(18 days)
Not Found
No
The device is a simple examination glove and the summary contains no mention of AI or ML.
No
The device is a glove intended to prevent contamination between patient and examiner, not to provide therapy.
No
Explanation: This device, a powder-free vinyl patient examination glove, is intended to prevent contamination between patient and examiner. It does not perform any diagnostic function such as identifying a disease or condition.
No
The device is a physical glove, not software. The description clearly states it is a "powder free vinyl patient examination glove" and references ASTM standards for physical properties.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device 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." This describes a barrier device used during physical examination, not a device used to examine specimens in vitro (outside the body) to diagnose or monitor a condition.
- Device Description: The description focuses on the physical characteristics and standards met by a glove.
- Lack of IVD Indicators: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process that would be performed in vitro.
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's function is purely as a physical barrier.
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 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(non-colored) that meets all of the requirements of ASTM standard D 5250-00-4
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
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 | Standard | Device performance |
|---|---|---|
| Dimension | ASTM standard D 5250-00c4 | Meets |
| Physical Properties | ASTM standard D 5250-00c4 | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Residual | ASTM standard D 5250-00c4 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
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 : | SHIJIAZHUANG WONDER PLASTIC CO.,LTD |
| Submitter's address : | NO.6 TONGDA ROAD, |
| JINZHOU CITY, HEBEI, 052260, P.R.CHINA | |
| Phone number : | (86) 311-4320507 |
| Fax number : | (86) 311-4320507 |
| Name of contact person: | Ms. Wang Jiawei |
| Date the summary was prepared: | 26 June 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, white(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 , white(non-colored) that meets all of the requirements of ASTM standard D 5250-0014.
Predicate device : FUGUAN (Brand) Powder-Free Vinyl Patient Examination Gloves, Shijiazhuang Fuguan Plastic Products Co., Ltd.. K032908 .
[(a)(4)] A description of the device
Device Description : powder free vinyl patient examination gloves, white(non-colored) that meets all of the requirements of ASTM standard D 5250-00-4
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[(a)(5)] The summary describes the intended use of the device
Device Intended Use: powder free vinyl patient examination glove, white(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 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 5250-00c4 | Meets |
| Physical Properties | ASTM standard D 5250-00c4 | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Residual | ASTM standard D 5250-00c4 | Meets |
| and D6124-01 |