(69 days)
The surgeon's glove is a device made of natural rubber intended to be worn by surgeons and/or operating room personnel to protect a surgical wound from contamination.
Class II natural rubber latex surgeon's glove, 79 KGO, powdered with absorbable dusting powder. It meets all of the requirements of ASTM standard D3577-99.
This document describes the acceptance criteria and performance data for WRP Specialty Products Sdn Bhd's DERMAGRIP POWDERED LATEX SURGICAL GLOVE, STERILE (K993215).
1. Table of Acceptance Criteria and Reported Device Performance
| Quality Requirement | Acceptance Criteria Before Aging | Reported Device Performance Before Aging | Acceptance Criteria After Aging | Reported Device Performance After Aging | Unit |
|---|---|---|---|---|---|
| Tensile Strength | Min 24 | Not explicitly stated (implied to meet) | Min 18 | Not explicitly stated (implied to meet) | MPa |
| Ultimate Elongation | Min 750 | Not explicitly stated (implied to meet) | Min 560 | Not explicitly stated (implied to meet) | % |
| Stress at 500% Elongation | Max 5.5 | Not explicitly stated (implied to meet) | Not Applicable | Not Applicable | MPa |
Powder Weight Criteria:
| Powder Location | Acceptance Criteria | Reported Device Performance (Size 7 ½) | Unit |
|---|---|---|---|
| Internal | 0.5 - 1.5% | 1.41 | % |
| External (Max) | 1.0% | 0.96 | % |
| Powder Weight* | Not specified | 204.7 | mg/glove |
| External Powder Weight | Not specified | 140.0 | mg/glove |
Note: The document states "WRP Specialty Products Sdn. Bhd. SIZE 7½ ACTUAL POWDER WEIGHT mg/glove" for 204.7, and "External (Max) : 1.0% 0.96 140.0" implying 140.0 mg/glove for external powder. The "Internal" powder is given as 1.41% and 204.7 mg/glove. This implies that 204.7 mg is the internal powder weight for a Size 7 1/2 glove to be 1.41%, and 140.0 mg is the external powder weight for a Size 7 1/2 glove to be 0.96%.*
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Physical Requirement Test: 13 pieces per batch.
- Batch Size: 300,000 pairs (based on one consignment quantity).
- Data Provenance: Not explicitly stated, but given the company's location (Malaysia), the testing was likely conducted in Malaysia. The document does not specify if the data is retrospective or prospective, but for product quality control, it would typically be prospective for each batch produced.
- Sample Size for Powder Weight: Average over eight (8) pieces.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The ground truth for this device is established by objective physical and chemical measurements (tensile strength, elongation, powder weight) against specified standards (ASTM D3577-99, ASTM D412-87). No human expert interpretation of results is mentioned beyond standard laboratory practice.
4. Adjudication Method for the Test Set
The adjudication method for the physical requirement test is based on an Acceptance Quality Limit (AQL) system in accordance with ISO 2859/ANSI/ASQC Z1.4.
- AQL: 4.0
- Acceptance Criteria: 1 pc (meaning 1 or fewer defective pieces in the sample of 13)
- Rejection Criteria: 2 pcs (meaning 2 or more defective pieces in the sample of 13)
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If So, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a medical device (surgical glove) for which AI assistance for human readers is not relevant. The testing focuses on the physical properties and sterility of the glove.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable. This is a physical medical device; there is no algorithm involved.
7. The Type of Ground Truth Used
The ground truth used is based on established industry standards and objective physical measurements:
- ASTM D 3577-99: Standard Specification for Rubber SURGICAL Gloves.
- ASTM D 412-87: Standard Test Methods for Rubber Properties in Tension.
- ISO 2859 / ANSI/ASQC Z1.4: Sampling Procedures and Tables for Inspection by Attributes.
- FDA watertight test requirements (mentioned in Attachment 7).
The ground truth for physical properties (Tensile Strength, Ultimate Elongation, Stress at 500% Elongation) and powder weight is derived from these standardized test methods and the acceptance criteria defined within them or by regulatory bodies.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI/ML algorithm. There is no concept of a "training set" in this context. Quality is assured by testing samples from production batches.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a physical medical device.
§ 878.4460 Non-powdered surgeon's glove.
(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's 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).