Surgical Isolation Cover Gown

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June 10, 2022 Wuhan Dymex Healthcare Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co.,Ltd P.O.box 120-119 Shanghai. 200120 China Re: K220528 Trade/Device Name: Surgical Isolation Cover Gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYC Dated: May 5, 2022 Received: May 9, 2022 Dear Diana Hong: 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-reporting- combination-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 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, Bifeng Qian, M.D., Ph.D. Acting 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 {2}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use 510(k) Number (if known) K220528 Device Name Surgical Isolation Cover Gown # Indications for Use (Describe) The Surgical Isolation Cover Gown is intended to protect health care persomel from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. In addition, the Surgical Isolation Cover Gown meets the requirements of an AAMI Level 3 barrier protection for an isolation gown per ANSI/A AMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities (ANSI/AAMI PB70). The Surgical Isolation Cover Gown is a single use, disposable medical device provided non-sterile. 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 This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92. The assigned 510(k) Number: K220528 - 1. Date of Preparation: 05/05/2022 - 2. Sponsor Identification Wuhan Dymex Healthcare Co., Ltd. Room 1701, Unit 2, Building 5, Jinsegangwan Phase 5, Dongfeng Avenue, Wuhan, 430000, China. Establishment Registration Number: 3013006775 Contact Person: Lynn Wu Position: Sales Manager Tel: +86-27-85827780 Fax: +86-27-85827780 Email: 1ynn.w@medlinkindustry.com - 3. Designated Submission Correspondent Ms. Diana Hong (Primary Contact Person) Ms. Jinlei Tang (Alternative Contact Person) ## Mid-Link Consulting Co., Ltd. P.O. Box 120-119, Shanghai, 200120, China Tel: +86-21-22815850, Fax: 360-925-3199 Email: info@mid-link.net - 4. Identification of Proposed Device Trade Name: Surgical Isolation Cover Gown Common Name: Isolation Gown Regulatory Information {4}------------------------------------------------ Classification Name: Surgical Isolation Gown Classification: II; Product Code: FYC; Regulation Number: 21 CFR 878.4040 Review Panel: General Hospital; Indications for Use: The Surgical Isolation Cover Gown is intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. In addition, the Surgical Isolation Cover Gown meets the requirements of an AAMI Level 3 barrier protection for an isolation gown per ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities (ANSI/AAMI PB70). The Surgical Isolation Cover Gown is a single use, disposable medical device provided non-sterile. Device Description: The proposed device is intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. The proposed device is a single use, disposable medical device provided non-sterile. The proposed device is available in nine sizes, including XS, S, M, L, XL, 2XL, 3XL, 4XL, 5XL. The barrier protection level for Surgical Isolation Cover Gown meets AAMI Level 3. The proposed device is provided in yellow. #### 5. Identification of Predicate Device 510(k) Number: K171535 Product Name: Surgical Isolation Gown {5}------------------------------------------------ #### 6. Summary of Technological characteristics | Item | Proposed Device | Predicate Device K171535 | Remark | |---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------| | Product Code | FYC | FYC | Same | | Regulation No. | 21CFR 878.4040 | 21CFR 878.4040 | Same | | Class | II | II | Same | | Indications for Use | The Surgical Isolation Cover<br>Gown is intended to protect health<br>care patients and health care<br>personnel from the transfer of<br>microorganisms, body fluids and<br>particulate material. Not intended<br>for use in the operating room. In<br>addition, the Surgical Isolation<br>Cover Gown meets the<br>requirements of an AAMI Level 3<br>barrier protection for an isolation<br>gown per ANSI/AAMI PB70:2012<br>Liquid Barrier Performance and<br>Classification of Protective<br>Apparel Drapes Intended for Use<br>in Health Care Facilities<br>(ANSI/AAMI PB70). The Surgical<br>Isolation Cover Gown is a single<br>use, disposable medical device<br>provided non-sterile. | The Surgical Isolation Gown is<br>intended to protect health care<br>patients and health care personnel<br>from the transfer of<br>microorganisms, body fluids