(14 days)
Not Found
No
The device is a simple examination glove and the summary contains no mention of AI, ML, or any related technologies.
No
The description states the device is intended "to provide a barrier against potentially infectious materials and other contaminants," which indicates a protective, not therapeutic, function.
No
The device is described as a "powder-free patient examination glove" intended to provide a barrier. It does not mention any function related to diagnosing diseases or conditions.
No
The device is a physical glove made of natural rubber latex, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is a "powder-free patient examination glove" intended to be worn on the hand or finger(s) for medical purposes to provide a barrier. This describes a physical barrier device used for protection during medical procedures.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Lack of Diagnostic Function: The provided description does not mention any diagnostic function, testing of biological samples, or analysis of bodily fluids or tissues.
The device described is a medical device, but it falls under the category of a barrier device rather than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
A powder-free patient examination glove is a disposable device made of natural rubber latex material that may bear a trace amount of glove powder and is intended to be worn on the hand or linger(s) for medical purposes to provide a barrier against potentially infectious materials and other contaminants.
Product codes
LYY
Device Description
A non-sterile, disposable, patient examination glove made of natural rubber latex, powder-free, with or without polymer coating.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand or finger(s)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
No Clinical Performance Data required.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
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FEB - 7 2005
510(k) Summary
510(k) # K050152
| Manufacturer's Name: | Dipped Products (Thailand) Limited |
|---|---|
| Facility Address: | 400 Deans Road |
| Colombo 10 | |
| Sri Lanka | |
| Telephone number: | +66 74 325329 |
| Facsimile Number: | +66 74 325730 |
| Contact name: | Ian Gordon, VP |
| Emergo Group, Inc. | |
| Clearwater, FL 33761 USA | |
| 727-797-4727 phone | |
| 727-797-4757 FAX | |
| Date of Preparation: | January 14, 2005 |
| Proposed Device: | Palm-Pro and Palm-Pro Premium |
| Powder-Free Latex Examination Gloves With Protein Content | |
| Labeling Claim (50 Micrograms or Less) | |
| Predicate Device: | Kimberly Clark Safeskin product, K012815 |
| Ansell Protective Products Accutech Ambi 91-109 product | |
| K913766 |
Description of Device:
A non-sterile, disposable, patient examination glove made of natural rubber latex, powder-free, with or without polymer coating.
The proposed and the predicate devices are Class I patient examination gloves, 80L Y Y, powder-frec, that meets all the requirements of ASTM standard D-3578 and FDA 21 CFR 800.20. .
A powder-free patient examination glove is a disposable device Intended Use: made of natural rubber latex material that may bear a trace amount of glove powder and is intended to be worn on the hand or finger(s) for medical purposes to provide a barrier against potentially infectious materials and other contaminants.
| Characteristics | Standards | Device Performance | SE to Predicate |
|---|---|---|---|
| Dimensions | ASTM D 3578-01a | Meets | Same |
| Physical Properties | ASTM D 3578-01a | Meets | Same |
| Freedom from pinholes | ASTM D-3578-01a | ||
| FDA 21 CFR 800.20 | Meets | Same | |
| Powder-Free | ASTM D 6124-01 |