Skypro, Surgical Gown 6021

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath. The logo is simple and professional, and it is easily recognizable. October 12, 2023 Skypro Medical Supplies Company Cyrus Wong General Manager C301, Tsing Yi Industrial Centre Phase 2. 1-33 Cheung Tat Road, Tsing Yi, N.T. Hong Kong. China Re: K230707 Trade/Device Name: Skypro, Surgical Gown 6021 Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYA Dated: September 14, 2023 Received: September 14, 2023 Dear Cyrus Wong: 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. 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" {1}------------------------------------------------ (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 OS 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). {2}------------------------------------------------ Sincerely, Image /page/2/Picture/3 description: The image shows the text "Bifeng Qian -S" in a simple, sans-serif font. The text is arranged horizontally, with "Bifeng" and "Qian" being the most prominent words. The "-S" is smaller and slightly offset to the right. The background is plain white. BiFeng Qian, M.D., 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 Enclosure {3}------------------------------------------------ # Indications for Use 510(k) Number (if known) K230707 Device Name Skypro, Surgical Gown 6021 Indications for Use (Describe) "Skypro. Surgical Gown 6021" are intended to protect both surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. They are classified as Level 3 surgical gowns in accordance with ANSI/AAMI PB70 and used in healthcare facilities. The gown is single use, disposable, and provided sterile. | Type of Use (Select one or both, as applicable) | | |---------------------------------------------------------------------------------|--| | <input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | | | <input checked="" type="checkbox"/> 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}------------------------------------------------ ## 510(k) Summary K230707 This 510(k) summary information is submitted in accordance with the requirements of 21 CFR 807.92. ### l. Submitter Company: Skypro Medical Supplies Company Address: Flat C301, 3/F, Block C, Phase 2, Tsing Yi Industrial Centre, 1-33 Cheung Tat Road, Tsing Yi, New Territories, Hong Kong, P. R. China Contact Person: Cyrus Wong (General Manager) Phone No.: 852-27110882 Fax No.: 852-27110116 Email: cyrus@skypro-med.com Date Prepared: October 12, 2023 US Agent and Correspondent of the Submitter: Company: SKYPRO MEDICAL SUPPLIES USA LTD COMPANY Address: 5722 Kendall Hill Ln, Sugar Land, TX 77479 Contact Person: Eve Luo Email: Eve@1masks.com Phone No.: 832-312-2668 EIN/TAX ID: 851587593 II. Device Device Manufacturer: SPRO Medical Products (Xiamen) Co., Ltd Address: No.139 Factory Building, TongAn Garden, TongAn Industrial Area, Xiamen, Fujian Province, 361100, P. R. China Device Trade Name: Skypro, Surgical Gown 6021 Regulation Name (Number): Surgical Apparel (21 CFR 878.4040) Class: Class II Classification Panel: General and Plastic Surgery Product Code: FYA Device Common Name/ Classification Name: Surgical Gown III. Predicate Device K162442 This predicate has not been subject to a design-related recall. Device Trade Name: ComfortGuard Surgical Gown, i500 Regulation Name (Number): Surgical Apparel (21 CFR 878.4040) Class: Class II Classification Panel: General and Plastic Surgery Product Code: FYA Device Common Name/ Classification Name: Surgical Gown ## IV. Device Description 1 {5}------------------------------------------------ "Skypro, Surgical Gown 6021" are sterile, disposable, and intended for single use. They are fundamentally made of blue non-woven spunbond-meltblown-spunbond (SMS) polypropylene fabrics, and come in a variety of sizes (XS, S, M, L, XL, and XXL). The gown features white elastic cuffs, a hook-and-loop tap for closing the neck, and four waist belts for closing the back. "Skypro, Surgical Gown 6021" is constructed in accordance with AAMI PB70 Level 3 specifications. The major raw material of the surgical gown is non-woven SMS polypropylene fabric, which is a trilaminate non-woven fabric with a densely packed structure (i.e., small micron pore sizes) to provide tortuous paths to block the penetration of particulate matter. The hydrophobic nature of the fabric can effectively prevent the absorption and penetration of liquids and body fluids. The joints and seam regions of the surgical gown are sealed via ultrasonic