(88 days)
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or fingers to prevent contamination between patient and examiner.
The subject device is a patient examination glove made of synthetic nitrile latex compound. It is Non-Sterile, Powder free and is Blue in color. The device is ambidextrous and can be worn on either the left or right hand. The device meets all the specifications in ASTM D6319-19, Standard specification for Nitrile Examination Gloves. Additionally, the gloves have been tested for biocompatibility per ISO 10993-11.
The provided text describes Shandong Intco Medical Products Co, Ltd.'s Basic Synguard Nitrile Exam Gloves. This is a medical device submission, and the acceptance criteria and study described relate to the physical and biocompatibility performance of these gloves.
Here's the breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimensions | ASTM D6319-19 | |
| Length | 230 mm min | Pass (240 mm min) |
| Width | XS: 70±10, S: 80±10, M: 95±10, L: 110±10, XL: 120±10, XXL: 130±10 | Pass (XS: avg 78.3mm, S: avg 86.5mm, M: avg 97.6mm, L: avg 108.7mm, XL: avg 115.4mm, XXL: avg 123.7mm) |
| Thickness | Palm: Minimum 0.05 mm, Finger: Minimum 0.05 mm | Pass (Palm 0.06mm min, Finger 0.082mm min) |
| Physical Properties | ASTM D6319-19 | |
| Before Aging | ||
| Tensile Strength | 14 MPa, min | Pass (22.6 MPa, min) |
| Elongation | 500%, min | Pass (531%, min) |
| After Aging | ||
| Tensile Strength | 14 MPa, min | Pass (21.9 MPa, min) |
| Elongation | 400%, min | Pass (437%, min) |
| Freedom from holes | ASTM D5151-19 (No leakage at sampling level of G-1, AQL 2.5) | Pass (No leakage, 312 of 315 gloves passed) |
| Residual Powder | ASTM D6124-06 (Reapproved 2017) ( |
§ 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.