(314 days)
Not Found
No
The device is a simple examination glove and the summary contains no mention of AI, ML, or any related technologies.
No.
The device description states it is a glove worn to prevent contamination between patient and examiner, which is a barrier function, not a therapeutic one.
No
Explanation: The device, powdered vinyl patient examination gloves, is described as a disposable device intended for medical purposes worn on the hand or finger to prevent contamination. It does not perform any diagnostic function such as detecting, diagnosing, or monitoring a disease or condition.
No
The device is a physical product (gloves) and the description focuses on material standards and physical properties, not software functionality.
No, 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 a sample taken from the body.
- Device Description: The description focuses on the material (powdered vinyl) and adherence to standards for examination gloves.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing information about a patient's health status based on in vitro testing.
- Performance Studies: The performance studies focus on meeting standards for gloves (ASTM D5250-06, ASTM D6124-01, 21 CFR 800.20, ISO10993-10), which are related to the physical properties and safety of the glove, not diagnostic accuracy.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a barrier device used during a physical examination.
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 (comma separated list FDA assigned to the subject device)
LYZ
Device Description
powdered vinyl patient examination gloves, Clear(non-colored) 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The powdered vinyl patient examination gloves, Clear (non-colored) non sterile are summarized with the following technological characteristics compared to ASTM or equivalent standard.
- Dimension: Meets ASTM standard D 5250-06
- Physical Properties: Meets ASTM standard D 5250-06
- Freedom from pinholes: Meets 21 CFR 800.20
- Powder Amount:
§ 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: KO3247 . " (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 : | Tangshan Dar Plastic & Rubber Products Co., Ltd. |
|---|---|
| Submitter's address : | Tangshan Sanxin High tech Industrial estate, Tanggu |
| Road, Tangshan city, Hebei province, 063100, P.R.China | |
| Phone number : | (86) 315-5028910 |
| Fax number : | (86) 315-5028929 |
| Name of contact person: | Mr. Wang Jincheng |
| Date the summary was prepared: | Sept. 04, 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,
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 5250-06.
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 5250-06.
[(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 5250-06 | Meets |
| Physical Properties | ASTM standard D 5250-06 | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Amount | ASTM standard D 5250-06 | Meets |
| Biocompatability | Primary Skin Irritation in | |
| rabbits |