(261 days)
Not Found
No
The 510(k) summary describes a standard surgical gown and its physical and barrier properties. There is no mention of AI or ML technology in the intended use, device description, or performance studies.
No
Explanation: The device, a surgical gown, is intended to protect operating room personnel and patients from the transfer of microorganisms, body fluids, and particulate material. It does not provide any therapeutic effect to the patient or user.
No
Explanation: The device is a surgical gown, which is a protective barrier intended to prevent the transfer of microorganisms and fluids during surgical procedures. It does not perform any diagnostic function.
No
The device description clearly indicates it is a physical surgical gown made of fabric and constructed with sewing and heat sealing. The performance studies also focus on physical properties and barrier performance, not software functionality.
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 surgical gowns are for protecting surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material during surgical procedures. This is a barrier function, not a diagnostic one.
- Device Description: The description focuses on the physical characteristics and barrier properties of the gown.
- Lack of Diagnostic Elements: There is no mention of the device being used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Performance Studies and Key Metrics: The performance studies and key metrics relate to the physical and barrier properties of the gown (strength, resistance to penetration, flammability, biocompatibility), not to diagnostic accuracy or performance.
IVD devices are specifically designed to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health status. Surgical gowns do not perform this function.
N/A
Intended Use / Indications for Use
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 material. 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). The Surgical Gowns are single use, disposable medical devices; provided non-sterile. Before the use, the Surgical Gowns must be sterilized by EO sterilization based on ISO 11135:2014.
Product codes (comma separated list FDA assigned to the subject device)
FYA
Device Description
The Surgical Gown is composed of collar, body, sleeve and tie, in a blue color, offered in sizes S, M, L, XL and XXL. The neck and waist are laced, the sleeves are made of polyester elastic 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 / 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Test Conclusion: The proposed device was tested and conformed to the related recognized standards and the requirements stated in the "Guidance on Premarket Notification [510(k)] Submissions for Surgical Gowns and Surgical Drapes" dated August, 1993. Based on ASTM F2407-20 Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities, the subject device has been conducted the test as following:
AATCC 42-2013 Water Resistance: Impact Penetration Test
AATCC 127-2014 Water Resistance: Hydrostatic Pressure Test
ASTM D5034-09(2017) Standard Test Method for Breaking Strength and Elongation of Texile Fabrics (Grab Test)
ASTM D5587-15(2019) Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure
ASTM D1683-17(2018) Standard Test Method for Failure in Sewn Seams of Woven Apparel Fabrics
ASTM F1868-17(2017) Standard Test Method for Thermal and Evaporative Resistance of Clothing Materials Using a Sweating Hot Plate
ISO 9073-10:2003 Textiles - Test methods for nonwovens - Part 10: Lint and other particles generation in the dry state
16 CFR Part 1610(a) Standard for The Flammability of Clothing Textiles
ISO 11737-2:2019 Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process.
Clinical Test Conclusion: No clinical study implemented for the Surgical Gown.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Impact Penetration: =50cm (Acceptance Criteria: Level 3, >=50cm)
Tensile strength: Machine direction mean>=32.9 lbf; Cross direction mean>=26.3 lbf. (Acceptance Criteria: Machine direction mean:>=18 lbf; Cross direction mean: >=12 lbf.)
Tear resistance: Machine direction mean>=9.3 lbf; Cross direction mean>=18.2 lbf. (Acceptance Criteria: Farbic direction A mean:>=4.0 lbf; Farbic direction B mean:>=2.5 lbf;)
Seam strength: Shoulder: >=10.1 lbf; Arm opening: >=7.2 lbf; Sleeve: >=10.1 lbf; (Acceptance Criteria: Shoulder: >=8.5 lbf; Arm opening: >=5.5 lbf; Sleeve: >=8.5 lbf;)
Evaporative Resistance of fabrics: Mean Evaporative Resistance (Ref)>=0.06(kPa·m²/W). (Acceptance Criteria: Mean Evaporative Resistance (Ref)>=0.06(kPa·m²/W).)
Lint and Other particles generation in the dry state: Index for Particulate Matter (IPM)
§ 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 shows 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, with the letters "FDA" in a blue square. Next to that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 16, 2023
Hubei Woozon Healthcare Co.,Ltd. % Boyle Wang General Manager Shanghai Truthful Information Technology Co., Ltd RM.1801,No.161 Lujiazui East Rd.,Pudong Shanghai, Shanghai 200120 China
Re: K222999
Trade/Device Name: Surgical Gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYA Dated: May 10, 2023 Received: May 22, 2023
Dear Boyle 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
1
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 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, MD, 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
2
Indications for Use
510(k) Number (if known) K222999
Device Name Surgical Gown
Indications for Use (Describe)
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 material. This surgical gown meets the requrements 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). The Surgical Gowns are single use, disposable medical devices; provided non-sterile. Before the use, the Surgical Gowns must be sterilized by EO sterilization based on ISO 11135:2014.
| 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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3
510(k) Summary K222999
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92.
