(115 days)
Not Found
No
The device is a simple examination glove and the summary contains no mention of AI or ML.
No
The device is a glove for preventing contamination, not for treating a disease or condition.
No
Explanation: The device description states its purpose is to "prevent contamination between patient and examiner," not to diagnose a condition. It is a barrier device, not one that gathers or processes data for diagnostic purposes.
No
The device is a physical glove, not software. The description clearly states it is a "non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger".
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 during physical examination, not a device used to examine specimens in vitro (outside the body).
- Device Description: The description focuses on the physical properties and standards met by the glove, consistent with a medical device for examination.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), using reagents, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening. This glove does not perform any such function.
N/A
Intended Use / Indications for Use
Nitrile Powder Free Patient Examination Gloves, Coloured (Blue) is a non-sterile 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
LZA
Device Description
Nitrile Powder Free Patient Examination Gloves that meets all of the requirements of ASTM standard D 6139-05
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
medical purposes
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
Non-clinical tests were conducted to demonstrate substantial equivalence. The Nitrile powder-free patient examination glove meet requirements per ASTM D6319-05, per ASTM D6124-06, per 21 CFR 800.20 and ISO10993-10. Clinical data was not needed. The conclusions drawn are that the device meets ASTM standard or equivalent standard and FDA requirements for waterleak test on pinhole AQL, and meets labeling claims.
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
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."
MAY 1 3 2011
"The assigned 510(k) number is: K110146 _ ." (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 : | TANGSHAN KAIYUE GLOVE CO., LTD. | |
|---|---|---|
| Submitter's address : | TANGLE ROAD, LUANNAN COUNTY,TANGSHAN CITY, | |
| HEBEI PROVINCE,063500,CHINA | ||
| Phone number : | (86)315-4169201 | |
| Fax number : | (86)315-4169311 | |
| Name of contact person: | Mr. ZHANG Liang | |
| Date the summary was prepared: | Jan.5th. 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: | Nitrile Powder Free Patient Examination Gloves, Coloured (Blue) |
|---|---|
| Proprietary/Trade name: | Nitrile Powder Free Patient Examination Gloves, Coloured (Blue) |
| 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: | LZA |
[(a)(3)]. An identification of the legally marketed device to which your firm is claiming substantial equivalence .
Class I* Nitrile Powder Free Patient Examination Gloves that meets all of the requirements of ASTM standard D 6139-05
Predicate device : Nitrile powder-free patient examination glove, JDA International Inc. K993247 .
[(a)(4)] A description of the device
Device Description : Nitrile Powder Free Patient Examination Gloves that meets all of the requirements of ASTM standard D 6139-05
1
[(a)(5)] The summary describes the intended use of the device
Device Intended Use: Nitrile Powder Free Patient Examination Gloves 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 6139-05 | Meets |
| Physical Properties | ASTM standard D 6139-05 | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Residual | ASTM standard D 5250-06 | Meets |
| Biocompatability | and D6124-06 |