(74 days)
Not Found
No
The device is a simple examination glove and the description and performance studies focus on material properties and safety, with no mention of AI/ML.
No
The device is described as a "patient examination glove" intended to "prevent contamination between patient and examiner," which is a barrier function, not a therapeutic one. It does not treat or cure any condition.
No
The device, a patient examination glove, is intended to prevent contamination between patient and examiner, not to diagnose a medical condition.
No
The device is a physical glove, not software. The description explicitly states it is a "powder free vinyl patient examination glove" and details its physical properties and testing.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is a "patient examination glove" worn on the hand or finger to prevent contamination between patient and examiner. This is a barrier device used during physical examination, not a device used to examine specimens from the human body in vitro (outside the body).
- Device Description: The description focuses on the physical properties and standards met by the glove (vinyl, powder-free, ASTM standards).
- Lack of IVD Characteristics: There is no mention of:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information about a patient's health status based on sample analysis
- Any reagents, calibrators, or controls typically associated with IVD tests.
The device described is a Class I medical device used for barrier protection during patient examination.
N/A
Intended Use / Indications for Use
Powder free vinyl patient examination glove 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
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
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The powder free vinyl patient examination gloves, non sterile are summarized with the following technological characteristics compared to ASTM or equivalent standard:
- Dimension: Meets ASTM standard D 5250-06 e1.
- Physical Properties: Meets ASTM standard D 5250-06 e1.
- Freedom from pinholes: Meets 21 CFR 800.20.
- Powder Residual:
§ 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
DEC - 8 2009
:・
"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: KO929C6 " (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 : | Jin Zhou Chang Hao Plastic Products Co.,Ltd. | |
|---|---|---|
| Submitter's address : | Dong Dui Village Mayu Town,Jinzhou,Shi Jia | |
| Zhuang City,Hebei Province,052260,China | ||
| Phone number : | 86-311-84355868 | |
| Fax number : | 86-311-84355868 | |
| Name of contact person: | Ms.Gao Su | |
| Date the summary was prepared: | Sep 09.2009 |
[(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,
Clear(non-colored) |
|-------------------------|--------------------------------------------------------------------------------|
| Proprietary/Trade name: | Powder Free Vinyl Patient Examination Gloves
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, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-06e1.
Section C
1
Passes
Not a Dermal sensitization
Predicate device: FUGUAN (Brand) Powder-Free Vinyl Patient Examination Gloves, Shijiazhuang Fuguan Plastic Products Co., Ltd.. K032908 .
[(a)(4)] A description of the device
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 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.
| 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 |