(91 days)
Not Found
Not Found
No
The device is a standard examination glove and the summary contains no mention of AI or ML capabilities.
No
The device, "Powder Free Latex Examination Gloves," is intended for prevention of contamination between patient and examiner and does not actively treat or mitigate a disease or condition.
No
The device is described as a glove intended to prevent contamination, not to diagnose a condition.
No
The device is a physical glove made of natural rubber latex, not software. The description focuses on material properties and physical performance tests.
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 gloves are for "medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner." This describes a barrier device used for protection, not a device used to examine specimens derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of disease or impairment.
- Device Description: The description focuses on the physical properties and standards met by the gloves (ASTM, FDA leak test). This aligns with a medical device used for protection, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting analytes, or providing diagnostic information. The performance studies and key metrics relate to the physical integrity and biocompatibility of the glove, not diagnostic accuracy.
Therefore, this device is a medical device (specifically, an examination glove) but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Powder Free Latex Examination Gloves, Non-Sterile (Contains 50 micrograms or less of Water Extractable Protein per gram) is a disposable device and made of Natural Rubber Latex 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 Gloves, Non Sterile (Contains 50 micrograms or less of Total Water Extractable Protein per gram) meets all the requirements of ASTM standard D 3578 - 01a 22 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
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 Powder Free Latex Examination Gloves, 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: Dimensions; STANDARDS: D 3578 - 01ae2; DEVICE PERFORMANCE: Meets
CHARACTERISTICS: Physical Properties; STANDARDS: D 3578 - 01ae2; DEVICE PERFORMANCE: Meets
CHARACTERISTICS: Freedom from Pinholes; STANDARDS: D 3578 - 01ae2, FDA 21 CFR 800.20; DEVICE PERFORMANCE: Meets
CHARACTERISTICS: Powder Residue; STANDARDS: D 3578 - 01ae2, D 6124 - 01; DEVICE PERFORMANCE:
§ 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
PT. Mandiri Inti Buana
JUN 3 0 2003
Jalan Listrik No. 6 Medan-20112 INDONESIA
+62-61-4566506 Tel +62-61-4566806 Fax
510 (K) SUMMARY
4031754
1.0 Submitter :
| Name | : PT. Mandiri Inti Buana |
|---|---|
| Address | : Jl. Listrik No. 6 |
| Medan - INDONESIA, 20112. | |
| Phone No. | : +61 4566506 |
| Fax No. | : +61 4566806 |
Date of Summary Prepared :
2.0 Contact Person :
| Name | : Mr. Ng Poy Sir |
|---|---|
| Phone No. | : +61 4566506 |
| Fax No. | : +61 4566806 |
3.0 Name of the device :
| Trade Name | 1). | Flexiskin, and |
|---|---|---|
| 2). | Multiple or Customers' Trade Name | |
| Device Name | : | Powder Free Latex Examination Gloves, Non-Sterile |
| Contains 50 micrograms or less of Total Water Extractable Protein per | ||
| gram | ||
| Common Name | : | Examination Gloves |
| Classification Name | : | Patient Examination Gloves (Class I) |
4.0 ldentification of The Legally Marketed Device :
Class I patient examination gloves, 80LYY, powder free, that meets all the requirements of ASTM standard D 3578 - 01a22 and FDA 1000 ml Water Leak Test.
5.0 Description of The Device :
The Powder Free Latex Examination Gloves, Non Sterile (Contains 50 micrograms or less of Total Water Extractable Protein per gram) meets all the requirements of ASTM standard D 3578 - 01a 22 and FDA 1000 ml Water Leak Test.
6.0 Intended Use of the Device :
.
The Powder Free Latex Examination Glove, Non Sterile (Contains 50 micrograms or less of Total Water Extractable Protein per gram) is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
1
PT. Mandiri Inti Buana
+62-61-4566506 Tel +62-61-4566806 Fax
Summary of The Technological Characteristics of The Device : 7.0
The Powder Free Latex Examination Gloves, 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 |
|-------------------------------|---------------------------------------------------------------|-----------------------------------------------------------------------------|
| Dimensions | D 3578 - 01ae2 | Meets |
| Physical Properties | D 3578 - 01ae2 | Meets |
| Freedom from Pinholes | D 3578 - 01ae2
FDA 21 CFR 800.20 | Meets |
| Powder Residue | D 3578 - 01ae2
D 6124 - 01 |