(102 days)
A powder-free sterile surgeon's glove is a disposable device made of synthetic rubber intended to be worn on the hands of healthcare personnel as a barrier for protection against cross-contamination between the healthcare personnel and patient. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs and Fentanyl Citrate.
Powder Free Polyisoprene Surgical Glove, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistance meets all the requirements of ASTM standard D3577, ASTM D6978-05 and FDA 21 CFR 878.4460. The powder free polyisoprene surgical glove is manufactured from 100% synthetic polyisoprene latex. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder on the glove surface. The glove is hand specific. The physical properties of qlove, i.e., tensile strength meets ASTM standard D3577. Device is intended for single use. The powder free polyisoprene surgical glove, sterile is supplied in the following sizes: 5½, 6, 6½, 7, 7½, 8, 8½ and 9. This glove comes in natural color and powder free.
The provided text describes the acceptance criteria and performance data for a medical device (Polyisoprene Surgical Glove) in the context of an FDA 510(k) submission. It focuses on the device's physical properties, safety (biocompatibility), and resistance to chemotherapy drugs and fentanyl. This is a medical device, not an AI/ML device, so many of the requested elements for AI/ML performance studies (e.g., sample size for test/training sets, expert ground truth, MRMC studies, effect size, etc.) are not applicable or present in this document.
However, I can extract the acceptance criteria and device performance based on the non-clinical testing sections provided.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance:
The document provides extensive tables (Table 1, starting on page 7, and the "Summary of Non-Clinical Testing" tables starting on page 16) detailing the characteristics, standards, acceptance criteria, and device performance. I will consolidate the key acceptance criteria and reported performance from these tables.
| Characteristic | Standard/Purpose of Testing | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Physical Properties | ASTM D412 (Standard Test Method for Vulcanized Rubber and Thermoplastic Elastomers - Tension) | Before Aging: Min. 17MPa (Tensile Strength), Min. 650% (Ultimate Elongation), Max. 7.0MPa (Stress at 500% Elongation) | Pass (Meets criteria) |
| After Aging: Min. 12MPa (Tensile Strength), Min. 490% (Ultimate Elongation), N/A (Stress at 500% Elongation) | Pass (Meets criteria) | ||
| Dimension (Length) | ASTM D3767 (Standard Practice for Rubber - Measurement of Dimensions) | Varies by size (e.g., 5½: Min. 245 mm, 6.0: Min. 265 mm, etc.) | Pass for all sizes (Meets criteria) |
| Dimension (Width) | ASTM D3767 (Standard Practice for Rubber - Measurement of Dimensions) | Varies by size (e.g., 5½: 70 ± 6 mm, 6.0: 76 ± 6 mm, etc.) | Pass for all sizes (Meets criteria) |
| Dimension (Thickness) | ASTM D3767 (Standard Practice for Rubber - Measurement of Dimensions) | Finger: Min. 0.10 mm, Palm: Min. 0.10 mm, Cuff: Min. 0.10 mm | Pass for all (Meets criteria) |
| Watertight | ASTM D5151 (Standard Test Method for Detection of Holes in Medical Gloves) | Sample size: 125 pcs, Inspection level: GI, AQL: 0.65, Acceptance No. 2, Found 1 | Pass (Found 1, which is within the AQL of 0.65) |
| Residual Powder | ASTM D6124 (Standard Test Method for Residual Powder on Medical Gloves) | Have a powder residue limit of 2.0 mg per glove | Pass (Meets ≤ 2.0 mg/glove) |
| Biocompatibility (Primary Skin Irritation) | ISO 10993-10 (E) & Consumer Product Safety Commission Title 16, Chapter II, Part 1500 | Not a primary skin irritation | Pass (Not a primary skin irritant) |
| Biocompatibility (Dermal Sensitization) | ISO 10993-10 (E) & Consumer Product Safety Commission, Title 16, Chapter II, Part 1500.3 (c) (4) | Not a contact sensitizer | Pass (Not a contact sensitizer) |
| Biocompatibility (Acute Systemic Toxicity) | ISO 10993-11 (E) | No biological reactivity shown | Pass (Concluded that the product did not induce any systemic toxicity) |
| Biocompatibility (Material Mediated Pyrogenicity) | ISO 10993-11 (E) | No increase of temperature | Pass (Concluded that the product is considered to be non-pyrogenic) |
| Chemotherapy Drug Permeation | ASTM D6978 (Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs) | Varies by drug (e.g., Cisplatin: > 240 mins, Carmustine: 24.0 mins, ThioTepa: 23.1 mins) | Reported specific breakthrough times, meeting or exceeding expectations for most drugs. Warnings issued for drugs with low permeation times. |
| Fentanyl Resistance | ASTM D6978 (Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs) | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set:
- For the Watertight test (ASTM D5151), the sample size was 125 pieces.
- For other physical and material tests (e.g., Physical Properties, Dimension, Residual Powder, Biocompatibility), specific sample sizes are not explicitly stated in the provided text, but testing standards (e.g., ASTM D412, D3767, D6124, ISO 10993 series) would prescribe minimum sample sizes for these tests.
- For Chemotherapy Drug and Fentanyl Permeation, the ASTM D6978 standard would specify the number of samples required, but this is not detailed in the document.
- Data Provenance: The testing was conducted as part of a 510(k) submission for a device manufactured by WRP Asia Pacific Sdn. Bhd. (Malaysia). The tests themselves are non-clinical, laboratory-based tests adhering to international and ASTM standards. The data is thus prospective, generated specifically for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is a medical device (glove) filing, not an AI/ML device requiring human expert annotation or ground truth establishment in the traditional sense. The "ground truth" for the device's performance is established by the results of standardized physical, chemical, and biological tests, not by human expert interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. As this is not an AI/ML study involving human interpretation of data where adjudication is needed, no such method was employed. The results are quantitative measurements against established test standards.
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:
- No. This is not an AI/ML device, and no MRMC comparative effectiveness study was performed. The device is a physical barrier (surgical glove).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This device is a physical product (glove), not an algorithm or AI. Its performance is inherent to its material and manufacturing, tested against physical and chemical standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance is based on objective measurements and chemical/physical analyses performed according to established and recognized international standards (ASTM, ISO). For example:
- Tensile strength (measured in MPa, physical property).
- Elongation (measured in %, physical property).
- Dimensions (measured in mm, physical property).
- Detection of holes (binary, based on water leakage).
- Residual powder (measured in mg/glove, chemical analysis).
- Permeation breakthrough time (measured in minutes, chemical analysis).
- Biocompatibility tests (evaluating biological reactions based on validated assays).
8. The sample size for the training set:
- Not Applicable. This is not an AI/ML device, 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 for an AI/ML model, there is no ground truth to establish for it.
§ 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).