(111 days)
No
The device is a standard examination glove and the summary contains no mention of AI or ML.
No
The device is a glove, intended to prevent contamination between patient and examiner, which is a barrier function, not a therapeutic one. It's used for examination, not treatment or therapy.
No
Explanation: The device, Nitrile Powder Free Patient Examination Gloves, is described as a disposable device worn on the hand or finger to prevent contamination. Its intended use is not for diagnosis, but for barrier protection between the patient and examiner.
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 gloves are for preventing contamination between patient and examiner by being worn on the hand or finger. This is a physical barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description focuses on the material (nitrile), form (powder-free), and color, and compliance with a standard for examination gloves. There is no mention of reagents, assays, or any components used for analyzing 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 or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The device is a medical device, specifically a patient examination glove, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
Nitrile Powder Free Patient Examination Gloves, Coloured (Blue) 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
LZA
Device Description
Powder Free Nitrile Patient Examination Gloves , Blue Color that meets all of the requirements of ASTM standard D 6139-10
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
Nonclinical study: Nitrile powder-free patient examination glove meet requirements per ASTM D6319-10, per ASTM D6124-06, per 21 CFR 800.20 and ISO10993-10.
Clinical study: Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.
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
510(k) 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."
KIZD970." (applicant leave blank) "The assigned 510(k) number is:
JUL 1 9 2012
جت t
ﺮ ﺍ
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 Zhonghong Pulin Plastic Co., Ltd. | |
|---|---|---|
| Submitter's address : | Industrial Zone, Pachigang, Luannan, Tangshan, Hebei, | |
| 063502, China | ||
| Phone number : | (86)315-4169201 | |
| Fax number : | (86)315-4168700 | |
| Name of contact person: | Mr. ZHANG Liang | |
| Date the summary was prepared: | Jun.20th. 2012 |
[(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 Nitrile Patient Examination Gloves, Blue Color |
|---|---|
| Proprietary/Trade name: | Powder Free Nitrile Patient Examination Gloves, Blue Color |
| 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, Blue Color that meets all of the requirements of ASTM standard D 6139-10
Predicate device : Nitrile powder-free patient examination glove, JDA International Inc. K993247 .
[(a)(4)] A description of the device
Device Description: Powder Free Nitrile Patient Examination Gloves , Blue Color that meets all of the requirements of ASTM standard D 6139-10
-1/2- (rev.01)
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 6139-10 | Meets |
| Physical Properties | ASTM standard D 6139-10 | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Residual | ASTM standard D 5250-06 | |
| and D6124-06 |