(103 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 D 3578-05 (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 provided text describes the 510(k) summary for the "Latex Examination Powder Free Gloves" device (K202377). This document focuses on demonstrating substantial equivalence to a predicate device (K192329) based on non-clinical performance data, as it is a Class I medical device. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study, ground truth establishment with experts, or similar clinical evaluation methods are not applicable here.
The "device" in this context is a pair of medical examination gloves, not an AI/software device. The "study" refers to non-clinical tests performed to demonstrate the physical and chemical properties of the gloves meet established standards.
Here's the breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Device Performance for Latex Examination Powder Free Gloves (K202377)
The acceptance criteria for this device are established by adherence to recognized ASTM standards for rubber examination gloves. The study proving the device meets these criteria involves laboratory testing of various physical and chemical properties of the gloves.
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristic | Standard Applied (Acceptance Criteria) | Device Performance (Reported Result) | Meets Criteria? |
|---|---|---|---|
| Length | ASTM D3578-05 (Reapproved 2015): Min 230 mm for all sizes | X-Small: 303 mm | |
| Small: 304 mm | |||
| Medium: 304 mm | |||
| Large: 305 mm | Yes | ||
| Width | ASTM D3578-05 (Reapproved 2015): | ||
| X-Small: 70+/-10 mm | |||
| Small: 80+/-10mm | |||
| Medium: 95+/-10 mm | |||
| Large: 111+/-10 mm | X-Small: 75 mm | ||
| Small: 84 mm | |||
| Medium: 94 mm | |||
| Large: 105 mm | Yes | ||
| Thickness | ASTM D3578-05 (Reapproved 2015): | ||
| Palm: 0.08 mm min | |||
| Finger: 0.08 mm min for all sizes | Palm: 0.16mm (all sizes) | ||
| Finger: 0.21mm (all sizes) | Yes | ||
| Tensile Strength (Before Ageing) | ASTM D3578-05 (Reapproved 2015): 18 Mpa Min for all sizes | X-Small: 22.13 Mpa | |
| Small: 22.20 Mpa | |||
| Medium: 22.25 Mpa | |||
| Large: 22.28 Mpa | Yes | ||
| Tensile Strength (After Ageing) | ASTM D3578-05 (Reapproved 2015): 14 Mpa Min for all sizes | X-Small: 18.57 Mpa | |
| Small: 18.64 Mpa | |||
| Medium: 18.70 Mpa | |||
| Large: 18.74 Mpa | Yes | ||
| Ultimate Elongation (Before Ageing) | ASTM D3578-05 (Reapproved 2015): 650% Min for all sizes | X-Small: 867% | |
| Small: 871% | |||
| Medium: 874% | |||
| Large: 877% | Yes | ||
| Ultimate Elongation (After Ageing) | ASTM D3578-05 (Reapproved 2015): 500% Min for all sizes | X-Small: 845% | |
| Small: 848% | |||
| Medium: 854% | |||
| Large: 860% | Yes | ||
| Stress at 500% Elongation (Before Ageing) | ASTM D3578-05 (Reapproved 2015): 5.5 Mpa Max for all sizes | X-Small: 5.1 Mpa | |
| Small: 5.1 Mpa | |||
| Medium: 5.2 Mpa | |||
| Large: 5.2 Mpa | Yes | ||
| Water Tightness (Holes) | ASTM D5151-06 (Reapproved 2015): AQL 2.5 | Passes AQL 1.5 | Yes |
| Residual Powder | ASTM D6124-06 (Reapproved 2017): 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 | Yes | ||
| Extractable Protein | ASTM D 5712-95 (Reapproved 2010): 200 µg/dm² Max for all sizes | X-Small: 50 µg/dm² | |
| Small: 50 µg/dm² | |||
| Medium: 50 µg/dm² | Yes | ||
| Biocompatibility | ISO 10993-10:2010(E) (Primary Skin Irritation/Dermal Sensitization), ISO 10993-5:2009(E) (In vitro cytotoxicity), ISO 10993-11:2017(E)/USP 41 (Material mediated Pyrogenicity), USP 42 (Bacterial Endotoxin), ISO 10993-11:2017(E) (Acute Systemic Toxicity) | Not an irritant, not a sensitizer, non-cytotoxic, non-pyrogenic, |
§ 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.