(147 days)
The 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.
Tactyl's powder free examination gloves are manufactured using TACTYLON™. TACTYLON™ gloves are made of a synthetic material that mimics latex but contain no natural rubber latex. It is also powder free for those users who will benefit from such requirements. The glove meets the physical property requirements of ASTM 3578-91 Rubber Examination Gloves. The 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.
This document is a 510(k) summary for a Powder Free Examination Glove, seeking substantial equivalence to a previously marketed device. It does not describe a study involving an AI or algorithm-based device, but rather a physical medical device (examination gloves). Therefore, many of the requested fields related to AI/algorithm performance are not applicable.
Here's the relevant information from the provided text, structured according to your request where applicable:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Physical property requirements of ASTM 3578-91 (Rubber Examination Gloves) | Meets these requirements. Physical properties remain comparable to TACTYLON™ examination gloves. |
| FDA test for water tightness (21 CFR 800) using 1000 ml water | Passed. |
| Acceptable Quality Level (AQL) of 4.0 for water tightness (21 CFR 800) | Passed. |
| Biocompatibility: No delayed dermal sensitization (Guinea Pig - Repeated Patch Method) | Showed no evidence of causing delayed dermal sensitization. |
| Biocompatibility: Not a primary skin irritant (New Zealand white albino rabbit - Primary Skin Irritation Test (FHSA)) | Demonstrated not to be a primary skin irritant. |
Note: The document states "The physical properties of the glove remain well within the requirements established by ASTM 3578 and remain comparable to TACTYLON™ examination gloves," but does not provide specific numerical values for each physical property.
Additional Information (Addressing fields where applicable for a physical device)
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Sample size used for the test set and the data provenance:
- Water Tightness Test: The document states gloves must pass an AQL of 4.0, which implies a sampling plan from production batches, but the specific sample size for a given test is not provided.
- Biocompatibility Tests: Sample sizes for the animal studies (Guinea Pig and Rabbit) are not specified.
- Provenance: This is a submission by TACTYL TECHNOLOGIES, INC. in the USA. The tests were likely conducted in a laboratory setting to evaluate the product.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for the performance of a physical examination glove is determined by established physical, chemical, and biological testing methods, not by expert interpretation like in image analysis or diagnostic AI.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Results from physical/biological tests are objective measurements based on defined protocols, not subject to opinion-based adjudication.
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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 document describes a physical medical device (gloves), not an AI or algorithm.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for this device's performance is based on:
- Standardized Test Methods: Adherence to ASTM (American Society for Testing and Materials) standards for physical properties and FDA regulations (21 CFR 800) for water tightness.
- Animal Biocompatibility Studies: Results from established protocols for delayed contact sensitization and primary skin irritation using animal models.
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The sample size for the training set: Not applicable. "Training set" is a concept for machine learning algorithms. This document is about a physical manufacturing process and product testing.
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How the ground truth for the training set was established: Not applicable.
§ 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.