High Protection Surgical Gown
Device Facts
| Record ID | K222456 |
|---|---|
| Device Name | High Protection Surgical Gown |
| Applicant | 3A Medical Products Co., Ltd. |
| Product Code | FYA · General, Plastic Surgery |
| Decision Date | Mar 12, 2023 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4040 |
| Device Class | Class 2 |
Indications for Use
High protection 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. Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the high protection surgical gown met the requirements for Level 4 classification.
Device Story
High Protection Surgical Gown; single-use, disposable sterile apparel. Worn by operating room personnel during surgical procedures. Provides barrier protection against microorganisms, body fluids, and particulate material. Meets AAMI Level 4 liquid barrier performance. Available in sizes S, M, L, XL, XXL. Constructed from blue SFS 3-ply lamination, PP spunbond nonwoven, polyester, and nylon. Protects both patient and staff from cross-contamination. Used in clinical surgical settings.
Clinical Evidence
No clinical data. Bench testing only. Performance verified via 16 CFR 1610 (flammability), AATCC 127 (hydrostatic pressure), AATCC 42 (water impact), ISO 9073-10 (linting), ASTM D1683 (seam strength), ASTM D5587 (tearing strength), ASTM D5034 (breaking strength), ASTM F1671 (viral penetration), and ASTM F88/F1929 (seal integrity). Biocompatibility confirmed per ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation/sensitization), and ISO 10993-7 (EO residuals).
Technological Characteristics
Materials: Blue SFS 3-Ply lamination, PP spunbond nonwoven, polyester, nylon. Barrier: AAMI Level 4. Sterilization: Ethylene Oxide (EO) to SAL 10^-6. Standards: ANSI/AAMI PB70:2012, ASTM F2407-20, ISO 10993 series, ISO 9073-10, 16 CFR 1610.
Indications for Use
Indicated for operating room personnel during surgical procedures to provide barrier protection against microorganisms, body fluids, and particulate material. Suitable for use in healthcare facilities requiring AAMI Level 4 liquid barrier performance.
Regulatory Classification
Identification
Surgical apparel are devices that 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. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.
Special Controls
*Classification.* (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible. (ii) Analysis and nonclinical testing must: (A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and (B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device. (iii) NIOSH approved under its regulation. (2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.
Predicate Devices
- Disposable Surgical Gown GD524ME65 (K212869)
Reference Devices
- 35g Standard SMMS Surgical Gown (K221819)
- 35g Reinforced SMMS Surgical Gown (K221819)
- 43g Standard SMMS Surgical Gown (K221819)
- 43g Reinforced SMMS Surgical Gown (K221819)
- 50g Standard SMMS Surgical Gown (K221819)
- 50g Reinforced SMMS Surgical Gown (K221819)
- BVB Surgical Gown (K221819)
Submission Summary (Full Text)
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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: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
March 12, 2023
3A Medical Products Co., Ltd % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai. 200120 China
Re: K222456
Trade/Device Name: High Protection Surgical Gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYA Dated: February 6, 2023 Received: February 8, 2023
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.
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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 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
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## DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
# Indications for Use
510(k) Number (if known) K222456
Device Name High Protection Surgical Gown
Indications for Use (Describe)
High protection 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.
Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the high protection surgical gown met the requirements for Level 4 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)
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# 510(k) Summary K222456
This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.
The assigned 510(k) Number: K222456
- 1. Date of Preparation: 02/07/2023
- 2. Sponsor Identification
# ЗА MEDICAL PRODUCTS СО., LTD
Yuan Industrial Park, Liuan City, China 237100 Establishment Registration Number: 3013735189
Contact Person: Amy Ma Position: Sales Director Tel: 86-551-64456982 Fax: 86-551-6556979 Email: info@3a-medical.cn
- 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
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#### 4. Identification of Proposed Device
Trade Name: High Protection Surgical Gown Common Name: Surgical Gown
## Regulatory Information
Classification Name: Gown, Surgical Classification: II; Product Code: FYA; Regulation Number: 21 CFR 878.4040 Review Panel: General Hospital;
## Indication for Use:
High protection 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.
Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the high protection surgical gown met the requirements for Level 4 classification.
