(83 days)
Not Found
Not Found
No
The summary describes a standard examination glove and contains no mention of AI, ML, or related technologies.
No
The device, an examination glove, is intended for preventing contamination, not for treating or alleviating a disease or condition.
No
The device, a patient examination glove, is intended to prevent contamination between patient and examiner, which is a protective function, not a diagnostic one. It does not provide information about a patient's medical condition or disease.
No
The device is a physical examination glove, which is a hardware medical device, 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 the device is a "patient examination glove... worn on the examiner's hand or finger to prevent contamination between patient and examiner." This describes a physical barrier device used for protection during examination.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The description of this device does not involve any such testing or analysis of biological samples.
- Device Description: The description focuses on the physical characteristics of the glove (material, coating, powder-free, protein content).
- Missing IVD-Related Information: The document lacks any mention of typical IVD elements such as:
- Analysis of biological samples
- Reagents or assays
- Diagnostic or screening purposes based on sample analysis
- Performance metrics related to diagnostic accuracy (sensitivity, specificity, etc.)
Therefore, the device described is a medical device, specifically a patient examination glove, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
A patient examination glove is a disposable device intended for medical purposes worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Product codes
LYY
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand or finger
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner
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)
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 contains the words "Public Health Service" in a bold, sans-serif font. The text is arranged on a single line, with each word clearly legible. The overall impression is clean and straightforward, suggesting an official or institutional context.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 14 1999
Dash Medical Gloves Sdn. Bhd. c/0: Mr. Robert J. Sullivan Jr. President Dash Medical Gloves, Incorporated 10180 South 54th Street Franklin, Wisconsin 53132
K992128 Re : Dash Siliconized Polymer Coated Powder Free Trade Name: Latex Examination Gloves with Protein Content Labeling Claim (50 micrograms or Less)/VitalGard Siliconized Polymer Coated Powder Free Latex Examination Gloves Requlatory Class: । Product Code: LYY June 9, 1999 Dated: Received: June 23, 1999
Dear Mr. Sullivan:
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, Druq, 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 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. ਰੋ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP 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
Image /page/0/Picture/9 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted with three intertwined lines forming a shape reminiscent of a bird or a human profile. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
1
Page 2 -Mr. Sullivan
obligation you might have under sections 531 through 542 of obligation you might have ahabi betronic Product Radiation che Act for devioes andorher Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA acboing of substantial equivalence of your device to a legally marketed predicate device results in a classification for your marroos 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) 594-4690. Additionally, for questions on the promotion and advertising of your device, please gontact 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,
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
2
ﺴﺘﺤﺮ ﻣ
: ::
510(k) Number (if known): K992128
Dash Siliconized Polymer Coated Powder Free Latex Examination Gloves with Protein Device Name: Content Labeling Claim (50 micrograms or Less)
VitalGard Siliconized Polymer Coated Powder Free Latex Examination Gloves Indications For Use:
A patient examination glove is a disposable device intended for medical purposes worn on the examiner's hand or finger to prevent contamination between patient and examiner.
(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. K992178
Prescription Use __
(Per 21 CFR 801.109)
OR
Over-The-Counter Use √
(Optional Format 1-2-96)