(70 days)
Not Found
Not Found
No
The document describes standard examination gloves and makes no mention of AI or ML technology.
No.
The device, "Powder Free Nitrile Examination Gloves," is intended to prevent contamination between patient and examiner, not to provide therapy or treatment for a disease or condition.
No
This device is described as examination gloves, which are used to prevent contamination, not to diagnose a medical condition.
No
The device is a physical product (gloves) and does not involve any software component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to be worn on the examiner's hands to prevent contamination between patient and examiner. This is a barrier device for protection, not a device used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or treatment.
- Device Description: The description focuses on the material and standards met for a protective glove.
- Lack of IVD Characteristics: There is no mention of analyzing samples, reagents, or any process related to diagnosing a condition based on in vitro testing.
IVD devices are specifically designed to perform tests on samples like blood, urine, tissue, etc., outside of the body to provide diagnostic information. This device is a physical barrier.
N/A
Intended Use / Indications for Use
The Powder Free Nitrile Examination Gloves, Blue, Non Sterile is a disposable device intended for medical purposes that is worn on the examiner's to prevent contamination between patient and examiner.
Powder Free Nitrile Examination. Gloves, Non -Sterile is a disposable device and made of Synthetic Polymer that exhibits rubber like characteristics intended for medical purposes that is worn on the examiner's hands of finger to prevent contamination between patient and examiner.
Product codes
LZA
Device Description
The Powder Free Nitrile Examination Gloves, Blue, Non Sterile meets all the requirements of ASTM standard D 6319-00a53 and FDA 1000 ml Water Leak Icct.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
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 equivalent is the same as mentioned immediately above.
Clinical data is not needed for gloves or for most devices cleared by the 510 (k) processes.
It can be concluded that The Powder Free Nitrile Blue Examination Gloves, Blue, Non Sterile will perform according to the gloves performance standards referenced in Section (7) above and mect ASTM standards, and FDA requirements for water leak test on pinhole AQL. Consequently, this device is substantially equivalent to currently marketed device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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
Image /page/0/Picture/0 description: This image contains the logo and contact information for PT. Mahakarya Inti Buana. The address is Jalan Sei Belumai, Desa Dalu 10 A Dusun 1 No. 18, Tanjung Morawa - 20362, SUMUT - INDONESIA. The telephone number is +62-61-7944880, and the fax number is +62-61-7944882.
Summary of The Technological Characteristics of The Device 7.0 The Powder Free Nitrile Examination Gloves, Blue, Non Sterile are summarized with the following technological characteristics compared to ASTM or equivalent standards.
| CHARACTERISTICS | STANDARDS | DEVICE
PERFORMANCE |
|-----------------------|---------------------------------------|----------------------------------------|
| Dimension | D 6319-00aE3 | Meets |
| Physical Properties | D 6319-00aE3 | Meets |
| Freedom from Pinholes | D 6319-00aF3
FDA 21 CFR 800.20 | Meets |
| Powder Residue | D 6319-00aE3
D6124 - 01 |