(27 days)
Not Found
No
The device is a simple examination glove and the summary contains no mention of AI, ML, or related technologies.
No
The device is described as a disposable glove intended to prevent contamination between patient and examiner, with no mention of treating or monitoring a disease or condition.
No
Explanation: The device is a "Powder Free Vinyl Patient Examination Gloves," which is used as a barrier for examination and does not diagnose any condition.
No
The device is a physical glove, not software. The description clearly states it is a disposable device worn on the hand or finger and references physical standards and tests.
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 function performed in vitro (outside the body).
- Device Description: The description focuses on the physical properties and standards met for a glove.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health condition.
- Performance Studies: The performance studies focus on the physical integrity and safety of the glove (dimensions, pinholes, irritation, sensitization), not on diagnostic accuracy.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This glove does not perform any of these functions.
N/A
Intended Use / Indications for Use
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) 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, Clear (non-colored) 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
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 data:
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored), meet requirements per ASTM D5250-06 e1, per ASTM D6124-06, per 21 CFR 800.20 and FDA recognition number 2-87: AAMI / ANSI / ISO 10993-10:2002.
Clinical data: Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.
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
Section C 510(k) Summary (21 CFR 807.92)
APR 22 2010
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 : | Suzhou Shengyuda Plastic Products Co.,Ltd. |
|---|---|
| Submitter's address : | Zhitang Industrial Park,Zhitang Town Changshu City |
| Jiangsu Province,215531,China | |
| Phone number : | 86-512-52553368 |
| Fax number : | 86-512-52515875 |
| Name of contact person: | Ms.Chen Su |
| Date the summary was prepared: | Mar.10, 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:
್ನ
Powder Free Vinyl Patient Examination Gloves. Clear (non-colored)
Proprietary/Trade name:
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) Other clients private labeling
Common Name: Classification Name: Device Classification: Regulation Number: Panel: Product Code:
Exam gloves Patient examination glove I 21 CFR 880.6250 General Hospital (80) 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 5250-06e1.
1
Predicate device: FUGUAN (Brand) Powder-Free Viny) Patient Examination Gloves, Shijiazhuang Fuguan Plastic Products Co., Ltd.. K032908 .
{(a)(4)| A description of the device .
ﺎ ﻟﻠ
Device Description: Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) 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, 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, 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 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 e1 | |
| and D6124-06 | Meets |