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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."
Here's the information parsed according to your request:
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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(252 days)
Non-Sterile, Powder-Free, Nitrile Examination Gloves Blue 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, Nitrile Examination Gloves Blue. A 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 the patient and the examiner.
Summary of Technological Characteristics:
Cuff: Beaded
Material: Nitrile
Powder Residue: Maximum 2mg/glove
Quality Assurance: In compliance with ASTM D6319-10, ISO 2859-1, manufactured under ISO9001:2008 and ISO 13485:2003
Physical Properties:
Overall Length: 240 mm minimum
Width: 95 mm minimum (for medium glove)
Thickness: .05 mm minimum
BEFORE AGING: Tensile Strength: 14.0 Mpa minimum, Ultimate Elongation: 500% minimum
AFTER AGING: Tensile Strength: 14.0 Mpa minimum, Ultimate Elongation: 400% minimum
Special Properties: None
Packaging: 150 pcs per dispenser box, 10 boxes per case, 1,500 gloves per case
Sizes: XS — XL
This document describes the acceptance criteria and performance of "Non-Sterile, Powder-Free, Nitrile Examination Gloves Blue" (K112012), not an AI device. Therefore, many of the requested sections related to AI device studies (e.g., sample size for test set, ground truth experts, MRMC studies, standalone performance, training set details) are not applicable.
Here's the available information based on the provided text, adapted to the closest relevant categories:
1. Table of Acceptance Criteria and Reported Device Performance
| Criteria | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Powder Residue | Maximum 2mg/glove | Not explicitly stated, but implies meeting this |
| Quality Assurance | In compliance with ASTM D6319-10, ISO 2859-1, ISO9001:2008, ISO 13485:2003 | Stated as being in compliance |
| Dimensions (Inspection) | AQL 4.0 (S-2 level) | Not explicitly stated as pass/fail, but implies meeting this |
| Physical Properties (Inspection) | AQL 4.0 (S-2 level) | Not explicitly stated as pass/fail, but implies meeting this |
| Water Tight Test (1000ml, Inspection) | AQL 1.5 (G-1 level) | Met both before and after aging |
| Visual Major Defects (Inspection) | AQL 1.5 (G-1 level) | Not explicitly stated as pass/fail, but implies meeting this |
| Visual Minor Defects (Inspection) | AQL 2.5 (G-1 level) | Not explicitly stated as pass/fail, but implies meeting this |
| Overall Length | 240 mm minimum | Not explicitly stated as a measured value, but implies meeting this |
| Width (medium glove) | 95 mm minimum | Not explicitly stated as a measured value, but implies meeting this |
| Thickness | 0.05 mm minimum | Not explicitly stated as a measured value, but implies meeting this |
| BEFORE AGING | ||
| Tensile Strength | 14.0 Mpa minimum | 14.0 Mpa minimum |
| Ultimate Elongation | 500% minimum | 500% minimum |
| AFTER AGING | ||
| Tensile Strength | 14.0 Mpa minimum | 14.0 Mpa minimum |
| Ultimate Elongation | 400% minimum | 400% minimum |
| Protein Labeling Claim Level | <50 ug/g | Met <50 ug/g |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes for each test (e.g., for dimensions, physical properties, water tight test). It refers to "inspection levels" (S-2, G-1) and AQL (Acceptable Quality Limit) values, which are used in statistical sampling plans for quality control, but the specific number of units sampled per lot is not provided.
The data provenance is from physical property tests, 1000ml water tight tests, biocompatibility tests, and residual powder content tests performed on the "Non-Sterile, Powder-Free, Nitrile Examination Gloves Blue". The study is inherently a prospective test of newly manufactured gloves against established standards. The country of origin of the data is not explicitly stated beyond the applicant being UG Healthcare (USA) Inc.
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 medical device (gloves) for which ground truth is established by objective physical and chemical measurements against recognized standards (e.g., ASTM D6319-10, FDA 1000 ml water test). It does not involve expert interpretation or diagnosis.
4. Adjudication method for the test set
Not applicable. Testing is based on objective physical/chemical measurements and statistical sampling plans (AQL) against predefined thresholds, not human adjudication of subjective data.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done
No, this is not an AI device, and therefore, an MRMC comparative effectiveness study involving human readers and AI assistance was not performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical medical device (gloves), not an algorithm.
7. The type of ground truth used
The ground truth is based on established industry standards and regulatory requirements, including:
- ASTM D 6319-10 (Standard Specification for Nitrile Examination Gloves for Medical Application)
- ISO 2859-1 (Sampling procedures for inspection by attributes)
- ISO 9001:2008 & ISO 13485:2003 (Quality management systems)
- FDA 1000 ml water test (for watertight integrity)
- Specific minimum/maximum thresholds for physical properties (e.g., tensile strength, elongation, dimensions, powder residue).
8. The sample size for the training set
Not applicable. As this is not an AI/machine learning device, there is no "training set."
9. How the ground truth for the training set was established
Not applicable. There is no training set for this device.
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(83 days)
The Powder-Free Black Examination Glove 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.
Trade Name: Powder-Free Black Latex Examination Glove With Protein Labeling Claim
Common Name: Examination Gloves
Classification Name: Patient Examination Glove (per 21 CFR 880.6251)
Class 1: Powder-Free Latex examination glove 80LYY that meets all of the requirements of ASTM D3578-05.