and<br>particulate material. Not intended<br>for use in the operating room. In<br>addition, the Surgical Isolation<br>Gown meets the requirements of<br>an AAMI Level 3 barrier<br>protection for an isolation gown<br>per ANSI/AAMI PB70:2012<br>Liquid Barrier Performance and<br>Classification of Protective<br>Apparel Drapes Intended for Use<br>in Health Care Facilities<br>(ANSI/AAMI PB70). The Surgical<br>Isolation Gown is a single use,<br>disposable medical device<br>provided non-sterile. | Same | | Design | Neck Closure<br>Yellow Belt Tie<br>Elastic Cuffs | Medical Tape Neck Closure<br>White Belt Tie<br>Snap fastener | Similar | | Use | Single Use, Disposable | Single Use, Disposable | Same | | Color | Yellow | Yellow | Same | | Labeling | Conform with 21CFR Part 801 | Conform with 21CFR Part 801 | Same | # Table 1 General Comparison | Table 2 Safety and Effectiveness Comparison | | |---------------------------------------------|--| |---------------------------------------------|--| | Item | Proposed Device | Reference Device K171535 | Remark | |-------------------|------------------------------------|--------------------------|-----------| | Weight per square | 35 g/m² | Testing not performed | Different | | Size | XS, S, M, L,<br>XL,2XL,3XL,4XL,5XL | U, XL, 2XL | Different | | Flammability | Class I | Class I | Same | {6}------------------------------------------------ | Hydrostatic<br>Pressure (cm H2O) | | Mean = 70.63<br>Max = 72.33<br>Min = 68.88 | CHEST/BACK/SLEEVE:<br>Mean = 69<br>Ind Min = 54<br>Ind Max = 84 | Different | |----------------------------------|----|----------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------| | Water impact (g) | | Mean = 0.58<br>Max = 0.69<br>Min = 0.49 | Sleeve Seams:<br>Mean = 0.04<br>Ind Min = 0.02<br>Ind Max = 0.08<br>CHEST:<br>Mean = 0.04<br>Ind Min = 0.02<br>Ind Max = 0.05<br>Back:<br>Mean = 0.05<br>Ind Min = 0.04<br>Ind Max = 0.07 | Different | | Breaking<br>strength | MD | Mean = 74.82 N<br>Max = 79.64 N<br>Min = 70.43 N | Mean = 20.71 lbs (92.16 N)<br>Ind Min = 19.73 lbs (87.80 N)<br>Ind Max = 21.87 lbs (97.32 N) | Different | | Breaking<br>strength | CD | Mean = 49.35 N<br>Max = 55.18 N<br>Min = 40.96 N | Mean = 12.21 lbs (54.33 N)<br>Ind Min = 11.20 lbs (49.84 N)<br>Ind Max = 14.11 lbs (62.79 N) | Different | | Tearing<br>strength | MD | Mean = 62.92 N<br>Max = 69.72 N<br>Min = 62.01 N | Mean = 3.48 lbs (15.49 N)<br>Ind Min = 2.82 lbs (12.55 N)<br>Ind Max = 3.93 lbs (17.49 N) | Different | | Tearing<br>strength | CD | Mean = 32.57 N<br>Max = 34.99 N<br>Min = 30.05 N | Mean = 7.15 (31.82 N)<br>Ind Min = 6.20 (27.59 N)<br>Ind Max = 7.70 (34.27 N) | Different | | Linting | | Side A:<br>Log10(lint count): Mean 3.4<br>Side B:<br>Log10(lint count): Mean 3.4 | SIDE A: OUTSIDE<br>TOTAL >0.3 1024<br>TOTAL >0.5 658<br>SIDE B: INSIDE<br>TOTAL >0.3 1066<br>TOTAL >0.5 697 | Different | | Seam strength | | Mean = 102.92 N<br>Max = 109.98 N<br>Min = 95.37 N | / | Different | | Air permeability | | Mean 35.4 ft³/min/ft² | / | Different | | Barrier protection<br>level | | Level 3 per AAMI PB 70 | Level 3 per AAMI PB 70 | Same | {7}------------------------------------------------ | Material | SMS Nonwoven Fabric | Polypropylene SMS non woven | Same | |---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|------| | Biocompatibility | | | | | Cytotoxicity<br>Irritation<br>Sensitization | The test was done against ISO10993-5 and ISO10993-10.<br>The result indicates the gown is noncytotoxic, non-irritating, and non-sensitizing per ISO 10993-1. | The test was done against ISO10993-5 and ISO10993-10.<br>The result indicates the gown is noncytotoxic, non-irritating, and non-sensitizing per ISO 10993-1. | Same | | Sterilization | Non-sterile | Non-sterile | Same | ## Similar - Design The design of the proposed device is not exactly the same as the predicate device. The belt tie of the proposed device is yellow, while the belt tie of the predicate device is white. However, the belt tie is used to close the back of the gown. The difference in the color of belt tie will not affect the device performance. # Different - Weight per square No information was available on the Weight per square of the predicate device. The weight per square for the proposed device is 35g/m², which is similar to the most products on the market. And the difference in the weight per square will not affect the intended use. In addition, the performance testing was conducted on the proposed device and the results demonstrate that the proposed device