(100 days)
Not Found
Not Found
No
The device is a medical examination glove, and the summary contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
Explanation: The device is an examination glove, which is used for preventing contamination, not for treating a disease or condition.
No
Explanation: The device is an examination glove, which is used for contamination prevention during medical examinations, not for diagnosing medical conditions.
No
The device description clearly identifies the device as a physical examination glove, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for preventing contamination between patient and examiner during medical examinations. This is a physical barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description is for a medical examination glove, which is a physical barrier device.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
IVDs are devices used to perform tests on samples taken from the human body to provide information about a person's health. This glove does not perform such a test.
N/A
Intended Use / Indications for Use
"An examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner."
Product codes
LYY
Device Description
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Mentions image processing
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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
Not Found
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
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination 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). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is an abstract symbol that resembles three human profiles facing to the right, with flowing lines connecting them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 0 1998
Mr. Neal Anderson, RAC · Director of Regulatory Affairs for U.S. Operations London International Group, Incorporated 2926 Columbia Highway Dothan, Alabama 36303
Re : K980785 Regent™ Safetex™ Sterile Latex Medical Trade Name: Examination Glove, Powder-Free,Less than 50mcg/gram Total Protein Requlatory Class: I Product Code: LYY Dated: May 28, 1998 May 29, 1998 Received:
Dear Mr. Anderson:
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 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 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 regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
1
Page 2 - Mr. Anderson
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 markets 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) 594-4692. 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 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/dsma/dsmamajp.html".
Sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
APPENDIX II
Indications for Use
Applicant - London International Group (Regent Medical)
510(K) Number (if known)
Device Name -Medical Examinatio Less than 50 mc total
Indications for use.
"An examination glove is a disposable device intended for medical purposes "An examinon Eroro is a carperation or finger to prevent contamination between patient and examiner."
Concurrence of CDRH Office of Device Evaluation
Qhin S. Lim
OR
Over the Counter
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number
Prescription Use
Per 21 CFR 801.109