(43 days)
Not Found
No
The device is a simple disposable glove and the summary contains no mention of AI, ML, or any related technologies.
No.
The device, a powdered vinyl patient examination glove, is intended for preventing contamination between patient and examiner, not for treating a disease or condition.
No
Explanation: The device, a powdered vinyl patient examination glove, is intended for preventing contamination during examination and does not perform any diagnostic function.
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 is clearly stated as a "disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner." This describes a barrier device used during physical examination, not a device used to examine specimens in vitro (outside of the body) to diagnose or monitor a condition.
- Device Description: The description focuses on the physical properties and standards met by the glove (powdered vinyl, ASTM standards). There is no mention of reagents, assays, or any components typically associated with in vitro testing.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting specific analytes (proteins, DNA, antibodies, etc.)
- Providing diagnostic or monitoring information based on laboratory results.
The device is a medical device, specifically a patient examination glove, but it falls under a different regulatory 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 (comma separated list FDA assigned to the subject device)
LYZ
Device Description
Powdered vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-06.
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 / 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 powdered vinyl patient examination gloves, Clear (non-colored) non sterile are summarized with the following technological characteristics compared to ASTM or equivalent standard.
- Dimension: Meets ASTM standard D 5250-06'
- Physical Properties: Meets ASTM standard D 5250-06'
- Freedom from pinholes: Meets 21 CFR 800.20
- Powder Amount: Meets ASTM standard D 5250-06'
- Biocompatibility:
§ 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
"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: ______________________________________________________________________________________________________________________________________________
JUL 27 2010
Premarket Notification {510(k)} Sumnary
1(2)(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 : | HEBEI EXCELLENT PLASTIC CO., LTD |
|---|---|
| Submitter's address : | RM602, UNIT 2, #43 BUILDING, LONGQUAN GARDEN, |
| SHANGZHUANG TOWN LUQUAN CITY, HEBEI, 050081, CHINA | |
| Phone number : | (86)- 311-83985366 |
| Fax number : | (86)- 311-83986358 |
| Name of contact person: | Mr. Edward Liu |
| Date the summary was prepared: | June 4th, 2010 |
[(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: | 1 |
| 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 5250-06.
Predicate device : FUGUAN (Brand) Powdered Vinyl 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 5250-06.
[(a)(5)] The summary describes the intended use of the device
Device Intended Use: powdered 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.
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 5250-06' | Meets |
| Physical Properties | ASTM standard D 5250-06' | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Amount | ASTM standard D 5250-06' | Meets |
| Biocompatability |