(87 days)
The Nitrile Patient Examination Gloves are non-sterile disposable devices intended for medical purposes that are worn on the examiner's hands or finger to prevent contamination between patient and examiner.
The subject device is powder free nitrile examination gloves. The glove is manufactured from nitrile. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder on the glove surface. The glove is ambidextrous, i.e., can be worn on right hand or left hand. The subject device is blue. The subject device is non-sterile, and single use device to prevent contamination between patient and examiner.
The subject device can be available in six specifications: XS、S、M、L、XL and XXL.
This document is a 510(k) Premarket Notification for Nitrile Patient Examination Gloves, which are Class I devices. The submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. It does not involve AI or complex medical imaging analysis. Therefore, many of the requested elements (e.g., number of experts, adjudication methods, MRMC studies, training set details) are not applicable to this type of medical device submission.
Here's an analysis of the provided text in the context of the requested information, focusing on what is relevant and explicitly stated:
Device: Nitrile Patient Examination Gloves (K211434)
This product is a simple, non-sterile, disposable examination glove. Its acceptance criteria and performance are based on established physical, chemical, and biocompatibility standards for such devices, not on complex algorithmic performance like AI.
1. Table of Acceptance Criteria and Reported Device Performance
The core of the performance evaluation is found in "Table 3 Performance Comparison" and the more detailed "Test Methodology" and "Results" table within Section 8.0 "Summary of Non-clinical Testing."
| Item | Test Methodology | Acceptance Criteria | Reported Device Performance/Results |
|---|---|---|---|
| Physical Dimensions | ASTM D6319 | Length (mm): XS/S: ≥220; M/L/XL: ≥230 | Length: >230 (all sizes, meeting criteria) |
| Width (mm): XS: 70±10; S: 80±10; M: 95±10; L: 110±10; XL: 120±10; XXL: 130±10 | XS: 78-80; S: 86-89; M: 97-99; L: 117-119; XL: 116-118; XXL: 128-131 (all Pass) | ||
| Thickness (mm): Finger: ≥0.05; Palm: ≥0.05 | Finger: 0.07-0.13 (Pass); Palm: 0.07-0.11 (Pass) | ||
| Physical Properties | ASTM D412 | Before Aging: Tensile Strength: ≥14MPa; Ultimate Elongation: ≥500% | Tensile Strength: 15.2-17.6 MPa (Pass); Ultimate Elongation: 520-579% (Pass) |
| After Aging: Tensile Strength: ≥14MPa; Ultimate Elongation: ≥400% | Tensile Strength: 15.3-17.5 MPa (Pass); Ultimate Elongation: 519-580% (Pass) | ||
| Freedom from Holes | ASTM D5151 | AQL=2.5 (Be free from holes when tested) | 2/125, 0/125, 0/125, 1/125, 0/125, 0/125 leaks (Pass) |
| Powder Content | ASTM D6124 |
§ 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.