(379 days)
Not Found
No
The device is a simple examination glove and the summary contains no mention of AI, ML, or related technologies.
No
The device is a patient examination glove used to prevent contamination, not to treat a disease or condition.
No
The device, a patient examination glove, is intended to prevent contamination between the patient and examiner, not to diagnose 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 references physical standards and tests.
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 "powder free vinyl patient examination glove," which is a physical barrier.
- 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 or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
- Reagents, calibrators, or controls
The device described is a Class I medical device (examination glove) used for infection control during patient contact.
N/A
Intended Use / Indications for Use
Powder free 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
LV7, LYZ
Device Description
powder free 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
Not applicable, device is worn on the examiner's hand or finger
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical data:
Powder free vinyl patient examination gloves, Clear(non-colored) meet requirements per ASTM D5250-06, per ASTM D6124-01, per 21 CFR 800.20 and ISO10993-10.
Clinical data:
Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.
Key results: It can be concluded that the Powder Free Vinyl Patient Examination Gloves meet the ASTM standard or equivalent standard and FDA requirements for waterleak test on pinhole AQL, meet labeling claims.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
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: KOB2649." (applicant leave blank)
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 :
| Submitter's name : | Tangshan Dar Plastic & Rubber Products Co., Ltd. |
|---|---|
| Submitter's address : | Tangshan Sanxin High tech Industrial estate, |
| Tanggu Road, Tangshan city, Hebei province, | |
| 063100, P.R.China | |
| Phone number : | (86) 315-5028910 |
| Fax number : | (86) 315-5028929 |
| Name of contact person: | Mr. Wang Jincheng |
| Date the summary was prepared: | Sept. 04. 2008 |
((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
Sept. 04, 2008
| Device Name: | Powder Free Vinyl Patient Examination Gloves, Clear(non-colored) |
|---|---|
| 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: | LV7 |
[(a)(3)]. An identification of the legally marketed device to which your firm is claiming
substantial equivalence substantial equivalence .
Class I* powder free vinyl patient examination gloves , Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-06.
Predicate device : FUGUAN (Brand) Powder-Free Vinyl Patient Examination Gloves, Shijiazhuang Fuguan Plastic Products Co., Ltd.. K032908 .
[(a)(4)] A description of the device
1
Device Description : powder free 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: powder free vinyl patient examination glove, Clear(non-colored) is a disposable device intended for medical purposes that is worn on the examined) is a
prevent contemination bet 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 | Meets |
| Biocompatability | and D6124-01 |