(90 days)
Blue Latex Examination Powder Free Gloves are disposable devices intended for medical purpose that are worn on the examiner's hand to prevent contamination between patient and examiner.
Blue Latex Examination Powder Free Gloves are manufactured to meet all the current specifications listed under the ASTM Specification D 3578-05 (Reapproved 2015), Standard Specification for Rubber Examination Gloves. They are made from Natural Rubber Latex. These gloves are blue in color and are powder free.
The document provided describes the acceptance criteria and the study results for the Blue Latex Examination Powder Free Gloves (K192329). This is a medical device, specifically examination gloves, and the studies evaluate physical properties and biocompatibility.
Here's the requested information:
1. A table of acceptance criteria and the reported device performance
| Characteristic / Test Method | Acceptance Criteria | Reported Device Performance (K192329) | Comparison with Predicate (K141042) |
|---|---|---|---|
| Dimensions - Length (ASTM D3578-05) | Min 230 mm for all sizes | Small: 304 mm, Medium: 304 mm, Large: 305 mm, X-Large: 305 mm, XX-Large: 305 mm | Similar |
| Dimensions - Width (ASTM D3578-05) | Small: 80+/-6 mm, Medium: 95+/-6mm, Large: 105+/-6 mm, X-Large: 114+/-6 mm, XX-Large: 120 +/-6 mm | Small: 84 mm, Medium: 94 mm, Large: 105 mm, X-Large: 114 mm, XX-Large: 123 mm | Similar |
| Thickness (ASTM D3578-05) | Palm: 0.08 mm min, Finger: 0.08 mm min for all sizes | Palm: 0.31mm (all sizes), Finger: 0.38mm (all sizes) | Similar |
| Physical Properties - Tensile Strength (ASTM D3578-05) | Before Ageing: 18 Mpa Min, After Ageing: 14 Mpa Min | Before Ageing: Small: 33.0 Mpa, Medium: 32.9 Mpa, Large: 32.2 Mpa, X-Large: 31.9 Mpa, XX-Large: 31.1 Mpa. After Ageing: Small: 30.0 Mpa, Medium: 30.6 Mpa, Large: 29.9 Mpa, X-Large: 29.7 Mpa, XX-Large: 28.2 Mpa | Similar |
| Physical Properties - Ultimate Elongation (ASTM D3578-05) | Before Ageing: 650% Min, After Ageing: 500% Min | Before Ageing: Small: 1322%, Medium: 1250%, Large: 1392%, X-Large: 1130%, XX-Large: 1149%. After Ageing: Small: 1046%, Medium: 1122%, Large: 1257%, X-Large: 1011%, XX-Large: 1110% | Similar |
| Physical Properties - Stress at 500% Elongation (ASTM D3578-05) | Before Ageing: 5.5 Mpa Max | Small: 5.1 Mpa, Medium: 5.2 Mpa, Large: 5.2 Mpa, X-Large: 5.1 Mpa, XX-Large: 5.2 Mpa | Not directly compared to predicate (N/A in predicate column) but meets the criteria |
| Water Tight (Holes) (ASTM D5151-06) | AQL 2.5 | Passes AQL 1.5 | Same |
| Powder Free Residue (ASTM D6124-06) | ≤ 2 mg/glove Max | Small: 0.20 mg/glove, Medium: 0.21 mg/glove, Large: 0.22 mg/glove, X-Large: 0.22 mg/glove, XX-Large: 0.23 mg/glove | Similar |
| Extractable Protein (ASTM D 5712-95) | 200 µg/dm² Max | Small: 45 µg/dm², Medium: 44 µg/dm², Large: 44 µg/dm², X-Large: 43 µg/dm², XX-Large: 45 µg/dm² | Not specified for predicate |
| Biocompatibility - Primary Skin Irritation (ISO 10993-10:2010(E)) | Not an irritant | Not an irritant | Same |
| Biocompatibility - Dermal Sensitization (ISO 10993-10:2010(E)) | Not a sensitizer | Not a sensitizer | Same |
| Biocompatibility - In vitro cytotoxicity (ISO10993-5:2009(E)) | Not explicitly stated in predicate, but implied (safe) | Cytotoxic, which is to be expected as latex is the positive control for this test. | Different (explained as expected) |
| Biocompatibility - Material mediated Pyrogenicity (ISO 10993-11:2017(E) / USP) | Data not available for predicate, implied non-pyrogenic if not listed. | Non-pyrogenic | Not available for predicate |
| Intended Use | For medical purposes to prevent contamination between patient and examiner. | Disposable devices intended for medical purpose that are worn on the examiner's hand to prevent contamination between patient and examiner. | Same |
| Material | Natural Latex | Natural Latex | Identical |
| Color | Blue | Blue | Identical |
| Texture | Finger Texture | Finger texture | Identical |
| Size (ASTM D3578-05) | Small, Medium, Large, X Large & XX Large | Small, Medium, Large, X Large & XX Large | Same |
| Single Use (Medical Glove Guidance Manual - Labeling) | Single Use | Single Use | Same |
| Sterile/non sterile | Non sterile | Non sterile | Same |
| Powder/Powder free | Powder free | Powder free | Same |
| Label and Labeling | Meets FDA's label and labeling requirements | Meets FDA's label and labeling requirements | Same |
2. Sample size used for the test set and the data provenance
The document provides specific values for various measurements (e.g., length, width, thickness, tensile strength, ultimate elongation, residual powder content, extractable protein content) across different glove sizes (Small, Medium, Large, X-Large, XX-Large). For tests like Water Tightness (AQL 1.5 achieved) and Biocompatibility testing (Primary Skin Irritation, Dermal Sensitization, In vitro cytotoxicity, Material mediated Pyrogenicity), the methodology implies testing on a statistically significant sample, but the exact sample sizes are not explicitly stated in the provided text for each test.
The data provenance is from non-clinical tests conducted by JR Engineering & Medical Technologies (M) SDN.BHD. in Malaysia. The study is a prospective assessment of the device's adherence to established ASTM standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the document describes non-clinical testing of physical and chemical properties of a medical device (gloves), not studies requiring expert interpretation of medical images or conditions to establish a ground truth. The "ground truth" here is defined by established engineering and medical device standards (e.g., ASTM, ISO).
4. Adjudication method for the test set
This is not applicable for the type of testing described (physical and chemical properties testing against standards). Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for medical image interpretation or diagnostic accuracy assessments where human expert consensus 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
This is not applicable. The document describes the performance of an examination glove, not an AI-powered diagnostic or assistive technology.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This document evaluates a physical medical device (gloves), not a software algorithm.
7. The type of ground truth used
The ground truth used for these tests is based on established industry standards and specifications:
- ASTM D3578-05 (Reapproved 2015) Standard Specification for Rubber Examination Gloves
- ASTM D5151-06 (Reapproved 2015) Standard Test Method for Detection of Holes in Medical Gloves
- ASTM D6124-06 (Reapproved 2017) Standard Test Method for Residual Powder on Medical Gloves
- ASTM D 5712-95 (Reapproved 2010) Standard Test Method for the Analysis of Protein in Natural Rubber
- ISO 10993-10:2010(E) for Primary Skin Irritation and Dermal Sensitization
- ISO 10993-5:2009(E) for In vitro cytotoxicity
- ISO 10993-11:2017(E) / USP for Material mediated Pyrogenicity
8. The sample size for the training set
This is not applicable as this pertains to a physical product's performance validation, not a machine learning model.
9. How the ground truth for the training set was established
This is not applicable (see #8).
§ 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.