(112 days)
The White Nitrile Examination Glove,Sterile, is a disposable device intended for medical purposes that is worn on the examiner Is 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
The subject device in this 510(k) Notification is White Nitrile Examination Gloves Sterile with tested for use with Chemotherapy drugs claims. The subject device is a patient examination glove made from nitrile latex compound, White color, powder free and sterile (Per 21 CFR 880.6250, class I). The White Nitrile Examination Glove ,Sterile, 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 (product Code LZA) and is used with chemotherapy drugs (Product code LZC).
The provided document is a 510(k) Premarket Notification for a medical device: "White Nitrile Examination Glove, Sterile Tested for use with Chemotherapy Drugs Claim." It outlines the acceptance criteria for the glove's performance, particularly its resistance to chemotherapy drugs, and summarizes the non-clinical testing performed.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The primary acceptance criteria for the chemotherapy drug resistance claim are defined by ASTM D6978-05 standards: Practice for assessment of Medical Glove to Permeation by chemotherapy Drugs. The device's performance is reported as the "Minimum Breakthrough detection time in minutes." The acceptance criteria are implicit in the comparison to the predicate device and the standard, aiming for breakthrough times that prevent drug permeation for a reasonable duration of use. The reported "Minimum Breakthrough detection time" for most drugs is "> 240 Minutes", indicating that no permeation was detected within the maximum test duration.
| Chemotherapy Drugs and Concentration | Acceptance Criteria (Implicit) | Reported Device Performance (Minimum Breakthrough detection time in minutes, 0.01 µg/cm2/minute) |
|---|---|---|
| Carmustine (BCNU) (3.3 mg/ml) | Adequate time to prevent permeation during anticipated use | 17.1 Minutes |
| Cyclophosphamide (20 mg/ml) | Adequate time to prevent permeation during anticipated use | > 240 Minutes |
| Cisplatin (1.0 mg/ml) | Adequate time to prevent permeation during anticipated use | > 240 Minutes (from table on page 2) |
| Dacarbazine (DTIC) (10 mg/ml) | Adequate time to prevent permeation during anticipated use | > 240 Minutes (from table on page 2) |
| Doxorubicin Hydrochloride (2.0 mg/ml) | Adequate time to prevent permeation during anticipated use | > 240 Minutes |
| Etoposide (20 mg/ml) | Adequate time to prevent permeation during anticipated use | > 240 Minutes |
| Fluorouracil (50 mg/ml) | Adequate time to prevent permeation during anticipated use | > 240 Minutes |
| Paclitaxel (6.0 mg/ml) | Adequate time to prevent permeation during anticipated use | > 240 Minutes |
| Thiotepa (10 mg/ml) | Adequate time to prevent permeation during anticipated use | 55.9 minutes |
| Cytarabine (10 mg/ml) | Adequate time to prevent permeation during anticipated use | > 240 Minutes (from table on page 4) |
| Methotrexate (25 mg/ml) | Adequate time to prevent permeation during anticipated use | > 240 Minutes (from table on page 4) |
Other acceptance criteria and performance related to the general glove properties (ASTM D6319-10 Standard specification for Nitrile Examination Gloves) and Biological Evaluation on medical device:
| Property | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Tensile Strength (MPa) - Before Ageing | 14 min | 14 min |
| Ultimate Elongation (%) - Before Ageing | 500 min | 500 min |
| Tensile Strength (MPa) - After Ageing | 14 min | 14 min |
| Ultimate Elongation (%) - After Ageing | 400 min | 400 min |
| Pin-hole Level | AQL 2.5 Inspection Level G-1 | Meets ASTM D6319-10 (AQL 2.5 Inspection Level G-1 via 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.