(92 days)
The Disposable Nitrile Glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
The Disposable Nitrile Gloves are non-sterile, single use only, disposable examination gloves intended for medical purposes to be worn by examiners to prevent contamination between the patient and the examiner. The gloves are blue or black color, powder free, nitrile ambidextrous gloves. The gloves are offered in large (L) size, packed in a paper box. The gloves are designed and manufactured in accordance with the ASTM D6319-19 standard.
The provided text describes the 510(k) premarket notification for Disposable Nitrile Gloves (ABC-DG01). It outlines the device's characteristics, its intended use, and a comparison to a predicate device (K171422). The submission focuses on demonstrating substantial equivalence through non-clinical testing.
Here's an analysis of the provided information to address your request:
Based on the provided document, the "device" in question is Disposable Nitrile Gloves (ABC-DG01). This is a Class I medical device, meaning it is considered low risk and subject to general controls. The acceptance criteria and "study" described are for physical and chemical performance, not for a diagnostic algorithm or AI.
Therefore, many of the questions regarding AI-specific studies (e.g., sample size for test set, data provenance, expert consensus, MRMC studies, standalone algorithm performance, training set details) are not applicable to this type of medical device submission.
The "study" refers to non-clinical performance testing conducted to demonstrate that the Disposable Nitrile Gloves meet established standards for patient examination gloves.
1. Table of Acceptance Criteria and Reported Device Performance
The relevant information is found in "Table 4. Performance Comparison" and "Summary of Non-Clinical Testing" (specifically the table under section G).
| Test Method (Acceptance Criteria) | Purpose | Acceptance Criteria (K230542) | Reported Device Performance (K230542) (Blue & Black) |
|---|---|---|---|
| Dimensions (ASTM D6319-19) | Evaluate the physical dimension of the glove | Width 110 ±10mm | |
| Length 230mm min | |||
| Palm - 0.05mm min. | |||
| Finger - 0.05mm min. | Pass | ||
| 106mm min width | |||
| 250mm min length | |||
| Palm – 0.06mm min. | |||
| Finger – 0.12mm min | |||
| Physical properties (ASTM D6319-19) | Evaluate the tensile strength and ultimate elongation before and after aging | Tensile Strength: | |
| Before Aging ≥ 14 MPa, min. | |||
| After Aging ≥ 14 MPa, min. | |||
| Elongation: | |||
| Before Aging 500%, min. | |||
| After Aging 400%, min. | Pass | ||
| Tensile Strength: | |||
| Before Aging 19.07MPa, min. | |||
| After Aging 18.11 MPa, min. | |||
| Elongation: | |||
| Before Aging 586.47%, min. | |||
| After Aging 469.20%, min. | |||
| Freedom from holes (ASTM D5151-19) | Detect holes in the gloves | No leakage at sampling level of G-1, AQL 2.5 | Pass |
| No leakage, 125 of 125 passed of each color | |||
| Residual Powder (ASTM D6124-06) | Detect the powder residue in the glove |
§ 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.