(66 days)
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Not Found
No
The 510(k) summary describes examination gloves, a simple medical device, and contains no mention of AI, ML, image processing, or any related concepts.
No
The device, examination gloves, is intended to prevent contamination and is not used to treat or cure a disease or condition.
No
Explanation: The device is described as "POWDERED NITRILE BLUE EXAMINATION GLOVES" and its intended use is to "PREVENT CONTAMINATION BETWEEN HEALTH CARE PERSONNEL AND THE PATIENT." This function is for protection and hygiene, not for identifying a disease or condition.
No
The device description clearly states it is "POWDERED NITRILE BLUE EXAMINATION GLOVES," which are physical hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to prevent contamination between healthcare personnel and the patient by being worn on the hands. This is a barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as "POWDERED NITRILE BLUE EXAMINATION GLOVES." This is a physical barrier device.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information about a patient's health condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
POWDERED NITRILE BLUE EXAMINATION GLOVES ARE WORN ON THE HANDS OF HEALTH CARE AND SIMILAR PERSONNEL TO PREVENT CONTAMINATION BETWEEN HEALTH CARE PERSONNEL AND THE PATIENT.
Product codes
LZA
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
hands
Indicated Patient Age Range
Not Found
Intended User / Care Setting
HEALTH CARE AND 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 is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird symbol, composed of three curved lines, representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol. The logo is simple and recognizable, representing the department's role in protecting the health of all Americans.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 9 1999
Mr. Loo S. Nooi Assistant QA Manager TG Medical Sdn. Bhd. Lot 5091, Jalan Teratai, 5th Miles, Off Jalan Meru 41050 Klang Selangor Darul Ehsan, Malaysia
Re: K992841
TG Medical Powdered Nitrile Blue Trade Name: Examination Gloves Regulatory Class: I Product Code: LZA Dated: October 8, 1999 Received: October 13, 1999
Dear Mr. Nooi:
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 Regulations, Title 21, Parts 800 to 895. ਰ 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
1
Page 2 - Mr. Nooi
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 leqally 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,
K. Ulatowski
Timothy A. Ulatowski
Timotmy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
- 3.0 Indications for Use Statement: Include the following or equivalent Indications for Use page. The ormation, data and labeling claims in the entire the 510(k) submission must support and agree with - Indications for Use statement.
INDICATIONS FOR USE
| Applicant: ___________________________________________________________________________________________________________________________________________________________________ | TG MEDICAL SDN. BHD. | |||||
|---|---|---|---|---|---|---|
| 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ | - GG 124, | |||||
| Device Name: -- | POWDERED NITRILE BLUE EXAMINATION GLOVES | |||||
Indications For Use:
تي
POWDERED NITRILE BLUE EXAMINATION GLOVES ARE WORN ON THE HANDS OF HEALTH CARE AND SIMILAR PERSONNEL TO PREVENT CONTAMINATION BETWEEN HEALTH CARE 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)
Qian S. Lin
(Division Sign-Off) Division of Dental, Infection Control. and General Hospital De 510(k) Number
Prescription Use Per 21 CFR 801.109
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ાર
Over-The-Counter
(Optional Pormal 1-2-91
· For a new submission, do NO'l' fill in the 510(k) number blank.