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510(k) Data Aggregation
K Number
K093797Manufacturer
Date Cleared
2010-02-23
(75 days)
Product Code
Regulation Number
880.6250Type
TraditionalPanel
General HospitalReference & Predicate Devices
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
A patient examination glove is disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
Classified by FDA's General Hospital and Personal Use Device panel as Class I, 21 Classince by I DA's Gelleral Hoopication Glove, 80 LYZ, and meets all requirements of ASTM standard D-5250-06e1.
AI/ML Overview
The provided text describes a 510(k) submission for Supermax Plastic Products Co., Ltd.'s Powder Free Vinyl Patient Examination Gloves. It details the device, its intended use, comparison to a predicate device, and the non-clinical tests performed to demonstrate substantial equivalence.
Here's an analysis based on your request, highlighting that this is for a medical device (glove), not an AI/software device, so many of your requested fields related to AI/software studies are "Not Applicable".
Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from ASTM D-5250-06e1 and FDA) | Reported Device Performance |
|---|---|
| Physical and Dimensions Testing: | |
| (Specifics not detailed, but implied by ASTM D-5250-06e1) | "All testing meets requirements for physical and dimensions testing conducted on gloves." |
| Freedom from Holes (FDA 1000 ml Water Fill Test): | |
| AQL 2.5, Inspection Level I | "The FDA 1000 ml. Water Fill Test was also conducted with samplings of AQL 2.5, inspection level I, meeting these requirements." |
| Primary Skin Irritation: | |
| No primary skin irritant reactions | "Primary Skin Irritation and Skin Sensitization (allergic contact dermatitis) testing was conducted with results showing no primary skin irritant... reactions." |
| Skin Sensitization (Allergic Contact Dermatitis): | |
| No sensitization reactions | "Primary Skin Irritation and Skin Sensitization (allergic contact dermatitis) testing was conducted with results showing no... sensitization reactions." |
| Residual Powder (for "powder-free" claim): | |
| No more than 2 mg powder per glove (based on ASTM D-6124-06) | "A Residual Powder Test that based on ASTM D-6124-06 for powder at finished inspection is conducted to insure that our gloves meet our 'powder-free' claims (contain no more than 2 mg powder per glove)." |
| General Manufacturing Quality: | |
| Inspection level S-2, AQL 4.0 (for general defects) | "Inspection level S-2, AQL 4.0." |
| Biocompatibility: (Implied by primary skin irritation and sensitization tests) | Met (as stated in conclusions: "biocompatibility requirements and labeling claims as shown by data in Section 7.") |
| Labeling Claims: No special claims, no hypoallergenic claim | "There are no special labeling claims and we do not claim our gloves as hypoallergenic on our labels." |
2. Sample size used for the test set and the data provenance
- Sample Size:
- For the FDA 1000 ml Water Fill Test: Sampling based on AQL 2.5, Inspection Level I (specific number of gloves not provided, but determined by the AQL standard).
- For general physical/dimensional testing: Inspection level S-2, AQL 4.0 (specific number of gloves not provided, but determined by the AQL standard).
- For Primary Skin Irritation and Skin Sensitization: Not specified, but standard biological tests would use a certain number of subjects/samples.
- For Residual Powder Test: Not specified, but based on ASTM D-6124-06.
- Data Provenance: Not explicitly stated, but the tests were conducted by the manufacturer (Supermax Plastic Products Co., Ltd. in China) and likely refer to internal testing data. It is a retrospective evaluation of manufactured batches.
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 (glove) evaluation, not an AI/software diagnostic tool. Ground truth is established by objective physical and chemical measurements (e.g., water leak, powder weight) and biological tests, not expert interpretation of outputs.
4. Adjudication method for the test set
- Not Applicable. As per point 3, ground truth is established by objective measurements and standardized tests, not by expert consensus requiring 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 a physical device (glove); there are no "human readers" or "AI assistance" in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical device (glove), not an algorithm.
7. The type of ground truth used
- The ground truth is established through adherence to recognized industry standards (ASTM D-5250-06e1, ASTM D-6124-06) and FDA-prescribed test methods (FDA 1000 ml Water Fill Test).
- It involves objective physical measurements, chemical analysis, and biological safety testing (primary skin irritation and sensitization).
8. The sample size for the training set
- Not Applicable. This is not an AI/ML model that requires a training set. The "training" in manufacturing would refer to process control and quality assurance over production runs, not data for an algorithm.
9. How the ground truth for the training set was established
- Not Applicable. As per point 8, there is no training set in the context of an AI/ML model for this device.
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