(120 days)
Not Found
No
The device is a standard examination glove and the summary explicitly states "Mentions AI, DNN, or ML: Not Found".
No
Explanation: The device is described as a disposable glove intended to prevent contamination between a patient and an examiner. Its function is protective and preventative, not therapeutic.
No
The device, Powder Free Latex Examination Gloves, is described as a disposable device intended for medical purposes to prevent contamination between patient and examiner. Its function is to provide a barrier, not to identify or determine the presence of a disease or condition.
No
The device description clearly states it is a physical product made of natural rubber latex (gloves) and does not mention any software components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the gloves are "intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner." This is a barrier function, not a diagnostic one.
- Device Description: The description focuses on the physical properties and standards met for a protective barrier (ASTM standards, water leak test). There is no mention of analyzing samples or providing diagnostic information.
- Lack of IVD Characteristics: 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 device does none of that.
The information provided describes a standard medical glove used for protection, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Powder Free Latex Examination Gloves, Non Sterile (contains 50 micrograms/dm² or less of total water extractable protein) is a disposable device intended for medical purpose that is worn on the examiners hand and finger to prevent contamination between patient and examiner.
Powder Free Latex Examination Gloves, Non Sterile (contains 50 micrograms/dm² or less of total water extractable protein) 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
Powder Free Latex Examination Gloves, Non Sterile (contains The 50 micrograms/dm² or less of total water extractable protein) is Class I Device. These gloves are made of natural rubber latex. The gloves can be used either right or left hand (ambidextrous), Disposable, Single Use and Non Sterile. The Specification of this device meets the requirements of ASTM Standard D 3578 - 05 and FDA 1000ml 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
Not Found
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, (contains 50 micrograms/dm² or less of total water extractable protein) technological characteristics are summarized in the following information compared with ASTM or equivalent standards:
Dimensions - Standards: D 3578 – 05, Performance: Meets
Physical Properties - Standards: D 3578 – 05, Performance: Meets
Freedom from Pinholes - Standards: FDA 21 CFR 800.20, Performance: Meets
Powder Residue - Standards: D 3578 – 05, D 6124 – 06, 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
P
NOV - 4 2011
PT. INTAN HEVEA INDUSTRY
Jalan Pulau trian No. 13 Kawasan Industri Medan I Jalan Yos Sudarso Km 10.5. Medan 20371. INDONESIA
| Tel | +62-61-6850169 |
|---|---|
| +62-61-6856335 | |
| Fax | +62-61-6850168 |
| +62-61-6856335 | |
| intanhevea@yahoo.com |
510k Summary
1.0
| Submitter : | |
|---|---|
| Name | : PT. INTAN HEVEA INDUSTRY |
| Address | : Jalan Pulau Irian No.13 Kawasan Industri Medan I Jalan Yos Sudarso Km 10.5 Medan 20371, INDONESIA |
| Phone No. | : +62-61-6850169, 6856335 |
| Fax No. | : +62-61-6850168, 6856335 |
Date of Summary Prepared : September 19, 2011
2.0 Contact Person :
| Name | : Darwin Tandjo |
|---|---|
| Phone No. | : +62-61-6850169, 6856335 |
| Fax No. | : +62-61-6850168, 6856335 |
3.0 Name of the Device :
| Trade Name | : SKIN GUARD and Multiple or Customer's Trade Name |
|---|---|
| Device Name | : Powder Free Latex Examination Gloves, Non Sterile |
| (contains 50 micrograms/ dm² or less of total water | |
| extractable protein). | |
| Common Name | : Examination Gloves |
| Classification Name | : Patient Examination Gloves (Class I) |
4.0 Identification of The Legally Marketed Device (Predicate Device) which Substantially Equivalent:
The Powder Free Latex Examination Gloves, Non Sterile (contains 50 micrograms/dm2 or less of total water extractable protein) are substantially equivalent with Latex Patient Examination Gloves, Powdered, Non-Sterile submitted and cleared under 510(k) number K894480. The different in this submission is the product Powder Free, Non Sterile with labeling claim contains 50 micrograms/dm² or less of total water extractable protein with no change in product design.
1
Image /page/1/Picture/0 description: The image shows a black and white drawing of a diamond. The diamond has a geometric shape with several facets. A vertical line extends from the bottom point of the diamond downwards. The drawing is simple and lacks shading or color.
PT. INTAN HEVEA INDUSTRY
Jalan Pulau Irian No. 13 Kawasan Industri Medan I Jalan Yos Sudarso Km 10.5. Medan 20371. INDONESIA.
Tel +62-61-6850169 +62-61-6856335 Fax 62-61-6850168 +62-61-6856335 Email intanhevea@yahoo.com
5.0 Description and Specification of The Device :
Powder Free Latex Examination Gloves, Non Sterile (contains The 50 micrograms/dm² or less of total water extractable protein) is Class I Device. These gloves are made of natural rubber latex. The gloves can be used either right or left hand (ambidextrous), Disposable, Single Use and Non Sterile. The Specification of this device meets the requirements of ASTM Standard D 3578 - 05 and FDA 1000ml Water Leak Test.
6.0 Intended Use of the Device :
The Powder Free Latex Examination Gloves (contains 50 micrograms/dm² or less of total water extractable protein) is a disposable device intended for medical purpose that is worn on the examiners hand and finger to prevent contamination between patient and examiner.
7.0 Summary of The Technological Characteristics of The Device :
The Powder Free Latex Examination Gloves, (contains 50 micrograms/dm² or less of total water extractable protein) technological characteristics are summarized in the following information compared with ASTM or equivalent standards ;
| Characteristics | Standards | Performance |
|---|---|---|
| Dimensions | D 3578 – 05 | Meets |
| Physical Properties | D 3578 – 05 | Meets |
| Freedom from Pinholes | FDA 21 CFR 800.20 | Meets |
| Powder Residue | D 3578 – 05 | |
| D 6124 – 06 |