(44 days)
Not Found
No
The 510(k) summary describes a standard medical glove and makes no mention of AI or ML technology.
No
The device, a patient examination glove, is intended to prevent contamination, not to treat or cure a disease or condition.
No
Explanation: The device, a powder-free vinyl patient examination glove, is intended to prevent contamination between the patient and examiner. Its function is to provide a barrier, not to diagnose a condition.
No
The device is a physical glove, not software. The description clearly states it is a "powder free vinyl patient examination glove" and mentions physical standards like ASTM D 5250-00e4.
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 physical barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a glove, designed for physical protection.
- Lack of IVD Indicators: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health status.
- Regulatory Standards: The device meets standards related to physical properties and biocompatibility (ASTM D5250, ASTM D6124, 21 CFR 800.20, ISO10993-10), which are typical for medical devices that are not IVDs.
IVD devices are specifically designed to perform tests on samples from the human body to provide information for diagnosis, monitoring, or screening. This glove does not fit that description.
N/A
Intended Use / Indications for Use
"Powder free vinyl patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand on finger to prevent contamination between patient and examiner."
"Powder free vinyl 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."
Product codes (comma separated list FDA assigned to the subject device)
LYZ
Device Description
"Device Description : powder free vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-00e4"
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" / 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 vinyl patient examination gloves, non sterile are summarized with the following technological characteristics compared to ASTM or equivalent standard.
Characteristics: Dimension; Standard: ASTM standard D 5250-00e4.; Device performance: Meets
Characteristics: Physical Properties; Standard: ASTM standard D 5250-00e4.; Device performance: Meets
Characteristics: Freedom from pinholes; Standard: 21 CFR 800.20; Device performance: Meets
Characteristics: Powder Residual; Standard: ASTM standard D 5250-00e4 and D6124-01; 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
Summary
NOV - 9 2006
"This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92."
"The assigned 510(k) number is: 1062-094" (applicant leave blank)
Premarket Notification [510(k)] Summary
[(a)(1)]. The summary contains on the first page, preferably on your letterhead paper, the submitter's name, address, phone and fax numbers, name of contact person, and date the summary was prepared :
| Submitter's name : | SUQIAN GREEN GLOVE CO., LTD |
|---|---|
| Submitter's address : | NO.1 XIANGSHAN ROAD, EAST AREA OF SUYU |
| DEVELOPMENT ZONE, SUQIAN CITY, JIANGSU | |
| PROVINCE, 223800, P.R China | |
| Phone number : | (86) 0527-4754999 |
| Fax number : | (86) 0527-4754998 |
| Name of contact person: | Mr. Zheng Gang |
| Date the summary was prepared: | Sep.22.2006 |
((a)(2)]. The name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known
| Device Name: | Powder Free Vinyl Patient Examination Gloves, Clear(non-colored) |
|---|---|
| Proprietary/Trade name: | Powder Free Vinyl Patient Examination Gloves |
| Other clients private labeling | |
| Common Name: | Patient examination glove |
| Classification Name: | Patient examination glove |
| Device Classification: | I |
| Regulation Number: | 21 CFR 880.6250 |
| Panel: | General Hospital (80) |
| Product Code: | LYZ |
[(a)(3)]. An identification of the legally marketed device to which your firm is claiming substantial equivalence .
.. . ":
Class I* powder free vinyl patient examination gloves , Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-00e4.
Predicate device : FUGUAN (Brand) Powder-Free Vinyl Patient Examination Gloves, Shijiazhuang Fuguan Plastic Products Co., Ltd.. K032908 .
{(a)(4)] A description of the device
1
Device Description : powder free vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-00e4
[(a)(5)] The summary describes the intended use of the device
Device Intended Use: powder free vinyl patient examination glove, Clear(non-colored) is a disposable device intended for medical purposes that is worn on the examinor's hand on finger to prevent contamination between patient and examiner.
[(a)(6)] A summary of the technological characteristics of new device compared to the predicate device.
The powder free vinyl patient examination gloves, non sterile are summarized with the following technological characteristics compared to ASTM or equivalent standard.
| Characteristics | Standard | Device performance |
|---|---|---|
| Dimension | ASTM standard D 5250-00e4. | Meets |
| Physical Properties | ASTM standard D 5250-00e4. | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Residual | ASTM standard D 5250-00e4 | Meets |
| Biocompatability | and D6124-01 | |
| Primary Skin Irritation in | ||
| rabbits |