can meet the barrier protection level 3 requirement as required by PB70. # Different - Size The size for the proposed device is different from the predicate device. The proposed device is available in nine size, including XS, S, M, L, XL,2XL,3XL,4XL,5XL, while the predicate device is available in three size, U, XL and 2XL. However, the difference in the size will not affect the device performance. Different sizes can be selected by surgeon's condition. ### Different - Hydrostatic pressure The hydrostatic pressure for the proposed device is different from the predicate device. the higher the hydrostatic pressure value, the higher the protection of the isolation gown. The hydrostatic pressure of the proposed device is 70.63 cm H2O, which is greater than the 69 cm H2O of the predicate device. ## Different - Water impact The water impact for the proposed device is different from the predicate device. However, the water in impact test was conducted on the proposed device and the results demonstrate that the proposed device meets the barrier protection level 3 requirement, i.e., no more than 1.0g, as required by PB70. Different - Breaking strength {8}------------------------------------------------ The breaking strength for the proposed device is different from the predicate device. Although the MD and CD breaking strength of the proposed device is smaller than the predicate device, the MD and CD breaking strength of the proposed device meets ASTM F2407-20's requirement of greater than 30N. ## Different - Tearing strength The tearing strength for the proposed device is different from the predicate device. Tearing strength is one of the indicators to evaluate the ability of the isolation gown to withstand destructive force. The greater the tearing strength value, the stronger the ability to withstand destructive force. The tearing strength of the proposed device is larger than the predicate device. #### Different - Linting The linting for the proposed device is different from the predicate device. However, the linting test was conducted on the proposed device and the testing results demonstrate that the proposed device can meet the requirements of log10<4. ### Different - Seam strength The seam strength was conducted on the proposed device and the testing results demonstrate that the seam strength of the proposed device meets ASTM F2407-20's requirement of greater than 30N. ### Different - Air permeability The air permeability was conducted on the proposed device and the testing results demonstrate that the air permeability of the proposed device meets the requirement of greater than 30 ft3/min/ft2. - 7. Summary of Non-Clinical Tests Non-clinical tests were conducted to verify that the proposed device met all design specifications as was same/similar to the predicate device. The test results demonstrate that the proposed device complies with the following standards: - > 16 CFR Part 1610 Standard for the Flammability of Clothing Textiles; - A AATCC 127: 2018 Water Resistance: Hydrostatic Pressure Test; - > AATCC 42: 2017 Water Resistance: Impact Penetration Test; - > ISO 9073-10: 2003 Textiles-Test Methods for Nonwovens-Part 10: Lint and Other Particles Generation in the Dry State; - > ASTM D1683/D1683M: 2017(2018) Standard Test Method for Failure in Sewn Seams of Woven Fabrics; - > ASTM D5587: 2015(2019) Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure: - > ASTM D5034: 2009(2017) Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test); {9}------------------------------------------------ - ISO 10993-5: 2009 Biological Evaluation of Medical Devices-Part 5: Tests for in Vitro > Cytotoxicity; - > ISO 10993-10: 2010 Biological Evaluation of Medical Devices-Part 10: Tests for Irritation and Skin Sensitization; - > ASTM D737-18: 2018 Standard Test Method for Air Permeability of Textile Fabrics | Test<br>Methodology | Purpose | Acceptance<br>Criteria | Result | |-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|--------------------------------------------------------------------------------------------------------------------| | Flammability | The test was performed in accordance<br>with 16 CFR Part 1610 Standard for<br>the Flammability of Clothing Textiles<br>to evaluate the flammability of the<br>test sample. | Meets Class 1<br>requirements | Class 1 | | Hydrostatic<br>pressure | The test was performed in accordance<br>with AATCC 127: 2017 Water<br>Resistance: Hydrostatic Pressure Test<br>to determine the hydrostatic pressure<br>of the test sample. | >50 cm