(36 days)
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Not Found
No
The summary describes basic examination gloves and contains no mention of AI or ML.
No.
The device description and intended use clearly state it is a medical glove for contamination prevention, not for treating any medical condition or improving health.
No
The device described is a medical glove used to prevent contamination, not to diagnose medical conditions or diseases.
No
The device description clearly states it is a physical medical glove, which is a hardware component, not software.
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 patients/environment. This is a barrier function, not a diagnostic function.
- Device Description: The device is a glove, which is a physical barrier.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health status.
- No Mention of IVD-Related Terms: The description does not include terms commonly associated with IVDs, such as "assay," "reagent," "analyzer," "diagnostic test," etc.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This glove does not perform any such function.
N/A
Intended Use / Indications for Use
This is a medical glove to be worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patients' body, fluids, waste or environment.
Product codes
LYY
Device Description
Cashmere Non-Sterile, Powder-Free Latex Examination Gloves Basic Non-Sterile, Powder-Free Latex Examination Gloves
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
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
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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 Department of Health & Human Services - USA. The logo features a stylized eagle with three stripes representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL -7 1999
Mr. Chan Chin Hong General Manager Seal Polymer Industries Sdn. Bhd. Lot 72706, Jalan Lahat Kawasan Perindustrian Bukit Merah 31500 Lahat, Perak MALAYSIA
Re : K991849 Non-Sterile Power-Free Latex Examination Trade Name: Gloves with a Protein Labeling Claim (50 Micrograms or Less Total Water Extractable Protein) Requlatory Class: I Product Code: LYY May 26, 1999 Dated: Received: June 1, 1999
Dear Mr. Chan Chin Hong:
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, qood 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 Regulations, 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 requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Page 2 - Mr. Chan Chin Hong
this response to your premarket notification Please note: Frease note: oneot affect any obligation you might have under sections 531 through 542 of the Act for devices under the Sections 351 chicagon Federal laws or regulations.
This letter will allow you to begin marketing your device as fire ibed in your 510(k) premarket notification. The FDA described in your sia wequivalence of your device to a legally rinang or edicate device results in a classification for your markees promits 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 comprimee as (od advertising of your device, please contact che promocion analiance at (301) 594-4639. Also, please note ene orrios or entitled, "Misbranding by reference to ene regaration" (21 CFR 807.97). Other general information on your responsibilities under the Act may be Information of Job Division of Small Manufacturers Assistance obtained from cle bribers (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
2
INDICATIONS FOR USE STATEMENT
: Seal Polymer Industries Sdn. Bhd. Applicant
K991849 510(K) Number :
: Cashmere Non-Sterile, Powder-Free Latex Examination Gloves Device Name Basic Non-Sterile, Powder-Free Latex Examination Gloves
Indication For Use:
This is a medical glove to be worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patients' body, fluids, waste or environment.
.............................................................................................................................................................................. Concurrence of CDRH Office of Device Evaluation (ODC)
Prescription Use: ... .. Per 21 CFR 80.109
OR Ove
Over-The-Counter X
Chun S. Lin
(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital I 510(k) Number