(41 days)
Not Found
No
The 510(k) summary describes a standard medical glove and makes no mention of AI or ML technology.
No
The device, powder-free vinyl patient examination gloves, is intended to prevent contamination between patient and examiner, serving as a barrier, not to provide therapy or treatment for a disease or condition.
No
Explanation: The device is a patient examination glove, which is used for contamination prevention during examination, not for diagnosing a medical condition.
No
The device is a physical glove, not software. The description clearly states it is a "powder free vinyl patient examination glove" and describes its physical properties and testing against ASTM standards.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is "worn on the examiner's hand or finger to prevent contamination between patient and examiner." This describes a barrier device used for protection during physical examination, not a device used to examine specimens in vitro (outside of the body) to diagnose a condition.
- Device Description: The description is for a physical glove, not a reagent, instrument, or software used for testing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting specific analytes (proteins, DNA, antibodies, etc.)
- Providing diagnostic information about a patient's health status.
- Regulatory Classification: Patient examination gloves are typically classified under a different regulatory category than IVDs (often Class I or Class II medical devices, but not specifically IVDs). The predicate device K number (K042119) would also confirm its non-IVD classification.
In summary, the device is a physical barrier intended for protection during patient examination, which is a different category of medical device than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Powder free vinyl patient examination glove colored (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
powder free vinyl patient examination gloves (white, yellow) that meets all of the requirements of ASTM standard D 5250-00t4.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
SHIJIAZHUANG MANFUL LIGHT INDUSTRIAL PRODUCTS CO., LTD K042119
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
C Summary
JUN 1 4 2005
"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: | 4 April 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: | Powder Free Vinyl Patient Examination Gloves, Colored
(White, Yellow) | |
|-------------------------|--------------------------------------------------------------------------------|--|
| Proprietary/Trade name: | Powder Free 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* powder free vinyl patient examination gloves (white, yellow) that meets all of the requirements of ASTM standard D 5250-0004.
Predicate device : Powder-Free Vinyl Patient Examination Gloves,. SHIJIAZHUANG MANFUL LIGHT INDUSTRIAL PRODUCTS CO., LTD K042119 .
[(a)(4)] A description of the device
Device Description : powder free vinyl patient examination gloves (white, yellow) that meets all of the requirements of ASTM standard D 5250-00t4.
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K05 1156
{(a)(5)] The summary describes the intended use of the device
Device Intended Use: powder free vinyl patient examination glove colored (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 powder free vinyl patient examination gloves, 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 Residual | ASTM standard D 5250-00e4 | Meets |
| and D6124-01 |