(44 days)
Not Found
No
The device is a disposable examination glove, and the description and performance studies focus on physical properties and biocompatibility, with no mention of AI or ML.
No.
The device, a patient examination glove, is intended to prevent contamination between patient and examiner, which is a barrier function, not a therapeutic action.
No
Justification: The device is a glove, intended for preventing contamination, not for diagnosing medical conditions.
No
The device is a physical product (gloves) and the summary describes physical properties and testing, not software functionality.
Based on the provided information, 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 from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description focuses on the physical properties and standards met by the glove, consistent with a medical device used for barrier protection.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
Therefore, this device falls under the category of a general medical device, specifically a patient examination glove, rather than an In Vitro Diagnostic device.
N/A
A. Intended Use / Indications for Use
Powder Free Vinyl Patient Examination Gloves, Colored (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.
B. Product codes (comma separated list FDA assigned to the subject device)
LYZ
C. Device Description
Powder free Vinyl Patient Examination Gloves, Colored (Yellow) that meets all of the requirements of ASTM standard D 5250-06.
D. Mentions image processing
Not Found
E. Mentions AI, DNN, or ML
Not Found
F. Input Imaging Modality
Not Found
G. Anatomical Site
hand or finger
H. Indicated Patient Age Range
Not Found
I. Intended User / Care Setting
medical purposes
J. Description of the training set, sample size, data source, and annotation protocol
Not Found
K. Description of the test set, sample size, data source, and annotation protocol
Not Found
L. Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical:
- Dimension: ASTM standard D 5250-06, Meets
- Physical Properties: ASTM standard D 5250-06, Meets
- Freedom from pinholes: 21 CFR 800.20, Meets
- Powder Residual: ASTM standard D 5250-06 and D6124-01,
§ 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
510(K) Summary
"This summary of 5 10(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: ______________________________________________________________________________________________________________________________________________
OCT 2 1 2010 .
),
Premarket Notification [510(k)] Summary
મે
【
[(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 : | TANGSHAN KANGJIE GLOVE CO., LTD. |
|---|---|
| Submitter's address : | PACHIGANG, LUANNAN COUNTY, TANGSHAN CITY, |
| HEBEI PROVINCE, 063500, CHINA | |
| Phone number : | (86) 315-4169201 |
| Fax number : | (86) 315-4169311 |
| Name of contact person: | Mr. Fred Zhang |
| Date the summary was prepared: | Aug. 10th, 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: | Powder free Vinyl Patient Examination Gloves, Colored
(Yellow) | |
|-------------------------|-------------------------------------------------------------------|--|
| Proprietary/Trade name: | Powder Free Vinyl Patient Examination Gloves | |
| 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 , colored (yellow) that meets all of the requirements of ASTM standard D 5250-06.
Predicate device : Powder free Vinyl Patient Examination Gloves(White, Yellow), SHUIAZHUANG MANFUL LIGHT INDUSTRIAL PRODUCTS CO., LTD. K051156 .
[(a)(4)] A description of the device
Device Description : Powder free Vinyl Patient Examination Gloves, Colored (Yellow) 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: Powder free Vinyl Patient Examination Gloves, Colored (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 5250-06 | Meets |
| Physical Properties | ASTM standard D 5250-06 | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Residual | ASTM standard D 5250-06 | |
| and D6124-01 |