(108 days)
LYDUS Nitrile Examination Gloves, Powder Free is a disposable device intended for medical purposes that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner.
The subject device in this 510(k) Notification is LYDUS Nitrile Examination Gloves, Powder Free. The subject device is a patient examination glove made from nitrile compound, blue color, powder free and non-sterile (Per 21 CFR 880.6250, Class I). The device meets the specifications in ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.
This document is a 510(k) Premarket Notification for LYDUS Nitrile Examination Gloves, Powder Free. It aims to demonstrate that this device is substantially equivalent to a predicate device already legally marketed. As such, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the performance tests conducted to show the new device performs as safely and effectively as the predicate device, adhering to relevant standards.
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Device Performance Study Details
The study focuses on demonstrating the substantial equivalence of the LYDUS Nitrile Examination Gloves, Powder Free to a legally marketed predicate device (K192333, "Blue Nitrile Examination Gloves Powder Free"). This is achieved through non-clinical performance testing.
1. Table of Acceptance Criteria and Reported Device Performance
Device: LYDUS Nitrile Examination Gloves, Powder Free
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance (Result) |
|---|---|---|---|
| Physical Dimensions (ASMT D6319-19) | To determine the width, length, and thickness of the gloves. | Width: 91 mm (Mean) (for medium size) | |
| Length: 241 mm (Mean) (for medium size) | |||
| Thickness: Finger - 0.13 mm (Mean), Palm - 0.09 mm (Mean) | Passed (Specific measurements not detailed in "Result" column, but stated as "Passed") | ||
| Physical Requirements (ASMT D6319-19) | To determine the tensile strength and ultimate elongation before and after acceleration aging. | Before Acceleration Aging: Tensile Strength (MPa): 34 (Mean), Ultimate Elongation (%): 601 (Mean) | |
| After Acceleration Aging: Tensile Strength (MPa): 34 (Mean), Ultimate Elongation (%): 571 (Mean) | Passed (Specific measurements not detailed in "Result" column, but stated as "Passed") | ||
| Freedom from Holes (ASTM D6319-19 / ASTM D5151-11) | To determine the holes in the gloves (water tight - 1000 ml). | AQL 2.5 | Passed |
| Residual Powder (ASMT D6319-19 / ASTM D6124-11) | To determine the residual powder in the gloves. |
§ 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.