(132 days)
Not Found
Not Found
No
The 510(k) summary describes surgical gowns, which are physical apparel and do not involve software or data processing, let alone AI/ML. There are no mentions of AI, ML, image processing, or any other indicators of such technology.
No
The device is a surgical gown, which is intended to protect against the transfer of microorganisms and particulate material, not to treat a disease or condition.
No
The device is described as "surgical apparel that are intended to be worn by operating room personnel during surgical procedures to protect both the patient and the operating room personnel from transfer of micro organisms, and particulate material." This function is protective and not diagnostic.
No
The device described is surgical gowns, which are physical garments and 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 surgical gowns are for protecting operating room personnel and patients from the transfer of microorganisms and particulate material during surgical procedures. This is a barrier function, not a diagnostic function.
- Lack of Diagnostic Activity: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
- Device Description (Not Found): While the description is not found, the intended use is the primary indicator of whether a device is an IVD.
- No Mention of Diagnostic Processes: The document does not mention any processes related to analyzing biological samples, image processing for diagnostic purposes, or the use of AI/ML for diagnostic interpretation.
In summary, the function of these surgical gowns 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
Medline Gore Panel Coverage Surgical Gowns and Gore Critical Coverage Surgical Gowns are surgical apparel that are intended to be worn by operating room personnel during surgical procedures to protect both the patient and operating room personnel from transfer of microorganisms, body fluids and particulate matter. The surgical gowns are available in gowns with and without non-Gore-Tex panels comprised of a 100% polyester material.
Product codes
KKX
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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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): 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).
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§ 878.4370 Surgical drape and drape accessories.
(a)
Identification. A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy.(b)
Classification. Class II (special controls). The device, when it is an ear, nose, and throat surgical drape, a latex sheet drape with self-retaining finger cot, a disposable urological drape, a Kelly pad, an ophthalmic patient drape, an ophthalmic microscope drape, an internal drape retention ring (wound protector), or a surgical drape that does not include an antimicrobial agent, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three curved lines representing its body and wings. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" is written around the circumference of the circle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 5 2006
Ms. Jennifer Mason Regulatory Affairs Specialist Medline Industries, Incorporated One Medline Place Mundelein, Illinois 60060
Re: K052833
Trade/Device Name: Gore-Tex Non-Sterile Surgical Gowns Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: KKX Dated: January 25, 2006 Received: January 27, 2006
Dear Ms. Mason:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your booker researchined the device is substantially equivalent (for the relerenced above and nave actemance re) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mensiale conninered prior to that have been reclassified in accordance with the provisions of Anchuments, or to act reser and Cosmetic Act (Act) that do not require approval of a premarket Inc Federal I vou, Drag, and Commay, therefore, market the device, subject to the general approvat uppliedaton (1777) 1777 1777 1771 177 177 1971 1991 1991 11 controls pro referents on a 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 If your device is classified (200 as additional controls. Existing major regulations affecting (1 MA), it may of subject to sack of Federal Regulations, Title 21, Parts 800 to 898. In your device can be round in the rannouncements concerning your device in the Federal Register.
1
Page 2 - Ms. Jennifer Mason
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA 3 issuallee of a baseballer complies with other requirements meall that IDA has made a determinations administered by other Federal agencies. of the Act of ally rederal statutes and regaraters, including, but not limited to: registration You must comply with an the Act 3 requirements and 801); good manufacturing practices
and listing (21 CFR Part 807); labeling (21 CFR Part 801); gEP Bart 830); and and ilsung (21 CFR Pat 807), laooling (21 CFR (QS) regulation (21 CFR Part 820); and if requirents as set form in the quality bjotchis (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) This letter will anow you to begal madies of substantial equivalence of your device to a premarket notification. The PDF Inization 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), If you desire specific advice for your de not on the Also, please note the regulation
please contact the Office of Compliance at (240) 276-0115. Also, please note the regul 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 may obtain other generational 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.
Susan Runner
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
K052833 510(k) Number (if known):__
Device Name: Medline Gore-Tex Barrier Surgical Gowns
Indications for Use:
Medline Gore Panel Coverage Surgical Gowns and Gore Critical Coverage Surgical Gowns are surgical apparel that are intended to be worn by operating room personnel during surgical surgical apparer that are meenage of of whicht and the operating room personnel from transfer of procedures to proceee both and cargrain carger and crial. The surgical gowns are available in outy fraits, micro organisms, an with non-Gore-Tex panels comprised of a 100% polyester material.
Prescription Use______________________________________________________________________________________________________________________________________________________________ × (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Shila F. Murphy, MD 2/5/06
Technology General Hospital,
Infection Control Dental Devices
K052833