(126 days)
Not Found
Not Found
No
The device description and intended use clearly define it as a disposable examination glove, with no mention of AI or ML capabilities. The performance studies focus on physical properties and biocompatibility, not algorithmic performance.
No
The device is described as an examination glove intended to prevent contamination, not to treat or directly manage a medical condition.
No
The device is described as an examination glove intended to prevent contamination between the patient and examiner, not to diagnose a condition.
No
The device is a physical examination glove, not a software application. The description clearly outlines a tangible product made of nitrile with added substances, intended for physical barrier protection.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a "disposable device intended for medical purpose that is worn on the examiner's hand or finger(s) to prevent contamination between patient and examiner." This describes a barrier device used for protection during physical examination, not a device used to examine specimens in vitro (outside of the body).
- Device Description: The description focuses on the physical properties and standards met by the glove (nitrile, powder-free, scent, ASTM standards, FDA regulations for gloves). It doesn't mention any components or functions related to analyzing biological samples.
- Lack of IVD Indicators: 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 samples
- Providing diagnostic information
- Reagents or test kits
The device is a medical glove, which falls under a different regulatory classification than IVDs.
N/A
Intended Use / Indications for Use
The Powder Free Nitrile Examination Glove (blue) with natural water soluble Vitamin E and Aloe Vera, Peppermint scented is a disposable device intended for medical purposes that are worn on the examiner's hands or fingers to provide a barrier against potentially infectious materials and other contaminants.
Product codes
LZA
Device Description
Class I powder free nitrile examination gloves (blue) with natural water soluble Vitamin E and Aloe vera, peppermint scented, 80LZA, non-sterile meets all the requirements of ASTM standard D6319-00ae3 and FDA 21 CFR 800.20.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hands or fingers
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 Nitrile Examination Gloves (blue) with natural water soluble Vitamin E and Aloe Vera, Peppermint Scented, are summarized with the following technological characteristics compared to ASTM or equivalent standards:
| Characteristics | Standards | Device Performance |
|---|---|---|
| Dimensions | ASTM D 6319-00ae3 | Meets |
| Physical Properties | ASTM D 6319-00ae3 | Meets |
| Freedom from Pinholes | ASTM D 6319-00ae3 | |
| FDA 21 CFR 800.20 | Meets | |
| Powder Residue | ASTM D 6124-01 | Meets, |
§ 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
AUG 1 5 2003
510(K) SUMMARY
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
POWDER FREE NITRILE EXAMINATIN GLOVES (BLUE) WITH NATURAL WATER SOLUBLE VITAMIN E AND ALOE VERA, PEPPERMINT SCENTED
This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990, and prepared on April 3,2003
The assigned 510(K) number is K031157
1.0 Submitter:
Qingdao Bestex Rubber & Plastic Products Co. Ltd. 14-2 Hangzhou Road. Pingdu., Qingdao, China
2.0 Regulatory Affairs Contact:
ZeChuan Shao Name: Phone No .: 408 980 1348 408 980 1356 Fax No .:
3.0 Name of device:
Undetermined Trade Name: Examination Glove Common Name: Classification Name: Patient Examination Glove, Powder Free
4.0 Identification of The Legally Marketed Device:
Class I nitrile patient examination gloves, 80LZA, non-sterile, powder free with natural water soluble Vitamin E and Aloe Vera, Peppermint Scented, that meets all the requirements of ASTM standard D 6319-00ae3 and FDA 21 CFR 800.20.
5.0 Device Description:
Class I powder free nitrile examination gloves (blue) with natural water soluble Vitamin E and Aloe vera, peppermint scented, 80LZA, non-sterile meets all the requirements of ASTM standard D6319-00ae3 and FDA 21 CFR 800.20.
6.0 Intended Use of The Device:
The powder free nitrile examination glove (blue) with natural water soluble Vitamin E and Aloe vera, peppermint scented, is a disposable device intended for medical purposes that are worn on the examiner's hands or fingers to provide a barrier against potentially infectious materials and other contaminants.
1
7.0 Summary of the Technological Characteristics of the Device:
The Powder Free Nitrile Examination Gloves (blue) with natural water soluble Vitamin E and Aloe Vera, Peppermint Scented, are summarized with the following technological characteristics compared to ASTM or equivalent standards:
| Characteristics | Standards | Device Performance |
|---|---|---|
| Dimensions | ASTM D 6319-00ae3 | Meets |
| Physical Properties | ASTM D 6319-00ae3 | Meets |
| Freedom from | ||
| Pinholes | ASTM D 6319-00ae3 | |
| FDA 21 CFR 800.20 | Meets | |
| Powder Residue | ASTM D 6124-01 | Meets, .............................................................................................................................................................................. Concurrence of CDRH Office of Device Evaluation(ODE) |
Prescription Use Per 21 CFR 801.109 OR
Over-The-Counter (Optional Format 1-2-96)
Qlin S. Lin
Division Sian-Off Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K031157
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