(170 days)
Not Found
No
The device description and intended use are for a standard surgical gown, and there is no mention of AI or ML technology in the provided text.
No.
A therapeutic device is one that treats or alleviates a disease or condition. This surgical gown is a protective barrier and not used for treatment.
No
This device is a surgical gown, intended to protect from transfer of microorganisms and fluids, not to diagnose a condition or disease.
No
The device description clearly states it is a physical surgical gown made of SMS nonwoven material and other components, intended for physical barrier protection. It is a tangible, disposable medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material during surgical procedures. This is a protective barrier function, not a diagnostic test performed on samples taken from the human body.
- Device Description: The device is a surgical gown made of nonwoven material. It is a physical barrier.
- No mention of in vitro testing: There is no indication that this device is used to examine specimens (like blood, urine, tissue) outside of the body to diagnose diseases or conditions.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This surgical gown does not fit that description.
N/A
Intended Use / Indications for Use
The Surgical Gown is 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. In addition, this surgical gown meets the requirements of AAMI Level 4 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 sterile.
Product codes
FYA
Device Description
The 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 polyester elastic closure by sewing, and the rest are made of SMS nonwoven material, in a blue color. It has been tested according to AAMI PB70:2012 and meet AAMI Level 4 barrier level protection for a surgical gown. The proposed devices are single use, disposable medical devices and EO that sterilized. They are available in six sizes: S, M, L, XL, XXL and XXXL
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 / operating room
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 specifications and is equivalent to the predicate device. The test results demonstrate that the proposed device complies with the following standards by passing all applicable acceptance criteria and is equivalent to the predicate device.
Test Methodology & Results:
AATCC 42: Pass
AATCC 127: Pass
ASTM D5034: Pass
ASTM D5587: Pass
ASTM D1683: Pass
ASTM F1868: Pass
ASTM F1671: Pass
ISO 9073-10: Pass
16 CFR Part 1610: Pass
ISO 11737-2: Pass
ISO 10993-5: Pass
ISO 10993-10 (Irritation): Pass
ISO 10993-10 (Sensitization): Pass
ISO 10993-7: Pass
No clinical study is included in this submission.
Key Metrics
Not Found
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 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.
January 26, 2023
Guangzhou Fuzelong Hygiene Material Co., Ltd % Boyle Wang General Manager Shanghai Truthful Information Technology Co., Ltd. RM. 1801, No. 161 Lujiazui East Rd. Pudong, Shanghai 200120 China
Re: K222403
Trade/Device Name: Surgical Gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYA Dated: December 18, 2022 Received: January 9, 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 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-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,
Allan Guan
For 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) K222403
Device Name Surgical Gown
Indications for Use (Describe)
The Surgical Gown is 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. In addition, this surgical gown meets the requirements of AAMI Level 4 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). The Surgical Gowns are single use, disposable medical devices, provided 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)
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510(k) Summary K222403
The following information is provided in accordance with 21 CFR 807.92 for the premarket 510(k) summary:
1.0 Submitter's information
Name: Guangzhou Fuzelong Hygiene Material Co., Ltd Address: #12, Guancun Road, Jiangpu Street, Conghua, Guangzhou, China 510900 Contact: Ms. Haiyan Zeng Phone Number: 86-020-87993188 Fax number: 86-020-87993188 Date of Preparation: Jan 13, 2023
Designated Submission Correspondent
Mr. Boyle Wang 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, XXXL
3.0 Classification
Production code: FYA Regulation number: 21 CFR 878.4040 Classification: Class II Panel: Surgical apparel
4.0 Predicate device information
Manufacturer: Weihai Hongyu Nonwoven Fabric Products Co., Ltd. Device: Disposable Surqical Gown 510(k) number: K214088 Product code: FYA Requlation number: 21 CFR 878.4040
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5.0 Intended Use/Indication for Use Statement
The Surgical Gown is 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. In addition, this surgical gown meets the requirements of AAMI Level 4 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 sterile.
6.0 Device description
The 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 polyester elastic closure by sewing, and the rest are made of SMS nonwoven material, in a blue color. It has been tested according to AAMI PB70:2012 and meet AAMI Level 4 barrier level protection for a surgical gown. The proposed devices are single use, disposable medical devices and EO that sterilized. They are available in six sizes: S, M, L, XL, XXL and XXXL
7.0 Technological Characteristic Comparison Table
| Item | Proposed device | Predicated device | Comparison |
|---|---|---|---|
| Product Code | FYA | FYA | Same |
| Regulation No. | 21 CFR 878.4040 | 21 CFR 878.4040 | Same |
| Class | II | II | Same |
| Product name | Surgical Gown | Disposable Surgical Gown | Similar |
| 510(k) No. | K222403 | K214088 | - |
| Sizes | S, M, L, XL, XXL, XXXL | S, M, L, XL, XXL, XXXL | Same |
| Intended Use/Indications for Use | Surgical Gown is 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. In addition, this surgical gown meets the requirements of AAMI Level 4 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. It is single use, disposable medical devices, provided sterile. | Disposable Surgical Gown is 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. In addition, this surgical gown meets the requirements of AAMI Level 4 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. It is single use, disposable medical devices, provided sterile | Similar |
| Item | Proposed device | Predicated device | Comparison |
| Material | SMS nonwoven fabric | ||
| polyester fiber | SMS nonwoven | ||
| TPU membrane | Similar | ||
| Color | Blue | Blue | Same |
| Sterility | Sterile | Sterile | Same |
| Sterilization | |||
| method | Ethylene Oxide | Ethylene Oxide | Same |
| EO and ECH | |||
| Residuals | EO: |