Device Description:
The proposed device 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. The proposed device is single use, disposable medical device and is provided in sterile. The proposed device is available in five product sizes, including S, M, L, XL, XXL. The barrier protection level for high protection surgical gowns meet AAMI Level 4.
- 5. Identification of Predicate Device
510(k) Number: K212869
Product Name: Disposable Surgical Gown ML515M45U Disposable Surgical Gown GD524ME65 (Selected as the predicate device) Disposable Reinforced Surgical Gown
- 6. Identification of Reference Device
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510(k) Number: K221819 Product Name: 35g Standard SMMS Surgical Gown; 35g Reinforced SMMS Surgical Gown; 43g Standard SMMS Surgical Gown; 43g Reinforced SMMS Surgical Gown; 50g Standard SMMS Surgical Gown; 50g Reinforced SMMS Surgical Gown; BVB Surgical Gown (Sterile status was selected as the reference device)
- Summary of Non-Clinical Test 7.
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 demonstrated that the proposed device complies with the following standards:
- > 16 CFR Part 1610 Standard for the Flammability of Clothing Textiles;
- > AATCC 127: 2018 Water Resistance: Hydrostatic Pressure Test;
- A 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);
- > ASTM F1671/F1671M-13 Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System;
- > ASTM F88/F88M: 2015 Standard Test Method for Seal Strength of Flexible Barrier Materials;
- > ASTM F1929: 2015 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration;
- > ISO 10993-7: 2008 Biological Evaluation of Medical Devices-Part 7: Ethylene Oxide Sterilization Residuals;
- > 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;
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| 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<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 | 204.6 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 | 0.02g |
| 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. | ≥30 N | Longitude:131.5N<br>Latitude:75.2N |
| Tearing<br>strength | The test was performed in accordance<br>with ASTM 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. | ≥10 N | Longitude:79.0N;<br>Latitude:33.8N |
| 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:3.1<br>Side B:3.2 |
| 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 | ≥30 N | Shoulder Seam:126.5N<br>Sleeve Seam:76.7N<br>Armhole Seam:75.3N |
| | Fabrics to evaluate the seam strength<br>of the test sample. | | |
| Resistance<br>against<br>penetration<br>of<br>Phi-X174<br>bacteriophage | The test was performed in accordance<br>with ASTM F 2407-2020 Standard<br>Specification for Surgical Gowns<br>Intended for Use in Healthcare<br>Facilities | No detectable<br>transfer of the<br>Phi-X174<br>Bacteriophage | No detectable transfer<br>of the Phi-X174<br>Bacteriophage |
| EO/ECH<br>Residue | The test was performed in accordance<br>with ISO 10993-7:2008 Biological<br>evaluation of medical devices - Part<br>7: Ethylene oxide sterilization<br>residuals to evaluate the level of<br>sterilant residues. | EO:<4mg/device<br>ECH:<9mg/device | The Method Detection<br>Limit (MDL) of EO<br>residue and ECH<br>residue is<br>0.093mg/device. The<br>total EO residue and<br>ECH residue of the<br>devices were less than<br>the MDL. |
Table 1 Summary of Performance Testing
4 / 10
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Summary of Biocompatibility Testing Table 2
| Test<br>Methodology | Purpose | Acceptance<br>Criteria | Result |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Cytotoxicity | The test was performed in accordance<br>with ISO 10993-5 Third edition<br>2009-06-01 Biological evaluation of<br>medical devices - Part 5: Tests for in<br>vitro cytotoxicity to evaluate the<br>cytotoxicity of the test sample. | The<br>viability<br>should be $\ge$ 70%<br>of the blank. And<br>the 50% extract of<br>the test sample<br>should have at<br>least the same or a<br>higher<br>viability<br>than the 100%<br>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 in accordance<br>with ISO 10993-10 Third Edition<br>2010-08-01 Biological evaluation of<br>medical devices - Part 10: Tests for<br>irritation and skin sensitization to<br>evaluate the sensitization of the test<br>sample. | Non-sensitizing | Under the conditions of<br>the study, the proposed<br>device<br>was<br>non-sensitizing. |
| Irritation | The test was performed in accordance<br>with ISO 10993-10 Third Edition<br>2010-08-01 Biological evaluation of | Non-irritating | Under the conditions of<br>the study, the proposed<br>device<br>was |
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| medical devices - Part 10: Tests for<br>irritation and skin sensitization to<br>evaluate the irritation of the test<br>sample. | | non-irritating. |
|--------------------------------------------------------------------------------------------------------------------------------|--|-----------------|
|--------------------------------------------------------------------------------------------------------------------------------|--|-----------------|
#### Summary of Clinical Test 8.
No clinical study is included in this submission.
