(25 days)
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Not Found
No
The summary describes a patient examination glove and contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
The device, a patient examination glove, is intended for barrier protection, not for treating or diagnosing a medical condition.
No
Explanation: The device is described as a "Powder-free Patient Examination glove" used to prevent "modition between patient and examiner," not to diagnose a condition.
No
The device description clearly indicates it is a physical glove, 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 for "modition between patient and patient and examiner's hand or finger to prevent Intended for modition between patient and examiner." This describes a physical barrier function for protection, not a diagnostic test performed in vitro (outside the body) on specimens.
- Device Description: The description confirms it's a "Powder-Free Latex Examination Trade Name: Gloves". This is a physical barrier device.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, detecting analytes, or providing diagnostic information.
IVD devices are used to examine specimens (like blood, urine, tissue) to provide information about a person's health status, diagnose diseases, or monitor treatment. This glove does not perform any of those functions.
N/A
Intended Use / Indications for Use
Powder-free Patient Examination glove is a disposable device which is primarily Intended for modition between patient and 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
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Input Imaging Modality
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Anatomical Site
examiner's hand or finger
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)
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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.
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 or bird symbol, with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 9 1999
Guthrie Medicare Products (NS) Sdn. Bhd. C/O Ms. Susan D. Goldstein-Falk MDI Consultants, Incorporated 55 Northern Boulevard, Suite 200 Great Neck, New York 11021
Re : K990228 Guthrie Prime Powder-Free Latex Examination Trade Name: Gloves with 50 Micrograms or Less of Total Water Extractable Protein Per Gram Regulatory Class: I Product Code: LYY Dated: January 20, 1999 Received: January 25, 1999
Dear Ms. Goldstein-Falk
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 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 requlations 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 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 regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in Please note: this response to your the Federal Reqister. premarket notification submission does not affect any obligation you might have under sections 531 through 542 of
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Paqe 2 - Ms. Goldstein-Falk
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.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 Radiological Health
Enclosure
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mdi Consultants, Inc.
Attachment #1
ت Page of 1
K 990228 SIO(K) NUMBER (IF KNOWN) : CATEX Powder-Free (Polymer Coated) Patient Examination Gloves DEVICE NAME: 50 magm OR less of fotal water ary First gloves contain INDICATIONS FOR USE:
Powder-free Patient Examination glove is a disposable device which is primarily Powder-free Patient Examination 'giove is a examiner's hand or finger to prevent Intended for modition 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)
Prescription Use (Per 21 CFR 801-109) OR
Over-The-Counter-Use (Optional Format 1-2
Qiu S. Lin
(Division Sign-Off) (Division Sign-Ont)
Division of Dental, Infection Control,
Division of Dental, Devices Division of Hospital De 510(k) Number
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