(271 days)
Not Found
No
The device is a simple examination glove and the description and performance studies focus on material properties and standard compliance, with no mention of AI/ML.
No.
The device is a glove for preventing contamination, not for treating a disease or condition.
No
The document describes a powdered vinyl patient examination glove, which is a barrier device for preventing contamination, not a device used for diagnosing a medical condition.
No
The device is a physical product (gloves) and the description focuses on material standards and performance tests related to the physical properties of the gloves, not software functionality.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to prevent contamination between patient and examiner by being worn on the hand or finger. This is a physical barrier function, not a diagnostic test performed in vitro (outside the body) on specimens like blood, urine, or tissue.
- Device Description: The description focuses on the material (powdered vinyl) and adherence to a standard for examination gloves (ASTM D 5250-06). This is consistent with a medical device used for protection, not for analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens.
- Detecting or measuring substances in the body.
- Providing information for diagnosis, monitoring, or screening.
- Using reagents or analytical methods.
The device is clearly described as a patient examination glove, which falls under the category of medical devices used for protection and hygiene during examinations.
N/A
Intended Use / Indications for 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.
Product codes
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
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.
Characteristics: Dimension, Standard: ASTM standard D 5250-06, Device performance: Meets
Characteristics: Physical Properties, Standard: ASTM standard D 5250-06, Device performance: Meets
Characteristics: Freedom from pinholes, Standard: 21 CFR 800.20, Device performance: Meets
Characteristics: Powder Amount, Standard: ASTM standard D 5250-06, Device performance: Meets
Characteristics: Biocompatability, Device performance:
§ 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
Attachment I.
og I of 2
Summary
APR 2 7 2011
"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: K102 151 - . " (applicant leave blank)
Premarket Notification [510(k)] Summary
I(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 : | HEBEI TENGDA PLASTIC CO., LTD | |
|---|---|---|
| Submitter's address : | RM102, UNIT 2, #6 BUILDING, #118 DONGFENG RD. | |
| SHIJIAZHUANG, 050000, CHINA | ||
| Phone number : | (86) - 311-83985266 | |
| Fax number : | (86) - 311-83986358 | |
| Name of contact person: | Ms. Sun Meng | |
| Date the summary was prepared: | July 28th, 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: | 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 5250-06.
Predicate device : FUGUAN (Brand) Powdered Vinyl Patient Examination Gloves, Shijiazhuang Fuguan Plastic Products Co., Ltd.. K032907.
[(a)(4)] A description of the device
Device Description : powdered vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-06.
1
{(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 |