(88 days)
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No
The 510(k) summary describes a standard patient examination glove and contains no mention of AI, ML, or related technologies.
No
The device is a patient examination glove, intended to prevent contamination between patient and examiner, not to provide therapy.
No
Explanation: The device is a patient examination glove, intended to prevent contamination between patient and examiner, not to diagnose a medical condition.
No
The device description clearly states it is a "Patient Examination Glove," which is a physical, hardware device. There is no mention of software as the primary component or function.
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 to prevent contamination between patient and examiner." This describes a physical barrier device used for protection, not a device used to examine specimens derived from the human body for the purpose of providing information for the diagnosis, monitoring, or treatment of a disease or condition.
- Device Description: The description "Extra-Care Powder Free Latex Patient Examination Glove - Polymer Coated" further reinforces that it's a physical barrier device.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting specific substances or markers
- Providing diagnostic information
Therefore, this device falls under the category of a general medical device, specifically a Class I or Class II medical device depending on the specific regulations and risk classification.
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 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
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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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§ 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.
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Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is an abstract design of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the largest and the bottom profile being the smallest.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 4 1999
Ms. Melanie Lim Marketinq Executive Ultrawin Sdn. Bhd. Lot 2, Pesiaran Perindustrian Kanthan 2 31200 Chemor, Perak Darul Ridzuan Malaysia
K992175 Re : Extra-Care Latex Patient Examination Glove, Trade Name: Powder-Free Polymer Coated Requlatory Class: I Product Code: LYY Dated: July 26, 1999 Received: Auqust 16, 1999
Dear Ms. Lim:
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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A 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 requlatory action. In addition, FDA may publish further announcements 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 through 542 of
1
Paqe 2 — Ms. Lim
the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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) 594-4690. 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 requlation 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
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Page
3.0 Indications for Use Statement
INDICATIONS FOR USE
| Applicant | Ultrawin Sdn Bhd |
|---|---|
| 510(k) Number (if known) | K992175 |
| Device Name | Extra-Care Powder Free Latex Patient Examination Glove - |
| Polymer Coated |
Indications For Use :
・
A patient examination glove is a disposable device intended for medical purposes worn on the examiner's hand to prevent contamination between patient and examiner.
| Concurrence of CDRH Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of Dental, Infection Control, | |
| and General Hospital Devices | |
| 510(k) Number | K 992175 |
| Prescription Use | OR Over-The-Counter X |
| Per 21 CFR 801.109 |
Ultrawin Sdn Bhd
Lot 2, Pesiaran Perindustrian Kanthan 2, 31200 Chemor, Perak Darul Ridzuan, Malaysia
Tel No 605 201 3888 Fax No 605 201 1818