(107 days)
Not Found
No
The 510(k) summary describes a disposable surgical gown and its physical properties and testing against standards. There is no mention of AI or ML technology.
No
The device is a disposable surgical gown intended to protect against transfer of microorganisms and body fluids. It is a barrier protection device, not one designed for therapy or treatment.
No
Explanation: The device described is a disposable surgical gown, intended to provide barrier protection against microorganisms and fluids during surgical procedures. It does not perform any diagnostic function.
No
The device description and performance studies clearly indicate this is a physical medical device (surgical gown) and not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for protecting surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate matter during surgical procedures. This is a barrier function, not a diagnostic function.
- Device Description: The description focuses on the physical components and barrier properties of the gown.
- Lack of Diagnostic Elements: There is no mention of the device being used to test samples (like blood, urine, or tissue) or to provide information about a patient's health status or condition.
- Performance Studies: The performance studies listed are related to the physical and barrier properties of the gown (flammability, strength, water resistance, etc.), not diagnostic accuracy or performance.
- No Mention of IVD-Specific Regulations or Standards: The standards listed are relevant to medical devices and textiles, but not specifically to IVDs.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This surgical gown does not fit that definition.
N/A
Intended Use / Indications for Use
The Disposable Surgical Gowns are intended to be worn by operating room personnel during surgical procedures to protect the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate matter.
In addition, this surgical gown meets the requirements of AAMI Level 3 barrier protection for a surgical gown per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (AAMI PB70). This is a single use, disposable device, provided sterile.
Product codes
FYA
Device Description
The Disposable surgical gown is composed of collar, body, sleeve and tie. The back is full opening, the neck and waist are laced, the sleeve are made of cotton closure by sewing, and the rest are made of heat sealing. It has been tested according to AAMI PB70:2012 and meet AAMI Level 3 barrier level protection for a surgical gown.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Operating room personnel during surgical procedures
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Non-clinical tests were conducted to verify that the proposed device met all design specification as same/similar to the predicate device. The test results demonstrated that the proposed device comply with the Guidance on Premarket Notification [510(k)] Submissions for Surgical Gowns and Surgical Drapes and the following standards:
- 16 CFR Part 1610 Standard for the Flammability of Clothing Textiles
- ASTM F2407: 2020 Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities
- AATCC 127: 2017 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)
- ASTM F1868: 2017 Test Method for Thermal and Evaporative Resistance of Clothing Materials Using a Sweating Hot Plate
- 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
No clinical study is included in this submission.
Key Metrics
- Tearing Strength: Pass (MD: average 52.03N, CD: average 29.15N)
- Tensile Strength: Pass (MD: average 135.83N, CD: average 98.25N)
- Seam Strength: Pass (Average 45.18N)
- Impact Penetration: Pass (0.16g max)
- Hydrostatic Pressure: Pass (52~98cm)
- Thermal and Evaporative Resistance: Pass (0.00542 Pa.m²/W)
- Linting: Pass (Average 2.2)
- Flammability: Pass (Class 1)
- EO/ECH residue: EO: not detected; ECH: Average 6.8 ug/device
- Cytotoxicity: Non-cytotoxic
- Irritation: Non-irritating
- Sensitization: Non-sensitizing
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4040 Surgical apparel.
(a)
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.(b)
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.
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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 and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 20, 2022
Xiantao Topmed Nonwoven Protective Products Co., Ltd. % Ivy Wang Technical Manager Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Century Avenue Shanghai, 200122 China
Re: K221977
Trade/Device Name: Disposable Surgical Gown (G4003) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYA Dated: September 19, 2022 Received: September 19, 2022
Dear Ivy Wang:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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. 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
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Indications for Use
510(k) Number (if known) K221977
Device Name Disposable Surgical Gown (G4003)
Indications for Use (Describe)
The Disposable Surgical Gowns are intended to be worn by operating room personnel during surgical procedures to protect the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate matter.
In addition, this surgical gown meets the requirements of AAMI Level 3 barrier protection for a surgical gown per ANSU AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (AAMI PB70). This is a single use, disposable device, provided sterile. The surgical gown has six sizes - S, M, L, XL, XXL and XXXL.
