(127 days)
Blue Nitrile Examination Gloves Powder Free is disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Blue Nitrile Examination Gloves Powder Free are Class I patient examination gloves bearing the product code Nitrile - LZA (21CFR880.6250). The gloves are made from acrylonitrile-butadiene copolymer dispersion. These gloves are blue in color and are powder free.
This document is a 510(k) summary for a medical device (Blue Nitrile Examination Glove Powder Free), demonstrating its substantial equivalence to a predicate device. This type of submission generally relies on non-clinical performance data rather than clinical studies for novel AI/ML devices. Therefore, a direct application of the typical "acceptance criteria" and "study that proves the device meets the acceptance criteria" for AI/ML performance (e.g., accuracy, sensitivity, specificity, MRMC studies) is not present here.
However, we can frame the information provided within the context of the requested questions by translating the device's technical specifications and performance data into a pseudo-"acceptance criteria" and "proof of meeting criteria."
Here's a breakdown based on the provided document:
1. A table of acceptance criteria and the reported device performance
For a physical device like a medical glove, "acceptance criteria" relate to its physical and biocompatibility properties, and "performance" refers to the test results demonstrating compliance with these standards.
| Characteristic | Standard/Test Method | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Dimensions | ASTM D6319-10 (Reapproved 2015) | Length Min 230 mm; Width depends on size (e.g., Medium: 95+/-10mm) | Meets/Exceeds (e.g., Length Min 230mm, Medium Width 92mm) |
| Physical Properties | ASTM D6319-10 (Reapproved 2015) | Before Aging: Tensile Strength min 14 Mpa, Ultimate Elongation Min 500% | |
| After Aging: Tensile Strength min 14 Mpa, Ultimate Elongation Min 400% | Meets/Exceeds (e.g., Before Aging: 18.62Mpa, 694%; After Aging: 17.68Mpa, 668% for Medium) | ||
| Thickness | ASTM D6319-10 (Reapproved 2015) | Palm min 0.05 mm, Finger min 0.05 mm | Meets/Exceeds (e.g., Palm 0.09mm, Finger 0.15mm for all sizes) |
| Powder Residue | ASTM D6319-10 / ASTM D6124-06 | ≤2 mg/glove | Meets (e.g., 0.22 mg/glove for Medium) |
| Water Tightness (Holes) | ASTM D5151-06 (Reapproved 2015) | Passes AQL-1.5 | Passes AQL 1.5 |
| Biocompatibility: | |||
| Primary Skin Irritation | ISO 10993-10:2010(E) | Not an irritant | Not an irritant |
| Dermal Sensitization | ISO 10993-10:2010(E) | Not a sensitizer | Not a sensitizer |
| In vitro cytotoxicity | ISO 10993-5:2009(E) | Non-cytotoxic | Cytotoxic (This is a discrepancy or a nuance to be explored within biocompatibility, as the acceptance criteria states "non cytotoxic" but result states "cytotoxic." Often, a cytotoxic result in vitro requires further in vivo investigation, but for gloves, the overall safety profile is considered.) |
| Acute Systemic Toxicity | ISO 10993-11:2017(E) | Extracts do not pose a systemic toxicity concern | Extracts do not pose a systemic toxicity concern |
| Material Mediated Pyrogenicity | ISO 10993-11:2017(E) / USP 41 | Non-pyrogenic | Non-pyrogenic |
| Bacterial Endotoxin | USP 42 | NMT 20 EU/pair of gloves |
§ 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.