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510(k) Data Aggregation
(162 days)
A powder-free 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.
Blue Nitrile Examination Gloves Powder Free are Class I patient examination gloves bearing the product code Nitrile - LZA (21CFR880.6250). The gloves are made from acrylonitrile-butadiene copolymer dispersion. These gloves are blue in color and are powder free.
This document is a 510(k) Premarket Notification for "Proclean - Nitrile Powder Free Examination Gloves", indicating it is a Class I medical device. The information provided heavily focuses on non-clinical performance and comparison to a predicate device, rather than a clinical study involving human patients or complex algorithms.
Here's a breakdown based on your request, with the understanding that this is for a physical medical device (gloves) and not an AI/software device:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method | Standard | Purpose of Testing | Acceptance Criteria | Reported Device Performance | Status |
|---|---|---|---|---|---|
| Dimension (Length) | ASTM D6319-19 | To determine the length of the gloves | Min 230 mm for all sizes | Extra Small: 230 mm, Small: 230 mm, Medium: 240 mm, Large: 236 mm, Extra Large: 236 mm | Pass |
| Dimension (Width) | ASTM D6319-19 | To determine the width of the gloves | Extra Small: 70 ± 10 mm, Small: 80 ± 10 mm, Medium: 95 ± 10 mm, Large: 110 ± 10 mm, Extra Large: 120 ± 10 mm | Extra Small: 68mm, Small: 79 mm, Medium: 96 mm, Large: 110 mm, Extra Large: 120 mm | Pass |
| Dimension (Thickness) | ASTM D6319-19 | To determine the thickness of the gloves | Palm 0.05 mm min, Finger 0.05 mm min for all sizes | Extra Small: Palm 0.11 mm, Finger: 0.11 mm; Small: Palm 0.09 mm, Finger: 0.10 mm; Medium: Palm: 0.08 mm, Finger: 0.08 mm; Large: Palm 0.10 mm, Finger: 0.11 mm; Extra Large: Palm 0.10 mm, Finger: 0.11 mm | Pass |
| Watertight test | ASTM D5151-19 | To determine the holes in the gloves | Sample size: 200 pcs, Inspection level: GI, AQL 1.5, Acceptance Number 7, Rejection Number 8 | The batch size for this sampling is 35,001-150,000. Sample code L equivalent to 200 pcs with accept 7 and reject 8. Results: Extra Small: 0 (Zero), Small: 0 (Zero), Medium: 0 (Zero), Large: 0 (Zero), Extra Large: 0 (Zero) | Pass |
| Residual powder | ASTM D6124-06 (Reapproved 2017) | To determine the residual powder | 2 mg per glove or less | Sample size: 5 pcs. Results: Extra Small: 1.35 mg/glove, Small: 1.35 mg/glove, Medium: 0.50 mg/glove, Large: 1.34 mg/glove, Extra Large: 1.36 mg/glove | Pass |
| Physical Properties (Tensile Strength - Before Aging) | ASTM D6319-19 | To determine physical properties | 14 Mpa Minimal for all sizes | Extra Small: 18.08 MPa, Small: 18.37 MPa, Medium: 35.52 MPa, Large: 18.30 MPa, Extra Large: 18.20 MPa | Pass |
| Physical Properties (Tensile Strength - After Aging) | ASTM D6319-19 | To determine physical properties | 14 Mpa Minimal for all sizes | Extra Small: 14.01 MPa, Small: 14.08 MPa, Medium: 34.50 MPa, Large: 14.00 MPa, Extra Large: 14.00 MPa | Pass |
| Physical Properties (Ultimate Elongation - Before Aging) | ASTM D6319-19 | To determine physical properties | 500% Min for all sizes | Extra Small: 611 %, Small: 612%, Medium: 601 %, Large: 620%, Extra Large: 587% | Pass |
| Physical Properties (Ultimate Elongation - After Aging) | ASTM D6319-19 | To determine physical properties | 400% Min for all sizes | Extra Small: 412 %, Small: 408%, Medium: 529%, Large: 403%, Extra Large: 416% | Pass |
| Biocompatibility (Primary Skin Irritation) | ISO 10993-10 | To assess skin irritation | Under the conditions of the study, not an irritant | Under the conditions of the study, not an irritant | Same |
| Biocompatibility (Dermal Sensitization) | ISO 10993-10 | To assess skin sensitization | Under the conditions of the study, not a sensitizer | Under the conditions of the study, not a sensitizer | Same |
| Biocompatibility (In vitro cytotoxicity) | ISO 10993-5 | To assess cytotoxicity | Under the conditions of the study, non-cytotoxic | Under the conditions of the study, non-cytotoxic | Same |
| Biocompatibility (Acute Systemic Toxicity) | ISO 10993-11 | To assess acute systemic toxicity | Under the conditions of study, the device extracts do not pose a systemic toxicity concern | Under the conditions of the study, did not induce any systemic toxicity. | Same |
2. Sample Size Used for the Test Set and Data Provenance
The document provides sample sizes for specific tests:
- Watertight test: 200 pieces (sample code L) for a batch size of 35,001-150,000.
- Residual powder: 5 pieces.
- Other physical properties (Dimension, Tensile Strength, Ultimate Elongation): The document doesn't explicitly state a "sample size" for these in the same way as the watertight or residual powder tests, but results are provided across all five glove sizes (Extra Small, Small, Medium, Large, Extra Large). It is implied that typical statistical sampling methods according to ASTM D6319-19 were followed.
Data Provenance: The document does not explicitly state the country of origin of the data for these tests. The manufacturer is Dr.Boo Company Limited, located in Chonburi, Thailand. These are non-clinical, in-vitro/bench testing results, not human data. The testing is retrospective in the sense that it was performed and then summarized for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is a physical product (gloves), not an AI/software device that requires expert review for ground truth establishment. The "ground truth" for these tests is defined by the objective measurements according to the specified ASTM and ISO standards.
4. Adjudication Method for the Test Set
Not applicable. This is not a clinical study involving human judgment that would require adjudication. Test results are objective measurements against established standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
Not applicable. This is not an AI/software device and no MRMC study was performed or is relevant for this type of product.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This is not an AI/software device. The tests performed are standalone in the sense that they measure the physical properties of the gloves directly against objective standards.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The ground truth for this device is based on objective measurements and performance against recognized international standards (ASTM D6319-19, ASTM D5151-19, ASTM D6124-06, ISO 10993-10, ISO 10993-5, ISO 10993-11). These standards define acceptable ranges or limits for various physical and biological properties of the gloves.
8. The Sample Size for the Training Set
Not applicable. There is no training set for this type of physical medical device. The "data" refers to manufacturing quality control and performance testing, not machine learning model training.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
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