(24 days)
Not Found
No
The device is a simple examination glove and the summary contains no mention of AI, ML, or related technologies.
No
The device, a patient examination glove, is intended to prevent contamination, not to treat or cure a disease or condition.
No
The device, a powdered vinyl patient examination glove, is intended to prevent contamination and is not used to diagnose a medical condition.
No
The device is a physical product (gloves) and the description focuses on material properties and performance standards for a physical barrier, 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 "worn on the examiner's hand or finger to prevent contamination between patient and examiner." This describes a barrier device used externally during a physical examination.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. This device does not perform any such testing.
- Device Description: The description focuses on the physical properties and standards met by a glove, not on any diagnostic capabilities.
- Lack of Diagnostic Information: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information.
Therefore, this powdered vinyl patient examination glove is a medical device, but it falls under a different classification than an IVD.
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, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-00ed
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 / 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
Nonclinical testing summarized by: table comparing characteristics (Dimension, Physical Properties, Freedom from pinholes, Powder Amount, Biocompatability) to ASTM standard D 5250-00e4, 21 CFR 800.20, Primary Skin Irritation in rabbits, and Dermal sensitization in the guinea pig. Device performance "Meets" for all except Powder Amount which 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
"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: 10 0 282 ." (applicant leave blank)
Premarket Notification [510(k)] Summary
OCT 2 0 2006
[(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: | Powdered Vinyl Patient Examination Gloves,
Clear (Non-colored) |
|-------------------------|-----------------------------------------------------------------------------|
| Proprietary/Trade name: | Powdered 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* powdered vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-0064.
Predicate device : FUGUAN (Brand) Powdered Vinyl Patient Examination Gloves, Shijiazhuang Fuguan Plastic Products Co., Ltd.. K032907.
[(a)(4)] A description of the device
1
Device Description : powdered vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-00ed
[(a)(5)] The summary describes the intended use of the device
Device Intended Use: powdered vinyl patient examination glove, Clear(non-colored) 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)(6)] A summary of the technological characteristics of new device compared to the predicate device.
The powdered vinyl patient examination gloves, Clear (non-colored) 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 Amount | ASTM standard D 5250-00e4 |