(39 days)
Not Found
Not Found
No
The device description and performance studies focus on the physical properties and biocompatibility of examination gloves, with no mention of AI or ML.
No
The device is a glove intended to prevent contamination between patient and examiner, which is a barrier function, not a therapeutic one.
No
This device, a Polymer Examination Glove, is intended for barrier protection to prevent contamination between patient and examiner, not for diagnosing medical conditions.
No
The device is a physical examination glove made of synthetic polymer, 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 "disposable device... intended for medical purpose that is worn on the examiner's hand or finger or prevent contamination between patient and examiner." This describes a barrier device used for protection during physical examination.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not interact with or analyze such specimens.
- Device Description: The description focuses on the physical properties and standards met by the glove, not on any diagnostic capabilities.
- Lack of Diagnostic Elements: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information.
This device is a medical glove, which falls under a different regulatory classification than IVDs.
N/A
Intended Use / Indications for Use
The Polymer Examination Glove, Powder Free, Non Sterile is a disposable device intended for medical purposes that is worn on the examincr's to prevent contamination between patient and examiner.
POLYMER EXAMINATION GLOVE, POWDER FREE, NON STERILE Indications For Use: "Olymer Examination Glove , Powder Free Non Sterile is a disposable device and made of Synthetic Polymer that exhibits rubber like characteristics intended for medical purpose that is worn on the examiner's hand or finger or prevent contamination between patient and examiner.
Product codes (comma separated list FDA assigned to the subject device)
LYY
Device Description
The Polymer Examination Gloves, Powder Free, Non Sterile (Contains 50 micrograms or less of Total Water Extractable Protein per gram) 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 or finger
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 performance test data of the non-clinical tests that support a determination of substantial equivalent is the same as mentioned immediately above.
The Polymer Examination Gloves, Powder Free, Non Sterile (Contains 50 micrograms or less of Total Water Extractable Protein per gram) are summarized with the following technological characteristics compared to ASTM equivalent standards.
CHARACTERISTICS: Dimension, Physical Properties, Freedom from Pinholes, Powder Free Residue, Water Soluble Protein Content, Biocompatibility (Primary Skin Irritation in Rabbits), Biocompatibility (Dermal Sensitization).
STANDARDS: D 3578 -01 ae², FDA 21 CFR 800.20, D6124 - 01, D 5712 - 99.
DEVICE PERFORMANCE: Meets for Dimension, Physical Properties, Freedom from Pinholes.
§ 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 logo with the letters "MB" in a bold, gothic-style font. The letters are black and appear to be hand-drawn or digitally rendered with a rough, textured edge. The overall design has a vintage or medieval feel due to the font choice and the solid black fill.
PT. MAHAKARYA INTI BUANA
Jalan Sei Belumai Desa Dalu 10 A Dusun 1 Tanjung Morawa -- 20362 SUMUT - INDONESIA
Tiel +62-61-7944880 +62-61-7944882 liax
510 (K) SUMMARY
| 1.0 | 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. Sasitharan Nair |
|---|---|---|
| Phone | : | +62-61-7944880 |
| Fax No. | : | +62-61-7944882 |
SEP 3 0 2005
3.0 Name or the device:
| Trade Name | 1) Senstouch and
2) Multiple or Customers' Trade Name |
|---------------------|------------------------------------------------------------|
| Device Name | Polymer Latex Examination Gloves, Powder Free, 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, 80 LYY, Powder Free, 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 Polymer Examination Gloves, Powder Free, Non Sterile (Contains 50 micrograms or less of Total Water Extractable Protein per gram) 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 Polymer Examination Glove, Powder Free, Non Sterile is a disposable device intended for medical purposes that is worn on the examincr's to prevent contamination between patient and examiner.
1
PT. MAHAKARYA INTI BUANA
Image /page/1/Picture/1 description: The image shows an address written in a block of text. The address is "Jalan Sei Belumai Desa Dalu 10 A Dusun 1 Tanjung Morawa - 20362 SUMUT -- INDONESIA". The address appears to be located in Indonesia.
Ticl 162-61-7944880 +62-61-7944882 l'ax
Summary of The Technological Characteristics of The Device 7.0
The Polymer Examination Gloves, Powder Free, Non Sterile (Contains 50 micrograms or less of Total Water Extractable Protein per gram) 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 Free Residue | D 3578 -01 ae²
D6124 - 01 |