(121 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 Examination Gloves, is intended to prevent contamination and is an examination glove, not a device used for therapy or treatment.
No
Explanation: The device is described as an examination glove intended to prevent contamination, not to diagnose medical conditions or diseases.
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 is to prevent 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) and compliance with standards related to gloves (ASTM D 6319-05).
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting substances, or providing diagnostic information about a patient's health condition.
- Performance Studies: The performance studies mentioned relate to the physical properties and safety of the glove, not the accuracy of a diagnostic test.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This glove does not fit that description.
N/A
Intended Use / Indications for Use
Powder Free Blue Patient Nitrile 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
LZA
Device Description
Nitrile Powder Free Patient Examination Gloves that meets all of the requirements of ASTM standard D 6319-05
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
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The powder free vinyl patient examination gloves, non sterile are summarized with the following technological characteristics compared to ASTM or equivalent standard.
- Dimension: Meets ASTM standard D 6319-05
- Physical Properties: Meets ASTM standard D 6319-05
- Freedom from pinholes: Meets 21 CFR 800.20
- Powder Residual:
§ 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
KOR2598
JAN - 7 2009
"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: ." (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 ZHONGHONG PULIN GROUP CO., LTD. 35 SONGHE ST, BENCHENG, LUANNAN COUNTY TANGSHAN, Submitter's address : HEBEI, 063500, CHINA (86)315-4169201 Phone number : Fax number . (86)315-4168700 Name of contact person: Ms. Zhao Ruiyou Oct.31.2008 Date the summary was prepared:
[(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
Nitrile Powder Free Patient Examination Gloves (Blue) Device Name: Nitrile Powder Free Patient Examination Gloves( Blue) Proprietary/Trade name: Patient examination glove Common Name: Patient examination glove Classification Name: Device Classification: I Regulation Number: 21 CFR 880.6250 General Hospital (80) Panel: LZA Product Code:
[(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 6319-05
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 6319-05
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 6319-05 | Meets |
| Physical Properties | ASTM standard D 6319-05 | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Residual | ASTM standard D 5250-06 | |
| and D6124-01 |