(111 days)
The Nitrile Powder Free Examination Glove (Blue) with Low Dermatitis Potential Claim is a disposable device intended for Medical purpose that is worn on the examiner's hands or finger to prevent contamination patient and examiner In addition these gloves was tested for use with Chemotherapy drugs in accordance with ASTM D6978-05 standards, Practice for assessment of medical glove to Permeation by chemotherapy Drugs.
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 standards ,Practice for assessment of Medical Glove to Permeation by chemotherapy Drugs . It is for overthe-counter use.
The subject device in this 510(k) Notification is Blue Nitrile Examination gloves, with claiming, this product contain Low Dermatitis Potential Claim and tested for use with Chemotherapy drugs. The subject device is a patient examination glove made from nitrile compound, Blue color, powder free and non sterile (Per 21 CFR 880.6250, class I). The device meets all the specifications in ASTM D6319-10, Standard specification for Nitrile Examination Gloves.
This document outlines the acceptance criteria and supporting studies for the "Powder Free Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for Use with Chemotherapy Drugs" (K152542).
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria | Reported Device Performance (K152542) |
|---|---|---|
| Product Code | LZA, LZC | LZA, LZC |
| 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 criteria. Additionally, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 standards, Practice for assessment of medical glove to Permeation by chemotherapy Drugs. |
| Material Use | Nitrile compound | Nitrile compound |
| Color | Blue | Blue |
| Sterility/Single Used | Non sterile, Single used | Non sterile, Single used |
| Dimensions (Overall Length, Width, Thickness) | Overall Length (mm): Min 270mm | |
| Width (±5mm): Size S = 85mm, Size M = 95mm, Size L = 105mm, Size XL = 115mm | ||
| Thickness at Palm (mm): Min; 0.10 mm | ||
| Thickness at Finger Tip (mm): Min 0.10 mm | Meets ASTM D6319-10 (Standard Specification for Nitrile Examination Gloves) | |
| Biological Evaluation - Primary Skin Irritation | Test article should be a non-irritant. | Under the conditions of this study, the test article was a non-irritant. |
| Physical Properties (Before Ageing) | Tensile Strength (MPa): >= 14min | |
| Ultimate Elongation (%): >= 500min | Meets ASTM D6319-10 | |
| Physical Properties (After Aging) | After Aging at 70°C for 168 hrs @ 100°C for 22 hrs: | |
| Tensile Strength (MPa): >= 14min | ||
| Ultimate Elongation (%): >= 400min | Meets ASTM D6319-10 | |
| Biological Evaluation - Dermal Sensitization Assay | Test article should be a non-sensitizer. | Under the conditions of this study, the test article was a non-sensitizer. |
| Resistance against Chemotherapy Drugs | Minimum Breakthrough Detection time in minutes (0.01 µg/cm²/minute) based on ASTM D6978-05 for specified drugs. | Carmustine (BCNU) (3.3mg/ml): 20.1 minutes |
| Cyclophosphamide (20mg/ml): > 240 minutes | ||
| Cisplatin (1.0mg/ml): > 240 minutes | ||
| Doxorubicin Hydrochloride (2 mg/ml): > 240 minutes | ||
| Etoposide (20mg/ml): > 240 minutes | ||
| Fluorouracil (50mg/ml): > 240 minutes | ||
| Methotrexate (25mg/ml): > 240 minutes | ||
| Paclitaxel (6mg/ml): > 240 minutes | ||
| Thiotepa (10mg/ml): 50.6 minutes | ||
| Freedom from Pinholes | AQL 2.5, Inspection Level G-1 | Meets ASTM D5151-06 |
| 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.