(98 days)
Not Found
Not Found
No
The summary describes a standard medical glove and explicitly states "Not Found" for mentions of AI, DNN, or ML, as well as for details related to training/test sets and performance studies typically associated with AI/ML devices.
No
The device is described as a medical glove worn by healthcare personnel to prevent contamination between themselves and patients, indicating a barrier function rather than active therapeutic intervention.
No
Explanation: The device, a medical glove, is intended to prevent contamination and is not used to diagnose any medical condition.
No
The device description clearly states it is a physical glove, which is a hardware component. There is no mention of any software functionality.
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 be worn on the hand to prevent contamination. It does not involve the examination of any biological samples.
- The device description and intended use clearly indicate a barrier function. The glove acts as a physical barrier between the healthcare personnel and the patient.
- There is no mention of any diagnostic purpose. The device is not used to diagnose, monitor, or treat any condition based on the analysis of biological samples.
Therefore, based on the provided information, this medical glove is a Class I medical device (in the US, typically) intended for barrier protection, not an IVD.
N/A
Intended Use / Indications for Use
A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient. It is a single use disposable glove.
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
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare and similar personnel
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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.
Not Found
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).
Not Found
§ 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 seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle, with three curved lines representing its wings and tail feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 31 1999
Mr. S. Segaran Managing Director Seltom Pacific Sdn. Bhd. Lot 25, Jalan PJS 7/17 Sunway Industrial Park 46150 Petaling Jaya, Selangor, MALAYSIA
K991777 Re : Latex Examination Gloves Powder-Free with Trade Name: Protein Labeling Claim (50 Micrograms or Less Total Extractable Protein) Requlatory Class: I LYY Product Code: July 8, 1999 Dated: Received: July 12, 1999
Dear Mr. Segaran
ーイ
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 Regulations, 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 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 Register.
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Page 2 - Mr. Segaran
premarket notification submission does not affect any premation you might have under sections 531 through 542 of obligation 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 described in your 510\n, promience of your device to a legally marketed predicate device results in a classification for your marice 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.fdfa.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
2
SELTOM PACIFIC SDN. BHD.
SELTOM PACIFIC
(CO. NO. 256686-M) Lot 25, Jalan PJS 7/17, Sunway Industrial Park, 46150 Petaling Jaya, Selangor, Malaysia.
603-7356010 -5826010 603-7342713 -Mail: seltom@pd.jaring.my
INDICATIONS FOR USE
Applicant
SELTOM PACIFIC SDN BHD
510(k) Number
K9911777
Device Name
LATEX Powder Free Patient Examination Gloves with A PROTEIN LABELING CLAIM 2 50 MICROGRAMS OF TOTAL EXTRACTABLE PROTETH Indications for Use:-
A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient.
It is a single use disposable glove.
Stawberchi
sion Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 8991777 510(k) Number .