(259 days)
A powder-free sterile surgeon's glove is a disposable device made of natural 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 and Fentanyl Citrate as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
This is a disposable natural rubber surgical glove that is tested for use with chemotherapy drugs and fentanyl resistance. The glove is supplied in the following sizes: 5½, 6, 6½, 7, 7½, 8, 8½ and 9.
The provided document describes the acceptance criteria and study results for two types of Natural Rubber Latex Surgical Gloves:
- Natural Rubber Latex Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl (Green)
- Natural Rubber Latex (Strip&Coat)/(Strip&Pack) Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl
This is a 510(k) Premarket Notification submission, which aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. The information provided focuses on the performance of the device against established standards (e.g., ASTM standards) rather than a clinical trial with human subjects or an AI-based study. As such, many of the requested points related to AI/MRMC studies, expert ground truth establishment, adjudication methods, and training/test set sample sizes for AI are not applicable to this type of device submission.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The "Summary of Non-Clinical Testing" (pages 15-16) and "Table 1" (pages 8-14) present the acceptance criteria and the device's performance.
Summary Table of Acceptance Criteria and Reported Device Performance
| Characteristic / Test Method | Standard(s) | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Physical Properties | ASTM D412 | ||
| Tensile Strength | - | Before Aging: Min. 24MPa; After Aging: Min. 18MPa | Before Aging: Pass; After Aging: Pass |
| Ultimate Elongation | - | Before Aging: Min. 750%; After Aging: Min. 560% | Before Aging: Pass; After Aging: Pass |
| Stress at 500% Elongation | - | Before Aging: Max. 5.5MPa; After Aging: N/A | Before Aging: Pass; After Aging: N/A |
| Dimension | ASTM D3767 | ||
| Length | Each size satisfies ASTM requirement | Length: Each size satisfies ASTM requirement | Pass (5½: Min. 245mm; 6.0-9.0: Min. 265mm for both devices) |
| Width | Each size satisfies ASTM requirement | Width: Each size satisfies ASTM requirement | Pass (e.g., 5½: 70 ± 6 mm; 9.0: 114 ± 6 mm for both devices) |
| Thickness | - | Finger: Min. 0.10 mm; Palm: Min. 0.10 mm; Cuff: Min. 0.10 mm | Pass |
| Watertight | ASTM D5151 | Freedom from holes at AQL 0.65 | Pass (Meets 21 CFR 800.20 and ASTM D3577 when tested in accordance with ASTM D5151 Inspection Level I, AQL 0.65) |
| Residual Powder | ASTM D6124 | Powder residue limit of ≤2.0 mg per glove | Pass |
| Protein Content | ASTM D5712 | ≤ 200 µg/dm2 | Pass |
| Biocompatibility | |||
| Primary Skin Irritation | ISO 10993-10 | Not a primary skin irritant | Not a primary skin irritation (Passes) |
| Dermal Sensitization | ISO 10993-10 | Not a contact sensitizer | Not a contact sensitizer (Passes) |
| Acute Systemic Toxicity | ISO 10993-11 | No biological reactivity shown | No biological reactivity shown (It is concluded that the devices did not induce any acute systemic toxicity) |
| Material Mediated Pyrogenicity | ISO 10993-11 | No increase of temperature (Non-pyrogenic) | No increase of temperature (It is concluded that the devices are non-pyrogenic) |
| Cytotoxicity - Direct Contact | ISO 10993-5 | Non-cytotoxic | Non-cytotoxic for S&C/S&P gloves |
| Cytotoxicity - MEM Elution | ISO 10993-5 | Non-cytotoxic | For Green gloves: Under the conditions of this study, the test article extract showed potential toxicity to L929 cells. For Strip&Coat/Strip&Pack gloves: Non-cytotoxic for S&C/S&P gloves (Note: This is a discrepancy with the table on page 16, which only shows the Green glove result for MEM Elution. However, the final conclusion states non-cytotoxic for S&C/S&P gloves in the direct contact test, implying potential difference in test methods or interpretation for the two types of gloves). |
| Bacterial Endotoxin | Limulus Amoebocyte Lysate (LAL) test | ≤20 EU/pair of gloves | Pass |
| Chemotherapy Drug Permeation | ASTM D6978-05 | Breakthrough Detection Time in Minutes: Generally >240 minutes | Green Glove: Most drugs >240 min. Exceptions: Carmustine (11.9 min), Thiotepa (14.7 min). Strip&Coat/Strip&Pack Glove: Most drugs >240 min. Exceptions: Carmustine (5.7 min), Thiotepa (13.8 min). WARNING labels are provided for Carmustine and Thiotepa. |
| Fentanyl Citrate Permeation | ASTM D6978-05 | Breakthrough Detection Time in Minutes: No breakthrough up to 240 minutes | No breakthrough up to 240 minutes (for both glove types). |
| Sterility Status | Medical Glove Guidance Manual - Labeling | Sterile | Sterile |
| Sterility Method | ISO 11137-1, ISO 11137-2 | Gamma Radiation (effective) | Gamma Radiation (Same as predicate) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not explicitly state the specific number of gloves (sample size) used for each physical, chemical, and biocompatibility test. It refers to compliance with ASTM standards, which typically specify minimum sample sizes for testing (e.g., ASTM D5151 for watertightness requires a specific inspection level and AQL, implying a certain sample size based on lot size). However, the exact sample numbers are not itemized here.
- Data Provenance: The tests are non-clinical (laboratory tests) performed on the manufactured gloves. The manufacturer is WRP Asia Pacific Sdn. Bhd., located in Malaysia (as per Section 1.0 Submitter). The data is generated from testing of the finished device. It is inherently "prospective" in the sense that the tests were conducted specifically for this submission, validating the device's properties.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable. This is a medical device submission based on a laboratory evaluation against recognized performance standards (ASTM, ISO, CFR). The "ground truth" for the device's physical and chemical properties is established by these objective, standardized test methods and their defined acceptance criteria, not by human expert interpretation or consensus as would be the case for an AI-enabled diagnostic device.
4. Adjudication Method for the Test Set
- Not Applicable. As the tests are objective, laboratory-based measurements (e.g., tensile strength, breakthrough time, watertightness), there is no need for expert adjudication. The results are quantitative and compared directly to predetermined numerical acceptance criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, a MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation (e.g., radiologists reading images) and the impact of AI assistance on that interpretation. This submission is for a physical barrier device (surgical gloves), not an AI-enabled diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an AI algorithm.
7. The Type of Ground Truth Used
- Ground Truth: The ground truth for this device is established by objective, standardized test methods and their defined acceptance criteria. These standards (e.g., ASTM D3577, ASTM D6978-05, ISO 10993 series) specify a methodology for testing and a quantitative or qualitative result that the device must meet (e.g., minimum tensile strength, maximum protein content, no breakthrough of chemicals). The chemical permeation results are based on the ASTM D6978-05 standard for chemotherapy drug permeation.
8. The Sample Size for the Training Set
- Not Applicable. There is no "training set" as this is not an AI/machine learning device. The glove is a manufactured product whose performance is evaluated against material and safety standards.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. Since there is no training set, this question is not relevant.
§ 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).