H2O | Mean = 70.63 cm H2O<br>Max = 72.33 cm H2O<br>Min = 68.88 cm H2O | | Water impact | The test was performed in accordance<br>with AATCC 127: 2017 Water<br>Resistance: Hydrostatic Pressure Test<br>to determine the hydrostatic pressure<br>of the test sample. | ≤1.0 g | Mean = 0.58 g<br>Max = 0.69 g<br>Min = 0.49 g | | Breaking<br>strength | The test was performed in accordance<br>with ASTM D 5034:2009(2017)<br>Standard Test Method for Breaking<br>Strength and Elongation of Textile<br>Fabrics (Grab Test) to evaluate the<br>breaking strength of the test sample. | >20 N | MD:<br>Mean = 74.82 N<br>Max = 79.64 N<br>Min = 70.43 N<br>CD:<br>Mean = 49.35 N<br>Max = 55.18 N<br>Min = 40.96 N | | Tearing<br>strength | The test was performed in accordance<br>with<br>ASTM<br>D5587:2015(2019)<br>Standard Test Method for Tearing<br>Strength of Fabrics by Trapezoid<br>Procedure to evaluate the tearing<br>strength of the test sample. | >20 N | MD:<br>Mean = 62.92 N<br>Max = 69.72 N<br>Min = 62.01 N<br>CD:<br>Mean = 32.57 N<br>Max = 34.99 N<br>Min = 30.05 N | Table 3 Summary of Performance Testing {10}------------------------------------------------ | Linting | The test was performed in accordance<br>with ISO 9073-10:2003 Textiles-Test<br>Methods for Nonwovens-Pat 10: Lint<br>and Other Particles Generation in the<br>Dry State to evaluate the linting of<br>the test sample. | Log10(particle<br>count) < 4 | Side A:<br>Log10(lint count): Mean<br>3.4<br>Side B:<br>Log10(lint count): Mean<br>3.4 | |---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|----------------------------------------------------------------------------------------| | | | | | | | | | | | | | | | | | | | | | Seam strength | The test was performed in accordance<br>with ASTM D1683/D1683M:<br>2017(2018) Standard Test Method for<br>Failure in Sewn Seams of Woven<br>Fabrics to evaluate the seam strength<br>of the test sample. | >50 N | Mean = 102.92 N<br>Max = 109.98 N<br>Min = 95.37 N | | | | | | | | | | | | | | | | | | | | | | Air<br>permeability | The test was performed in accordance<br>with ASTM D737: 2018 Standard<br>Test Method for Air Permeability of<br>Textile Fabrics to evaluate the air<br>permeability of the test sample. | >30 ft³/min/ft² | Mean 35.4 ft³/min/ft² | | | | | | | | | | | | | | | | | | | | | # Table 4 Summary of Biocompatibility Testing | Test Methodology | Purpose | Acceptance Criteria | Result | |------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Cytotoxicity | The test was performed<br>in accordance with ISO<br>10993-5 Third edition<br>2009-06-01 Biological<br>evaluation of medical<br>devices - Part 5: Tests<br>for in vitro cytotoxicity<br>to evaluate the<br>cytotoxicity of the test<br>sample. | The viability should be<br>$\ge$ 70% of the blank.<br>And the 50% extract of<br>the test sample should<br>have at least the same or<br>a higher viability than<br>the 100% extract. | The viability was $\ge$ 70%<br>of the blank. And the<br>50% extract of the test<br>sample had a higher<br>viability than the 100%<br>extract. Under the<br>conditions of the study,<br>the proposed device<br>was non-cytotoxic. | | Sensitization | The test was performed<br>in accordance with ISO<br>10993-10 Third Edition<br>2010-08-01 Biological<br>evaluation of medical<br>devices - Part 10: Tests<br>for irritation and skin<br>sensitization to evaluate<br>the sensitization of the<br>test sample. | Non-sensitizing | Under the conditions of<br>the study, the proposed<br>device was<br>non-sensitizing. | {11}------------------------------------------------ | Irritation | The test was performed<br>in accordance with ISO<br>10993-10 Third Edition<br>2010-08-01 Biological<br>evaluation of medical<br>devices - Part 10: Tests<br>for irritation and skin<br>sensitization to evaluate<br>the irritation of the test<br>sample | Non-irritating | Under the conditions of<br>the study, the proposed<br>device<br>was<br>non-irritating. | |------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|----------------------------------------------------------------------------------------| |------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|----------------------------------------------------------------------------------------| #### Clinical Test Conclusion 8. No clinical study is included in this submission. #### 9. Conclusion The conclusions drawn from the nonclinical tests demonstrate that the proposed devices are as safe, as effective, and perform as well as or better than the legally marketed predicate device K171535.