(82 days)
A Patient Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hands or fingers to prevent contamination between patient and examiner.
Blue Nitrile Medical Examination gloves powder free, non sterile, as described in this 510(k) Notification is substantially equivalent to the current class I patient examination gloves with product Code LZA (21CFR 880.6250). It meets all the specifications in ASTM D6319-10, Standard specification for Nitrile Examination Gloves. They are made nitrile from nitrile latex compound,Blue colour, powder free and non sterile.
The provided document describes the acceptance criteria and performance of the "EMG Blue Nitrile Medical Examination Gloves Powder Free (Non Sterile)". This is a medical device for patient examination, not an AI or software device. Therefore, many of the requested categories in the prompt, such as those related to AI algorithm performance, human expert involvement, and ground truth establishment, are not applicable.
Here's an analysis of the provided information, focusing on the relevant sections for a medical device:
1. A table of acceptance criteria and the reported device performance
The document provides a detailed comparison table on page 5, which is further summarized on page 7-8.
| Characteristics / Acceptance Criteria | Reported Device Performance (EMG Blue Nitrile Medical Examination Gloves Powder Free) |
|---|---|
| Product Code | |
| LZA | LZA |
| Intended use | |
| A powder free 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. The device is for over-the-counter use. | A powder free 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. The device is for over-the-counter use. |
| Material use | |
| Not made from Natural Rubber Latex | Nitrile latex compound |
| Colour | |
| Blue | Blue |
| Sterility | |
| Non sterile | Non sterile |
| Dimensions (Meets ASTM D6319-10) |
- Overall Length (mm): ≥ 230mm
- Width (± 5mm): Size S = 85mm, Size M = 95mm, Size L = 105mm, Size XL = 115mm
- Thickness at Palm (mm): ≥ 0.05min
- Thickness at Finger Tip (mm): ≥ 0.05min | Meets ASTM D6319-10 (Pages 5 and 7 state "Meets ASTM D6319-10" for dimensions) |
| Physical properties (Before Ageing - Meets ASTM D6319-10) - Tensile Strength (MPa): ≥ 14min
- Ultimate Elongation (%): ≥ 500min | Meets ASTM D6319-10 (Pages 5 and 7 state "Meets ASTM D6319-10" for physical properties before ageing) |
| Physical properties (After Ageing at 70℃ for 168 hrs @ 100ºC for 22 hrs - Meets ASTM D6319-10) - Tensile Strength (MPa): ≥ 14min
- Ultimate Elongation (%): ≥ 400min | Meets ASTM D6319-10 (Pages 5 and 7 state "Meets ASTM D6319-10" for physical properties after ageing) The table on page 5 specifically says "Meets ASTM D6319-10" for the proposed device, and also for the predicate (K 112928) physical properties after aging, implying similarity and compliance. Page 7 confirms the proposed device meets ASTM D6319-10 for physical properties. |
| Freedom from pinholes
AQL 2.5, Inspection Level G-1 (Meets ASTM D6319-10) | Meets ASTM D6319-10 (Page 5: "Meets ASTM D6319-10"; Page 8: "Specification within ASTM D6319-10") |
| Residual Powder
§ 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.