(66 days)
Not Found
No
The device is a simple examination glove and the summary contains no mention of AI or ML.
No
The device, "Powder Free Vinyl Patient Examination Gloves", is intended to prevent contamination and is not described as treating or alleviating a medical condition, which is characteristic of a therapeutic device.
No
Explanation: The device is a "Powder Free Vinyl Patient Examination Gloves", which is an examination glove. Its purpose is to prevent contamination, not to diagnose a condition or disease.
No
The device is described as physical gloves, which are hardware, not software.
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 "worn on the examiner's hand or finger to prevent contamination between patient and examiner." This describes a barrier device used for protection during physical examination, not a device used to examine specimens derived from the human body for diagnostic purposes.
- Device Description: The description focuses on the physical properties and standards met by the gloves (ASTM D 5250-06), which are relevant to their function as a barrier.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information. The device's function is purely protective.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.
N/A
Intended Use / Indications for Use
Powder Free Vinyl Patient Examination Gloves, Colored (White) 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, Colored (White) 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 powder free vinyl patient examination gloves, 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 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
510 (K) Summary
NOV 1 2 2010
"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: ______________________________________________________________________________________________________________________________________________
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 HENGDA PLASTIC PRODUCTS
CO.,LTD. | |
|--------------------------------|---------------------------------------------------------------------------------|--|
| Submitter's address : | NORTH ROAD, LUANNAN COUNTY,
TANGSHAN CITY , HEBEI PROVINCE, 063500,
CHINA | |
| Phone number : | (86) 315-4169201 | |
| Fax number : | (86) 315-4169311 | |
| Name of contact person: | Mr. Fred Zhang | |
| Date the summary was prepared: | Aug 10th, 2010 | |
[(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) |
|---|---|
| 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, Colored (White) that meets all of the requirements of ASTM standard D 5250-06.
Predicate device : Powder free Vinyl Patient Examination Gloves,. SHIJIAZHUANG MANFUL LIGHT INDUSTRIAL PRODUCTS CO., LTD.,K051156 .
[(a)(4)] A description of the device
1
Device Description : powder free vinyl patient examination gloves, Colored (White) 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, Colored (White) 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 D6124-06 |