(295 days)
The biodegradable nitrile examination glove is intended to be worn on the hands of examiner's to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.
The propose devices is powder free nitrile patient examination gloves, provided as non-sterile and disposable device. The gloves are offered in six sizes, extra-small (6.5"), small (7"), medium (8"), large (8.5"), extra-large (9"), extra extra-large (9.5"). Three colors are available for all size, includes blue, blue violet and green.
This document, K221983, is a 510(k) Premarket Notification for Biodegradable Powder Free Nitrile Examination Gloves. The device in question is a Class I medical device, meaning it is subject to general controls and typically does not require extensive clinical studies for clearance if substantial equivalence to a predicate device can be demonstrated.
Based on the provided text, the "device" is a Nitrile Examination Glove, not an advanced AI or diagnostic device that would involve AI-assisted reading or complex image analysis. Therefore, the questions related to AI (e.g., effect size of human readers improving with AI, standalone algorithm performance, training set size, adjudication methods, number of experts for ground truth) are not applicable to this type of medical device submission.
The "study" referenced in this document is a series of non-clinical, in-vitro laboratory tests performed to demonstrate that the glove meets established industry standards and specifications, proving its safety and performance equivalence to a legally marketed predicate device.
Here's the information extracted from the document relevant to your request, but tailored to the nature of this Class I device:
1. A table of acceptance criteria and the reported device performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319 | Physical Dimensions Test | Length: | |
| Extra-Small: ≥ 220mm | |||
| Small: ≥ 220mm | |||
| Medium: ≥ 230mm | |||
| Large: ≥ 230mm | |||
| Extra-Large: ≥ 230mm | |||
| Extra-Extra-Large: ≥ 230mm |
Width:
Extra-Small: 70 ± 10 mm
Small: 80 ± 10mm
Medium: 95 ± 10mm
Large: 110 ± 10mm
Extra-Large: 120 ± 10mm
Extra-Extra-Large: ≥120mm | Pass |
| ASTM D6319 | Physical properties (Thickness) | Thickness (mm):
Finger: ≥0.05
Palm: ≥0.08 | Pass |
| ASTM D6319 | Physical properties (Before Aging) | Tensile Strength: ≥14MPa
Ultimate Elongation: ≥500% | Pass |
| ASTM D6319 | Physical properties (After Aging) | Tensile Strength: ≥14MPa
Ultimate Elongation: ≥500% | Pass |
| ASTM D5151 | Freedom from pinholes | Meet the requirements of ASTM D5151 Test for AQL 2.5 | Pass |
| ASTM D6124 | Powder Residue | Meet the requirements of 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.