(50 days)
Not Found
Not Found
No
The device description is for surgical gowns, which are physical barriers and do not involve any computational or data processing elements. The summary explicitly states "Not Found" for mentions of AI, DNN, or ML, and there are no descriptions of software, algorithms, or data processing that would indicate the presence of AI/ML.
No
The device is a surgical gown, which is used for protection during surgical procedures, not for therapeutic purposes.
No
The device, proMedical Surgical Gowns, is described as protective apparel for operating room personnel, intended to prevent the transfer of microorganisms, body fluids, and particulate matter. It is not designed or intended to diagnose any medical condition.
No
The device description clearly states it is a physical surgical gown made from fabric materials, not software.
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 gowns are for protecting operating room personnel and patients from the transfer of micro-organisms, body fluids, and particulate matter during surgical procedures. This is a barrier function, not a diagnostic function.
- Device Description: The description details the materials and types of surgical gowns. There is no mention of any components or functions related to testing samples from the human body (like blood, urine, tissue, etc.) to diagnose a condition.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Providing information about a patient's health status, disease, or condition.
- Using reagents or assays.
- Measuring analytes.
In summary, the proMedical Surgical Gowns are personal protective equipment (PPE) designed for physical protection in a surgical setting, not for performing diagnostic tests.
N/A
Intended Use / Indications for Use
proMedical 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 the transfer of micro-organisms, body fluids, and particulate matter.
Product codes
FYA
Device Description
proMedical Surgical Gowns are disposable, single use, sterile surgical gowns manufactured from non-woven spunbond-meltblown-spunbond polypropylene or spun-laced fabrics. Gowns are provided as listed below.
| No. | Model Number | Name | Size | Category |
|---|---|---|---|---|
| 1 | 18-001 | OR Spunlace Gown, Standard | Medium, Large, X-large, XX-Large | Standard |
| 2 | 18-101 | OR Spunlace Gown, with Fabric Reinforcement | Medium, Large, X-large, XX-Large | Reinforced |
| 3 | 18-201 | OR Spunlace Gown, with Poly Reinforcement | Medium, Large, X-large, XX-Large | Reinforced |
| 4 | 18-301 | OR SMS Gown, Standard | Medium, Large, X-large, XX-Large | Standard |
| 5 | 18-401 | OR SMS Gown, with Fabric Reinforcement | Medium, Large, X-large, XX-Large | Reinforced |
| 6 | 18-501 | OR SMS Gown, with Poly Reinforcement | Medium, Large, X-large, XX-Large | Reinforced |
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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.
0
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its head turned to the left, and its wings forming three curved lines. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 4 2008
Mr. Leo Wei Executive Director proMedical Products Company Limited # 206 Huang He Road West Changzhou, Jiangsu CHINA 213022
Re: K080627
Trade/Device Name: ProMedical Surgical Gowns Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FYA Dated: February 28, 2008 Received: March 25, 2008
Dear Mr. Wei:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 - Mr. Wei
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sujitte Y. Michau Omd.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known): _ K080627
Device Name: proMedical Surgical Gowns
Indications for Use:
proMedical 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 the transfer of micro-organisms, body fluids, and particulate matter.
proMedical Surgical Gowns are disposable, single use, sterile surgical gowns manufactured from non-woven spunbond-meltblown-spunbond polypropylene or spun-laced fabrics. Gowns are provided as listed below.
| No. | Model
Number | Name | Size | Category |
|-----|-----------------|---------------------------------------------|-------------------------------------|------------|
| 1 | 18-001 | OR Spunlace Gown, Standard | Medium, Large, X-large,
XX-Large | Standard |
| 2 | 18-101 | OR Spunlace Gown, with Fabric Reinforcement | Medium, Large, X-large,
XX-Large | Reinforced |
| 3 | 18-201 | OR Spunlace Gown, with Poly Reinforcement | Medium, Large, X-large,
XX-Large | Reinforced |
| 4 | 18-301 | OR SMS Gown, Standard | Medium, Large, X-large,
XX-Large | Standard |
| 5 | 18-401 | OR SMS Gown, with Fabric Reinforcement | Medium, Large, X-large,
XX-Large | Reinforced |
| 6 | 18-501 | OR SMS Gown, with Poly Reinforcement | Medium, Large, X-large,
XX-Large | Reinforced |
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Shila A. Murphy, 16
Page 1 of 1
(Division Sign-Off) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K080627
- 03-03-2023