#### Summary of Technological characteristics 9.
| Item | Proposed Device | Predicate<br>Device<br>K212869 | Reference<br>Device<br>K221819 | Remark | |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|-----------|
| Product<br>Name | High protection surgical<br>gown | Disposable Surgical<br>Gown GD524ME65 | BVB Surgical Gown<br>(Sterile) | / | |
| Product<br>Code | FYA | FYA | FYA | Same | |
| Regulation<br>No. | 21CFR 878.4040 | 21CFR 878.4040 | 21CFR 878.4040 | Same | |
| Class | II | II | II | Same | |
| Indication<br>for Use | High protection 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 high | Disposable Surgical Gown and Disposable Reinforced Surgical Gown are 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 | 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, 35g | Different | |
| | | | | | |
| | protection surgical gown<br>met the requirements for<br>Level 4 classification. | drapes intended for use<br>in health care facilities,<br>Disposable Surgical<br>Gown ML515M45U met<br>the requirements for<br>Level 3 classification,<br>Disposable Surgical<br>Gown GD524ME65 and<br>Disposable Reinforced<br>Surgical Gown met the<br>requirements of Level 4<br>classification. | Standard SMMS Surgical<br>Gown met the<br>requirements for Level 2<br>classification; 35g<br>SMMS Reinforced<br>Surgical Gown, 43g<br>Standard SMMS Surgical<br>Gown, 43g Reinforced<br>SMMS Surgical Gown,<br>50g Standard SMMS<br>Surgical Gown and 50g<br>Reinforced SMMS<br>Surgical Gown met the<br>requirements for Level 3<br>classification;<br>BVB<br>Surgical gown met the<br>requirements for Level 4<br>classification. Non-sterile<br>gowns are to be sold to<br>re-packager/re-labeler<br>establishments for<br>ethylene oxide (EtO)<br>sterilization according to<br>ISO 11135-1 prior to<br>marketing to the end<br>users and sterile surgical<br>gowns are to be sold<br>directly to the end users<br>after EtO sterilization<br>validation to ISO<br>11135-1. | | |
| Style | Non-reinforced | Non-reinforced | Non-reinforced | Same | |
| Durability | Single use, Disposable | Single use, Disposable | Single use, Disposable | Same | |
| Color | Blue | Blue | Blue | Same | |
| Labeling | Conform with 21CFR Part<br>801 | Conform with 21CFR<br>Part 801 | Conform with 21CFR<br>Part 801 | Same | |
| Item | Proposed Device | Table 4 Safety and Effectiveness Comparison<br>Predicate Device K212869 | | Device Reference K221819 | Remark |
| Product Name | High protection surgical gown | Disposable Surgical Gown GD524ME65 | | BVB Surgical Gown (Sterile) | / |
| Weight per square (g) | 80 g/m² | 67g/m² | | 64 g/m² | Different |
| Size | S, M, L, XL, XXL | S, M, L, XL, XXL, XXXL | | M, L, LL, XL, XLL, XXL | Different |
| Flammability | Class I | Class I | | Class I | Same |
| Hydrostatic pressure | ≥50 cm H2O | >50 cm H2O | | >50 cm H2O | Same |
| Water impact | ≤1.0 g | ≤1.0 g | | ≤1.0 g | Same |
| Breaking strength | Longitude:131.5N<br>Latitude:75.2N | Longitude: 184 N<br>Latitude: 111 N | | Longitude: 237.72 N<br>Latitude: 148.93N | Different |
| Tearing strength | Longitude:79.0N;<br>Latitude:33.8N | Longitude: 137 N<br>Latitude: 90 N | | Longitude: 53.98 N<br>Latitude: 49.23N | Different |
| Linting | Log10<4 | Log10<4 | | Log10<4 | Same |
| Seam Strength | Shoulder Seam: 126.5N<br>Sleeve Seam: 76.7N<br>Armhole Seam: 75.3N | 117N | | 70.35N | Different |
| Bacterial Penetration | No detectable transfer of the Phi-X174 Bacteriophage | No detectable transfer of the Phi-X174 Bacteriophage | | No detectable transfer of the Phi-X174 Bacteriophage | Same |
| Barrier protection level | Level 4 per AAMI PB 70 | Level 4 per AAMI PB 70 | | Level 4 per AAMI PB 70 | Same |
| Material | Blue SFS 3-Ply Lamination Material, Blue PP Spunbond Nonwoven Fabric, Polyester Fiber and Nylon | SMS nonwoven, PE film, Polyester and blue masterbatch; | | Blue BVB fabric, PP non-woven, Polyester and Mixing polyester with nylon | Different |
| | Biocompatibility | | | | |
| Cytotoxicity | Under the conditions of the study, the device is | Under the conditions of the study, the device is | | Under the conditions of the study, the device is | Same |
