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510(k) Data Aggregation
(106 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. This glove has been tested for use with specific chemotherapy drugs listed below.
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Powder Free Nitrile Patient Examination Glove, Orange Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs meet all of the requirements of ASTM D6319-10. The gloves are ambidextrous single-use disposable devices that come in five sizes (XS, S, M, L, XL) in blue or orange color.
The provided document is a 510(k) Premarket Notification for Powder Free Nitrile Patient Examination Gloves. This type of device is a physical product and does not involve AI/ML. Therefore, many of the requested categories in the prompt are not applicable.
Here's the information that can be extracted relevant to the performance of these gloves:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Standards Requirements) | Reported Device Performance (Results Summary) | Conclusion |
|---|---|---|---|
| Dimensions | ASTM D6319-10 (Length ≥ 270mm, Palm Thickness ≥ 0.10mm, Finger Thickness ≥ 0.10mm, Specific Widths for XS-XL) | - Length ≥ 270mm - Palm Thickness ≥ 0.10mm - Finger Thickness ≥ 0.10mm - Widths: X-Small 70-80mm, Small 80-90mm, Medium 90-100mm, Large 101-111mm, X-Large ≥ 111mm | Meets Standard Requirements |
| Physical Properties | ASTM D6319-10 (Before Aging: Tensile Strength ≥ 14 MPA, Elongation > 500%; After Aging: Tensile Strength ≥ 14 MPA, Elongation > 400%) | - Before Aging: Tensile Strength ≥ 14 MPA, Elongation > 500% - After Aging: Tensile Strength ≥ 14 MPA, Elongation > 400% | Meets Standard Requirements |
| Freedom from Pinholes | ASTM D5151-11, ASTM D6319-10 (Pass quality level at G1 AQL 1.5) | Tested in accordance with ASTM D5151 test method. Pass quality level at G1 AQL 1.5 | Meets Standard Requirements |
| Powder Free Residue | ASTM D6124-11, ASTM D6319-10 (≤ 2 mg of residual powder per glove) | Result generated values ≤ 2 mg of residual powder per glove | Meets Standard Requirements |
| Biocompatibility (Dermal Sensitization) | ISO 10993-10:2010 (Not a contact skin sensitizer) | Not a contact skin sensitizer | Meets Standard Requirements |
| Biocompatibility (Primary Skin Irritation Test) | ISO 10993-10:2010 (Not a primary skin irritant) | Not a primary skin irritant | Meets Standard Requirements |
| Chemotherapy Drug Permeation (Blue Glove) | ASTM D6978-05 (Minimum Breakthrough Detection Time in Minutes) | Carmustine (3.3 mg/ml): 15.1 Cisplatin (1.0 mg/ml): >240 Cyclophosphamide (20 mg/ml): >240 Cytarabine (100 mg/ml): >240 Dacarbazine (DTIC) (10.0 mg/ml): >240 Doxorubicin Hydrochloride (2.0 mg/ml): >240 Etoposide (20.0 mg/ml): >240 Fluorouracil (50.0 mg/ml): >240 Ifosfamide (50.0 mg/ml): >240 Methotrexate (25 mg/ml): >240 Mitomycin C (0.5 mg/ml): >240 Mitoxantrone (2.0 mg/ml): >240 Paclitaxel (Taxol) (6.0 mg/ml): >240 Thiotepa (10.0 mg/ml): >240 Vincristine Sulfate (1.0 mg/ml): >240 | Tested for Use with Chemotherapy Drugs. Carmustine has extremely short permeation times of 15.1 minutes. |
| Chemotherapy Drug Permeation (Orange Glove) | ASTM D6978-05 (Minimum Breakthrough Detection Time in Minutes) | Carmustine (3.3 mg/ml): 17.9 Cisplatin (1.0 mg/ml): >240 Cyclophosphamide (20 mg/ml): >240 Cytarabine (100 mg/ml): >240 Dacarbazine (DTIC) (10.0 mg/ml): >240 Doxorubicin Hydrochloride (2.0 mg/ml): >240 Etoposide (20.0 mg/ml): >240 Fluorouracil (50.0 mg/ml): >240 Ifosfamide (50.0 mg/ml): >240 Methotrexate (25 mg/ml): >240 Mitomycin C (0.5 mg/ml): >240 Mitoxantrone (2.0 mg/ml): >240 Paclitaxel (Taxol) (6.0 mg/ml): >240 Thiotepa (10.0 mg/ml): >240 Vincristine Sulfate (1.0 mg/ml): >240 | Tested for Use with Chemotherapy Drugs. Carmustine has extremely short permeation times of 17.9 minutes. |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify a numerical sample size for the various tests (Dimensions, Physical Properties, Freedom from Pinholes, Powder Free Residue, Biocompatibility, Chemotherapy Drug Permeation). It generally refers to testing "in accordance with" the various ASTM and ISO standards, which inherently include sampling plans. For instance, "Pass quality level at G1 AQL 1.5" for pinholes refers to a specific sampling plan within ASTM D5151.
- Data Provenance: The document implies that testing was conducted by the manufacturer, Top Calibre Sdn. Bhd., located in Malaysia. The testing is retrospective, performed to demonstrate compliance with established standards for premarket notification.
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 physical device, and the "ground truth" is established through standardized laboratory testing procedures based on material science and safety standards (ASTM, ISO), rather than expert interpretation of data like images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. As mentioned above, "adjudication" in the context of expert review of data is not relevant for this type of device testing. Performance is measured against objective, quantifiable criteria defined by the 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:
- Not Applicable. This is a physical device, not an AI/ML algorithm or a system involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable. This is a physical device, not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" is established by the specified ASTM and ISO standards themselves. These standards define the acceptable physical properties, chemical resistance, and biocompatibility limits for patient examination gloves. Laboratory tests are performed to objectively measure these characteristics against the defined thresholds.
8. The sample size for the training set:
- Not Applicable. This is a physical device; there is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established:
- Not Applicable. There is no "training set" or AI/ML model for which ground truth would be established. Performance is based on direct physical and chemical testing.
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