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 (K221977)
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.
Prepared date: 2022-04-28 A. Applicant: Xiantao Topmed Nonwoven Protective Products Co., Ltd Address: North of the National Road 318, Tongjiazui Village, Huchang Town, Xiantao City, Hubei Province, China 433000 Contact Person: Vivian Zhu Tel: + 862787861070 Fax: +862787861011 Email: info@topmeddisposable.com
Submission Correspondent: Primary contact: Ms. Ivy Wang Shanghai SUNGO Management Consulting Co., Ltd. Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: haiyu.wang@sungoglobal.com Secondary contact: Mr. Raymond Luo Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: fda.sungo@gmail.com
B. Device:
Trade Name: Disposable Surgical Gown Common Name: Surgical Gown Model: G4003
Regulatory Information Classification Name: Gown, Surgical Classification: Class II Product code: FYA Regulation Number: 878.4040 Review Panel: Surgical Apparel
C. Predicate device:
K211809 Surgical Gown Wuhan Dymex Healthcare Co., Ltd.
D. Indications for use of the device:
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The Disposable Surgical Gowns are intended to be worn by operating room personnel during surgical procedures to protect the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate matter.
In addition, this surgical gown meets the requirements of AAMI Level 3 barrier protection for a surgical gown per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (AAMI PB70). This is a single use, disposable device, provided sterile.
E. Device Description:
The Disposable surgical gown is composed of collar, body, sleeve and tie. The back is full opening, the neck and waist are laced, the sleeve are made of cotton closure by sewing, and the rest are made of heat sealing. It has been tested according to AAMI PB70:2012 and meet AAMI Level 3 barrier level protection for a surgical gown.
| Item | Proposed Device | Predicate Device | Result |
|---|---|---|---|
| 510K number | - | K211809 | - |
| Model name | Disposable Surgical Gown | Surgical Gown | Similar |
| Classification | Class II Device, FYA (21 CFR878.4040) | Class II Device, FYA (21 CFR878.4040) | Same |
| Intended use | The Disposable Surgical Gowns are intended to be worn by operating room personnel during surgical procedures to protect the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate matter. | ||
| In addition, this surgical gown meets the requirements of AAMI Level 3 barrier protection for a surgical gown per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (AAMI PB70). This is a single use, disposable device, provided sterile. | 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 surgical gown met the requirements for Level 3 classification. | Same | ||
| Style | Non-reinforced | Non-reinforced | Same |
| Color | Blue | Blue | Same |
F. Comparison with predicate device
Table 1 General Comparison
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| Use | Single Use, Disposable | Single Use, Disposable | Same |
|---|---|---|---|
| ----- | ------------------------ | ------------------------ | ------ |
Table 2 Technological comparison
| Item | Proposed Device | Predicate Device (K211809) | Result |
|---|---|---|---|
| Size | S, M, L, XL, XXL, XXXL | S, M, L, XL, XXL, XXXL | Same |
| Material | SMMS nonwoven | ||
| Polypropylene, Cotton, Nylon | SMS, Polyester, Nylon | Different | |
| Weight per square(g) | 45g/m2 | 43g/m2 | Different |
| Impact Penetration | 50cmH2O for critical zone | >50cmH2O for critical zone | Same |
| Tensile Strength | MD: average 135.83N | ||
| CD: average 98.25N | MD: Average 74.88 | ||
| CD: Average 50.73 | Similar | ||
| Tear Strength | MD: average 52.03N | ||
| CD: average 29.15N | MD: Average 63.87 | ||
| CD: Average 34.91 | Similar | ||
| Seam Strength | Average 45.18N | Not available | Different |
| Linting | Log10≤4 | Log10≤4 | Same |
| Evaporative | |||
| Resistance | 50 cm | Pass | |
| 52~98cm | |||
| Thermal and | |||
| Evaporative | |||
| Resistance | The test was performed in | ||
| accordance with ASTM | |||
| F1868: 2017 Test Method | |||
| for Thermal and Evaporative | |||
| Resistance of Clothing | |||
| Materials Using a Sweating | |||
| Hot Plate to evaluate the | |||
| evaporative resistance of the | |||
| test sample. |