(34 days)
A powder free patient examination glove is a disposable device intended for medical purposes that is worn on the examiners hand or finger to prevent contamination between patient and examiner.
Powder free Latex Examination Glove is a class I device having product code LYY. It is a disposable device that meets all requirements of ASTM D3578-05.
Here's an analysis of the provided text regarding the acceptance criteria and study for the 'KS-CARE' Powder Free Polymer Coated Latex Examination Glove:
The provided document is a 510(k) Summary for a medical device: 'KS-CARE' Powder Free Polymer Coated Latex Examination Glove with Protein Content labeling Claim (50 Micrograms or Less). This type of submission aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving novel safety and effectiveness through extensive clinical trials.
The "study" in this context refers to the testing performed against recognized standards and comparative data with predicate devices to demonstrate the new device is as safe and effective as existing ones.
Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are largely derived from ASTM D3578-05 (Standard Specification for Rubber Examination Gloves) and in comparison to predicate devices.
| Acceptance Criteria (from ASTM D3578-05 / Predicate Comparison) | Reported Device Performance (KS-CARE Powder Free Polymer Coated Latex Examination Glove) |
|---|---|
| Physical Dimensions | |
| Width (size Medium) | 95 +/- 5 mm (Matches predicate 2, within range of predicate 1 (90-97mm)) |
| Overall Length | Min 240 mm (Matches predicate 2, min 240mm; predicate 1 is 241mm) |
| Palm Thickness | Min 0.08 mm (Lower than predicates (0.10mm, 0.10mm)) |
| Finger Thickness | Min 0.08 mm (Lower than predicates (0.13mm, 0.10mm)) |
| Physical Properties | |
| Tensile Strength Pre-aging (min) | Min 18 Mpa (Matches predicate 2, lower than predicate 1 (27 Mpa)) |
| Tensile Strength After-aging (min) | Min 14 Mpa (Matches predicate 2, lower than predicate 1 (25.8 Mpa)) |
| Ultimate Elongation Pre-aging (min) | Min 650% (Matches predicate 2, lower than predicate 1 (830%)) |
| Ultimate Elongation After-aging (min) | Min 500% (Matches predicate 2, lower than predicate 1 (730%)) |
| Biocompatibility | |
| Biocompatibility (Meets relevant standards) | YES (Passes) |
| Skin Irritation Test | Pass |
| Dermal Sensitization Test | Pass |
| Quality/Defect Levels | |
| Acceptable Quality Level (AQL) (Pinhole, typically) | 1.5% (Better than predicate 1 (2.5%), no info for predicate 2) |
| Chemical Residue | |
| Residual Powder Content (max) | Max 2.0 mg/glove (Higher than predicate 1 (1.1 mg/glove), no info for predicate 2) |
| Residual Protein Level |
§ 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.