(106 days)
Not Found
No
The device description and performance studies focus on the physical properties and standards compliance of examination gloves, with no mention of AI or ML.
No
The device is described as 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," indicating a preventative and barrier function rather than a therapeutic one.
No
Explanation: The device is described as "Powder Free Vinyl Patient Examination Gloves," which are intended to prevent contamination between the patient and examiner. There is no mention of the device being used for diagnosis, disease detection, or medical assessment.
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 clearly states the device is "worn on the examiner's hand or finger to prevent contamination between patient and examiner." This describes a barrier device used for infection control during physical examination.
- Lack of IVD Characteristics: An IVD is a medical device intended to be used in vitro for the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring or compatibility purposes. The description of these gloves does not involve any of these activities. There is no mention of analyzing samples, providing diagnostic information, or being used in a laboratory setting for testing.
- Device Description: The description focuses on meeting standards for physical properties and barrier function (ASTM D 5250-06e1, waterleak test). This aligns with the characteristics of a protective glove, not an IVD.
- Performance Studies: The performance studies mentioned are nonclinical tests related to the physical integrity and safety of the glove (waterleak test, biocompatibility). These are not the types of performance studies typically associated with IVDs, which would involve evaluating analytical and clinical performance related to the diagnostic information provided.
In summary, the intended use, device description, and performance studies all point to this device being a barrier device for infection control during patient examination, not an IVD.
N/A
Intended Use / Indications for Use
Powder Free Vinyl Patient Examination Gloves, White 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.
Product codes
LYZ
Device Description
Powder Free Vinyl Patient Examination Gloves, White 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
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 tests were conducted to demonstrate substantial equivalence. Powder Free Vinyl Patient Examination Gloves, White Color, meet requirements per ASTM D5250-06 e1 (Dimension, Physical Properties, Powder Residual), per ASTM D6124-06 (Powder Residual), per 21 CFR 800.20 (Freedom from pinholes) and FDA recognition number 2-87: AAMI / ANSI / ISO 10993-10:2002 (Biocompatibility: Primary Skin Irritation in rabbits, Dermal sensitization in the guinea pig). It was concluded that the device meets ASTM standard or equivalent standard and FDA requirements for waterleak test on pinhole AQL, and meets labeling claims. Clinical data was not needed for gloves.
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
MAR - 4 2010
Section C 510(k) Summary (21 CFR 807.92)
PDA CDRH DMC
JAN 27 2010
510(k) Summary
Received
"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 : | Jiangsu Cureguard Gloves Co.,Ltd. |
|---|---|
| Submitter's address : | No.205 Jianling Road, The Economic Development |
| Zone of Suqian City,Jiangsu | |
| Province,223800,China | |
| Phone number : | 86-527-88286001 |
| Fax number : | |
| Name of contact person: | Ms.Lynn Lee |
Date the summary was prepared: Oct.30, 2009
[(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 Color |
|---|---|
| Proprietary/Trade name: | Other clients private labeling |
| Common Name: | Exam gloves |
| 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 Color that meets all of the requirements of ASTM standard D 5250-06e1.
Section C(rev.02)
1
Predicate device: Powder-Free Vinyl Patient Examination Gloves (Light Yellow), JIANGSU CUREGUARD GLOVE CO.,LTD. K081655
[(a)(4)] A description of the device
Device Description : Powder Free Vinyl Patient Examination Gloves, White 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: Powder Free Vinyl Patient Examination Gloves, White 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 Powder Free Vinyl Patient Examination Gloves, White 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 e1. | Meets |
| Physical Properties | ASTM standard D 5250-06 e1. | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Residual | ASTM standard D 5250-06 e1 | |
| and | ||
| D6124-06 | Meets |