(18 days)
Not Found
No
The device is a standard examination glove and the summary contains no mention of AI or ML.
No
This device is a patient examination glove, intended for preventing contamination between patient and examiner, not for treating a disease or condition.
No
Explanation: The "Intended Use / Indications for Use" states that the device is "worn on the examiner's hand or finger to prevent contamination between patient and examiner." This describes a barrier device, not one used for diagnosis. There is no mention of recording, analyzing, or interpreting data for diagnostic purposes.
No
The device is a physical glove, not software. The description clearly states it is a "powder free vinyl patient examination glove" and mentions meeting ASTM standards for physical properties like waterleak tests.
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 taken from the body.
- Device Description: The description is for a glove, a physical barrier.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information about a patient's condition.
- Performance Studies: The performance studies focus on physical properties like waterleak tests and meeting ASTM standards for gloves, not on diagnostic accuracy metrics.
IVD devices are 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
"Powder free vinyl patient examination glove colored (white, yellow) 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
"powder free vinyl patient examination gloves (white, yellow) that meets all of the requirements of ASTM standard D 5250-0084."
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" / "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 (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 | 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 and D6124-01 |
§ 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
C 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."
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 : | Zibo SinoCare Plastic Products Co., Ltd |
|---|---|
| Submitter's address : | NO. 208 YiXi Road, Linzi District, Zibo, Shandong, |
| P.R. China, 255411 | |
| Phone number : | (86) 533-7488136 |
| Fax number : | (86) 533-7524666 |
| Name of contact person: | Chen Yan |
| Date the summary was prepared: | 20. May 2005 |
[(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, Colored (White, Yellow) | |
|---|---|---|
| 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: | 1 | |
| 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 frec vinyl patient examination gloves (white, yellow) that meets all of the requirements of ASTM standard D 5250-0064.
Predicate device : Powder-Free Vinyl Patient Examination Gloves,. SHIJIAZHUANG MANFUL LIGHT INDUSTRIAL PRODUCTS CO., LTD.,K015156
{(a}(4)] A description of the device
Device Description : powder free vinyl patient examination gloves (white, yellow) that meets all of the requirements of ASTM standard D 5250-0084.
1
Device Description : powder free vinyl patient examination gloves (white, yellow) that meets all of the requirements of ASTM standard D 5250-004
[(a)(5)] The summary describes the intended use of the device
Device Intended Use: powder free vinyl patient examination glove colored (white, yellow) 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.
J(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 |