMI<br>PB70) | Standard: Level 2<br>Reinforced: Level 3 | Level 3 | Standard: Level 2<br>Reinforced: Level 3 | Similar | | Attribute | Subject Gown<br>K213844 | Predicate Gown<br>K202706 | Reference Device<br>K190950 | Comparison | | Device Materials | SMS Polypropylene<br>nonwoven, Polyester | SMS Polypropylene<br>nonwoven, Polyester | SMS Polypropylene<br>nonwoven, Polyester | Same | | Device Design | Standard<br>(nonreinforced) &<br>Reinforced | Standard (nonreinforced) | Standard (nonreinforced)<br>& Reinforced | Similar | | Durability | Single-Use (Disposable) | Single-Use (Disposable) | Single-Use (Disposable) | Same | | Sizes | Small (S), Medium (M),<br>Large (L), Extra Large<br>(XL), Extra Extra Large<br>(XXL), Extra Extra Extra<br>Large (XXXL) | Small (S), Medium (M),<br>Large (L), Extra Large<br>(XL), Extra Extra Large<br>(XXL), Extra Extra Extra<br>Large (XXXL) | Small (S), Medium (M),<br>Large (L), Extra Large<br>(XL), Extra Extra Large<br>(XXL), Extra Extra Extra<br>Large (XXXL) | Same | | Color | Blue | Blue | Blue | Same | | Flammability<br>16 CFR Part 1610 | Class I | Class I | Class I | Same | | Hydrostatic<br>Pressure<br>AATCC 127 | Level 2 > 20 cm<br>Level 3 > 50 cm | > 50 cm | - | Similar | | Impact<br>Penetration<br>AATCC 42 | <1.0 g water | <1.0 g water | - | Same | | Tear Strength<br>ASTM D 5587<br>(Trapezoid<br>Procedure) | Length Direction > 20 N<br>Width Direction > 20 N | > 20 N | - | Same | | Tensile<br>Strength<br>ASTM F 2407<br>(ASTM D 5034) | Length Direction ≥ 115N<br>Width Direction ≥ 115N | > 20 N | - | Same | | Seam Strength<br>ASTM D1683 | ≥ 20 N | > 20 N | - | Same | | Linting<br>ISO 9073-10 | Log10 <4 | Log10 <4 | - | Same | | Sterilization<br>Method | Ethylene Oxide | Ethylene Oxide Sterilized<br>and Non-Sterile Versions | - | Similar | | EO and ECH<br>Residuals | EO: not detected<br>ECH: not detected | Passed | - | Same | | Biocompatibility<br>Cytotoxicity<br>ISO 10993-5 | Non-cytotoxic | Non-cytotoxic | - | Same | | Attribute | Subject Gown<br>K213844 | Predicate Gown<br>K202706 | Reference Device<br>K190950 | Comparison | | Biocompatibility<br>Irritation<br>ISO 10993-10 | Non-irritating | Non-irritating | - | Same | | Biocompatibility<br>Sensitization<br>10993-10 | Non-sensitizing | Non-sensitizing | - | Same | {6}------------------------------------------------ {7}------------------------------------------------ #### 9. Non-Clinical Performance Data Non-clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrate that the proposed device complies with the following standards by passing all applicable acceptance criteria. | Test Method | Purpose | Acceptance<br>Criteria | Res<br>ult | |------------------------------|--------------------------------------------|---------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------| | AATCC 127 | Hydrostatic pressure | Level 2 > 20 cm<br>Level 3 > 50 cm | Pass | | AATCC 42 | Impact penetration | ≤1g | Pass | | ASTM F 2407<br>(ASTM D 5034) | Tensile Strength | Length Direction ≥ 115N<br>Width Direction ≥ 115N | Pass | | ASTM D 5587 | Tearing strength by<br>Trapezoid Procedure | Length Direction > 20 N<br>Width Direction > 20 N | Pass | | ASTM D 1683 | Seam strength | ≥ 20 N | Pass | | 16 CFR Part 1610 | Flammability of Textiles | Class 1 | Class 1 | | ISO 10993-7 | Ethylene oxide residues | EO residual ≤ 4 mg/device<br>ECH residual ≤ 9 mg/device | Pass | | ISO 9073-10 | Linting | Log10 <4 | Pass | | Biocompatibility | Cytotoxicity | ISO 10993-5:2009 | ISO 10993-5; Under the conditions of the<br>study, the proposed device extract was<br>determined to be non-cytotoxic | | | Irritation | ISO 10993-10:2010 | ISO 10993-10; Under the conditions of the<br>study, the proposed device extract was<br>determined to be non-irritating | | | Sensitization | ISO 10993-10:2010 | ISO 10993-10; Under the conditions of the<br>study, the proposed device extract was<br>determined to be non-sensitizing | #### Table 2 – Summary of Performance Testing #### 10. Clinical Performance Data No clinical study is included in this submission. {8}------------------------------------------------ #### 11. Conclusion The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K202706.