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510(k) Data Aggregation
(232 days)
Powder Free Nitrile Patient Examination Gloves, Blue Color is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
The proposed device is Powder Free Nitrile Examination Gloves. The proposed device is blue. The proposed device is non-sterile.
The provided document is a 510(k) Premarket Notification for Powder Free Nitrile Patient Examination Gloves. It details the device's characteristics and compares them to a predicate device to establish substantial equivalence.
Based on the information provided, here's a breakdown of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The device's performance is compared against established standards, primarily ASTM D6319-10 (Reapproved 2015) for Nitrile Examination Gloves for Medical Application, along with other ISO and ASTM standards for biocompatibility and specific tests.
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D 6319-06 (Reapproved 2015) | Dimension | ||
| - Length | ≥230mm min | 232 mm min for all sizes (Similar to predicate) | |
| - Width | Small: 70-90 mm | ||
| Medium: 85-105mm | |||
| Large: 100-120mm | |||
| X large: 110-130 mm | Small: 75-90 mm | ||
| Medium: 88-102 mm | |||
| Large: 107-117mm | |||
| X large: 114-128 mm (Similar to predicate) | |||
| - Thickness | Fingertip: ≥0.05mm min. | ||
| Palm: ≥0.05mm min. | Fingertip: ≥0.08mm | ||
| Palm: ≥0.08mm (Similar to predicate) | |||
| ASTM D 6319-06 (Reapproved 2015) | Physical Properties | ||
| - Tensile strength (Before & After aging) | ≥ 14MPa | 17-24 (Before Aging), 17-22 (After Aging) (Similar to predicate) | |
| - Before aging Elongation | ≥500% | 540-610 (Similar to predicate) | |
| - After aging Elongation | ≥400% | 460-570 (Similar to predicate) | |
| 21 CFR 800.20 | |||
| ASTM D 6319-06 (Reapproved 2015) | |||
| ASTM D5151-19 | Freedom from pinholes | Water leakage test: Inspection Level I, AQL 2.5, and Accept/Reject criteria of 10/11. | 5 noncompliance is allowed (Similar to predicate) |
| ASTM D6319-10 (Reapproved 2015) | |||
| ASTM D6124-06 (Reapproved 2017) | Powder Residual |
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(60 days)
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) 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.
Poly Vinyl Chloride (PVC) films form a barrier to prevent contamination between patient and examiner. The PVC rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure. The Poly (vinyl chloride) glove acts as a barrier to prevent contamination between patient and examiner. The glove is manufactured in accordance with the requirements of ASTM D5250 and ASTM D5151.
This document pertains to the 510(k) premarket notification for Powder Free Vinyl Patient Examination Gloves, Clear (non-colored). The information provided heavily focuses on proving substantial equivalence to a predicate device through non-clinical performance data, primarily compliance with established ASTM and ISO standards for medical gloves.
Here's the breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Characteristics | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Dimensions | ASTM D 5250-06 (Reapproved 2015) | Met ASTM D 5250-06 (Reapproved 2015) |
| Length | ≥230mm | Subject Device: 231-241mm (Predicate: 231-242mm) - Stated as "Similar" |
| Width (Small) | 80-90 mm | Subject Device: 81-89mm (Predicate: 82-89mm) - Stated as "Similar" |
| Width (Medium) | 90-100mm | Subject Device: 93-99mm (Predicate: 93-99mm) - Stated as "Similar" |
| Width (Large) | 100-110mm | Subject Device: 102-110mm (Predicate: 103-109mm) - Stated as "Similar" |
| Width (X-Large) | 110-120 mm | Subject Device: 111-119mm (Predicate: 114-119mm) - Stated as "Similar" |
| Thickness (Fingertip) | ≥0.05mm | Subject Device: 0.09-0.10mm (Predicate: 0.05-0.10mm) - Stated as "Similar" |
| Thickness (Palm) | ≥0.08mm | Subject Device: 0.10-0.11mm (Predicate: 0.09-0.13mm) - Stated as "Similar" |
| Physical Properties | ASTM D 5250-06 (Reapproved 2015) | Met ASTM D 5250-06 (Reapproved 2015) |
| Tensile Strength | ≥11MPa (Before & After aging) | Subject Device: 15-22 MPa (Predicate: 16-20 MPa) - Stated as "Similar" |
| Elongation Rate | ≥300% (Before & After aging) | Subject Device: 350-420% (Predicate: 380-410%) - Stated as "Similar" |
| Freedom from Pinholes | 21 CFR 800.20 | |
| ASTM D5250-06 (Reapproved 2015) | ||
| ASTM D5151-19 | ||
| Holes at Inspection Level I AQL2.5 | Subject Device: "Passed Standard Acceptance Criteria" | |
| Holes at Inspection Level I AQL2.5 (Same as predicate) | ||
| Powder Residual | ASTM D5250-06 (Reapproved 2015) | |
| ASTM D6124-06 (Reapproved 2017) |
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