(133 days)
No
The device description and intended use clearly define the device as a disposable examination glove, with no mention of any computational or analytical capabilities that would involve AI/ML.
No
Explanation: The device is a patient examination glove, intended to prevent contamination between patient and examiner. It is a barrier device, not designed to diagnose, treat, or prevent disease in a therapeutic manner.
No
Explanation: The device is described as "Powder Free Nitrile Patient Examination Gloves," which are used for preventing contamination. There is no mention of it being used to diagnose conditions or process diagnostic data.
No
The device is described as a physical glove made of nitrile synthetic rubber, clearly indicating it is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the gloves are "worn on the examiner's hand or finger to prevent contamination between patient and examiner." This is a barrier function, not a diagnostic function.
- Device Description: The description reinforces the barrier function and mentions meeting ASTM standards for examination gloves.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing information for diagnosis, monitoring, or treatment decisions based on in vitro analysis.
- Performance Studies: The performance studies focus on physical properties, freedom from pinholes, powder residual, and biocompatibility – all related to the barrier and safety function of a glove, not diagnostic accuracy.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic purposes. This device is a physical barrier used during medical examinations.
N/A
Intended Use / Indications for Use
Powder Free Nitrile Patient Examination Gloves,Blue Color 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
Powder Free Nitrile Patient Examination Gloves,Blue Color are disposable device which made of nitrile synthetic rubber , intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner and they meets all of the requirements of ASTM standard D 6319 00a (2005)e1.
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 device meets the following standards/criteria:
- Dimension: Meets ASTM standard D 6319 00a (2005)e1.
- Physical Properties: Meets ASTM standard D 6319 00a (2005)e1.
- Freedom from pinholes: Meets 21 CFR 800.20.
- Powder Residual: Meets ASTM standard D 6319 00a (2005)e1. and D6124-06 (
§ 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
Section C (rev.02)510(k) Summary (21 CFR 807.92)
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."
"The assigned 510(k) number is: K 110247
Premarket Notification [510(k)] Summary
Submitter's name :
JiangSu DongLing Plastic & Rubber Co.,Ltd
DongWu Road, Economic Development Zone,
SuQian,JiangSu Province, 223800,China
Submitter's address :
Name of contact person:
Proprietary/Trade name:
Phone number :
Fax number :
Mr.ZhiJun Xu
0086-527-82860080
0086-527-82860080
Dec.24, 2010 Date the summary was prepared:
Device Name:
Powder Free Nitrile Patient Examination Gloves,Blue Color
Powder Free Nitrile Patient Examination Gloves, Blue Color clients private labeling Other
Common Name: Classification Name: Device Classification: Regulation Number: Panel: Product Code:
Exam gloves Patient examination glove 21 CFR 880.6250 General Hospital (80) LZA
Class 1* Powder Free Nitrile Patient Examination Gloves,Blue Color that meets all of the requirements of ASTM D 6319 00a(2005)e1.
Predicate device: POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVE TANGSHAN ZHONGHONG PULIN GROUP CO., LTD. K082598.
Device Description: Powder Free Nitrile Patient Examination Gloves,Blue Color are disposable device which made of nitrile synthetic rubber , intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner and they meets all of the requirements of ASTM standard D 6319 00a (2005)e1.
1
Device Intended Use (indication for use): Powder Free Nitrile Patient Examination Device Intended 'Use (Indication' for use). Towardical purposes that is worn on the Gloves,Blue Color is a disposable device intended for then patient and examiner.
A summary of the technological characteristics of new device compared to the predicate device.
The Powder Free Nitrile Patient Examination Gloves,Blue Color, non sterile are summarized The Powder Free Nitrile Patient Exammation Croves,Bhile Colors, Mor equivalent standard.
| Characteristics | Standard | Device performance |
|---|---|---|
| Dimension | ASTM standard D 6319 00a (2005)el. | Meets |
| Physical Properties | ASTM standard D 6319 00a (2005)el. | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Residual | ASTM standard D 6319 00a (2005)el. | |
| and D6124-06 | Meets |