(73 days)
Not Found
No
The device is a standard examination glove and the summary contains no mention of AI or ML.
No
The device, Nitrile Powder Free Patient Examination Gloves, is described as a barrier to prevent contamination, not as an active treatment or therapy for a disease or condition.
No
Explanation: The device, Nitrile Powder Free Patient Examination Gloves, is described as a disposable device worn on the examiner's hand to prevent contamination. Its purpose is protective, not to diagnose a condition or disease.
No
The device is a physical glove, not software. The description clearly states it is a "disposable device intended for medical purposes that is worn on the examiner's hand or finger".
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 a glove worn on the hand or finger to prevent contamination between patient and examiner. This is a barrier device used for protection during medical examinations.
- Lack of IVD Characteristics: An IVD is a device intended for use in the collection, preparation, and examination of specimens taken from the human body to provide information for diagnostic purposes. This description does not mention any of these activities.
- Device Description: The description focuses on the material and standards met for a glove.
- No Mention of Specimen Analysis: There is no indication that this device is used to analyze any biological specimens.
Therefore, this device falls under the category of a medical device, specifically a patient examination glove, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
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
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 tests were performed. Nitrile powder-free patient examination glove meet requirements per ASTM D6319-05, per ASTM D6124-06, per 21 CFR 800.20 and ISO10993-10. It can be concluded that the Nitrile powder-free patient examination glove 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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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: K110185 " (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 BAOJIE GLOVE CO.,LTD. | |
---|---|---|
Submitter's address : | PACHIGANG INDUSTRIAL ZONE,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, 2011 |
[(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 |