(204 days)
LYY
Not Found
No
The 510(k) summary describes a standard medical glove and contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML. The performance studies focus on physical properties and biocompatibility, not algorithmic performance.
No.
The device (gloves) is intended to prevent contamination, not to diagnose, cure, mitigate, treat, or prevent disease.
No
The device description indicates it is a glove used to prevent contamination, and its performance metrics relate to physical properties and biocompatibility, not to diagnosing a patient's condition.
No
The device is a physical product (gloves) and does not involve any software components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device 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." This describes a barrier device used during physical examination, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description focuses on the physical properties and standards met by the glove, not on any diagnostic function.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting specific analytes or markers
- Providing diagnostic information
- Using reagents or assays
The device is a Class I medical device (as indicated by the predicate device description) used for barrier protection during patient examination.
N/A
Intended Use / Indications for Use
A 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.
Product codes
LYY
Device Description
The Powdered, Natural Color, Latex Examination Gloves, Non-Sterile meets all the requirements of ASTM standard D 3578-01a22 and FDA 1000 ml Water Leak Test.
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 or finger
Indicated Patient Age Range
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Intended User / Care Setting
examiner / medical purposes
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
The performance test data of the non-clinical tests that support a determination of substantial equivalent is the same as mentioned immediately above. Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.
Key Metrics
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Predicate Device(s)
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Reference Device(s)
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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/0 description: The image shows the letters BPG in a bold, sans-serif font. The letters are large and take up most of the frame. The letters are black, and the background is white. The letters are slightly distressed, with some small imperfections and rough edges.
I PUTRA GLUVES SUN.BHD. (580515-T)
& 1358, Jin Kg. Mohd Taib, Kawas 3000 Rawang, Selangor Da +03-6092 1042 +03-6092 1142 Fax: +0 E-mail : bog@streamyx.com Website
Image /page/0/Picture/3 description: The image contains two sets of logos. The first set includes the "nqa. ISO 9001 Registered" logo and the "UKAS ENVIRONMENTAL MANAGEMENT 015" logo. The second set includes the "nqa. ISO 14001 Registered" logo and the "UKAS ENVIRONMENTAL MANAGEMENT 015" logo.