(49 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 powdered vinyl patient examination glove, is intended for preventing contamination between patient and examiner and does not provide therapy or treatment for a disease or condition.
No
Explanation: The device is a powdered vinyl patient examination glove, which is used for contamination prevention during examinations. Its intended use does not involve diagnosing medical conditions, but rather providing a barrier.
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 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 5250-00-3). This is consistent with a medical device used for protection, not for diagnosing a condition.
- 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 assays.
The device is clearly described as a patient examination glove, which falls under the category of medical devices used for protection and barrier purposes.
N/A
Intended Use / Indications for Use
Powdered vinyl patient examination glove (white, yellow) 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, yellow) that meets all of the requirements of ASTM standard D 5250-00-3.
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 was performed. Powdered vinyl patient examination gloves (white, yellow) meet requirements per ASTM D5250-0054, per ASTM D6124-01, per 21 CFR 800.20 and ISO10993-10. Clinical data was not needed. The conclusions drawn from the nonclinical tests demonstrate that the device is as safe, as effective, and performs as well or better than the legally marketed device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
SEP - 2 2005 Premarket Notification 【510(K)】 Summa
"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 : | SHIJIAZHUANG MANFUL LIGHT INDUSTRIAL
PRODUCTS CO., LTD | |
|--------------------------------|---------------------------------------------------------------|--|
| Submitter's address : | NO.78 CANGSHI ROAD, JINZHOU CITY, HEBEI, 052260,
P.R.CHINA | |
| Phone number : | (86)0311-4318269 | |
| Fax number : | (86)0311-4322592 | |
| Name of contact person: | Mr. Guo Huanqiang | |
| Date the summary was prepared: | 15 August 2005 | |
[(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,Colored
(White, Yellow) |
|-------------------------|-----------------------------------------------------------------------------|
| 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 (white, yellow) that meets all of the requirements of ASTM standard D 5250-00-4.
Predicate device : Powdered Vinyl Patient Examination Gloves, Powdered Vinyl Patient Examination Gloves,K042120
[(a)(4)] A description of the device
Device Description : powdered vinyl patient examination gloves (white, yellow) that meets all of the requirements of ASTM standard D 5250-00-3.
1
Device Intended Use: powdered vinyl patient examination glove (white, yellow) 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, yell low) 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 |