(64 days)
Not Found
No
The device is a simple examination glove and the summary contains no mention of AI or ML.
No
The device, a patient examination glove, is intended to prevent contamination, not to treat or cure a disease or condition.
No
A diagnostic device is used to identify a disease, condition, or injury. Examination gloves are used to prevent contamination and are not involved in diagnosis.
No
The device is a physical glove, not software. The description clearly states it is a "powdered vinyl patient examination glove" and references physical standards (ASTM) and regulations (21 CFR 800.20).
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 during a physical examination.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. This device does not perform any such testing.
- Device Description: The description is for a physical glove, not a test kit or analytical instrument.
- Lack of IVD-related information: There is no mention of analyzing samples, detecting biomarkers, or any other activity associated with in vitro diagnostics.
Therefore, this powdered vinyl patient examination glove is a medical device, but it falls under a different category than IVDs.
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, white(non-colored) that meets all of the requirements of ASTM standard D 5250-0064
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 / 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
Nonclinical tests were conducted to demonstrate that the device is as safe, as effective, and performed as well or better than the legally marketed device.
The powdered vinyl patient examination gloves, white (non-colored) non sterile are summarized with the following technological characteristics compared to ASTM or equivalent standard:
- Dimension: Meets ASTM standard D 5250-00e4.
- Physical Properties: Meets ASTM standard D 5250-00e4.
- Freedom from pinholes: Meets 21 CFR 800.20
- Powder Amount: Meets ASTM standard D 5250-00e4
- Biocompatibility: Primary Skin Irritation in rabbits Passes (
§ 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
"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: K032907 ." (applicant leave blank)
NOV 2 0 2003
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 : | Shijiazhuang Fuguan Plastic Products Co., Ltd. |
|---|---|
| Submitter's address : | The Jia Village, Dahe County , Lu Quan City, Hebei Province, |
| 050204 P.R.China | |
| Phone number : | (86) 311 229 4202 |
| Fax number : | (86) 311 229 1575 |
| Name of contact person: | Chun-jing AN |
| Date the summary was prepared: | 12 September 2003 |
[(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,
White (Non-colored) | |
|-------------------------|-----------------------------------------------------------------------------------------------|--|
| Proprietary/Trade name: | FUGUAN (Brand) 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, white(non-colored) that meets all of the requirements of ASTM standard D 5250-0064.
Predicate device : powdered synthetic vinyl patient examination gloves, Shijiazhuang Eversharp Plastics Products Co., Ltd. K011884 .
[(a)(4)] A description of the device
Page 1of 2 Section C
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Device Description : powdered vinyl patient examination gloves, white(non-colored) that meets all of the requirements of ASTM standard D 5250-0064
[(a)(5)] The summary describes the intended use of the device
Device Intended Use: powdered vinyl patient examination glove , white(noncolored) 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, white (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 |