(44 days)
Not Found
No
The device is a simple examination glove and the summary contains no mention of AI or ML.
No
This device, a glove, is intended to prevent contamination, not to provide therapy or treatment for a disease or condition.
No
The device is described as examination gloves used to prevent contamination, which is a protective barrier, not a diagnostic tool.
No
The device is a physical glove, not software. The description clearly states it is a disposable device worn on the hand or finger.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a barrier device worn on the hand or finger to prevent contamination between patient and examiner. This is a physical barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description focuses on the material (vinyl), color, and adherence to a standard for examination gloves (ASTM D 5250-06). This is consistent with a medical device for examination, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information about a patient's health status.
- Performance Studies: The performance studies focus on physical properties like waterleak tests and adherence to standards for gloves, not diagnostic accuracy metrics.
IVDs are devices used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
Powder Free Vinyl Patient Examination Gloves, Colored (Yellow), 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 (Yellow) 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 / medical purposes
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
Nonclinical testing: Powder free Vinyl Patient Examination Gloves, Colored (Yellow) meet requirements per ASTM D5250-06, per ASTM D6124-01, per 21 CFR 800.20 and ISO10993-10. Clinical data: Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
"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. |
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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 (Yellow) |
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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 , colored (yellow) that meets all of the requirements of ASTM standard D 5250-06.
Predicate device : Powder free Vinyl Patient Examination Gloves(White, Yellow), SHIJIAZHUANG MANFUL LIGHT INDUSTRIAL PRODUCTS CO., LTD. K051156 .
[(a)(4)] A description of the device
Device Description : Powder free Vinyl Patient Examination Gloves, Colored (Yellow) that meets all of the requirements of ASTM standard D 5250-06.
f the device
1
[(a)(5)] The summary describes the intended use of the device
Device Intended Use: Powder free Vinyl Patient Examination Gloves, Colored (Yellow) 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 | Meets |
and D6124-01 |