(120 days)
Not Found
Not Found
No
The device is a standard examination glove and the summary contains no mention of AI or ML.
No.
The device, "POWDER TREE NITRILE EXAMINATION GLOVES, BLUE NON STERILE," is described as a disposable device intended for preventing contamination, not for treating or preventing disease.
No
Explanation: This device is described as examination gloves used to prevent contamination, not to diagnose a condition.
No
The device is a physical product (gloves) and not software. The description focuses on material properties and physical tests.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to be worn on the finger to prevent contamination between patient and examiner. This is a barrier function, not a diagnostic test performed on a sample from the body.
- Device Description: The description focuses on material properties and leak testing, which are relevant to a barrier device, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
- Predicate Device: The predicate device is also described as "Class I Nitrile Examination Gloves," reinforcing its classification as a barrier device.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device's function is purely protective and preventative.
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.
Product codes (comma separated list FDA assigned to the subject device)
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 Test.
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
examiner's
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) process.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
K 042239
Image /page/0/Picture/1 description: The image shows a stylized, gothic-style monogram consisting of the letters 'M', 'I', and 'B'. The letters are rendered in a bold, black color, with sharp, angular edges that give them a medieval or fantasy-like appearance. The design is compact and the letters are closely intertwined, creating a unified and distinctive logo or emblem.
1.0
PT MANDIRI INTI BUANA
DEC 1 6 2004
Jalan Sei Belumai Desa Dalu 10 A Dusun I Tanjung Morawa - 20362 SUMUT - INDONESIA
+62-61-7944880 Tel Fax +62-61-7944882
510 (K) SUMMARY
| Submitter: | |
|---|---|
| Name | PT MANDIRI INTI BUANA |
| Address | Jl. Sei Belumai, Desa Dalu 10 A Dusun I |
| 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 |
3.0 Name or the device:
| Trade Name | : | 1) Flexiskin and |
|---|---|---|
| 2) Multiple or Customers' Trade Name | ||
| Device Name | : | Powder Free Nitrile Blue Examination Gloves, |
| Blue, Non | ||
| Sterile | ||
| Common Name | : | Examination Gloves |
| Classification Name | : | Nitrile Blue Examination Gloves (Class I) |
4.0 Identification of The Legally Marketed Device:
Class I Nitrile Examination Gloves, 80LZA, powder free, that meets all the Test.
5.0 Description of The Device
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 Test.
6.0 Intended Use of The Device
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.
1
Image /page/1/Picture/0 description: The image shows a stylized logo with the letters "MB" in a gothic-style font. The letters are bold and black, with intricate details and sharp edges. The overall design has a vintage or medieval feel, with the letters slightly overlapping each other.
Jalan Sei Belumai Desa Dalu 10 A Dusun 1 Tanjung Morawa - 20362 SUMUT - INDONESIA
+62-61-7944880 Tel +62-61-7944882 Fax
Summary of The Technological Characteristics of The Device 7.0
The Powder Free Latex Examination Gloves, Blue, Non Sterile (Contains 50 micrograms or less of Total Water Extractable Protein per gram) 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 6319-00aE3
FDA 21 CFR 800.20 | Meets |
| Powder Residue | D 6319-00aE3
D6124 - 01 |