(154 days)
Not Found
Not Found
No
The 510(k) summary describes surgical gowns, which are physical barriers and do not involve software or data processing, let alone AI/ML. The summary also explicitly states "Mentions AI, DNN, or ML: Not Found".
No
The device, a surgical gown, is intended for protection from microorganisms and fluids, not for treating a disease or condition.
No
Explanation: The device, surgical gowns, is intended to protect against transfer of microorganisms and fluids during surgical procedures, not to diagnose a condition or disease.
No
The device is described as "Surgical Gowns," which are physical garments and not software. The summary provides no information suggesting a software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the surgical gowns are 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 function performed in vitro (outside the body).
- Lack of Diagnostic Elements: There is no mention of analyzing samples (like blood, urine, tissue), detecting biomarkers, or providing information for diagnosis, monitoring, or screening.
- Device Description (Not Found): While the description is missing, the intended use is the primary indicator of whether a device is an IVD.
- No Mention of Image Processing, AI, DNN, ML: These are often associated with more complex diagnostic devices, but their absence doesn't definitively rule out an IVD. However, in this context, it further supports the non-IVD nature.
- Input Imaging Modality/Anatomical Site: These are not applicable to a surgical gown, which is a physical barrier.
In summary, the function of a surgical gown as described is to provide a physical barrier during surgery, which is not the purpose of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Surgical Gowns 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
Not Found
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
Not Found
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)
Not Found
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.
Not Found
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.
0
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 17,2014
Cobes Industries Company Limited C/O Ms. Lynn Fu Shenzhen Rendermed Consulting Company Limited 23 Dengliang Road, Hanking Center 7E-011 Shenzhen, Gguangdong 518052 CHINA
Re: K141606
Trade/Device Name: Surgical Gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FYA Dated: October 11, 2014 Received: October 17, 2014
Dear Ms. Fu:
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. 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
Page 2 - Ms. Fu
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Susan Runno DDS, MA
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K141606
Device Name
Surgical Gown
Indications for Use (Describe)
Surgical Gowns 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Product Models are provided below:
| Model Category | Model | Size | Reinforced method | Material |
|---|---|---|---|---|
| 21Series | 21001 | Large | SMS-35gsm | |
| 21002 | X-Large | Non-Reinforced | ||
| 21003 | XX-Large | |||
| 21004 | XXX-Large | |||
| 21101 | Large | Fabric Reinforced | ||
| 21102 | X-Large | |||
| 21103 | XX-Large | |||
| 21201 | Large | Poly-Reinforced | ||
| 21202 | X-Large | |||
| 21203 | XX-Large | |||
| 21204 | XXX-Large | |||
| 21205 | XXXX-Large | |||
| 21206 | XXXXX-Large | |||
| 21301 | Large | Poly-Reinforced, | ||
| Breathable Trilaminate Sleeves | ||||
| 21302 | X-Large | |||
| 21303 | XX-Large | |||
| 21304 | XXX-Large | |||
| 22Series | 22001 | Large | SMS-47gsm | |
| 22002 | X-Large | Non-Reinforced | ||
| 22003 | XX-Large | |||
| 22004 | XXX-Large | |||
| 22005 | XXXX-Large | |||
| 22101 | Large | Fabric Reinforced | ||
| 22102 | X-Large | |||
| 22103 | XX-Large | |||
| 22201 | Large | Poly-Reinforced | ||
| 22202 | X-Large | |||
| 22203 | XX-Large | |||
| 22204 | XXX-Large | |||
| 22205 | XXXX-Large | |||
| 22301 | Large | Poly-Reinforced, | ||
| Breathable Trilaminate Sleeves | ||||
| 22302 | X-Large | |||
| 22303 | XX-Large | |||
| 23Series | 23001 | Large | SMS-47gsm soft | |
| 23002 | X-Large | Non-Reinforced | ||
| 23003 | XX-Large | |||
| 23004 | XXX-Large | |||
| 23101 | Large | Fabric Reinforced | ||
| 23102 | X-Large | |||
| 23103 | XX-Large | |||
| 23201 | Large | Poly-Reinforced | ||
| 23202 | X-Large | |||
| 23203 | XX-Large | |||
| 23204 | XXX-Large | |||
| 23205 | XXXX-Large | |||
| 23206 | XXXXX-Large | |||
| 23301 | Large | Poly-Reinforced, | ||
| Breathable Trilaminate Sleeves | ||||
| 23302 | X-Large | |||
| 23303 | XX-Large | |||
| Model | ||||
| Category | Model | Size | Reinforced method | Material |
| 24Series | 24001 | Large | Breathable Trilaminate Sleeves | SFS-68gsm |
| 24002 | X-Large | |||
| 24003 | XX-Large | |||
| 24004 | XXX-Large | |||
| 24005 | XXXX-Large | |||
| 24006 | XXXXX-Large |
4
| First code: | Second code | Third code | Fourth~Fifth code |
|---|---|---|---|
| 2-Surgical Gown | 1- SMS-35gsm | 0- Non-Reinforced | 01-Large |
| 2-Surgical Gown | 2- SMS-47gsm | 1- Fabric Reinforced | 02-X-Large |
| 2-Surgical Gown | 3-SMS-47gsm Soft | 2- Poly-Reinforced | 03- XX-Large |
| 2-Surgical Gown | 4- SFS-68gsm | 3-Poly-Reinforced, Breathable Trilaminate Sleeves | 04- XXX-Large |
| 2-Surgical Gown | 4- SFS-68gsm | 4- Non-Reinforced, Breathable Viral Barrier | 05-XXXX-Large |
| 2-Surgical Gown | 4- SFS-68gsm | 4- Non-Reinforced, Breathable Viral Barrier | 06-XXXXX-Large |