(228 days)
The surgeon's glove is a device made of synthetic copolymer intended to be worn by surgeons and/or operating room personnel to protect a surgical wound from contamination.
Class I synthetic surgeon's glove, 79 KGO, powdered. It is a styrene-butadiene block copolymer glove.
The provided text describes the acceptance criteria and performance of "PROFEEL SYNTHETIC COPOLYMER SURGICAL GLOVES (POWDERED)" based on a 510(k) submission (K982600) to the FDA. The study aims to demonstrate substantial equivalence to a predicate device by meeting ASTM D3577-91 Type 2 and FDA 1000 ml watertight test requirements.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| TEST | Acceptance Criteria (ASTM D3577-91 Type 2) | Reported Device Performance (PROFEEL Synthetic Copolymer Surgical Gloves) |
|---|---|---|
| 1. Watertight (1000 ml) | S-4, AQL 1.5 | Pass based on: |
- Single Sampling Plan, S-4, AQL 1.5
- Multiple Sampling Plan, GII, AQL 2.5 |
| 2. Length (mm) | | |
| Size 6½ | min 265 | 301 |
| Size 7 | min 265 | 299 |
| Size 7½ | min 265 | 298 |
| Size 8 | min 265 | 301 |
| Size 8½ | min 265 | 303 |
| 3. Palm Width (mm) | | |
| Size 6½ | 83 ± 6 | 85 |
| Size 7 | 89 ± 6 | 92 |
| Size 7½ | 95 ± 6 | 96 |
| Size 8 | 102 ± 6 | 104 |
| Size 8½ | 108 ± 6 | 110 |
| 4. Single Wall Thickness (mm) | | |
| Finger | min 0.10 | 0.27 |
| Palm | min 0.10 | 0.25 |
| Cuff | min 0.10 | 0.20 |
| 5. Physical Properties (Type 2) | | |
| Before Aging: | | |
| Tensile Strength (MPa) | min 17 | 19.62 |
| Ultimate Elongation (%) | min 650 | 1108 |
| Stress at 500% Elongation (MPa) | max 7.0 | 1.92 |
| After Aging: | | |
| Tensile Strength (MPa) | min 12 | 16.35 |
| Ultimate Elongation (%) | min 490 | 1101 |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the exact numerical sample size for each test. However, for the watertight test, it refers to "Single Sampling Plan, S-4, AQL 1.5" and "Multiple Sampling Plan, GII, AQL 2.5." These are statistical sampling plans defined by ISO standards (or equivalent for medical devices) that dictate sample size based on lot size and acceptable quality limits (AQL). Without the lot size, the exact sample numbers cannot be determined from this text alone. For other physical property tests, specific sample sizes are not mentioned.
- Data Provenance: The data originates from "WEMBLEY RUBBER PRODUCTS (M) SDN BHD" located in Sepang, Selangor Darul Ehsan, Malaysia. The data appears to be retrospective as it's presented in a regulatory submission to demonstrate compliance of an already manufactured device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of study (device performance against a standard) does not typically involve human experts establishing a "ground truth" in the same way an AI diagnostic study would. The acceptance criteria themselves (ASTM D3577-91 Type 2 and FDA 1000ml watertight test) serve as the objective 'ground truth' against which the device performance is measured. The tests are typically conducted by trained technicians in a laboratory setting according to the standard's procedures. The document does not mention any experts in this context.
4. Adjudication Method for the Test Set
Not applicable. As described above, this is a performance test against objective standards, not a diagnostic task requiring expert adjudication of results. The "adjudication" is whether the measured values meet the specified limits of the ASTM standard and FDA watertight test.
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 study evaluating the physical performance specifications of a medical device (surgical gloves), not a comparative effectiveness study involving human readers or AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI algorithm study. It's a physical device performance study.
7. The Type of Ground Truth Used
The ground truth used is objective performance standards defined by:
- ASTM D3577-91 Type 2 (Standard Specification for Rubber Surgical Gloves)
- FDA 1000 ml watertight test requirements
These standards specify the acceptable ranges for various physical and performance characteristics of surgical gloves.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI study, so there is no "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set. The "ground truth" for evaluating the glove's performance against regulatory requirements is established by the specifications within the ASTM D3577-91 Type 2 standard and the FDA's watertight test criteria.
§ 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).