(91 days)
Not Found
Not Found
No
The device description and intended use clearly define a simple physical barrier (a bouffant cap) with no mention of software, data processing, or any technology that would involve AI/ML.
No
A bouffant cap is a protective barrier worn by hospital personnel to prevent the transfer of microorganisms; it does not provide any therapeutic benefit to a patient.
No
Explanation: A diagnostic device is used to identify a disease, condition, or state. The Bouffant Cap's intended use is to protect from transfer of microorganisms, body fluids, and particulate materials, not to diagnose.
No
The device description clearly indicates a physical item (Bouffant Cap) and does not mention any software component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Bouffant Cap Function: The description clearly states the Bouffant Cap is a protective garment worn by hospital personnel to prevent the transfer of microorganisms, body fluids, and particulate materials. It does not involve testing samples from the body.
Therefore, based on the provided information, the Bouffant Cap is a personal protective equipment (PPE) item, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Bouffant Cap is a device intended to be worn by hospital personnel during procedures to protect both the patient and the hospital personnel from transfer of microorganisms, body fluids and particulate materials.
Product codes
FYF
Device Description
Bouffant Cap
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
hospital personnel / hospital procedures
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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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)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Joseph Tung President American Seal Company 25029 Viking Street Hayward, California 94545
9 1997 SEP
K972187 Re : Bouffant Cap Trade Name: Regulatory Class: I FYF Product Code: Dated: August 7, 1997 Received: August 14, 1997
Dear Mr. Tung:
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 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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਰ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (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 regulatory 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 obliqation you miqht have under sections 531
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Page 2 - Mr. Tung
through 542 of the Act for devices under the Electronic chrough Siz Or Chorol 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 deberibus in your in your device of your device to a legally marketed predicate device results in a classification for your markets 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) 594-4618. 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 Other general 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/dsmamain.html".
Sincerely yours,
Tim A. Ulatowski
Timo Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/2/Picture/0 description: The image shows the word "DUPLICATE" in large, bold, sans-serif font. Above the word "DUPLICATE" is a series of handwritten numbers and letters. The handwritten text is less clear than the word "DUPLICATE", but it appears to be a combination of numbers and letters.
Page
510(k) Number (if known): K972187
Device Name:_Bouffant_Cap
Indications For Use:
The Bouffant Cap is a device intended to be worn by hospital personnel during procedures to protect both the patient and the hospital personnel from transfer of microorganisms, body fluids and particulate materials.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Chùm S. tìn
(Division Sign-Off)
Unision of Dental, Info and General Hospita 510(k) Number
Prescription Use (Per 21 CFR 801.109)
CR
Over-The-Counter UseX
(Optional Format 1-2-96)
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