(292 days)
Not Found
Not Found
No
The document describes a standard surgical glove and explicitly states "Not Found" for mentions of AI, DNN, or ML.
No
The device, a surgical glove, is intended to protect a surgical wound from contamination, which is a preventative measure rather than a treatment for a disease or condition.
No
Explanation: The "Intended Use / Indications for Use" states that the device is a "surgeon's glove... worn by operating room personnel to protect a surgical wound from contamination." This describes a protective barrier, not a tool used to diagnose medical conditions or diseases.
No
The device description clearly states it is a "Surgical Glove," which is a physical hardware device made of rubber. There is no mention of software functionality.
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 a surgical wound from contamination by being worn by operating room personnel. This is a physical barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description is of a physical glove.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting substances, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. A surgical glove does not fit this definition.
N/A
Intended Use / Indications for Use
A surgeon's glove is a device made of natural or systemic rubber insended to be worn by operating room personnel to protect a surgical wound from contamination.
Product codes
KGO
Device Description
Not Found
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
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4460 Non-powdered surgeon's glove.
(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls).
0
Image /page/0/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 overlapping bodies, representing the department's commitment to health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Michael Forer Executive Vice President ECI Medical Technologies, Incorporated 2 Cook Road Bridgewater, Nova Scotia, CANADA
FEB - 9 1998
K971471 Re: Elastyren Powder-Free Surgical Glove Trade Name: Regulatory Class: I Product Code: KGO December 18, 1997 Dated: Received: December 23, 1997
Dear Mr. Forer:
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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 ... A ... .................................................................................................................... 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 regulation 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 obligation you might have under sections 531
1
Page 2 - Mr. Forer
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 regulation (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 premarket notification" (21 CFR 807.97). 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,
Alilatra
hy A. Ulatowski Timo Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Page
510(k) Number (1) known): K97147 | Powder -- 160 Device Name: Indications For Use:
A surgeon's glove is a device made of natural or systemic rubber insended to be worn by operating room personnel to protect a surgical wound from contamination.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concu rence of CDRH, Office of Device Evaluation (ODE)
Chùm Silam
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number [2971471]
Prescription Use_**_ OR Over-The-Counter Use X
(Per 21 CFR 801.109)
(Optional Format 1-2-96)