(60 days)
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Not Found
No
The device is a standard examination glove and the summary contains no mention of AI or ML technology.
No
The device is described as a glove intended to provide a barrier against contaminants, not to treat or cure a medical condition.
No
Explanation: The device is a glove intended to provide a barrier against infectious materials and contaminants, not to diagnose a medical condition.
No
The device is a physical examination glove made of latex, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a barrier device worn on the hand or finger(s) to protect against potentially infectious materials and contaminants. This is a physical barrier function, not a diagnostic function performed in vitro (outside the body).
- Device Description: The description aligns with a medical glove, referencing standards for physical properties and biocompatibility.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information.
IVD devices are designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This glove does not perform any such function.
N/A
Intended Use / Indications for Use
The powder free latex examination glove with Aloe Vera, water soluble natural Vitamin E and C 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.
Product codes
LYY
Device Description
Class I powder free latex examination gloves with Aloe Vera, natural water soluble Vitamin E and C and protein labeling claim(50 microgram or less), 80LYY, nonsterile meets all the requirements of ASTM standard D3578-01 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
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 Latex Examination Gloves with Aloe Vera, natural water soluble Vitamin E and C 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 3578-01
- Physical Properties: Meets ASTM D 3578-01
- Freedom from Pinholes: Meets ASTM D 3578-01 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
NOV 2 6 2004
510(K) SUMMARY
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
POWDER FREE LATEX EXAMINATIN GLOVES WITH ALOE VERA,NATURAL WATER SOLUBLE VITAMIN E AND VITAMIN C 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 Oct. 20, 2004
The assigned 510(K) number is K 042645
1.0 Submitter:
Qingdao Bestex Rubber & Plastic Products Co. Ltd. 14-2 Hangzhou Road, Pingdu., Qingdao, China
2.0 Regulatory Affairs Contact:
Name: ZeChuan Shao Phone No.: 408 980 1348 Fax No .: 408 980 1356
3.0 Name of device:
Trade Name: Undetermined Common Name: Examination Glove 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, natural water soluble Vitamin E and C, that meets all the requirements of ASTM standard 3578-01 and FDA 21 CFR 800.20.
5.0 Device Description:
Class I powder free latex examination gloves with Aloe Vera, natural water soluble Vitamin E and C and protein labeling claim(50 microgram or less), 80LYY, nonsterile meets all the requirements of ASTM standard D3578-01 and FDA 21 CFR 800.20.
6.0 Intended Use of The Device:
The powder free latex examination glove with Aloe Vera, water soluble natural Vitamin E and C 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.
1
04-2645
7.0 Summary of the Technological Characteristics of the Device:
The Powder Free Latex Examination Gloves with Aloe Vera, natural water soluble Vitamin E and C and with Protein Content Labeling (50 micrograms or less) are summarized with the following technological characteristics compared to ASTM or equivalent standards:
| Characteristics | Standards | Device Performance |
|---|---|---|
| Dimensions | ASTM D 3578-01 | Meets |
| Physical Properties | ASTM D 3578-01 | Meets |
| Freedom from | ASTM D 3578-01 | Meets |
| Pinholes | FDA 21 CFR 800.20 | Meets |
| Powder Free | ASTM D 6124-01 |