vibration- assisted welding to avoid the penetration of liquids through joints and seam stitching. The whole of the surgical gown exhibits a barrier performance of Level 3. ### V. Indications for Use/ Intended Use "Skypro, Surgical Gown 6021" are intended to protect both surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. They are classified as Level 3 surgical gowns in accordance with ANSI/AAMI PB70 and used in healthcare facilities. The gown is single-use, disposable, and provided sterile. | Description | Predicate Device | Subject Device | Comparison | |--------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | K162442<br>"ComfortGuard Surgical<br>Gown, i500" | K230707<br>"Skypro, Surgical Gown 6021" | | | Indications for Use | ComfortGuard Surgical<br>Gown, i500 are single use<br>surgical gowns intended to<br>protect surgical patients<br>and operating room<br>personnel from the<br>transfer of microorganisms,<br>body fluids, and particulate<br>material.<br>ComfortGuard Surgical<br>Gown, i500 have been<br>tested and are classified as<br>Level 3 in the critical zones<br>per AAMI Standard PB70<br>Liquid barrier performance<br>and classification of<br>protective apparel and<br>drapes intended for use in<br>healthcare facilities. | "Skypro, Surgical Gown 6021"<br>are intended to protect both<br>surgical patients and operating<br>room personnel from the<br>transfer of microorganisms,<br>body fluids, and particulate<br>material. They are classified as<br>Level 3 surgical gowns in<br>accordance with ANSI/AAMI<br>PB70 and used in healthcare<br>facilities. The gown is single-<br>use, disposable, and provided<br>sterile. | Similar | | Design | Neck binder, hook-and-<br>loop neck closures. belt | Raglan sleeves, hook-and-loop<br>neck closures. and tie waist | Same | | | ties, removable transfer<br>accessory, and cuffs. | closures | | | Material | Single-layer nonwoven<br>SMS polyolefin fabrics<br>throughout the entire<br>gown, with no additional<br>reinforcement | Non-woven SMS polypropylene<br>fabrics throughout the entire<br>gown, with no additional<br>reinforcement | Same | | Color | Blue | Blue | Same | | Performance Characteristics | | | | | AAMI PB 70<br>Classification | Level 3 | Level 3 | Same | | Tensile Strength<br>(ASTM D5034 or<br>ASTM D5035) | Body/sleeve material:<br>- MD: 82.8 N<br>- CD: 58.54 N<br>Back material:<br>- MD: 89.52 N<br>- CD: 56.32 N | Warp yarns torn (MD): 179.7 N<br>Weft yarns torn (CD): 103.7 N | Similar | | Seam Strength<br>(ASTM<br>D16836/D1683M-17) | Sleeve seam: ≥ 15 N<br>Armhole seam:<br>Experimental data are not<br>available<br>Shoulder seam:<br>Experimental data are not<br>available | Sleeve seam: 113.3 N<br>Armhole seam: 73.2 N<br>Shoulder seam: 111.1 N | Different<br>Data is not<br>available for<br>the predicate<br>device. Data<br>demonstrates<br>subject device<br>complies with<br>ASTM F2407. | | Tearing Strength<br>(ASTM D5587) | Body/sleeve material<br>- MD:19.01 N<br>- CD: 28.14 N<br>Back material<br>- MD: 21.19 N<br>- CD: 37.00 N | Warp yarns torn (MD): 53.9 N<br>Weft yarns torn (CD): 29.2 N | Similar | | Lint Generation<br>(ISO 9073-10) | Not stated | Side A (face):<br>Total linting: 140.9<br>Coefficient of linting: 2.15<br>Side B (back):<br>Total linting: 242.2<br>Coefficient of linting: 2.38 | Different<br>Data is not<br>available for<br>the predicate<br>device. | | Evaporative<br>Resistance (ASTM<br>F1868-17) | Not stated | 0.00215 kPa·m²/W | Different<br>Data is not<br>available for<br>the predicate<br>device. | | Water Resistance:<br>Hydrostatic Pressure<br>(AATCC 127 and<br>ANSI/AAMI PB70) | Base material: 657 mmH2O<br>Sleeve seam: 760 mmH2O<br>Tie attachments: 668<br>mmH₂O | Base material: > 50 cmH₂O<br>Sleeve Seam: > 50 cmH2O<br>Tie attachment with/without<br>film: > 50 cmH₂O | Similar | | Water Resistance:<br>Impact Penetration<br>(AATCC 42 and<br>ANSI/AAMI PB70) | Base material: 0.04 g<br>Sleeve seam: 0.04 g<br>Tie attachments: 0.02 g<br>No penetration can be<br>observed | Base material: 0 g<br>Sleeve Seam: 0 g<br>Tie attachment with/without<br>film: 0 g<br>No penetration can be<br>observed | Similar | | Flammability Class 16<br>CFR Part 1610 | Class 1 | Class 1 | Same | | Biocompatibility | | | | | Cytotoxicity | Under conditions of the<br>testing, non-cytotoxic | Under conditions of the testing,<br>non-cytotoxic | Same | | Sensitization | Under conditions of the<br>testing, not a sensitizer | Under conditions of the testing,<br>not a sensitizer | Same | | Primary Skin<br>Irritation | Under