(106 days)
Not Found
No
The device is a simple medical glove and the summary contains no mention of AI, ML, or any related technologies.
No
The device, "Powdered Vinyl Patient Examination Gloves," is intended to prevent contamination between patient and examiner, serving as a barrier device rather than providing therapeutic treatment.
No
The device is a non-sterile disposable glove, intended to prevent contamination, not to diagnose medical conditions.
No
The device is a physical product (gloves) and the description focuses on material standards and physical properties, not software functionality.
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 on a sample taken from the body.
- Device Description: The description focuses on the material and adherence to standards for examination gloves.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health condition.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / Indications for Use
Powdered 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 (comma separated list FDA assigned to the subject device)
LYZ
Device Description
Powdered 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
hand or finger
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical studies submitted: The device meets requirements per ASTM D5250-06 e1, per ASTM D6124-06, per 21 CFR 800.20 and FDA recognition number 2-152: AAMI / ANSI / ISO 10993-10:2002/Amd. 1:2006. Key results: Passes Primary Skin Irritation in rabbits (Not a Primary Skin Irritation), Passes Dermal sensitization in the guinea pig (Not a Dermal sensitization). Meets dimensional requirements, physical properties, freedom from pinholes, and powder amount (
§ 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)
510(k) Summary
JUL 2 1 2011
"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."
KIIO96 (applicant leave blank) "The assigned 510(k) number is: _
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:
Powdered Vinyl Patient Examination Gloves, Light Yellow Color
Proprietary/Trade name:
Powdered Vinyl Patient Examination Gloves, Light Yellow Color 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* Powdered Vinyl Patient Examination Gloves, Light Yellow Color that meets all of the requirements of ASTM standard D 5250-06e1.
1
Powdered Vinyl Patient Examination Gloves. Predicate device: Clear(Non-colored) ,ZHANG JIA GANG FENGYUAN PLASTIC PRODUCTS CO LTD. K091662.
[(a)(4)] A description of the device
Device Description: Powdered 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: Powdered 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 Powdered 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 Amount | ASTM standard D 5250-06 el | |
| and D6124-06 | Meets |