(59 days)
The Powder Free Nitrile Examination Glove (Aqua Green) is a disposable device intended for Medical purpose that is worn on the examiner's hands or finger to prevent contamination patient and examiner.
The subject device in this 510(k) Notification is Powder Free Nitrile Examination Glove (Aqua Green). The subject device is a patient examination glove made from nitrile compound, Aqua Green color, powder free and non-sterile (Per 21 CFR 880.6250, class I). The device meets the specifications in ASTM D6319-10, Standard specification for Nitrile Examination Gloves.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Powder Free Nitrile Examination Glove (Aqua Green):
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | Acceptance Criteria | Reported Device Performance (Powder Free Nitrile Examination Glove (Aqua Green), K200326) |
|---|---|---|
| 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. | Meets intended use description. |
| Material Use | Nitrile compound | Nitrile compound |
| Color | N/A (not a criterion for equivalence, but noted as different from predicate) | Aqua Green |
| Sterility | N/A | Non sterile |
| Single Use | Single used | Single used |
| Dimensions | Overall Length: Min 230mm; Width (± 5mm): Size S = 85mm, Size M = 95mm, Size L = 105mm, Size XL = 115mm; Thickness at Palm: Min 0.05 mm; Thickness at Finger Tip: Min 0.05 mm (Per ASTM D6319-10) | Meets ASTM D6319-10 (Specific values provided in another table confirm compliance with these) |
| Physical Properties (Before Aging) | Tensile Strength: 14min MPa; Ultimate Elongation: 500min % (Per ASTM D6319-10) | Meets ASTM D6319-10 (Specific values provided in another table confirm compliance with these) |
| Physical Properties (After Aging) | Tensile Strength: 14min MPa; Ultimate Elongation: 400min % (after 70ºC for 168 hrs @ 100ºC for 22 hrs) (Per ASTM D6319-10) | Meets ASTM D6319-10 (Specific values provided in another table confirm compliance with these) |
| Freedom from Pinholes | AQL 2.5, Inspection Level G-1 (Per ASTM D5151-06) | Meets ASTM D5151-06 (AQL 2.5, Inspection Level G-1) |
| 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.