(35 days)
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Not Found
No
The device is a standard examination glove and the summary describes physical and chemical properties, not software or algorithmic functions.
No
The device is a glove intended to prevent contamination, not to provide therapy.
No
The device is described as 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 indicates its purpose is protective, not diagnostic.
No
The device is a physical examination glove, which is a hardware device, not software. The summary describes physical properties and performance tests related to the material and construction of the glove.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device's intended use: The intended use of these gloves is to be worn on the examiner's hand or finger to prevent contamination between the patient and the examiner. This is a barrier function, not a diagnostic test performed on a specimen.
- Device description: The description focuses on physical properties, freedom from defects, and protein content, all related to the glove's function as a barrier and its safety for the user and patient.
- Performance studies and key metrics: The performance studies and metrics listed (dimensions, physical properties, pinholes, powder, protein level, biocompatibility) are all related to the glove's physical integrity, safety, and barrier function. None of them involve analyzing a biological specimen for diagnostic purposes.
The information provided clearly indicates that this device is a medical glove intended for barrier protection, not for performing diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
The Powder Free Latex Examination Glove with Aloe Vera and Protein Content Labeling Claim (50 micrograms or less), Non Sterile are disposable devices intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Product codes (comma separated list FDA assigned to the subject device)
LYY
Device Description
The Powder Free Latex Examination Glove with Aloe Vera and Protein Content Labeling Claim (50 micrograms or less), Non Sterile meets all the requirements of ASTM Standard D 3578 - 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
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
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 performance test data of the non-clinical tests that support a determination of substantial equivalence 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 results:
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE |
|---|---|---|
| Dimensions | ASTM D 3578 - 00 | Meets |
| Physical Properties | ASTM D 3578 - 00 | Meets |
| Freedom from pinholes | ASTM D 3578 - 00 FDA 21 CFR 800.20 | Meets |
| Powder-Free | ASTM D 6124 - 00 |
§ 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
KO12876
510(k) SUMMARY
1.0 Submitter:
| Name: | WRP Specialty Products Sdn. Bhd. | ||
|---|---|---|---|
| Address: | Lot 11, Jalan 2, Kawasan Perusahaan Bandar Baru Salak | ||
| Tinggi, 43900 Sepang, Selangor Darul Ehsan, MALAYSIA | |||
| Phone No.: | +60 3 8706 9788 | ||
| Fax No.: | +60 3 8706 5020 |
Date of Summary Prepared: 14th August, 2001
2.0 Contact Person:
| Name: | Mr. Mohd Haizan Hussein |
|---|---|
| Phone No.: | +60 3 8706 9788 |
| Fax No.: | +60 3 8706 5020 |
Name of the device: 3.0
| Trade Name: | Powder Free Latex Examination Glove with Aloe Vera and
Protein Content Labeling Claim (50 micrograms or less),
Non Sterile |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Examination Gloves |
| Classification Name: | Patient Examination Gloves (per 21 CFR 880.6250) |
Identification of The Legally Marketed Device: 4.0
Class I patient examination gloves, 80LYY, powder free, that meets all the requirements of ASTM standard D 3578 - 00 and FDA 21 CFR 800.20.
5.0 Description of The Device:
.
The Powder Free Latex Examination Glove with Aloe Vera and Protein Content Labeling Claim (50 micrograms or less), Non Sterile meets all the requirements of ASTM Standard D 3578 - 00 and FDA 21 CFR 800.20.
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Intended Use of the Device: 6.0
The Powder Free Latex Examination Glove with Aloe Vera and Protein Content Labeling Claim (50 micrograms or less), Non Sterile are disposable devices intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Summary of The Technological Characteristics of The Device: 7.0
The Powder Free Latex Examination Glove with Aloe Vera and Protein Content Labeling Claim (50 micrograms or less), Non Sterile are summarized with the following technological characteristics compared to ASTM or equivalent standards.
| CHARACTERISTICS | STANDARDS | DEVICE
PERFORMANCE |
|-----------------------|---------------------------------------------------------------|---------------------------------------------------------------------------------|
| Dimensions | ASTM D 3578 - 00 | Meets |
| Physical Properties | ASTM D 3578 - 00 | Meets |
| Freedom from pinholes | ASTM D 3578 - 00
FDA 21 CFR 800.20 | Meets |
| Powder-Free | ASTM D 6124 - 00 |