(66 days)
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No
The 510(k) summary describes a patient examination glove, which is a physical barrier device. There is no mention of software, data processing, or any terms related to AI/ML.
No.
The device is a patient examination glove, which is intended to provide a barrier against potential infectious materials, not to treat or cure a disease or condition.
No
The device is described as a "barrier against potential infectious materials and other contaminants," which indicates a protective function rather than a diagnostic one.
No
The device is described as a physical glove made of latex material, which is a hardware component, 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 "powder free patient examination glove" intended to be worn on the hand or fingers as a barrier against infectious materials and contaminants. This describes a physical barrier device used externally on the body.
- IVD Definition: In vitro diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside the body (in vitro) to analyze these samples.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, testing for diseases, or any other activity typically associated with IVDs.
Therefore, the device described is a medical glove, which is a Class I or Class II medical device depending on its intended use and materials, but it is not an IVD.
N/A
Intended Use / Indications for Use
A powder free patient examination glove is a disposable device made of latex material that may bear a trace amount of glove powder and is intended to be worn on the hand or fingers for medical purposes to provide a barrier against potential infectious materials and other contaminants.
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
hand or fingers
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.)
Not Found
Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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 circular logo. The logo features a stylized depiction of an eagle or bird in flight, composed of three curved lines. Encircling the bird is text that reads 'DEPARTMENT OF HEALTH & HUMAN SERVICES - USA'. The text is arranged along the circumference of the circle, with the bird image positioned in the center.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20050
JAN 2 0 2000
Mr. Stanley Thai Managing Director Supermax Glove Manufacturing SDN. BHD. Lot 42, Putra Industrial Park Bukit Rahman Putra 47000 Sungai Buloh Selangor Darul Ehsan. Malaysia
K993864 Re : Green Peppermint Flavored Powder Free Latex Trade Name: Examination Gloves with Protein Content Labeling Claim (50 micrograms or less) Regulatory Class: I LYY Product Code: November 11, 1999 Dated: November 15, 1999 Received:
Dear Mr. Thai:
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 Regulations, Title 21, Parts 800 to 895. ਸੈ substantially equivalent determination assumes-compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (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 regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in
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Page 2 - Mr. Thai
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 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 requlation (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" (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.fdalgov/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 Radiological Health
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Enclosure
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510 (k) NUMBER (IF KNOWN) : KG9 3864
DEVICE NAME GREEN PEPPERMINT FLAVORED POWDER FREE LATEX EXAMINATION WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LE:
INDICATIONS FOR USE :
A powder free patient examination glove is a disposable device made of latex material that may bear a trace amount of glove powder and is intended to be worn on the hand or fingers for medical purposes to provide a barrier against potential infectious materials and other contaminants.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
Prescription Use __ OR Over-The-Counter- Use
(per 21 CFR 801.109) (Optional Format 1-2-96)
(Division Sign-Off
Division of Dental Infection Control,
and General Hospital Devices
510(k) Number K993864
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