(154 days)
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.
Not Found
This document explicitly states that the submission is for a "Surgical Gown" and is a 510(k) premarket notification. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring formal clinical studies with acceptance criteria and ground truth in the way medical imaging or diagnostic AI devices do.
Therefore, the provided text does not contain information about:
- A table of acceptance criteria and the reported device performance: This is not applicable to a 510(k) for a surgical gown in the context of clinical performance metrics. The relevant acceptance criteria for a surgical gown would typically involve performance standards outlined in recognized standards (e.g., AAMI PB70 for liquid barrier performance or ASTM F1670 for synthetic blood penetration), and these results would be presented in a different format than a clinical study's performance table.
- Sample size used for the test set and the data provenance: Not applicable for this type of device and submission. Performance tests for gowns would involve material samples, not patient data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for algorithm performance (e.g., expert consensus on medical images) is not relevant here. Performance is measured against physical standards.
- Adjudication method for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. MRMC studies are for assessing diagnostic performance with and without AI assistance, which is outside the scope of a surgical gown.
- If a standalone (i.e., algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI/algorithm device.
- The type of ground truth used: Not applicable in the context of clinical/diagnostic ground truth; performance is measured against physical material standards.
- The sample size for the training set: Not applicable. This is not a machine learning or AI device.
- How the ground truth for the training set was established: Not applicable.
The "study" in this context refers to the testing performed against recognized standards to demonstrate the physical performance characteristics of the surgical gown, such as barrier effectiveness, strength, and breathability. The provided document is simply the FDA's clearance letter and the "Indications for Use" statement, not the detailed testing report itself.
To answer your request, if this were an AI device, the FDA submission would contain a separate section detailing the clinical performance study, including the elements you listed. Since this is a surgical gown, the "performance" discussed in such a 510(k) would be related to how well the gown meets established material and barrier standards, and the "study" would be the associated lab testing.
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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.
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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
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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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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 | |||
| ModelCategory | 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 |
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| 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 |
§ 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.