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510(k) Data Aggregation
(189 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
These gloves were tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 (2023), Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:
| Tested Chemotherapy Drugs | Concentration | Minimum Breakthrough Detection Time in minutes |
|---|---|---|
| *Carmustine | 3.3mg/ml | 22.5 |
| Cisplatin | 1 mg/ml | >240 |
| Cyclophosphamide | 20 mg/ml | >240 |
| Dacarbazine | 10 mg/ml | >240 |
| Doxorubicin, HCl | 2 mg/ml | >240 |
| Etoposide | 20 mg/ml | >240 |
| Fluorouracil | 50 mg/ml | >240 |
| Methotrexate | 25 mg/ml | >240 |
| Mitomycin | 0.5 mg/ml | >240 |
| Oxaliplatin | 5 mg/ml | >240 |
| Paclitaxel | 6 mg/ml | >240 |
| *Thiotepa | 10 mg/ml | 34.5 |
| Vincristine | 1 mg/ml | >240 |
| Tested Opioid Drugs | Concentration | Minimum Breakthrough Detection Time in minutes |
|---|---|---|
| Fentanyl Citrate Injection | 100mcg/2ml | >240 |
Warning: Do not use with Carmustine and Thiotepa.
Note:
Please note that the following drugs have low permeation times:
(1) Carmustine - 22.5 minutes
(2) Thiotepa - 34.5 minutes.
The Nitrile Powder Free Examination Glove with Tremella Fuciformis Extract, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate - Blue are Class 1, Polymer Patient Examination Gloves and Chemotherapy Gloves.
The glove is made of Nitrile Butadiene Rubber. They are ambidextrous with beaded cuffs, fingertip texture and come in different sizes - Small, Medium, Large and Extra Large. Gloves meet the specification of ASTM D6319-19 and have been tested for resistance to permeation by chemotherapy drugs and fentanyl citrate as per ASTM D6978-05(2023). The gloves are single use and provided non-sterile.
The provided FDA 510(k) clearance letter pertains to Nitrile Powder Free Examination Gloves, not a software-based medical device or AI system. Therefore, the questions regarding ground truth, expert adjudication, MRMC studies, standalone performance, training sets, and data provenance are not applicable to this document.
However, based on the non-clinical performance testing detailed in the submission, we can address the acceptance criteria and demonstrated performance for the physical device.
Acceptance Criteria and Reported Device Performance for Nitrile Powder Free Examination Gloves K243694
The acceptance criteria for this medical device are based on various physical, chemical, and biological tests, primarily adhering to ASTM and ISO standards for examination gloves and their specific claims (chemotherapy and fentanyl resistance).
1. Table of Acceptance Criteria and the Reported Device Performance
| Test Method | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Physical Dimensions (ASTM D6319) | Length: S: ≥220mm, M/L/XL: ≥230mmWidth: S: 80±10 mm, M: 95±10 mm, L: 110±10 mm, XL: 120±10 mmThickness: Palm: ≥0.05 mm, Finger: ≥0.05 mm | Length: S: ≥220mm (Pass), M/L/XL: ≥230mm (Pass)Width: S: 86-88/Pass, M: 98-99/Pass, L: 105-110/Pass, XL: 117-119/PassThickness: Palm: S-XL: 0.06mm/Pass, Finger: S-L: 0.08mm/Pass, XL: 0.09mm/Pass |
| Watertightness Test for Detection of Holes (ASTM D5151, ASTM D6319) | Meet AQL 2.5 with G1 | Meet AQL 2.5 with G1 (Pass) |
| Powder Content (ASTM D6124, ASTM D6319) | Meet the requirement of ASTM D 6124-06 (≤2.0mg/glove) | S: 0.63mg/glove, M: 1.02mg/glove, L: 0.28mg/glove, XL: 0.38mg/glove (Pass) |
| Physical Properties (Tensile Strength & Elongation) (ASTM D412, ASTM D6319) | Tensile Strength: before aging ≥14 MPa, after aging ≥14 MPaUltimate Elongation: before aging ≥500 %, after aging ≥400% | Tensile Strength: Before aging: Pass, After aging: PassUltimate Elongation: Before aging: Pass, After aging: Pass |
| Chemotherapy drug and Fentanyl Citrate claim (ASTM D6978) | The subject device was tested for use with chemotherapy drugs and Fentanyl Citrate. Implicit acceptance is that breakthrough times meet or exceed safe working periods, and any low permeation drugs are adequately warned. | No breakthrough detected up to 240 minutes for: Cisplatin, Cyclophosphamide, Dacarbazine, Doxorubicin HCl, Etoposide, Fluorouracil, Methotrexate, Mitomycin, Oxaliplatin, Paclitaxel, Vincristine, Fentanyl Citrate Injection.Low permeation times: Carmustine (22.5 minutes), ThioTEPA (34.5 minutes) - Warning issued for these two. |
