(172 days)
Not Found
Not Found
No
The device description and performance studies focus on the physical properties and barrier protection of a surgical gown, with no mention of AI or ML technology.
No
The device is a surgical gown intended to protect personnel and patients from the transfer of microorganisms, body fluids, and particulate material, not to treat a disease or condition.
No
The device, a surgical gown, is intended for protection during surgical procedures and its performance studies focus on physical barrier properties, not on diagnosing medical conditions.
No
The device description clearly states it is a reusable surgical gown made of fabric, which is a physical hardware component, 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 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 test performed in vitro (outside the body) on biological samples.
- Device Description: The device is a reusable surgical gown. This is a physical barrier, not a reagent, instrument, or system intended for the examination of specimens derived from the human body.
- Performance Studies: The performance studies focus on physical properties like strength, tear resistance, fluid repellency, and bacterial barrier properties. These are relevant to the gown's function as a protective barrier, not to diagnostic accuracy or analytical performance on biological samples.
IVD devices are typically used to diagnose, monitor, or screen for diseases or conditions by analyzing samples like blood, urine, tissue, etc. This surgical gown does not perform any such analysis.
N/A
Intended Use / Indications for Use
"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
FYA
Device Description
A reusable surgical gown fabricated from 99% polyester, 1% carbon, chemically treated fabric and designed to provide fluid protection through up to 150 laundry/sterilization cycles.
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)
The Rotecno® 2000 Surgical Gown has been tested for breaking strength, tear resistance, air permeability water repellency, impact penetration, hydrostatic head, flammability, and aqueous bacterial barrier and found acceptable for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
SafeCare™ Reusable Surgical Gown
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
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| Manufacturer: | Dowling Textile Company
615 Macon Road
McDonough, Georgia 30253
(770) 957-3981 |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory Contact: | Tim Cummins |
| Common Name: | Reusable Surgical Gown, NON STERILE |
| Trade Name: | Rotecno® 2000 Surgical Gown |
| Classification Number: | 79FYA |
| Class, Regulation: | II per 21 CFR §878.4040 |
| Predicate Device: | SafeCare™ Reusable Surgical Gown |
| Device Description: | A reusable surgical gown fabricated from 99%
polyester, 1% carbon, chemically treated fabric and
designed to provide fluid protection through up to 150
laundry/sterilization cycles. |
| Intended Use: | "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." |
| Substantial Equivalence: | The Rotecno® 2000 Surgical Gown is substantially
equivalent to the SafeCare™ Gown in material,
design, form, fit, and function. |
| Toxicity Testing Summary: | The material used in the fabrication of the Rotecno®
2000 Surgical Gown has been found acceptable for its
intended use. |
| Performance Testing Summary: | The Rotecno® 2000 Surgical Gown has been tested
for breaking strength, tear resistance, air permeability
water repellency, impact penetration, hydrostatic
head, flammability, and aqueous bacterial barrier and
found acceptable for its intended use. |
.
K982059 XVI. 510 (k) Summary
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 30 1998
Mr. Tim Cummins RA/QA Manager Dowling Textile Company 615 Macon Road McDonough, Georgia 30253
K982059 Re : Rotecno® 2000 Reusable Surgical Gown, Trade Name: Nonsterile Regulatory Class: II Product Code: FYA Dated: October 21, 1998 Received: October 27, 1998
Dear Mr. Cummins:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਕੇ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
2
Page 2 - Mr. Cummins
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address
"http://www.fda.gov/cdrh/dsma/dsmamajin.html".
Sincerely yours,
Timothy A. Ulatowski
Director Infection Control, Division of Dental, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
K 982059 Indications for Use XVII.
Rotection 2000 Surgical Gown, NONSTERILE AND REUSHALE Device Name:
The Rotecno® 2000 Surgical Gown is "intended to be worn by operating room personnel during The Rolection 2000 Surgical Goth the surgical patient and the operating room personnel from the transfer of microorganisms, body fluids, and particulate material."
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) ( Division of Dental, Infection Control, and General Hospital Devices 510(k) Number
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use X
(Optional Format 1-2-96).