(48 days)
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No
The device description and performance studies focus on the physical properties and biocompatibility of examination gloves, with no mention of AI or ML.
No.
The device, a patient examination glove, prevents contamination but does not treat or cure a disease or condition.
No
A patient examination glove is a barrier device used to prevent contamination, not to diagnose a medical condition.
No
The device description clearly states it is a physical product (gloves) and does not mention 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 "patient examination glove" worn on the hands or fingers to prevent contamination between patient and examiner. This is a physical barrier device used during patient examination.
- Device Description: The description details a glove made of latex with specific properties (powder-free, colored, aloe vera, protein labeling). This aligns with a physical barrier device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (blood, urine, tissue, etc.) or providing information about a physiological state, health, or disease. IVDs are designed to perform tests on these specimens.
- Regulatory Classification: The device is classified as Class I, which is a low-risk classification for medical devices. While some IVDs can be Class I, the overall description and intended use point away from an IVD.
- Performance Studies and Metrics: The performance studies and metrics focus on the physical properties, integrity (pinholes), powder content, protein levels, and biocompatibility of the glove itself. These are relevant to a barrier device, not an IVD.
In summary, the device's function is to act as a physical barrier during patient examination, which is not the purpose of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The powder free colored latex examination glove with aloe vera and protein labeling claim(50 microgram or less) is a disposable device made of natural rubber latex that may bear a trace amount of glove powder and is intended for medical purposes that are worn on the examiner's hands or fingers to provide a barrier against potentially infectious materials and other contaminants.
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner. (21CFR 880.6250)
Product codes
LYY
Device Description
Class I powder free colored(green) latex examination gloves with aloe vera and protein labeling claim(50 microgram or less) ,80LYY, non-sterile meets all the requirements of ASTM standard D3578-00 and FDA 21 CFR 800.20.
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 or fingers
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner
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)
The Powder Free Colored Latex Examination Gloves with Aloe Vera and with Protein Content Labeling(50 micrograms or less) are summarized with the following technological characteristics compared to ASTM or equivalent standards:
- Dimensions: Meets ASTM D 3578-00
- Physical Properties: Meets ASTM D 3578-00
- Freedom from Pinholes: Meets ASTM D 3578-00 and FDA 21 CFR 800.20
- Powder Free:
§ 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
OCT = 1 2001
510(K) SUMMARY
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
COLORED(Green)POWDER FREE LATEX EXAMINATIN GLOVES WITH ALOE VERA AND PROTEIN LABELING CLAIM(50 MICROGRAM OR LESS PER GRAM OF GLOVE)
This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990, and prepared on July 25, 2001
The assigned 510(K) number is KO12709
1.0 Submitter:
Oingdao Bestex Rubber & Plastic Products Co. Ltd. 14-2 Hangzhou Road, Pingdu., Oingdao, China
2.0 Regulatory Affairs Contact:
ZeChuan Shao Name: Phone No .: 408 980 1348 Fax No .: 408 980 1356
3.0 Name of device:
Trade Name: Undetermined Examination Glove Common Name: Classification Name: Patient Examination Glove, Powder Free
4.0 Identification of The Legally Marketed Device:
Class I patient examination gloves, 80LYY, non-sterile, powder free with aloe vera, that meets all the requirements of ASTM standard 3578-00 and FDA 21 CFR 800.20.
5.0 Device Description:
Class I powder free colored(green) latex examination gloves with aloe vera and protein labeling claim(50 microgram or less) ,80LYY, non-sterile meets all the requirements of ASTM standard D3578-00 and FDA 21 CFR 800.20.
6.0 Intended Use of The Device:
The powder free colored latex examination glove with aloe vera and protein labeling claim(50 microgram or less) is a disposable device made of natural rubber latex that may bear a trace amount of glove powder and is intended for medical purposes that are worn on the examiner's hands or fingers to provide a barrier against potentially infectious materials and other contaminants.
7.0 Summary of the Technological Characteristics of the Device:
The Powder Free Colored Latex Examination Gloves with Aloe Vera and with Protein Content Labeling(50 micrograms or less) are summarized with the following technological characteristics compared to ASTM or equivalent standards:
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| Characteristics | Standards | Device Performance |
|---|---|---|
| Dimensions | ASTM D 3578-00 | Meets |
| Physical Properties | ASTM D 3578-00 | Meets |
| Freedom from | ASTM D 3578-00 | Meets |
| Pinholes | FDA 21 CFR 800.20 | Meets |
| Powder Free | ASTM D 6124-97 |