(49 days)
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Not Found
No
The device is a medical glove, and the summary does not mention any AI or ML capabilities.
No
The device, a medical glove, is intended to prevent contamination and is a barrier device. It does not provide any therapeutic benefit or treatment to a condition.
No
Explanation: The device, "Powderfree Latex Examination Gloves," is described as a barrier to prevent contamination. It does not perform any diagnostic function such as detecting, identifying, or monitoring a disease or condition.
No
The device is a physical medical glove, not a software application.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to diagnose, monitor, or screen for health issues.
- Device Function: The intended use of this device is to act as a barrier to prevent contamination between healthcare personnel and patients. It is a physical barrier worn on the hand.
- Lack of Diagnostic Function: The device does not perform any test on a biological sample to provide diagnostic information. It does not analyze any bodily fluid or tissue.
Therefore, based on the provided information, the medical glove described is a Class I medical device (in the US, typically) intended for barrier protection, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between health care personnel and patient. It is a single use disposable gloves.
Product codes
LYY
Device Description
Powderfree Latex Examination Gloves with Trade Name: Protein Content Labeling Claim (50 Micrograms of Less)
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
Indicated Patient Age Range
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Intended User / Care Setting
healthcare 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 shows the logo for the U.S. Department of Health & Human Services. The logo is circular and features an abstract image of an eagle. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged around the top of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. N. S. Kumar Quality Control Manager Servicom Services Sdn. Bhd. Bangunan Angkasa Raya Suite GH, 17th Floor Janan Ampang, Kuala Lumpur, Malaysia
FEB | | 1998
K974832 Re : Powderfree Latex Examination Gloves with Trade Name: Protein Content Labeling Claim (50 Micrograms of Less) Regulatory Class: I Product Code: LYY Dated: December 17, 1997 December 24, 1997 Received:
Dear Mr. Kumar:
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. ਜੋ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does
1
Page 2 - Mr. Kumar
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 requlations.
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) 594-4618. 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 one rogalacion Choubox" (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 R. Walatrust
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Image /page/2/Picture/0 description: The image shows a black background with white text. The text appears to be "SPIRA IK ONI". The letters are somewhat distorted and have a rough, textured appearance, possibly due to the image being low-resolution or having been processed in some way.
SERVICES SDN. BHD.
| Suite GH 17th Floor | Tel : 603-244 6426 |
|---|---|
| Bangunan Angkasa Raya | : 603-248 9700 |
| Jalan Ampang 50450 | Fax : 603-244 6362 |
| Kuala Lumpur, Malaysia. | : 603-245 2321 |
Attachment 2
INDICATIONS FOR USE
Applicant
SERVICOM SERVICES SDN BHD
510(k) number
Device Name
ent Examination Gloves WITH PROTEIN CONTENT CLAIM ( 50 MICROGRAMS OR LESS)
Indication for Use: -
A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between health care personnel and patient.
It is a single use disposable gloves.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Rien S. Lin
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number
974832
Prescription Use (Per 21 CFR 801.109) ~OR
Over-The-Counter Use X
(Optional Format 1-2-96)