(69 days)
Not Found
No
The device is a simple disposable glove and the summary contains no mention of AI or ML technology.
No.
The device, a powdered vinyl patient examination glove, is intended for medical purposes to prevent contamination between patient and examiner, not to treat or alleviate a disease or condition.
No
The device description indicates it is a glove used for preventing contamination, not for diagnosing medical conditions.
No
The device is a physical product (gloves) and the summary describes physical properties and performance tests related to the material and manufacturing, not software functionality.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to be worn on the hand or finger to prevent contamination between patient and examiner. This is a physical barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description focuses on the physical properties and standards met by the glove.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition.
- Performance Studies: The performance studies focus on the physical integrity and biocompatibility of the glove, not on diagnostic accuracy.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This glove does not fit that description.
N/A
Intended Use / Indications for Use
Powdered 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
LYZ
Device Description
powdered vinyl patient examination gloves, (Light Yellow) that meets all of the requirements of ASTM standard D 5250-06.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand or finger
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
Nonclinical testing was performed.
Study type: Dimension, Physical Properties, Freedom from pinholes, Powder Amount, Biocompatibility (Primary Skin Irritation in rabbits, Dermal sensitization in the guinea pig).
Key results: The device meets ASTM standard D 5250-06, ASTM standard D 6124-01, 21 CFR 800.20, and ISO10993-10 standards. Freedom from pinholes meets 21 CFR 800.20. Powder Amount is
§ 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
AUG 20 2008 "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: K08) 657 - . " (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 : | JIANGSU CUREGUARD GLOVE CO., LTD. |
|---|---|
| Submitter's address : | NO. 205 JIANLING ROAD, THE ECONOMIC |
| DEVELOPMENT ZONE OF SUQIAN CITY, JIANGSU | |
| 223800 CHINA | |
| Phone number : | (86) 0527-4568102 |
| Fax number : | (86) 0527-4568100 |
| Name of contact person: | Mr.Zhang Bohoo |
| Date the summary was prepared: | May.26.2008 |
[(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: | Powdered Vinyl Patient Examination Gloves, (Light Yellow) |
|---|---|
| Proprietary/Trade name: | Rubber -Like |
| 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* powdered vinyl patient examination gloves, (Light Yellow) that meets all of the requirements of ASTM standard D 5250-06.
Predicate device : Powdered Vinyl Patient Examination Gloves, JIANGSU CUREGUARD GLOVE CO., LTD., K070075
[(a)(4)| A description of the device
1
Device Description : powdered vinyl patient examination gloves, (Light Yellow) that meets all of the requirements of ASTM standard D 5250-06.
[(a)(5)] The summary describes the intended use of the device
Device Intended Use: powdered vinyl patient examination glove, (Light Yellow) is a disposable device intended for nedical purposes that is worn on the examiner's hand or 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 powdered vinyl patient examination gloves,(Light Yellow)non sterile are summarized with the following technological characteristics compared to ASTM or equivalent standard.
| Characteristics | Standard | Device performance |
|---|---|---|
| Dimension | ASTM standard D 5250-06 | Meets |
| Physical Properties | ASTM standard D 5250-06 | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Amount | ASTM standard D 5250-06 |