(74 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.
No.
The device is described as a barrier against infectious materials and contaminants, not as something that treats or prevents a disease or condition.
No
The device is described as an examination glove intended to provide a barrier against infectious materials and contaminants, not to diagnose a condition or disease.
No
The device description clearly states it is a physical glove made of natural rubber latex, not software.
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 made of natural rubber latex that may bear a trace amount of glove powder and is intended for medical purpose that is worn on the examiner's hand or finger(s)to provide a barrier against potentially infectious materials and other contaminants." This describes a physical barrier device used on a person.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. This device does not perform any such testing.
- Device Description: The description reinforces that it's a "Class I powder free latex examination gloves."
- Lack of IVD-related information: There is no mention of analyzing samples, detecting analytes, or any other activities associated with in vitro diagnostics.
Therefore, this device is a medical glove intended for barrier protection, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The powder free latex examination glove (green) with natural water soluble Vitamin E nd protein labeling claim (50 microgram or less) is a disposable device made of natural rubber latex that may bear a trace arnount 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.
The Powder-Free Latex Examination Glove (green) with natural water soluble Vitamin E and Protein Labeling Claim(50 microgram or less per gram of glove) is a disposable device made of natural rubber latex that may bear a trace amount of glove powder and is intended for medical purpose that is worn on the examiner's hand or finger(s)to provide a barrier against potentially infectious materials and other contaminants.
This device is not intended to be used as a chemical barrier.
Product codes (comma separated list FDA assigned to the subject device)
80 LYY
Device Description
Class I powder free latex examination gloves (green) with natural water soluble Vitamin E and protein labeling claim(50 microgram or less), 80L Y Y, non-sterile 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
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
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)
The Powder Free Latex Examination Gloves (green) with natural water soluble Vitamin E 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 Pinholes | ASTM D 3578-01, FDA 21 CFR 800.20 | Meets |
| Powder Free | ASTM D 6124-97 |
§ 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 5 2002
510(K) SUMMARY
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
POWDER FREE LATEX EXAMINATIN GLOVES (GREEN) WITH NATURAL WATER SOLUBLE VITAMIN E 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 Sep. 20, 2002
The assigned 510(K) number is KORQ5000
1.0 Submitter:
Oingdao Bestex Rubber & Plastic Products Co. Ltd. 14-2 Hangzhou Road, Pingdu., Oingdao, China
2.0 Regulatory Affairs Contact:
Name: ZeChuan Shao Phone No .: 408 980 1348 Fax No .: 408 980 1356
3.0 Name of device:
Undetermined Trade Name: Common Name: Examination Glove Classification Name: Patient Examination Glove, Powder Free
4.0 Identification of The Legally Marketed Device:
Class I patient examination gloves, 80L Y , non-sterile, powder free with natural water soluble Vitamin E 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 (green) with natural water soluble Vitamin E and protein labeling claim(50 microgram or less), 80L Y Y, non-sterile 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 (green) with natural water soluble Vitamin E nd protein labeling claim (50 microgram or less) is a disposable device made of natural rubber latex that may bear a trace arnount 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
7.0 Summary of the Technological Characteristics of the Device:
The Powder Free Latex Examination Gloves (green) with natural water soluble Vitamin E 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 6124-97 |