1.0 Submitter's information
Name: Hubei Woozon Healthcare Co.,Ltd. Address: Nongfeng Road, Nonwoven Fabric Industrial Park, Wangzhou Avenue, Pengchang Town, Xiantao City, Hubei, China. Contact: Li Chunlin Phone Number: 86-728-3280667 Fax number: 86-728-3280667 Date of Preparation: June 12, 2023
Designated Submission Correspondent
Contact: Mr. Boyle Wang Address: Shanghai Truthful Information Technology Co., Ltd. Room 1801, No. 161 Lujiazui East Rd., Pudong Shanghai, 200120 China Tel: +86-21-50313932 Email: Info@truthful.com.cn
2.0 Device information
| Trade name: | Surgical Gown |
|---|---|
| Common name: | Surgical gown |
| Classification name: | Gown, Surgical |
| Model(s): | S, M, L, XL, XXL |
3.0 Classification
| Production code: | FYA - Gown, Surgical |
|---|---|
| Regulation number: | 21CFR 878.4040 - Surgical apparel |
| Classification: | Class II |
| Panel: | Surgical apparel |
4.0 Predicate device information
Manufacturer: Hubei Wanli Protective Products Co. Ltd
4
Surgical Gown Device: K211509 510(k) number:
5.0 Intended Use/Indication for Use Statement
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 material. 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). The Surgical Gowns are single use, disposable medical devices; provided non-sterile. Before the use, the Surgical Gowns must be sterilized by EO sterilization based on ISO 11135:2014.
6.0 Device description
The Surgical Gown is composed of collar, body, sleeve and tie, in a blue color, offered in sizes S, M, L, XL and XXL. The neck and waist are laced, the sleeves are made of polyester elastic 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.
| Table 3 - General Comparison | |||
|---|---|---|---|
| Item | Proposed device | ||
| (K222999) | Predicated device | ||
| (K211509) | Remark | ||
| Product Code | FYA | FYA | Same |
| Regulation No. | 21 CFR 878.4040 | 21 CFR 878.4040 | Same |
| Class | II | II | Same |
| Product name | Surgical Gown | Surgical Gown | Same |
| 510(k) No. | K222999 | K211509 | / |
| Models | S,M,L,XL,XXL | S,M,L,XL,XXL | Same |
| Intended | |||
| Use/Indications for | |||
| Use | 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 material. 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). The Surgical Gowns are single | Same | ||
| 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 material. 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). The Surgical Gowns are single use, disposable | |||
| use, disposable medical devices; | |||
| provided non-sterile. Before the | |||
| use, the Surgical Gowns must be | |||
| sterilized by EO sterilization based | |||
| on ISO 11135:2014. | medical devices; provided non- | ||
| sterile. | |||
| Material | SMS nonwoven fabric | ||
| polyester fiber | Sleeve/body | ||
| (polyethylene SMS Nonwoven) | Similar | ||
| Color | Blue | Blue | Same |
| Sterility | Sterile for end-user | Sterile for end user | Same |
| Single Use | Yes | Yes | Same |
| Impact Penetration | ≤1.0 g | ≤1.0 g | Same |
| Hydrostatic | |||
| Resistance | >50 cm | >50 cm | Same |
| Tensile strength | Machine direction mean≥32.9 lbf; | ||
| Cross direction mean≥26.3 lbf. | Machine direction mean≥27.8 lbf; | ||
| Cross direction mean≥19.1 lbf | * Gap 1 | ||
| Tear resistance | Machine direction mean≥9.3 lbf; | ||
| Cross direction mean≥18.2 lbf | Machine direction mean≥10.7 lbf; | ||
| Cross direction mean≥6.2 lbf | * Gap 2 | ||
| Steam strength | Shoulder: 48.7N | ||
| Armhole:33.9N | |||
| Sleeve: 49.6N | Shoulder: 71.8N | ||
| Armhole: 66.0N | |||
| Sleeve: 77.0N | * Gap 3 | ||
| 16 CFR Part 1610 | |||
| Flammability | Meets requirements of Flame | ||
| Resistant CPSC 1610 Class 1 | Meets requirements of Flame | ||
| Resistant CPSC 1610 Class 1 | Same | ||
| Linting | Log10 |