Powder Residue: Maximum 2mg/glove
Cuff: Beaded
Material: Latex Material. Latex Quality ASSurancer 11: Com859-1:1999 and manufactured under ISO9001:2000
Overall Length: 240 mm minimum
Width: 95 mm minimum (for medium glove)
Palm Thickness: 0.13 to 0.18mm (at center of palm)
Finger Thickness: 0.15 to 0.20 mm (at 15mm from tip of center finger)
Cuff Thickness: 0.10 to 0.15 mm (at 40mm from the beaded end)
BEFORE AGING Tensile Strength: 21.0 Mpa minimum
BEFORE AGING Ultimate Elongation: 700% minimum
BEFORE AGING Pinhole AQL 1.5 minimum
AFTER AGING 16.0 Mpa minimum
AFTER AGING 500% minimum
AFTER AGING 1.5 minimum
Special Properties: Black Colorant
Packaging: 100 pcs per dispenser box, 10 boxes per case, 1,000 gloves per case
Sizes: XXS — XXL
The provided document describes the acceptance criteria and performance of a Powder-Free Black Latex Examination Glove. It does not describe a study involving an AI-powered device or human readers. Therefore, several requested sections, such as those pertaining to AI model performance, human expert involvement, and training/test set details, are not applicable.
Here's the available information presented in the requested format:
1. A table of acceptance criteria and the reported device performance
| Criteria | Acceptance Criteria (Minimum/Maximum) | Reported Device Performance |
|---|---|---|
| Physical Properties | Meets all requirements of ASTM D3578-05 | Meets all requirements of ASTM D3578-05 |
| Powder Residue | Maximum 2 mg/glove | Not explicitly stated, but "Powder-Free" implies meeting this or better. |
| Overall Length | 240 mm minimum | 240 mm minimum |
| Width (for medium glove) | 95 mm minimum | 95 mm minimum |
| Palm Thickness | 0.13 to 0.18 mm (at center of palm) | 0.13 to 0.18 mm (at center of palm) |
| Finger Thickness | 0.15 to 0.20 mm (at 15mm from tip of center finger) | 0.15 to 0.20 mm (at 15mm from tip of center finger) |
| Cuff Thickness | 0.10 to 0.15 mm (at 40mm from the beaded end) | 0.10 to 0.15 mm (at 40mm from the beaded end) |
| Before Aging | ||
| Tensile Strength | 21.0 Mpa minimum | 21.0 Mpa minimum |
| Ultimate Elongation | 700% minimum | 700% minimum |
| Pinhole AQL | 1.5 minimum | 1.5 minimum |
| After Aging | ||
| Tensile Strength | 16.0 Mpa minimum | 16.0 Mpa minimum |
| Ultimate Elongation | 500% minimum | 500% minimum |
| Pinhole AQL | 1.5 minimum | 1.5 minimum |
| Water Tightness | Meets FDA 1000 ml water test (both before and after aging) | Meets FDA 1000 ml water test (both before and after aging) |
| Protein Labeling Claim | <50 ug/g total water extractable protein per gram of glove | <50 ug/g total water extractable protein per gram of glove |
| Inspection Parameters | ||
| Dimensions | AQL 4.0 | Not explicitly reported as "performance," but stated as an inspection AQL. |
| Physical Properties | AQL 4.0 | Not explicitly reported as "performance," but stated as an inspection AQL. |
| Water Tight Test 1000ml | AQL 1.5 | Not explicitly reported as "performance," but stated as an inspection AQL. |
| Visual Major Defects | AQL 1.5 | Not explicitly reported as "performance," but stated as an inspection AQL. |
| Visual Minor Defects | AQL 2.5 | Not explicitly reported as "performance," but stated as an inspection AQL. |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample size used for the specific tests to verify these specifications (e.g., how many gloves were tested for tensile strength or pinholes). It refers to "Inspection Parameters" with AQL (Acceptable Quality Level) values (e.g., G-1 AQL 1.5 for Water Tight Test), which implies a sampling plan based on established quality control standards. However, the exact sample size for the presented performance data is not provided.
Data Provenance: The data is generated from testing of the manufacturer's gloves to demonstrate compliance with ASTM D3578-05 and FDA requirements. It is implied to be prospective testing for regulatory submission. The country of origin of the data is not specified beyond the applicant's US address.
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 medical device (examination glove) subject to physical and chemical property testing against established standards, not an AI-powered diagnostic device requiring expert interpretation for ground truth.
4. Adjudication method for the test set
Not applicable. This is a medical device (examination glove) subject to physical and chemical property testing, not an AI-powered diagnostic device requiring expert 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 medical device (examination glove) and not an AI-powered diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device (examination glove) and not an AI-powered diagnostic device.
7. The type of ground truth used
The "ground truth" for this device's performance is based on:
- Established industry standards: ASTM D3578-05 for physical properties of latex examination gloves.
- Regulatory requirements: FDA 1000 ml water test.
- Specific claims: Protein labeling claim (<50 ug/g).
- Inspection methods: Specified AQL levels for various quality attributes.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This is a physical medical device, not an AI model.
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