(16 days)
Not Found
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 between patient and examiner, not to treat or cure a disease or condition. It is a barrier device for protection.
No
Explanation: The device is a "patient examination glove" intended to "prevent contamination between patient and examiner." Its function is barrier protection, not diagnosis.
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 5250-000.
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 barrier function, not a diagnostic test performed in vitro (outside the body) on specimens like blood, urine, or tissue.
- Device Description: The description is for a physical barrier (a glove) and references standards related to the physical properties and safety of gloves (ASTM D 5250-000, ASTM D6124-01, 21 CFR 800.20, ISO10993-10). These are not standards related to diagnostic testing.
- Lack of IVD-related information: There is no mention of analyzing specimens, detecting substances, or providing diagnostic information. The performance studies focus on nonclinical tests demonstrating equivalence based on physical properties and safety, not diagnostic accuracy metrics like sensitivity or specificity.
Therefore, this device is a medical device, specifically a patient examination glove, but it does not fit the definition of 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 5250-000
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 indicated that the device meets requirements per ASTM D5280-00th, per ASTM D6124-01, per 21 CFR 800.20 and ISO10993-10. Clinical data was not needed.
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
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: 107 0000 (applicant leave blank) | ||||
|---|---|---|---|---|
| ------------------------------------------------------------------ | -- | -- | -- | -- |
JAN 19 2007
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 : | ZIBO HENGDE PLASTIC&RUBBER PRODUCTS CO., LTD |
|---|---|
| Submitter's address : | Zhangdian District ,SCIENCE/TEC.PARK OF |
| ZIBO , SHANGDONG PROVINCE, 255087, P.R. CHINA | |
| Phone number : | (86)- 533-3819127 |
| Fax number : | (86) - 533-3818127 |
| Name of contact person: | Mr. NIE Jian |
| Date the summary was prepared: | Dec. 28,2006 |
(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 5250-0004.
Predicate device/. FUGUAN (Brand) Powder-Free Vinyl Patient Examination Gloves, Shijjazhuang 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 5250-000
[(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 5250-00cd | Meets |
| Physical Properties | ASTM standard D 5250-00cd | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Residual | ASTM standard D 5250-00cd | Meets |
| Biocompatability | and D6124-01 |