(131 days)
Latex Examination Powder Free Gloves are disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Latex Examination Powder Free Gloves are manufactured to meet all the current specifications listed under the ASTM Specification D3578-05 (Reapproved 2015), Standard Specification for Rubber Examination Gloves. They are made from Natural Rubber Latex. These gloves are natural in color (No color is added) and are powder free.
The document provided is a 510(k) premarket notification for "Latex Examination Powder Free Gloves." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through non-clinical performance data against established standards for medical gloves, rather than clinical studies using AI.
Therefore, the requested information regarding AI study details (sample sizes for test and training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth for AI, how ground truth for training was established) is not applicable to this submission, as it does not involve an AI/ML powered device.
However, I can extract the acceptance criteria and device performance based on the non-clinical tests described.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method & Purpose | Acceptance Criteria (from Standards) | Reported Device Performance |
|---|---|---|
| Dimensions | ||
| ASTM D3578-05 (Reapproved 2015) - Length | Min 230 mm for all sizes | X-Small: 236 mm, Small: 236 mm, Medium: 242 mm, Large: 248 mm, X-Large: 252 mm |
| ASTM D3578-05 (Reapproved 2015) - Width | X-Small: 70+/-10 mm, Small: 80+/-10mm, Medium: 95+/-10 mm, Large: 111+/-10 mm, X-Large: 115+/-10 mm | X-Small: 76 mm, Small: 85 mm, Medium: 98 mm, Large: 106 mm, X-Large: 116 mm |
| Physical Properties | ||
| ASTM D3578-05 (Reapproved 2015) - Thickness | Palm: 0.08 mm min, Finger: 0.08 mm min for all sizes | All sizes (X-Small to X-Large): Palm 0.12 mm, Finger 0.14 mm |
| ASTM D3578-05 (Reapproved 2015) - Tensile Strength (Before Ageing) | 18 Mpa Min for all sizes | X-Small: 22.08 Mpa, Small: 22.16 Mpa, Medium: 22.22 Mpa, Large: 22.30 Mpa, X-Large: 22.32 Mpa |
| ASTM D3578-05 (Reapproved 2015) - Tensile Strength (After Ageing) | 14 Mpa Min for all sizes | X-Small: 18.50 Mpa, Small: 18.56 Mpa, Medium: 18.65 Mpa, Large: 18.74 Mpa, X-Large: 18.76 Mpa |
| ASTM D3578-05 (Reapproved 2015) - Ultimate Elongation (Before Ageing) | 650% Min for all sizes | X-Small: 856%, Small: 868%, Medium: 874%, Large: 880%, X-Large: 882% |
| ASTM D3578-05 (Reapproved 2015) - Ultimate Elongation (After Ageing) | 500% Min for all sizes | X-Small: 842%, Small: 850%, Medium: 855%, Large: 860%, X-Large: 862% |
| ASTM D3578-05 (Reapproved 2015) - Stress at 500% Elongation (Before Ageing) | 5.5 Mpa Max for all sizes | X-Small: 5.1 Mpa, Small: 5.1 Mpa, Medium: 5.2 Mpa, Large: 5.2 Mpa, X-Large: 5.2 Mpa |
| Barrier Integrity | ||
| ASTM D5151-06 (Reapproved 2015) - Detection of Holes (Water Tight) | AQL 2.5 | Gloves Pass AQL 1.5 |
| Other Properties | ||
| ASTM D6124-06 (Reapproved 2017) - Residual Powder on Medical Gloves | 2 Mg/Glove Max | X-Small: 0.21 mg/glove, Small: 0.21 mg/glove, Medium: 0.22 mg/glove, Large: 0.22 mg/glove, X-Large: 0.22 mg/glove |
| ASTM D5712-95 (Reapproved 2010) - Analysis of Protein in Natural Rubber | 200 µg/dm² Max for all sizes | All sizes (X-Small to X-Large): 32 µg/dm² |
| ISO 10993-10:2010(E) - Primary Skin Irritation | Not an irritant | Under the condition of study, not an irritant |
| ISO 10993-10:2010(E) - Dermal Sensitization | Not a sensitizer | Under the conditions of the study, not a sensitizer |
| ISO 10993-5:2009(E) - In vitro cytotoxicity | Non-cytotoxic | Under the conditions of the study, non-cytotoxic |
| ISO 10993-11:2017(E) / USP - Material mediated Pyrogenicity | Non-pyrogenic | Under the conditions of the study, non-pyrogenic |
| USP 42 - Bacterial Endotoxin Test |
§ 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.