| Cytotoxicity (ISO 10993-5) | Non-cytotoxic | Under conditions of the study, device extract is cytotoxic (This seems to be a clerical error in the document as it proceeds to state 'Non-cytotoxic' in subsequent summary sections of the same document for the same test, and a device would not be cleared if cytotoxic. Given the context of clearance, it likely passed or the initial statement is a misphrasing where the high concentrations showed cytotoxicity but the diluted, in-use concentrations did not, aligning with the "Under the condition of this test, exhibited cytotoxicity reactivity from 100.0% extract concentration to 25.0% extract concentrations and exhibited no cytotoxicity reactivity from 12.5% extract concentration to 3.125% extract concentrations" within the Summary of Technological Characteristic section. The overall conclusion for biocompatibility in Table 1 Part 4 of 8 "Similar" for this test, and the clearance, suggests it was deemed acceptable). |
| Irritation (ISO 10993-23) | Non-irritating | Under the conditions of the study, device is not an irritant. / Pass |
| Sensitization (ISO 10993-10) | Non-sensitizing | Under the conditions of the study, device is not a sensitizer. / Pass |
| Acute Systemic Toxicity (ISO 10993-11) | Non-acute systemic toxicity | Under the conditions of the study, device did not show acute systemic toxicity in vivo. / Pass |
| Bioburden Determination (ISO 11737-1:2018) | ≤ 200 CFU/device | 80-119 CFU/glove (Pass) |
| Material-Mediated Pyrogenicity (USP <151>) | Non-pyrogenic | Under the conditions of the study, non-pyrogenic (Pass) |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the specific "sample size" for each individual test reported (e.g., how many gloves were tested for watertightness, how many for a specific drug permeation). However, these tests are typically performed on a statistically representative sample of manufactured gloves as per the respective ASTM/ISO standards.
- Data Provenance: The testing was conducted as part of the 510(k) submission process for a device manufactured by Mah Sing Healthcare Sdn. Bhd. in Malaysia. The data would therefore be prospective for the purpose of demonstrating the device's adherence to the standards for this specific submission. The data is generated from laboratory testing of the physical product.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This relates to physical/chemical/biological testing of a medical glove, not the establishment of ground truth for an AI or imaging diagnostic system. The "ground truth" here is the objective measurement against established physical/chemical/biological standards.
4. Adjudication method for the test set:
Not applicable. Adjudication methods (like 2+1, 3+1) are relevant to human review of diagnostic medical data, often for establishing a consensus "ground truth" when a definitive objective truth is unavailable (e.g., interpreting medical images). For physical device testing, the results are typically objectively measured and do not require expert adjudication in this manner.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
No. MRMC studies are used to evaluate the impact of a new diagnostic aid (like AI) on physician performance. This is for a physical medical device (examination gloves), not an AI system or diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This question pertains to AI algorithm performance.
7. The type of ground truth used:
Objective Experimental Measurement and Compliance with Standardized Protocols. For each test (e.g., tensile strength, chemical permeation, cytotoxicity), the "ground truth" is the quantitative measurement obtained through standardized laboratory procedures (e.g., ASTM D6319 for physical properties, ASTM D6978 for chemical permeation, ISO 10993 series for biocompatibility) and compared against the defined acceptance criteria within those standards.
8. The sample size for the training set:
Not applicable. This question pertains to AI/machine learning models. Examination gloves do not have a "training set."
9. How the ground truth for the training set was established:
Not applicable. Again, this relates to AI/machine learning.
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