(58 days)
Not Found
Not Found
No
The device is a simple examination glove and the summary contains no mention of AI or ML.
No
The device, "Latex Examination Gloves," is intended to prevent contamination between patient and examiner, not to provide therapy or treatment for a disease or condition.
No
Explanation: The device is described as "Latex Examination Gloves" intended to prevent contamination between patient and examiner. This function is for protection and hygiene, not for diagnosing any medical condition.
No
The device is described as a physical product (Latex Examination Gloves) and the description focuses on material properties and physical performance tests, not software functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to prevent contamination between patient and examiner by being worn on the hand or finger. This is a barrier function, not a diagnostic test performed on a sample from the body.
- Device Description: The description focuses on physical properties and standards related to the glove's integrity and composition.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information about a patient's health condition.
- Performance Studies: The performance studies focus on physical characteristics and standards, not on diagnostic accuracy metrics like sensitivity, specificity, etc.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This glove does not perform such a function.
N/A
Intended Use / Indications for Use
The Latex Examination Glove, Powdered, Blue, Non Sterile is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Latex Examination Gloves, Powdered, Blue, Non-Sterile 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
LYY
Device Description
The Latex Examination Gloves, Powdered, Blue, Non Sterile meets all the requirements of ASTM standard D 3578 - 01a22 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 (of the examiner)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Examiner (medical purposes)
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
The Latex Examination Gloves, Powdered, Blue, Non Sterile are summarized with the following technological characteristics compared to ASTM or equivalent standards:
- Dimensions: Meets D 3578 – 01ae2
- Physical Properties: Meets D 3578 - 01ae2
- Freedom from Pinholes: Meets D 3578 - 01ae2, FDA 21 CFR 800.20
- Powder Amount:
§ 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
WRP Buana Multicorpora
Jalan Jermal No. 20-B, Kelurahan Sei Mati, Medan-Labuhan Km 17, INDONESIA
MAR 2 6 2003
| Tel | +62-61-6942461 |
|---|---|
| +62-61-6942462 | |
| Fax | +62-61-6942463 |
510 (K) SUMMARY
1.0 Submitter :
| Name | : PT. WRP Buana Multicorpora |
|---|---|
| Address | : Jl. Jermal No.20B Kelurahan Sei Mati |
| Medan Labuhan KM 17, INDONESIA. | |
| Phone No. | : +61 6942461, 6942462 |
| Fax No. | : +61 6942463 |
Date of Summary Prepared : January 21, 2003
2.0 Contact Person :
| Name | : Mr. Ng Poy Sin |
|---|---|
| Phone No. | : +61 6942461, 6942462 |
| Fax No. | : +61 6942463 |
3.0 Name of the device :
| Trade Name | 1). Glovetex, and
2). Multiple or Customers' Trade Name |
|---------------------|------------------------------------------------------------|
| Device Name | : Latex Examination Gloves, Powdered, Blue, Non-Sterile |
| 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, powdered, that meets all the requirements of ASTM standard D 3578 – 01a 2 and FDA 1000 ml Water Leak Test.
5.0 Description of The Device :
The Latex Examination Gloves, Powdered, Blue, Non Sterile meets all the requirements of ASTM standard D 3578 - 01a22 and FDA 1000 ml Water Leak Test.
6.0 Intended Use of the Device :
The Latex Examination Glove, Powdered, Blue, Non Sterile is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
1
Image /page/1/Picture/0 description: The image shows a sequence of alphanumeric characters, specifically "KO30273". The characters are written in a bold, sans-serif font, and they appear to be handwritten. The image is in black and white, and the characters are clearly legible against the white background.
Jalan Jermal No. 20-B, Kelurahan Sei Mati, Medan-Labuhan Km 17, INDONESIA
+62-61-6942461 Tel +62-61-6942462 +62-61-6942463 Fax
Summary of The Technological Characteristics of The Device : 7.0
RP Buana Multicorpora
The Latex Examination Gloves, Powdered, Blue, Non Sterile 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 Amount | D 3578 - 01ae2
D 6124 - 01 |