(47 days)
No
The device is a simple examination glove and the summary contains no mention of AI or ML.
No.
The device, a patient examination glove, is intended to prevent contamination rather than to treat or cure a disease or condition.
No
Explanation: The device is a patient examination glove, which is used for contamination prevention rather than diagnosing medical conditions.
No
The device is a physical product (gloves) and does not involve any software component.
Based on the provided information, 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 in vitro (outside the body) on specimens like blood, urine, or tissue.
- Device Description: The device is a glove, which is a physical barrier.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, 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 meeting ASTM standards for gloves, not on diagnostic accuracy metrics like sensitivity or specificity.
IVD devices are specifically designed to perform tests on specimens from the human body to provide information for diagnosis, monitoring, or screening. This glove does not fit that description.
N/A
Intended Use / Indications for Use
"powder free vinyl patient examination glove, white(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."
"This 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, white(non-colored) that meets all of the requirements of ASTM standard D 5250-00c4."
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 to demonstrate that the device meets requirements per ASTM D5250-004, ASTM D6124-01, 21 CFR 800.20 and ISO10993-10. This included evaluation of Dimension, Physical Properties, Freedom from pinholes, Powder Residual, and Biocompatability (Primary Skin Irritation in rabbits and Dermal sensitization in the guinea pig). The device meets all these specified standards and requirements. Clinical data was not needed for this device.
Key Metrics
Freedom from pinholes: 21 CFR 800.20 (Meets)
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
C 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: 1003415 " (applicant leave blank)
Premarket Notification [510(k)] Summary
((a)(1)]. The summary contains on the first page, preferably on vour letterhead paper, the submitter's name, address, phone and fax numbers, name of contact person, and date the summary was prepared :
| Submitter's name : | SHIJIAZHUANG WINFUL PLASTIC CO.,LTD | |
|---|---|---|
| Submitter's address : | NO.6 CANGSHI ROAD, JINZHOU CITY,HEBEI, 052260, | |
| P.R. China | ||
| Phone number : | (86)-311-4320503 | |
| Fax number : | (86)-311-4336614 | |
| Name of contact person: | Mr. Yin Mingfei | |
| Date the summary was prepared: | Dec.06.2004 |
(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, white(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 , white(non-colored) that meets all of the requirements of ASTM standard D 5250-00-4
Predicate device : FUGUAN (Brand) Powder-Free Vinyl Patient Examination Gloves, Shijiazhuang Fuguan Plastic Products Co., Ltd., K032908 .
[(a)(4)] A description of the device
Device Description : powder free vinyl patient examination gloves, white(non-colored) that meets all of the requirements of ASTM standard D 5250-00c4.
Section C Page 1of 2
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[(a)(5)] The summary describes the intended use of the device
Device Intended Use: powder free vinyl patient examination glove, white(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 5250-00e4 | Meets |
| Physical Properties | ASTM standard D 5250-00e4 | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Residual | ASTM standard D 5250-00e4 | Meets |
| Biocompatability | and D6124-01 |