(134 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, a patient examination glove, is intended for preventing contamination, not for treating any medical condition or disease.
No
The device is a glove, used to prevent contamination, not to diagnose a condition.
No
The device is a physical glove, not software. The description clearly states it is a "Powder free vinyl patient examination glove" and mentions physical testing standards like ASTM.
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: It's a glove, a physical barrier.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting substances, or providing information about a patient's health status.
- Regulatory Classification: Patient examination gloves are typically classified as Class I medical devices and are regulated under different sections of the FDA regulations than IVDs.
IVDs are devices intended for use in vitro for the examination of specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This glove does not fit that description.
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
Not Found
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 / 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)
Non-clinical testing data was submitted, referenced or relied on to demonstrate that the Subject Device is safe and effective, and whose performance meets the requirements of its pre-defined acceptance criteria and intended uses.
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)meet requirements per ASTM D5250-06, per ASTM D6124-06, per 21 CFR 800.20 and ISO10993-10. , it is safe and effective, and it's performance meets the requirements of its pre-defined acceptance criteria and intended uses.
Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
| Characteristics | Standard | Device performance | Result of comparison |
|---|---|---|---|
| Predicate device | Subject device | ||
| Dimension | ASTM standard D 5250-06 | Meets | Meets |
| Physical Properties | ASTM standard D 5250-06 | Meets | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets | Meets |
| Powder Residual | ASTM standard D 5250-06 and D6124-06 | Meets |
§ 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
"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(c)."
"The assigned 510(k) number is: [120397 7_ ." (applicant leave blank)
Premarket Notification [510(k)] Summary
I(a)(1)). The summary contains on the first page, preferably on your letterhead paper, the submitter's name, address, phone and fax purchers, name of contact person, and date the summary was prepared :
| Submitter's name : | Shandong Shouguang KingLiYuan Medical Apparatus &
Instrument Co.,Ltd |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter's address : | North of Xinhua Road & West of Dajiu Road, Houzhen
Project Concentration Zone, Shouguang City, Weifang
City, Shandong Province, China |
| Phone number : | (86)536-5399866 |
| Fax number : | (86)536-5399990 |
| Name of contact person: | Mr. Hao Feng |
| Date the summary was prepared: | Mar. 13th, 2012 |
[(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, Clear (non-colored) |
|---|---|
| Proprietary/Trade name: | Powder Free Vinyl Patient Examination Gloves |
| 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, Clear (non-colored) that meets all of the requirements of ASTM standard D 5250-06.
Predicate device : FUGUAN (Brand) Powder-Free Vinyl Patient Examination Gloves, Shijiazhuang Fuguan Plastic Products Co., Ltd.. K032908 .
[(a)(4)] A description of the device
1
[(a)(5)] The summary describes the intended use of the device
Device Intended Use: Powder Free Vinyl Patient Examination Gloves, 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 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 | Result of comparison | |
|---|---|---|---|---|
| Predicate device | Subject device | |||
| Dimension | ASTM standard | |||
| D 5250-06 | Meets | Meets | substantial equivalence | |
| Physical Properties | ASTM standard | |||
| D 5250-06 | Meets | Meets | substantial equivalence | |
| Freedom from | ||||
| pinholes | 21 CFR 800.20 | Meets | Meets | substantial equivalence |
| Powder Residual | ASTM standard | |||
| D 5250-06 | ||||
| and D6124-06 | Meets |