(224 days)
A powder free nitrile examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands and finger to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTMD6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:
These patient examination gloves are formulated using nitrile, non-sterile, powder free, meet all the requirements of ASTM D6319 and tested for use with chemotherapy drugs.
The provided text describes the acceptance criteria and performance of "Non-Sterile Powder Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs." This is a medical device, and the data presented relates to its physical and chemical properties, not an AI/ML powered device. Therefore, many of the requested fields are not applicable.
Here's the information extracted from the document based on the prompt:
1. A table of acceptance criteria and the reported device performance
| Characteristics | Standards | Acceptance Criteria (Predicate) | Reported Device Performance (Current) |
|---|---|---|---|
| Manufacturer | - | Kossan International Sdn Bhd | Maxter Gloves Manufacturing Sdn Bhd |
| 510 (K) Number | - | K151750 | K172864 |
| Dimensions | ASTM D6319-10 | ≥ 230mm | ≥ 230mm |
| Physical Properties | ASTM D6319-10 | Meet | Meet |
| Thickness - Finger - Palm | ASTM D6319-10 | ≥ 0.05mm | ≥ 0.05mm |
| Freedom From Holes | ASTM D6319-10 and ASTM D5151 | Pass | Pass |
| Powder Free Residue | ASTM D6319-10 and ASTM D6124 | Meet | Meet |
| Resistance to Permeation by Chemotherapy Drugs (ASTM D6978-05) | |||
| Carmustine (BCNU) 3.3mg/ml | Concentration | 10.1 minutes | 8.3 minutes |
| Cisplatin 1.0mg/ml | Concentration | >240 minutes | >240 minutes |
| Cyclophosphamide (Cytoxan) 20mg/ml | Concentration | >240 minutes | >240 minutes |
| Cytarabine 100mg/ml | Concentration | >240 minutes | >240 minutes |
| Dacarbazine (DTIC) 10.0mg/ml | Concentration | >240 minutes | >240 minutes |
| Doxorubicin Hydrochloride 2.0mg/ml | Concentration | >240 minutes | >240 minutes |
| Etoposide (Toposar) 20.0mg/ml | Concentration | >240 minutes | >240 minutes |
| Fluorouracil 50.0 mg/ml | Concentration | Not explicitly stated for Predicate in table, but indicated as >240 for Current device. Given the "similar to predicate" statement, it's reasonable to infer a similar acceptance criteria. | >240 minutes |
| Ifosfamide 50.0 mg/ml | Concentration | >240 minutes | >240 minutes |
| Methotrexate 25mg/ml | Concentration | >240 minutes | >240 minutes |
| Mitomycin C 0.5mg/ml | Concentration | >240 minutes | >240 minutes |
| Mitoxantrone 2.0mg/ml | Concentration | >240 minutes | >240 minutes |
| Paclitaxel (Taxol) 6.0mg/ml | Concentration | >240 minutes | >240 minutes |
| Thiotepa 10.0mg/ml | Concentration | 30.2 minutes | 38.0 minutes |
| Vincristine Sulfate 1.0mg/ml | Concentration | >240 minutes | >240 minutes |
| Warning Statement | - | Warning: Please note that the following drugs have extremely low permeation times: Carmustine(BCNU): 10.1 minutes and Thiotepa: 30.2 minutes | Warning: Please note that the following drugs have low permeation time of less than 240 minutes: Carmustine (BCNU): 8.3 minutes and Thiotepa: 38.0 minutes. Do not use with Carmustine or Thiotepa. |
| Biocompatibility: Primary Skin Irritation | ISO 10993 | Non-irritant | Non-irritant |
| Biocompatibility: Dermal Sensitization | ISO 10993 | Non-sensitizer | Non-sensitizer |
| Biocompatibility: In vitro Cytotoxicity | ISO 10993 | Not available (for Predicate) | The device extract was not cytotoxic. |
| Material | ASTM D6319-10 | Nitrile | Nitrile |
| Color | - | Blue, and white | Blue |
| Texture | - | Finger Textured | Finger Textured |
| Size | Medical Glove Guidance Manual-Labeling | Extra Small, Small, Medium, Large, Extra Large | Extra Small, Small, Medium, Large, Extra Large |
| Single Use | Medical Glove Guidance Manual-Labeling | Single use | Single use |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample size for the tests conducted to determine the breakthrough detection times or other physical properties. It generally refers to conducting tests "in accordance with ASTMD6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs," and other ASTM and ISO standards. These standards typically specify sample sizes for their respective tests. The provenance of the data is implied to be from the manufacturer's testing (Maxter Glove Manufacturing Sdn Bhd) in Malaysia, as they are the submitter of the 510(k). The tests are prospective in nature, as they are performed to demonstrate compliance with standards for the device being submitted.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is a physical device (gloves) and the "ground truth" is established through standardized laboratory testing against chemical permeation and physical properties, not through expert consensus on medical images or diagnoses.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is a physical device.
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 powered medical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device is based on objective measurements conducted according to established international and national standards (e.g., ASTM D6319-10, ASTM D5151, ASTM D6124, ASTM D6978-05, ISO 10993). This involves laboratory measurements for physical dimensions, tensile strength, elongation, freedom from holes, powder residue levels, breakthrough time for chemotherapy drugs, and biocompatibility endpoints (irritation, sensitization, cytotoxicity).
8. The sample size for the training set
Not applicable. This is a physical device, not an AI/ML-powered device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is a physical device.
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination 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). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.