(55 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 is a patient examination glove intended to prevent contamination, not to treat or alleviate a disease or condition.
No
Explanation: The device is described as a patient examination glove, which is used to prevent contamination, not to diagnose a condition or disease.
No
The device description clearly states it is a physical product (examination gloves) and does not mention any software components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use of this device is to prevent contamination between healthcare personnel and the patient by being worn as a glove. It does not involve the examination of any biological samples.
- The device description confirms it's a physical barrier. It's a glove, designed for physical protection and contamination prevention, not for diagnostic testing.
- The provided information lacks any mention of diagnostic procedures, analysis of biological samples, or any function related to determining a medical condition.
Therefore, based on the provided information, this device is a medical device, but it falls under the category of a Class I or Class II medical device (depending on specific regulations and claims), not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
A patient examination glove that is worn by the healthcare or similar personnel to prevent contamination between the healthcare personnel and the patient.
Product codes (comma separated list FDA assigned to the subject device)
LYY
Device Description
Powdered Latex Examination Gloves with Protein and Powder Claim (100 MICROGRAMS OF LESS) CONTENT LABELING
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
healthcare or similar personnel
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.
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 circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with three curved lines above them, resembling a bird in flight.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 20 2000
Mr. Tan Chwee Hock Executive Director Glovco (M) SDN BHD Lot 760, Jalan Haji Sirat Off Jalan Meru Klang Selangor D.E., Malaysia
Re : K994013 Powdered Latex Examination Gloves With Trade Name: Protein Content Labeling Claim (100 micrograms or less) Regulatory Class: I Product Code: LYY November 15, 1999 Dated: Received: November 26, 1999
Dear Mr. Hock:
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 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 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
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Page 2 - Mr. Hock
requlation may result in regulatory 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 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) 594-4692. 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
thy 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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PRE-MARKET NOTIFICATION [510(K)] FOR POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN AND POWDER LABELING CLAIM
: GLOVCO (M) SDN BHD. Applicant Date : NOVEMBER 15, 1999.
Page 5 of 11
3.0 INDICATION FOR USE
| 510(K) Number (If known) | K994013 |
|---|---|
| Device Name | Powdered Latex Examination Gloves with Protein and Powder |
| Claim ( | 100 MICROGRAMS OF LESS) |
| Indications For Use: |
CONTENT LABELING"A patient examination glove that is worn by the healthcare or similar personnel to prevent contamination between the healthcare personnel and the patient".
(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 1-2-96)
usion Sign-Off
of Dental, Infection Control, ିଲେମ୍ବର Hospital Devices umber ________________________________________________________________________________________________________________________________________________________________________