(46 days)
Not Found
No
The 510(k) summary describes a standard medical glove and makes no mention of AI or ML technology.
No
The device is a patient examination glove, intended to prevent contamination, not to treat a disease or condition.
No
Explanation: This device is a patient examination glove, which is used to prevent contamination. It does not perform any diagnostic function.
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 standards like ASTM D 5250-06.
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 properties and standards met by the glove (vinyl, powder-free, ASTM standards). This aligns with a medical device used for protection, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, reagents, calibrators, controls, or any other components typically associated with IVD devices.
- Performance Studies: The performance studies mentioned are nonclinical tests related to the physical properties and safety of the glove, not analytical or clinical performance studies typical for IVDs.
In summary, the device's purpose is to provide a physical barrier during patient examination, which falls under the category of a general medical device, not an In Vitro Diagnostic device.
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
LYZ
Device Description
powder free 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)
Nonclinical tests were conducted. "Powder free vinyl patient examination gloves , Clear(non-colored) meet requirements per ASTM D5250-06, per ASTM D6124-01, per 21 CFR 800.20 and ISO10993-10."
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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 Residual:
§ 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: ." (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 LINYUAN PLASTIC PRODUCTS
CO.,LTD. | |
|--------------------------------|--------------------------------------------------------------------------------|--|
| Submitter's address : | SIGEZHUANG, LUANNAN COUNTY,
TANGSHAN CITY, HEBEI PROVINCE,
063503, CHINA | |
| Phone number : | (86) 315-4169201 | |
| Fax number : | (86) 315-4169311 | |
| Name of contact person: | Mr. Zhang Liang | |
| Date the summary was prepared: | Sep. 1st,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: | Powder Free Vinyl Patient Examination Gloves, Clear(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 , 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
Device Description ; powder free 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: powder free 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 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 5250-06 | Meets |
| Physical Properties | ASTM standard D 5250-06 | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Residual | ASTM standard D 5250-06 | |
| and D6124-01 |