Bodygard SFS Surgical Gown Level 3

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February 24, 2022 Feliks Plastik Laminasyon Ve Ambalaj Malzemeleri Sanayi % Darren Reeves President DP Distribution & Consulting, LLC 12240 Hunting Horn Lane Rockville, Virginia 23146 Re: K202845 Trade/Device Name: Bodygard SFS Surgical Gown Level 3 Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYA Dated: February 8, 2022 Received: February 8, 2022 Dear Darren Reeves: 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. 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 {1}------------------------------------------------ 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, Clarence W. Murray III, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K202845 Device Name BodyGard SFS Surgical Gown Level 3 #### Indications for Use (Describe) The Bodygard SFS Surgical Gown Level 3 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. Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, Bodygard SFS Surgical Gown Level 3 met the requirements for Level 3 classification. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|---| | Prescription Use (Part 21 CFR 801 Subpart D) | | | 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-K202845 Traditional 510(k) In accordance with 21 CFR §807.92 and the following information is provided for the Bodygard SFS Surgical Gown Level 3 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document, 'Format for Traditional and Abbreviated 510(k)s', issued on August 12, 2005. | Sponsor: | Feliks Plastik Lam Ve Amb Mal San Ve Tic LTD Sti<br>Eskishir Organize Sanayi Bolgesi 26. Cad No. 9 26110<br>Eskisehir | |---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person/<br>Prepared by: | Darren Reeves<br>President<br>DP Distribution & Consulting, LLC<br>(804) 307-7706<br>dreeves@dpdconline.com<br>7305 Hancock Village Drive<br>Suite 109<br>Chesterfield, Virginia 23832 | | Date: | 02/17/2022 | | Subject Device: | Trade Name: Bodygard SFS Surgical Gown Level 3<br>Common Name: Surgical Gown<br>Classification Name: Surgical Gown (21 CFR 878.4040<br>Product Code FYA) | | Predicate Device: | Medical Surgical Gowns (K202844) | #### Purpose and Device Description: The Bodygard SFS Surgical Gown Level 3 is a poly reinforced surgical gown, SMS Nonwoven/Film/SMS Nonwoven (SFS) that provides AAMI Level 3 liquid barrier protection in the critical zones (arms and chest) and non-critical zones of the gown. The Bodygard SFS Surgical Gown Level 3 is manufactured using ultrasonic bonding technique and are available in four different sizes (M, L, XL, and XXL). Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities. The {4}------------------------------------------------ Bodygard SFS Surgical Gown Level 3, meets the requirements for Level 3 classification, are disposable medical devices and provided in sterile. # Intended Use and Indication for Use: The Bodygard SFS Surgical Gown Level 3 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. Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, Bodygard SFS Surgical Gown Level 3 met the requirements for Level 3 classification. ## Technological Characteristic Comparison of Predicate Device: | Elements of<br>Comparison | Proposed Device<br>K202845 | Predicate Device<br>K202844 | Comparison | |---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | | Bodygard SFS Surgical<br>Gown Level 3 | Medical Surgical Gowns | | | 510 (k)<br>Number | K202845 | K202844 | N/A | | Product Code | FYA | FYA | Same | | Regulation<br>Number | 878.4040 | 878.4040 | Same | | Indication for Use | The Bodygard SFS<br>Surgical Gown Level 3 is<br>a poly reinforced<br>surgical gown, SMS<br>Nonwoven/Film/SMS<br>Nonwoven (SFS) that<br>provides AAMI Level 3<br>liquid barrier protection<br>in the critical zones<br>(arms and chest) and<br>non-critical zones of the<br>gown. The Bodygard SFS<br>Surgical Gown Level 3 is<br>manufactured using<br>ultrasonic<br>bonding technique | The Medical Surgical<br>Gowns is intended to be<br>worn by operating room<br>personnel during surgical<br>procedure to protect<br>both the surgical patient<br>and the operating room<br>personnel from trans- fer<br>of microorganisms, body<br>fluids, and particulate<br>material.<br>Per ANSI/AAMI<br>PB70:2012<br>Liquid barrier<br>performance and | Similar | | | and are available in<br>four different sizes<br>(M, L, XL, and XXL).