(290 days)
Not Found
No
The device is a simple examination glove and the summary contains no mention of AI, ML, or related technologies.
No
This device, a powdered vinyl patient examination glove, is intended to prevent contamination between patient and examiner rather than treat a disease or condition.
No
The device is described as a glove intended to prevent contamination, not to diagnose a medical condition.
No
The device described is a physical medical device (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 is "worn on the examiner's hand or finger to prevent contamination between patient and examiner." This describes a barrier device used externally for protection, not a device used to examine specimens in vitro (outside the body) to diagnose a condition.
- Device Description: The description is for a "powdered vinyl patient examination glove," which is a physical barrier.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process that would be performed in vitro to provide diagnostic information.
IVDs are devices used to examine specimens taken from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This glove does not fit that description.
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
LYZ
Device Description
powdered vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-0084.
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
Nonclinical testing demonstrated that the device meets requirements per ASTM D5250-004, per ASTM D6124-01, per 21 CFR 800.20 and ISO10993-10, including freedom from pinholes, physical properties, powder amount, and biocompatibility (Primary Skin Irritation in rabbits and Dermal sensitization in the guinea pig). Clinical data was not needed for a 510(k) clearance. The device was concluded to be as safe and effective as the predicate device.
Key Metrics
Freedom from pinholes: Meets 21 CFR 800.20
Biocompatibility: Primary Skin Irritation in rabbits
§ 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
MAY - 8 2000
"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: ______________________________________________________________________________________________________________________________________________
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 : | Tangshan hongyun Plastic Products co., ltd |
|---|---|
| Submitter's address : | South wangzhuang, Pachigang, Luannan Town, Hebei |
| Province, 063500, P. R. China | |
| Phone number : | (86) - 315-4426258 |
| Fax number : | (86) - 315-4426258 |
| Name of contact person: | Mr. GENG Haitao |
| Date the summary was prepared: | Jul. 10.2007 |
[(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: | 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, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-0084.
Predicate device : FUGUAN (Brand) Powdered Viny) Patient Examination Gloves, Shijiazhuang Fuguan Plastic Products Co., Ltd.. K032907.
[(a)(4)] A description of the device
1
Device Description : powdered vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-0084.
[(a)(5)] The summary describes the intended use of the device
Device Intended Use: powdered vinyl patient cxamination 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 5250-00e4 | Meets |
| Physical Properties | ASTM standard D 5250-00e4 | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Amount | ASTM standard D 5250-00e4 | Meets |
| Biocompatability | Primary Skin Irritation in rabbits |