| Irritation<br>Sensitization | non-toxic, non-irritating,<br>and non-sensitizing. | non-toxic, non-irritating,<br>and non-sensitizing. | non-toxic, non-irritating,<br>and non-sensitizing. | | |
| Sterilization | Sterile<br>Method: Ethylene Oxide (EO);<br>Sterilization Assurance Level (SAL): 10-6 | Sterile<br>Method: Ethylene Oxide (EO);<br>Sterilization Assurance Level (SAL): 10-6 | Sterile<br>Method: Ethylene Oxide (EO);<br>Sterilization Assurance Level (SAL): 10-6 | Same | |
#### Table 3 General Comparison
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# Different - Indication for Use
The predicate device and reference device are available in many types. The type GD524ME65 in K212869 is selected as the predicate device, and the BVB Surgical Gown (Sterile) in K221819 is
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selected as the reference device. The indications for use for the proposed device, predicate device and reference device are the same.
Table 4 Safety and Effectiveness Comparison
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## Different - Weight per square
The weight per square for the proposed device is different from the predicate device and reference device. However, the difference in the weight per square will not affect the intended use. In addition, the performance testing results demonstrated that the proposed device can meet the barrier protection level 4 requirement as required by PB70. Therefore, this difference will not affect the safety and effectiveness of the proposed device.
## Different - Size
The size for the proposed device is different from the predicate device and reference device. The proposed devices are available in 5 product sizes, including S, M, L, XL and XXL. However, the difference in the size will not affect the device performance. Different size can be selected by surgeon's condition. Therefore, this difference will not affect the safety and effectiveness of the proposed device.
## Different - Breaking strength
The breaking strength for the proposed device is different from the predicate device and reference device. Although the longitude and latitude breaking strength of the proposed device are smaller than the predicate device and reference device, the longitude and latitude breaking strength of the proposed device meets ASTM F2407-20's requirement of greater than 30N. Therefore, this difference will not affect the safety and effectiveness of the proposed device.
## Different - Tearing strength
The tearing strength for the proposed device is different from the predicate device and reference device. However, the longitude and latitude tearing strength of the proposed device meets ASTM F2407-20's requirement of greater than 10N. Therefore, this difference will not affect the safety and effectiveness of the proposed device.
### Different - Seam Strength
The seam strength for the proposed device is different from the predicate device and reference device. The shoulder seam strength, sleeve seam strength and armhole seam strength were conducted on the proposed device. The sleeve seam strength and armhole seam strength of the proposed device are smaller than the predicate device, while these seam strengths are similar to the reference device. And
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these seam strength of the proposed device meets ASTM F2407-20's requirement of greater than 30N. Therefore, this difference will not affect the safety and effectiveness of the proposed device.
## Different - Material
The material for the proposed device is different from the predicate device and reference device. However, the biocompatibility test for proposed device was performed and the results showed no adverse effect. Therefore, this difference will not affect the safety and effectiveness of the proposed device.
## 10. Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and perform as well as or better than the legally marketed predicate device K212869.
