(145 days)
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. In addition these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
The Medline Powder-Free Blue Nitrile Exam Glove, Extended Cuff (Tested for Use with Chemotherapy Drugs) are single use only, disposable gloves intended for medical purposes to be worn on the hands or fingers of examiners. The gloves are powder-free and are made of nitrile with a blue colorant. The gloves are offered non-sterile and are available in small, medium, large and extra-large sizes.
Permeation testing was conducted to support the addition of the labeling claim: Tested for use with chemotherapy drugs. The subject device was tested according to ASTM D6978, Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. Minimum breakthrough times were determined for a wide range of chemotherapy agents.
This document is a 510(k) premarket notification for Medline Powder-Free Blue Nitrile Exam Gloves, Extended Cuff, which have been tested for use with chemotherapy drugs. It is a submission to the FDA seeking to demonstrate substantial equivalence to a legally marketed predicate device.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document explicitly refers to acceptance criteria by stating "Complies with ASTM D6319-10" or by providing specific thresholds. The "reported device performance" is implicitly shown by the claim of compliance or the listed breakthrough times.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Physical Properties (per ASTM D6319-10) | ||
| Dimension - Length | 270mm min. | Complies with ASTM D6319-10 (270mm min.) |
| Dimension - Width | Small - 80 ±10mm min. | |
| Medium - 95 ±10mm min. | ||
| Large - 110±10mm min. | ||
| Extra-Large - 120±10mm min. | Complies with ASTM D6319-10 (Small - 80 ±10mm min., Medium - 95 ±10mm min., Large - 110±10mm min., Extra-Large 120±10mm min.) Note: Predicate device had slightly different width ranges (e.g., 85 ±5mm), but the proposed device still falls within acceptable ranges per ASTM D6319-10. | |
| Dimension - Thickness | Palm - 0.10mm min. | |
| Finger - 0.10mm min. | Complies with ASTM D6319-10 (Palm - 0.10mm min., Finger - 0.10mm min.) | |
| Tensile Strength | Before Aging - 14 MPa, min. | |
| After Aging - 14 MPa, min. | Complies with ASTM D6319-10 (Before Aging - 14 MPa, min., After Aging - 14 MPa, min.) | |
| Elongation | Before Aging – 500% min. | |
| After Aging - 400% min. | Complies with ASTM D6319-10 (Before Aging – 500% min., After Aging - 400% min.) | |
| Freedom from Holes | AQL 1.5 Inspection level G-2 | Meets ASTM D6319-10 (AQL 1.5 Inspection level G-2) |
| 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.