<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 Bodygard SFS<br>Surgical Gown Level 3,<br>meets the requirements<br>for Level 3 classification,<br>are disposable medical<br>devices and provided in<br>sterile. | classification of<br>protective apparel<br>and drapes intended<br>for use in<br>health care facilities,<br>the Medical<br>Surgical Gowns met the<br>requirements for Level<br>3 classification. | | | Style | Poly Reinforced | Poly reinforced | Same | | Durability | Disposable | Disposable | Same | | Color | Blue | Blue | Same | | Material | Spundbond SMS<br>polypropylene,<br>polyester, PP Velcro | SMS Nonwoven,<br>polyethylene | Similar | | Weight per<br>quote | 60 g/m2 | 55 g/m2 | Similar | | Size | M, L, XL, and XXL | S, M, L, XL, XXL, XXXL | Similar | | Break Strength | >30N | >20N | Similar | | Tear Strength | >20N | >20N | Similar | | Seam Strength | > 50 N | Not known | Similar | | lint | Log10<4 | Log10<4 | Same | | Flammability | Class I | Class I | Same | | Hydrostatic<br>pressure | >50cm | >50cm | Same | | Water impact | ≤1.0 g | ≤1.0 g | Same | | Level | Level 3 Per AAMI PB70 | Level 3 per AAMI PB70 | Same | | Water Vapor Transmission | Average<br>transmission/permeatio n<br>rate 4.360 gm/m2 day | Unknown | Unknown | | Elements of Comparison | Proposed Device | Predicate Device | Remark | | Biocompatibility | | | | | Cytotoxicity | No Cytotoxicity | No Cytotoxicity | Same | | Skin Irritation | No Irritation | No Irritation | Same | | Sensitization | No Sensitization | No Sensitization | Same | | Sterile | Ethylene Oxide (EO),<br>SAL=10-6 | Ethylene Oxide (EO),<br>SAL=10-6 | Same | #### Table 1 Technological Characteristic Comparison {5}------------------------------------------------ {6}------------------------------------------------ # Summary of Non-Clinical Test: # Non-Clinical Tests: The product was tested in alignment with "Guidance on Premarket Notification 510(k) Submissions for Surgical Gowns and Surgical" Guidance Document | Test Method | Purpose | Acceptance Criteria | Results | |----------------------|--------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|------------------------------------------------------------| | AATCC 127 | Water resistance<br>Hydrostatic Pressure | >50cmH2O (AQL 4%,<br>RQL=20%) | All were > 50cmH2O | | AATCC 42 | Water Resistance impact<br>penetration | <1.0 g penetration<br>(AQL 4%, RQL=20%) | All were < 1 g<br>penetration | | ASTM D 5034-09 | Breaking<br>Strength | >30 N (AQL 4%,<br>RQL=20%) | All were >30N | | ASTM D5587- 14 | Tearing Strength | >20 N (AQL 4%,<br>RQL=20%) | All were >20 N | | 16 CFR 1610 | Flammability<br>testing | Class I | Meets Class I | | ASTM D4169- 16 | Seam Strength | >50 N (AQL 4%,<br>RQL=20%) | All were>50 N | | D6701-16 | Water vapor<br>transmission of | >500gram/m2 Day<br>WVTR | Passed | | | Nonwoven and<br>plastic Barriers | | | | ASTM D3776/D | Mass Per Area (Weight)<br>of fabric | - | Has met acceptance<br>criteria | | ASTM F1670 | Resistance by synthetic<br>Blood | No Penetration at 2 psi<br>(13.8 kPA) | Passed | | ISO 9073-<br>10:2003 | Lint and Other particles<br>generation in the dry<br>state | Log 10<4 | Below Log10<4 Passed | | ASTM D4169- 16 | Performance testing of<br>shipping containers<br>and systems | Products must with-<br>stand the distribution<br>environment | Passed | | ASTM F88-07A | Seal strength of<br>Flexible Barrier<br>Materials | Package Seal integrity<br>must be intact. | Passed | | ASTM F2096- 04 | Detecting Gross Leaks in<br>medical packaging by in-<br>ternal pressurization<br>(Bubble test) | Package integrity must<br>be intact with- out failed<br>seal locations. | Passed | | ASTM F1980- 07 | Accelerated Aging of<br>Sterile Barrier Systems for<br>medical devices | Package integrity must<br>be intact after<br>accelerated aging | Passed | | ISO 10993-5 | Biological Evaluation of<br>medical devices - Part 5 :<br>tests for In vitro<br>cytotoxicity of<br>medical devices | Device must not be<br>cytotoxic | Device is noncytotoxic | | ISO 10993-10 | Biological Evaluation of<br>medical devices — Part<br>10: Tests for irritation<br>and skin<br>sensitization / Irritation | Device must not be<br>irritant | Device is not an irritant | | ISO 10993-10 | Biological Evaluation of<br>medical<br>devices — Part | Device must not be<br>sensitizer | Device is not a<br>sensitizer | | | 10: Tests for irritation<br>and skin sensitization /<br>sensitization | | | | ISO 10993-7 | Biological Evaluation of<br>medical devices- Part 7:<br>Ethylene Oxide<br>Sterilization Residuals | Residual Ethylene oxide<br>levels must be below<br>limits | Ethylene Oxide residual<br>levels are below<br>limitations | {7}------------------------------------------------ {8}------------------------------------------------ #### Summary of Clinical Tests: No clinical tests were performed. ### Conclusion The conclusion drawn from the nonclinical tests demonstrates that the device Bodygard SFS Surgical Gown Level 3 is as safe, as effective, and performs as well as or better than the legally marketed predicate device Medical Surgical Gowns.