(33 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 powdered vinyl patient examination glove, is intended for medical purposes to prevent contamination between patient and examiner, not to provide therapy.
No
Explanation: The device is described as a "powdered vinyl patient examination glove" intended to prevent contamination. There is no mention of it being used to diagnose a medical condition or disease.
No
The device is a physical product (gloves) and not software. The description clearly outlines a tangible medical device intended for physical use.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "worn on the examiner's hand or finger to prevent contamination between patient and examiner." This describes a barrier device used externally during a physical examination.
- Device Description: The description is for a "powdered vinyl patient examination glove." This is a physical barrier.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze such specimens.
- No Mention of Diagnostic Testing: The description and performance studies focus on the physical properties and safety of the glove as a barrier, not on any diagnostic capabilities.
Therefore, this device falls under the category of a medical device, but specifically a patient examination glove, which is not an IVD.
N/A
Intended Use / Indications for Use
Powdered 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 (comma separated list FDA assigned to the subject device)
LVZ, LYZ
Device Description
powdered vinyl patient examination gloves, Clear(non-colored) 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)
Nonclinical tests were conducted. "Powdered vinyl patient examination gloves, Clear(non-colored) meet requirements per ASTM D5250-06, per ASTM D6124-01, per 21 CFR 800.20 and ISO10993-10." The characteristics tested were Dimension, Physical Properties, Freedom from pinholes, Powder Amount, and Biocompatability (Primary Skin Irritation in rabbits, Dermal sensitization in the guinea pig). The device performance met all listed standards.
Clinical data was not needed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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: ______________________________________________________________________________________________________________________________________________ ." (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 : | SHIJIAZHUANG UNIVERSAL CHANNEL PLASTIC CO., LTD |
|---|---|
| Submitter's address : | INDUSTRIAL PARK, PINGSHAN COUNTY, SHIJIAZHUANG, |
| 050000, CHINA | |
| Phone number : | (86)- 311-83985366 |
| Fax number : | (86)- 311-83986358 |
| Name of contact person: | Mr. Mike Xu |
| Date the summary was prepared: | Apr. 28, 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: | Powdered Vinyl Patient Examination Gloves,
Clear (Non-colored) | |
|-------------------------|-----------------------------------------------------------------------------|--|
| Proprietary/Trade name: | Powdered 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: | LVZ | |
((a)(3)]. An identification of the legally marketed device to which your firm is claiming substantial equivalence .
Class I* powdered vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-06.
Predicate device : FUGUAN (Brand) Powdered Vinyl Patient Examination Gloves, Shijiazhuang Fuguan Plastic Products Co., Ltd.. K032907.
[(a)(4)] A description of the device
Device Description : powdered vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-06.
1
[(a)(5)] The summary describes the intended use of the device
Device Intended Use: powdered 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 powdered vinyl patient examination gloves, Clear (non-colored) 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 Amount | ASTM standard D 5250-06 | Meets |
| Biocompatability | Primary Skin Irritation in rabbits |