(161 days)
Not Found
No
The device description and performance studies focus on material properties and barrier protection, with no mention of AI or ML.
No
The device, a surgical gown, is intended for protection from transfer of microorganisms, body fluids, and particulate material, not for treating or diagnosing a disease or condition.
No
The device description clearly states that the surgical gown is intended to "protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material," not to diagnose medical conditions.
No
The device description clearly indicates a physical surgical gown made of fabric with specific features like seams, closures, and cuffs. There is no mention of software components or 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 gown is for protecting operating room personnel and patients 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 materials of the gown, designed for protection and comfort during surgery. There is no mention of analyzing samples from the human body.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes)
- Providing information for diagnosis, monitoring, or treatment decisions based on sample analysis.
- Performance Studies: The performance studies listed are related to the physical properties and barrier function of the gown (biocompatibility, strength, liquid barrier), not diagnostic accuracy.
In summary, the surgical gown is a medical device intended for physical protection during surgery, not for performing diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
Surgical gown 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.
Product codes (comma separated list FDA assigned to the subject device)
FYA
Device Description
The surgical gown is 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. It is made of soft, air permeable SMS non-woven fabric.
The Jianerkang Surgical Gown is made of a laminate with adhesive taped seams and have a hook and loop closure at the back of the neck and a waist tie feature to secure the gown to the body of the user. The sleeves of the gown have knit cuffs sewn onto the end of the sleeve at the user's wrists to keep the sleeves in place on the wearer. The entire gown including the gown sleeves are made of the same material and utilize the same manufacturing processes.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility testing
The biocompatibility evaluation for the Surgical Gown was conducted in accordance with the International Standard ISO 10993-1:2018, "Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process" as recognized by FDA. The biocompatible testing included the following tests:
- Cytotoxicity - (ISO 10993-5: 2009)
- Sensitization - (ISO 10993-10:2010)
- Skin Irritation - (ISO 10993-10:2010)
Performance testing
Performance testing was conducted on the Surgical Gown. All of the tested parameters met the predefined acceptance criteria.
| Standards | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| AATCC 42 | Spray Impact | Water Resistance | PASS |
| AATCC 127 | Hydrostatic Pressure | Water Resistance | PASS |
| ANSI/AAMI PB70:2012 AAMI Level 3 | Liquid Barrier Performance | Water Resistance | PASS |
| ASTM D 5733 | Standard Test Method for Tearing Strength of Nonwoven Fabrics by the Trapezoid Procedure | Tearing Strength | PASS |
| ASTM D5034 –2017 | Grab Tensile, Peak Stretch, and Peak Energy - Nonwovens | Tensile Strength | PASS |
| ASTM 1683-17 (2018) | Standard Test Method for Failure in Sewn Seams of Woven Apparel Fabrics | Seam Strength | PASS |
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
July 7, 2021
Jiangsu Province Jianerkang Medical Dressing Co., Ltd Tang Hongfang Quality System Director No.1 Jianerkang Road, Zhixi Industry Concentration Area, Zhixi Town Changzhou, Jiangsu 213251 China
Re: K210215
Trade/Device Name: Surgical Gowns Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYA Dated: June 20, 2021 Received: June 24, 2021
Dear Tang Hongfang:
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 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,
Ryan Ortega, PhD 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
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Indications for Use
510(k) Number (if known) K210215
Device Name Surgical Gown
Indications for Use (Describe)
Surgical gown 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.
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows a logo with two distinct elements. The first element is a green leaf-like shape, and the second is a blue, curved shape resembling a wave or a stylized letter 'C'. Below these shapes, the word "JIANERKANG" is written in capital letters. The logo appears to be designed to convey a sense of nature and fluidity.
510(k) Summary
K210215
In accordance with 21 CFR 807.92 the following summary of information is provided:
1. SUBMITTER
Jiangsu Province Jianerkang Medical Dressing Co., Ltd No.1 Jianerkang Road, Zhixi Industry Concentration Area, Zhixi Town,213251 Jintan Changzhou City, PEOPLE'S REPUBLIC OF CHINA Phone: +86-519-82444628 Fax: +86-519-82444750 Primary Contact Person: Hongfang Tang
Quality System Director
Jiangsu Province Jianerkang Medical Dressing Co., Ltd Tel: (+86)-519-8244 4628 Fax: (+86) -519-8244 4745
June 20 , 2021 Date prepared:
- DEVICE
| Device Name: | Surgical Gown |
|---|---|
| Common name: | Gown, Surgical |
| Classification Names: | Surgical apparel |
| Model: | |
| Regulation number | 21 CFR 878.4040 |
| Regulation Class: | 2 |
| Product Code: | FYA |
-
- PREDICATE DEVICE
K141467, Surgical gown XuChang ZhengDe Environstar Medical Products Co., Ltd This predicate has not been subject to a design-related recall.
- PREDICATE DEVICE
DEVICE DESCRIPTION 4.
The surgical gown is 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. It is made of soft, air permeable SMS non-woven fabric.
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Image /page/4/Picture/0 description: The image shows a logo with a green leaf-like shape on the top left and a blue wave-like shape on the bottom right. The green and blue shapes are intertwined, creating a sense of harmony and balance. Below the shapes, the word "JIANERKANG" is written in blue, indicating the name of the organization or brand associated with the logo. The logo appears to be designed to convey a message of nature, health, or environmental consciousness.
The device description of the Jianerkang Surgical Gowns is in accordance with the Guidance on Premarket Notification [510(k)] Submissions for Surgical Gowns and Surgical Drapes, issued on August 1, 1993 and Guidance for Industry and FDA Staff: Premarket Notification Requirements Concerning Gowns Intended for Use in Healthcare Settings, issued on December 9, 2015.
The Jianerkang Surgical Gown is made of a laminate with adhesive taped seams and have a hook and loop closure at the back of the neck and a waist tie feature to secure the gown to the body of the user. The sleeves of the gown have knit cuffs sewn onto the end of the sleeve at the user's wrists to keep the sleeves in place on the wearer. The entire gown including the gown sleeves are made of the same material and utilize the same manufacturing processes.
5.
ம் INDICATIONS FOR USE
Surgical gown 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.
| Specification | Predicate Device | Proposed | Conclusion |
|---|---|---|---|
| K number | K141467 | K210215 | - |
| Manufacturer | XuChang ZhengDe Environstar Medical | ||
| Products Co., Ltd | Jiangsu Province Jianerkang Medical | ||
| Dressing Co., Ltd | - | ||
| Indication for | |||
| Use | Surgical gown 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. | Surgical gown 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. | same | ||
| Material | SMS | SMS | same |
| Weight per | |||
| square (g) | 45 | 45 | same |
| Durability | Disposable | Disposable | same |
| Size | M-S, M, L, XL, XXL | M-S, M, L, XL, XXL | same |
| Color | Blue | Blue | same |
| Style | Reinforced and non reinforced | non reinforced | similar |
| Specification | Predicate Device | Proposed | Conclusion |
| Hydrostatic | |||
| pressure: | |||
| AATCC 127 | >50 cm | >50 cm | same |
| Impact | |||
| penetration: | |||
| AATCC 42 |