(162 days)
Not Found
No
The device is a patient examination glove, and the description and testing focus on physical properties and safety, with no mention of AI or ML.
No
The device is described as a "patient examination glove" intended to prevent contamination, which is a barrier function, not a therapeutic one.
No
Explanation: The device is a patient examination glove, intended to prevent contamination. It does not perform any diagnostic function.
No
The device is a physical patient examination glove, which is a hardware device, not software.
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 "patient examination glove...worn on the examiner's hand or finger to prevent contamination between patient and examiner." This describes a barrier device used during physical examination, not a device used to examine specimens derived from the human body for diagnostic purposes.
- Device Description: The device is classified as a "Polymer Patient Examination Glove" under 21 CFR 880.6250, which falls under the General and Plastic Surgery Device panel. IVDs are typically classified under different panels related to clinical chemistry, immunology, microbiology, etc.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information.
IVDs are devices used to perform tests on specimens from the human body to provide information for the diagnosis, treatment, or prevention of disease. This glove does not fit that description.
N/A
Intended Use / Indications for Use
A patient examination glove is disposable non-sterile device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Product codes
LZA
Device Description
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Polymer Patient Examination Gloves, 80 LZA, and meets all requirements of ASTM standard D 6319-10.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Tests Performed for Determination of Substantial Equivalence:
- Dimensions: ASTM D 6319-10, Meets
- Physical Properties: ASTM D 6319-10, Meets
- Freedom from holes: ASTM D 6319-10, Meets
- Residual Powder Test: ASTM D 6319-10, ASTM D6124-06 (Reapproved 2011), Meets
- Primary Skin Irritation and Skin Sensitization: ISO 10993 Part 10, 16CFR 1500.41, 16CFR 1500.3, Meets
Clinical Tests Performed:
Not Applicable - There is no hypoallergenic Claim.
Conclusions:
Hongye Plastic Products Co., Ltd.'s Powder Free Nitrile Examination Gloves (Black, White, Green) conform fully to ASTM D6319-10 standard as well as applicable 21 CFR references, and meets pinhole FDA requirements, applicable 21 Of References and labeling claims as shown by data in Section 7. There are no safety/efficacy issues or new claims from the "substantial I hele are no'salecty/cricacy ibacases of the complete list of non-clinical tests, the oquiralerse - predioned is as safe and effective as the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
Hongve Plastic Products Co., Ltd
Donggao Industrial Zone Zanhuang, Hebei, China 050000
EXHIBIT #1 Page 1 of 4
510(K) SUMMARY
JAN 1 7 2013
This summary of 510(K) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 510(K) number is: _