(186 days)
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No
The device description and performance studies focus on the physical properties and barrier function of examination gloves, with no mention of AI or ML technologies.
No
The device, a Powdered Latex Examination Glove, is intended to provide a barrier against infectious materials and contamination, not to treat or cure a disease or condition.
No
Explanation: The device, Powdered Latex Examination Glove, is intended to provide a barrier against infectious material and contamination during medical procedures. Its stated performance tests focus on physical properties, pinholes, powder residue, protein content, and biocompatibility. There is no mention of it being used to identify, measure, or monitor a disease, injury, or other condition.
No
The device is a physical product (gloves) and does not involve any software component.
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 barrier worn on the hand for medical purposes to protect against infectious material and contamination. This is a physical barrier function, not a diagnostic test performed in vitro (outside the body) on specimens like blood, urine, or tissue.
- Device Description: The description focuses on the physical properties and standards related to the glove's integrity and composition.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information about a patient's health status.
- Anatomical Site: The device is applied to the hand, which is an external anatomical site, not used for collecting or processing internal biological samples for diagnosis.
Therefore, this device is a medical device, specifically an examination glove, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Powdered Latex Examination Glove, Powdered, Non Sterile is a disposable device intended for medical purposes that is worn on the examiner's to prevent contamination between patient and examiner.
A Powdered Latex Examination Glove Non Sterile is a disposable device made of natural rubber latex that bears powder to facilitate donning and is intended to be worn on the hand of finger(s) for a medical purpose to provide a barrier againts potentially insfectious material and other contaminations.
Product codes
LYY
Device Description
The Powdered Latex Examination Gloves, Non Sterile (Contains 200 micrograms or less of Total Water Extractable Protein per dm4) meets all the requirements of ASTM standard D 3578-01 a22 and FDA 1000 ml Water Leak Test.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand of finger(s)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Powdered Latex Examination Gloves, Powdered, Non Sterile (Contains 200 micrograms or less of Total Water Extractable Protein per dm2) are summarized with the following technological characteristics compared to ASTM equivalent standards.
CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE
Dimension | D 3578 -01 ae2 | Meets
Physical Properties | D 3578 -01 ae2 | Meets
Freedom from Pinholes | D 3578 -01 ae2 FDA 21 CFR 800.20 | Meets
Powder Residue | D 3578 -01 ae2 D6124 - 01 |
§ 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: The image shows a stylized, black and white graphic of the letters 'MB' in a gothic or medieval-style font. The letters are bold and blocky, with sharp angles and thick strokes, giving them a somewhat imposing appearance. The overall design has a vintage or old-fashioned feel due to the font choice and the slightly rough or textured quality of the image.
1.0
PT. MAHAKARYA INTI BUANA
JUN - 2 2006
Jalan Sei Belumai Desa Dalu 10 A Dusun 1 Tanjung Morawa - 20362 SUMUT - INDONESIA
Tel +62-61-7944880 +62-61-7944882 Fax
| 510 (K) SUMMARY | K063305 | |
|---|---|---|
| Submitter: | ||
| Name | PT. MAHAKARYA INTI BUANA | |
| Address | Jl. Sei Belumai, Desa Dalu 10 A Dusun I No. 18 Tanjung Morawa - 20362 SUMUT – INDONESIA |
| Phone No. | +62-61-7944880 |
|---|---|
| Fax No. | +62-61-7944882 |
| Date of Summary Prepared |
2.0 Contact Person:
| Name | : | Mr. V. Nadarajan |
|---|---|---|
| Phone | : | +62-61-7944880 |
| Fax No. | : | +62-61-7944882 |
3.0 Name or the device:
| Trade Name | 1) Senstouch and
2) Multiple or Customers' Trade Name |
|---------------------|----------------------------------------------------------|
| Device Name | Powdered Latex Examination Gloves, Non Sterile |
| Common Name | Examination Gloves |
| Classification Name | Patient Examination Gloves (Class I) |
4.0 Identification of The Legally Marketed Device:
Class I Examination gloves, LYY, Powdered, that meets all the requirements of ASTM standard D 3578-01 a22 and FDA 1000 ml Water Leak Test.
5.0 Description of The Device
The Powdered Latex Examination Gloves, Non Sterile (Contains 200 micrograms or less of Total Water Extractable Protein per dm4) meets all the requirements of ASTM standard D 3578-01 a22 and FDA 1000 ml Water Leak Test.
6.0 Intended Use of The Device
The Powdered Latex Examination Glove, Powdered, Non Sterile is a disposable device intended for medical purposes that is worn on the examiner's to prevent contamination between patient and examiner.
Page 1 of 2
1
PT. MAHAKARYA INTI BUANA
Image /page/1/Picture/1 description: The image shows a stylized, black and white graphic of the letters "MB" in a gothic or old English font. The letters are bold and have a textured appearance, giving them a slightly rough or aged look. The overall design is simple yet striking, with the letters being the primary focus.
11053305
Jalan Sei Belumai Desa Dalu 10 A Dusun 1 Tanjung Morawa - 20362 SUMUT - INDONESIA
Tel +62-61-7944880 +62-61-7944882 Fax
Summary of The Technological Characteristics of The Device 7.0
The Powdered Latex Examination Gloves, Powdered, Non Sterile (Contains 200 micrograms or less of Total Water Extractable Protein per dm2) are summarized with the following technological characteristics compared to ASTM equivalent standards.
| CHARACTERISTICS | STANDARDS | DEVICE
PERFORMANCE |
|----------------------------------|---------------------------------------|-----------------------|
| Dimension | D 3578 -01 ae2 | Meets |
| Physical Properties | D 3578 -01 ae2 | Meets |
| Freedom from Pinholes | D 3578 -01 ae2
FDA 21 CFR 800.20 | Meets |
| Powder Residue | D 3578 -01 ae2
D6124 - 01 |