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510(k) Data Aggregation
(252 days)
The Non-Sterile, Powder-Free, Latex Examination Gloves, Green and with Protein Labeling Claim (50 micrograms or less total water extractable protein per gram of glove), is a disposable device intended for Medical Purposes that is worn on the examiners hand to prevent contamination between patient and examiner.
Non-Sterile, Powder-Free, Latex Examination Gloves, Green and with Protein Labeling Claim
The provided text describes the acceptance criteria and performance data for "Non-Sterile, Powder-Free, Latex Examination Gloves, Green and with Protein Labeling Claim."
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1. Table of Acceptance Criteria and Reported Device Performance
| Criteria | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Material | Latex | Latex |
| Cuff | Beaded | Beaded |
| Powder Residue | Maximum 2mg/glove | In compliance with ASTM D3578-10 |
| Quality Assurance | ISO 2859-1:1999, ISO 9001:2000, ISO 13485 | Manufactured under ISO9001:2000 and ISO 13485 (implicitly meets ISO 2859-1:1999 as per ASTM) |
| Dimensions | Inspection Level S-2, AQL 4.0 | (Implicitly met as per ASTM D3578-10 compliance) |
| Overall Length | 240 mm minimum | (Implicitly met as per ASTM D3578-10 compliance) |
| Width (medium glove) | 95 mm minimum | (Implicitly met as per ASTM D3578-10 compliance) |
| Thickness | 0.08mm minimum | (Implicitly met as per ASTM D3578-10 compliance) |
| Physical Properties | Inspection Level S-2, AQL 4.0 | (Implicitly met as per ASTM D3578-10 compliance) |
| Before Aging-Tensile Strength | 18.0 Mpa minimum | (Implicitly met as per ASTM D3578-10 compliance) |
| Before Aging-Ultimate Elongation | 650% minimum | (Implicitly met as per ASTM D3578-10 compliance) |
| After Aging-Tensile Strength | 14.0 Mpa minimum | (Implicitly met as per ASTM D3578-10 compliance) |
| After Aging-Ultimate Elongation | 500% minimum | (Implicitly met as per ASTM D3578-10 compliance) |
| Water Tight Test 1000ml | Inspection Level G-1, AQL 1.5 | Meets the FDA 1000 ml water test both before and after aging |
| Visual Major Defects | Inspection Level G-1, AQL 1.5 | (Implicitly met as per ASTM D3578-10 compliance) |
| Visual Minor Defects | Inspection Level G-1, AQL 2.5 | (Implicitly met as per ASTM D3578-10 compliance) |
| Protein Content | <50 ug/glove (Protein Labeling Claim) | Meets the Protein Labeling Claim Level at <50 ug/g |
2. Sample size used for the test set and the data provenance
The document refers to adherence to ASTM D3578-10 and ISO 2859-1:1999 for inspection parameters and AQL (Acceptance Quality Limit) levels. These standards define sampling plans for lot acceptance.
- Sample size: Not explicitly stated as a single number, but indicated by inspection levels and AQL values (e.g., S-2, G-1). ASTM D3578-10 and ISO 2859-1:1999 would specify the exact sample sizes based on lot size and these inspection levels.
- Data provenance: Not explicitly stated; however, given it's a 510(k) submission, the testing would typically be performed by the manufacturer or accredited labs to demonstrate compliance with standards. It's implied to be prospective testing for the submitted device batch. Country of origin not specified for the test data itself, but the applicant is UG Healthcare (USA) Inc.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable to this type of device (examination gloves). The "ground truth" for glove performance is established through objective, quantitative measurements and adherence to recognized international standards (e.g., ASTM, ISO, FDA water test), not through expert interpretation or clinical decision-making.
4. Adjudication method for the test set
Not applicable. Measurements are objective and quantitative; therefore, no adjudication by experts is required.
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/software device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI/software device.
7. The type of ground truth used
The ground truth is established by objective functional and material performance standards as defined by ASTM D3578-10, ISO 2859-1:1999, the FDA 1000 ml water test, and specific physical/chemical property measurements (e.g., tensile strength, protein content).
8. The sample size for the training set
Not applicable. This is a manufactured product undergoing quality control and performance testing against established standards, not an AI model requiring a training set.
9. How the ground truth for the training set was established
Not applicable. Same as above.
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