conditions of the<br>testing, not an irritant | Under conditions of the testing,<br>not an irritant | Same | | Sterility and Shelf Life | | | | | Sterilization | Sterile; single-use | Sterile; single-use | Same | | Sterility Assurance<br>Level | Not stated | 10-6 | Different<br>Data is not<br>available for<br>predicate<br>device. Data<br>demonstrates<br>subject device<br>has<br>acceptable<br>sterility<br>assurance<br>level. | | Sterilization modality | Ethylene Oxide | Ethylene Oxide | Same | | Sterilant Residuals | Not stated | EO: < 4 mg /device<br>ECh: < 9 mg / device | Different<br>Data is not<br>available for<br>predicate<br>device. Data<br>demonstrates<br>subject device<br>does not have<br>excessive<br>sterilant<br>residuals. | | Shelf Life | Not stated | 2 years | Different<br>The predicate<br>does not have<br>a stated shelf<br>life. | ## VI. Comparison of Technological Characteristics with the Predicated Device {6}------------------------------------------------ {7}------------------------------------------------ The differences in the Indications For Use do not impact the safety or effectiveness of the gown. The additional data provided for the subject gown, including the tensile properties {8}------------------------------------------------ of the armhole and shoulder seam, the lint generation and evaporative resistance, and the Sterility Assurance Level and sterilant residuals provide additional confidence in gown safety and performance. Designation of a shelf life provides confidence that the subject device will maintain performance properties throughout its listed shelf life. ### VII. Summary of Non-Clinical Testing | Test Performed | Purpose | Criteria | Result | |-----------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|--------| | 1. ASTM F2407-20, Section 7.2 Tensile Strength<br>ASTM D5034-09(R17) | To evaluate the tensile strength of the gown material | ≥ 30N | Pass | | 2. ASTM F2407-20, Section 7.2 Seam Strength<br>ASTM D1683/D1683M-22 | To evaluate the tensile strength of the gown seam | ≥ 30N | Pass | | 2. ASTM F2407-20, Section 7.2 Tearing Strength<br>ASTM D5733-99 | To evaluate the tear strength of the gown material | ≥ 10N | Pass | | 3. ASTM F2407-20, Section 7.3 Lint Generation<br>ISO 9073-10:2003 | To evaluate the potential for linting of the gown | Documentation only | Pass | | 4. ASTM F2407-20, Section 7.3 Evaporative Resistance<br>ASTM F1868-17 | To evaluate the evaporative resistance of the gown | Documentation only | Pass | | 5. Water Resistance:<br>Hydrostatic Pressure<br>AATCC 42:2017 | To evaluate the hydrostatic water resistance of the gown | ≥ 50cmH20 | Pass | | 6. Water Resistance:<br>Impact Penetration<br>AATCC 127:2018e | To evaluate the water spray resistance of the gown | ≤ 1.0g | Pass | | 7. ASTM F2407-20, Section 6.3 Flame Spread<br>16 CFR 1610 | To evaluate the flame resistance of the gown | Class 1 | Pass | | 8. Cytotoxicity Test: MEM Elution<br>ISO 10993-5:2009 | To evaluate the cytotoxic potential of the gown | Under conditions of the testing, non-cytotoxic | Pass | | 9. Sensitization Test: Kligman Maximization Test<br>ISO 10993-10:2021 | To evaluate the sensitization potential of the gown | Under conditions of the testing, not a sensitizer | Pass | | 10. Primary Skin Irritation Test:<br>Intracutaneous Injection Test<br>ISO 10993-10:2021 | To evaluate the skin irritation potential of the gown | Under conditions of the testing, not an irritant | Pass | | 11. Sterilant Gas Residue Analysis<br>ISO 10993-7 | To verify low levels of residual ethylene oxide and ethylene chlorohydrin | EO: < 4 mg /device<br>ECh: < 9 mg / device | Pass | | 12. Seal Peel Test<br>ASTM F88 | To evaluate the force necessary to open the sterile barrier seals | 0.375 lbf (average) | Pass | | 13. Dye Migration Test | To verify the integrity | No leakage | Pass | | ASTM F1929 | of the sterile barrier | | | | 14. Simulated Aging Test<br>ASTM F1980 | To verify the ability of<br>the sterile barrier to<br>maintain integrity<br>during its shelf life | Meets performance<br>specifications after<br>accelerated aging, no<br>visually apparent<br>change | Pass | {9}------------------------------------------------ ## VIII. Clinical Testing No clinical testing was performed in support of this submission. # lX. Conclusions The conclusions drawn from the non-clinical tests demonstrate that the subject device, Skypro, Surgical Gown 6021, is as safe, as effective, and performs as well as or better than the legally marketed predicate device K162442.