(61 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 described as examination gloves used to prevent contamination, which is a barrier function, not a therapeutic intervention.
No
Explanation: The device is described as an examination glove intended to prevent contamination, not to diagnose medical conditions or diseases.
No
The device is described as "Powder Free Vinyl Patient Examination Gloves," which are physical gloves and not software. The description and performance studies focus on physical properties and standards related to gloves.
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 for preventing contamination between patient and examiner by being worn on the hand or finger. This is a barrier function, not a diagnostic test performed in vitro (outside the body).
- Device Description: The description focuses on the physical characteristics and adherence to standards for examination gloves.
- Lack of IVD Indicators: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health condition.
- Anatomical Site: The anatomical site is the hand or finger, which is where the glove is worn, not where a diagnostic test would be performed.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
Powder Free Vinyl Patient Examination Gloves, Light Yellow Color is a non-sterile 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, Light Yellow Color that meets all of the requirements of ASTM standard D 5250-06e1.
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
Nonclinical testing was performed based on ASTM standard D 5250-06 e1, ASTM D6124-06, 21 CFR 800.20 and FDA recognition number 2-152: AAMI / ANSI / ISO 10993-10:2002/Amd. 1:2006. The device met the performance criteria for dimension, physical properties, freedom from pinholes, 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
Section C 510(k) Summary (21 CFR 807.92)
JUN - 6 2011
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: ______________________________________________________________________________________________________________________________________________ " (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 : | PPP Medical and Safety Products Company
Limited |
|--------------------------------|----------------------------------------------------|
| Submitter's address : | Xinlian,Houqiao Town, Wuxi,Jiangsu,214106,China |
| Phone number : | 0086-510-88725378 |
| Fax number : | 0086-510-88725378 |
| Name of contact person: | Mr. Zou Xiaojun |
| Date the summary was prepared: | Feb 9. 2011 |
[(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,
Light Yellow Color |
|-------------------------|-------------------------------------------------------------------------------------------------------|
| Proprietary/Trade name: | Powder Free Vinyl Patient Examination Gloves,
Light Yellow Color
Other clients private labeling |
| Common Name: | Exam gloves |
| 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, Light Yellow Color that meets all of the requirements of ASTM standard D 5250-06e1.
1
Predicate device: Powder-Free Vinyl Patient Examination Gloves, Clear (Non-colored), ZHANG JIA GANG FENGYUAN PLASTIC PRODUCTS CO LTD.. K091663 .
[(a)(4)] A description of the device
Device Description: Powder Free Vinyl Patient Examination Gloves, Light Yellow Color that meets all of the requirements of ASTM standard D 5250-06e1.
[(a)(5)] The summary describes the intended use of the device
Device Intended Use: Powder Free Vinyl Patient Examination Gloves, Light Yellow Color 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, Light Yellow Color, 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 el. | Meets |
| Physical Properties | ASTM standard D 5250-06 el. | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Residual | ASTM standard D 5250-06 el | |
| and D6124-06 | Meets |