(91 days)
Mint Flavour, Blue Colour Powder Free BarrierPro™ Copolymer Rubber Examination Glove is a single use device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between the healthcare personnel and the patient.
Cleantexx TM Mint Flavour, Blue Colour Powder Free Barrier
Pro TM Polybutadiene Copolymer Examination Gloves
meets all the current specifications listed under the ASTM
Specification D 6319-00a, Standard Specification for Nitrile
Examination Gloves for Medical Application. They are
made from BarrierPro TM synthetic copolymer rubber latex, a
polybutadiene based copolymer. They are mint flavour,
blue in colour, are powder free.
The provided text describes the regulatory clearance of "CLEANTEXX™ MINT FLAVOUR, BLUE COLOUR POWDER FREE BARRIER PRO™ POLYBUTADIENE COPOLYMER EXAMINATION GLOVES". This is a medical device, specifically an examination glove, and the submission is for a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a new medical diagnosis or treatment through extensive clinical studies like those for AI/ML-based diagnostic devices.
Therefore, many of the requested points are not applicable to this type of device and submission. I will address the relevant points and indicate when information is not provided or applicable.
Acceptance Criteria and Reported Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (from ASTM D 6319-00a) | Reported Device Performance |
|---|---|---|
| Physical Properties | All current specifications listed under ASTM Specification D 6319-00a, Standard Specification for Nitrile Examination Gloves for Medical Application. | "Gloves meet all the current ASTM D 6319-00a Standard Specification for Nitrile Examination Gloves." |
| Biocompatibility | Not explicitly stated, but generally implies no irritation or sensitization. | Primary skin irritation testing in the rabbit and delayed contact sensitization testing in the guinea pig indicate no irritation or sensitization. |
| Powder Content | Negative for starch (for powder-free claims). | Final product is negative for the presence of starch using the USP iodine test. |
Study Proving Device Meets Acceptance Criteria:
The study proving the device meets the acceptance criteria is a series of non-clinical tests performed according to recognized standards and methods.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The submission does not specify the exact sample sizes used for each test (e.g., for physical properties, irritation, or sensitization). ASTM standards typically prescribe minimum sample sizes for specific tests.
- Data Provenance: The tests were performed by the manufacturer, LATEXX MANUFACTURING SDN. BHD., located in Malaysia. The tests are non-clinical (laboratory/animal-based) as opposed to human subject data.
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. For this type of device (examination gloves), ground truth is established through objective, standardized physical, chemical, and biological tests, not through expert human interpretation or consensus like in diagnostic imaging. Biocompatibility testing (irritation/sensitization) involves animal models and laboratory analysis.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically employed in studies where human expert disagreement on interpretation of data is possible and needs resolution (e.g., in medical image reading). The nature of the tests for examination gloves (physical, chemical, animal-based) does not require such adjudication.
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 not an AI/ML diagnostic device, and therefore, MRMC studies are not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for this device is based on objective measurements and observations derived from:
- Standardized test methods (e.g., breaking strength, elongation, dimensions) as specified in ASTM D 6319-00a.
- Laboratory analysis (e.g., USP iodine test for starch).
- Animal test results for biocompatibility (primary skin irritation in rabbits, delayed contact sensitization in guinea pigs).
8. The sample size for the training set
Not applicable. This is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device requiring a training set.
§ 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.