(115 days)
This is a medical glove to be worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.
Class I latex patient examination glove 80LZA, powder free and meeting all the requirements of ASTM-D3578-61) Standard Specification for Latex Examination Gloves for Medical Application, except for the elongation at break parameter.
This document describes the acceptance criteria and performance of the "POWDER-FREE, 'BARRIER-PRO™, SYNTHETIC BUTADIENE CO-POLYMER EXAM GLOVES, COLOR: GREEN" manufactured by Shield Gloves, as submitted for 510(k) clearance (K011613).
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (ASTM D3578-00/99) | Reported Device Performance (Shield Gloves) |
|---|---|---|
| Dimension | ||
| X-Small Width | 70 mm +/- 10 mm | 70 - 75 mm |
| Small Width | 80 mm +/- 10 mm | 80 - 85 mm |
| Medium Width | 95 mm +/- 10 mm | 90 - 97 mm |
| Large Width | 111 mm +/- 10 mm | 105 - 111 mm |
| Length (all sizes) | 230 mm minimum | 242 mm |
| Finger Thickness | 0.08 mm minimum | 0.08 mm minimum |
| Palm Thickness | 0.08 mm minimum | 0.08 mm minimum |
| Tensile Strength (Mpa) | ||
| Before Aging | 14.0 | X-Small: 25.3, Small: 26.0, Medium: 28.9, Large: 22.0 |
| After Aging | 14.0 | X-Small: 21.3, Small: 23.4, Medium: 23.6, Large: 21.7 |
| Ultimate Elongation (%) | ||
| Before Aging | 700 | X-Small: 840, Small: 850, Medium: 860, Large: 840 |
| After Aging | 500 | X-Small: 890, Small: 930, Medium: 940, Large: 900 |
| Water Tight Test (Leakage) | 2.5% AQL (Acceptance Quality Limit) | Un-aged: X-Small (2/125), Small (0/125), Medium (1/125), Large (0/125) |
| Aged: X-Small (1/125), Small (2/125), Medium (1/125), Large (0/125) (All within 2.5% AQL) | ||
| Biocompatibility | Non-dermal irritant, non-skin sensitizer | Neither a dermal irritant nor a skin sensitizer |
| Residual Powder Content (ASTM D 6124-00) | 2 mg/glove max | Range: 0.7-1.5 mg/glove, Mean: 1.05 mg/glove |
| Presence of Cornstarch | Negative | Negative |
Note: The device explicitly states that it meets/exceeds ASTM-D3578 Standard Specifications for Latex Examination Gloves, except for the elongation at break parameter. However, the provided tables show that the "Ultimate Elongation" for the Shield Gloves exceeds the ASTM-D3578-00 requirement for both before and after aging. This might be a misunderstanding of the "elongation at break parameter" or an older ASTM standard being referenced in the summary text. Based on the provided table, the performance for Ultimate Elongation is better than the ASTM standard.
2. Sample Sizes Used for the Test Set and Data Provenance
- Water Tight Test: 125 pieces per size (X-Small, Small, Medium, Large) for both un-aged and aged gloves. This totals 1000 gloves tested specifically for the water leak test (4 sizes * 125 gloves/size * 2 aging conditions).
- Tensile Strength & Ultimate Elongation: The data is reported for each size (X-Small, Small, Medium, Large) for both before and after aging. The specific number of samples tested for these mechanical properties is not explicitly stated, but it is reported for "Lot# 1128".
- Residual Powder Content: The range (0.7-1.5mg/glove) and mean (1.05 mg/glove) suggest multiple samples were tested, but the total sample size is not specified.
- Data Provenance: The document does not explicitly state the country of origin for the data or whether it was retrospective or prospective. Given that Shield Gloves Manufacturing (M) Sdn Bhd is the applicant and is located in Malaysia (implied by "Sdn. Bhd." and context), it is highly likely the testing was conducted by or for the manufacturer, presumably in Malaysia, as part of their product development and regulatory submission. The testing would be considered prospective for the purpose of this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This device is a medical glove, and its performance is evaluated against engineering and material standards (e.g., ASTM D3578) and regulatory requirements (e.g., FDA water leak test, biocompatibility, powder content). Ground truth is established by these objective standards and tests, not by expert interpretation of clinical images or subjective assessments typically requiring expert consensus.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like 2+1 or 3+1 are used for subjective assessments (e.g., in clinical trials or image interpretation) where multiple experts might disagree on an outcome. For objective physical and chemical tests of a medical glove, the results are typically quantitative measurements or pass/fail criteria based on defined standards, not requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not applicable. This device is a physical medical glove and does not involve AI or human "readers" in its intended use or evaluation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a physical medical glove and does not involve an algorithm.
7. The Type of Ground Truth Used
The ground truth for most of the performance criteria is based on established industry standards and regulatory requirements:
- ASTM-D3578-00/99: "Standard Specification for Latex Examination Gloves for Medical Application" (for Dimension, Tensile Strength, Ultimate Elongation).
- FDA specified water leak test: A specific methodology for determining watertight integrity.
- Biocompatibility standards: Tests for dermal irritation and skin sensitization.
- ASTM D 6124-00: For Residual Powder Content.
- FDA claim criterion: For a powder-free glove (presence of cornstarch).
These standards define the objective and measurable criteria for acceptable performance.
8. The Sample Size for the Training Set
Not applicable. This device is a physical medical glove, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The manufacturing process of physical goods involves quality control and process validation, which might use statistical sampling (e.g., during production runs) but is distinct from an AI training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this physical device.
§ 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.