(590 days)
The Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim is a specialty medical glove which is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient. In addition these gloves are worn to protect the wearer against exposure to chemotherapy drugs. Tested chemotherapy drugs are as follows:
Cisplatin, 1.0 mg/ml ≥ 240
Cyclophosphamide (Cytoxan), 20.0 mg/ml ≥ 240
Cytarabine, 100 mg/ml ≥ 240
Cytovene, 10 mg/ml ≥ 240
Dacarbazine (DTIC), 10.0 mg/ml ≥ 240
Docetaxel, 10.0 mg/ml ≥ 240
Doxorubicin Hydrochloride, 2.0 mg/ml ≥ 240
Etoposide (Toposar), 20.0 mg/ml ≥ 240
Fluorouracil, 50.0 mg/ml ≥ 240
Ifosfamide, 50.0 mg/ml ≥ 240
Irinotecan Hydrochloride, 20 mg/ml ≥ 240
Mechlorethamine HCI, 1.0 mg/ml ≥ 240
Methotrexate, 25 mg/ml ≥ 240
Mitomycin C, 0.5 mg/ml ≥ 240
Mitoxantrone, 2 mg/ml ≥ 240
Oxaliplatin, 5mg/ml ≥ 240
Paclitaxel (Taxol), 6.0 mg/ml ≥ 240
ThioTEPA 75.8
Vincristine Sulfate, 1.0 mg/ml ≥ 240
Vinorelbine, 10 mg/ml ≥ 240
Low Permeation Time (minutes) 1.7
Carmustine (BCNU), 3.3 mg/ml
Please note that the following drug has an extremely low permeation time: Carmustine (BCNU) 1.7 (mins)
Powder-Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim, meeting all the requirements of ASTM standards D6319-10 and ASTM D6124-06. The gloves are non-sterile, single-use, disposable devices.
The provided text is a 510(k) summary for "Powder-Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim." This document describes the device's characteristics and performance to demonstrate substantial equivalence to a predicate device. It is not an AI/ML device, and therefore several of the requested sections (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set size) are not applicable.
Here's the information that can be extracted:
Acceptance Criteria and Device Performance Study for Powder-Free Nitrile Examination Gloves
This device is not an AI/ML device, and thus many of the requested sections related to AI/ML study design are not applicable. The device is a physical medical glove.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Standard/Acceptance Criteria | Device Performance |
|---|---|---|
| Dimensions | ASTM D6319-10 | Meets standard requirements |
| Physical Properties | ASTM D6319-10 | Meets standard requirements |
| Thickness | ASTM D6319-10 | Meets standard requirements (Palm Thickness: ≥0.10 mm; Finger Thickness: ≥0.10 mm; Length: ≥270 mm) |
| Biocompatibility | Primary Skin Irritation Study (ISO 10993-0:2002E); Dermal Sensitization (ASTM-F 720-81) | Passes (Not a primary skin irritant); Passes (Not a contact sensitizer) |
| Watertight - 1000 ml (Freedom from Holes) | 21 CFR 800.20 (AQL 2.5 required per standard) | Passes (Gloves Free of Holes at quality level of AQL 1.5, which is better than required) |
| Resistance to Permeation by Chemotherapy Drugs | ASTM D6978-05 (Specific breakthrough times for various drugs) | Meets standard requirements for most drugs: |
- Cisplatin, 1.0 mg/ml: ≥ 240 minutes
- Cyclophosphamide (Cytoxan), 20.0 mg/ml: ≥ 240 minutes
- Cytarabine, 100 mg/ml: ≥ 240 minutes
- Cytovene, 10 mg/ml: ≥ 240 minutes
- Dacarbazine (DTIC), 10.0 mg/ml: ≥ 240 minutes
- Docetaxel, 10.0 mg/ml: ≥ 240 minutes
- Doxorubicin Hydrochloride, 2.0 mg/ml: ≥ 240 minutes
- Etoposide (Toposar), 20.0 mg/ml: ≥ 240 minutes
- Fluorouracil, 50.0 mg/ml: ≥ 240 minutes
- Ifosfamide, 50.0 mg/ml: ≥ 240 minutes
- Irinotecan Hydrochloride, 20 mg/ml: ≥ 240 minutes
- Mechlorethamine HCl, 1.0 mg/ml: ≥ 240 minutes
- Methotrexate, 25 mg/ml: ≥ 240 minutes
- Mitomycin C, 0.5 mg/ml: ≥ 240 minutes
- Mitoxantrone, 2 mg/ml: ≥ 240 minutes
- Oxaliplatin, 5mg/ml: ≥ 240 minutes
- Paclitaxel (Taxol), 6.0 mg/ml: ≥ 240 minutes
- Vincristine Sulfate, 1.0 mg/ml: ≥ 240 minutes
- Vinorelbine, 10 mg/ml: ≥ 240 minutes
Exceptions: - ThioTEPA: 75.8 minutes
- Carmustine (BCNU), 3.3 mg/ml: 1.7 minutes (noted as extremely low permeation time) |
| Design Specifications & Glove Performance | ASTM D6319-10 (Tensile Strength ≥ 14MPa; Elongation ≥400%) | Meets ASTM D6319-10 (Tensile Strength ≥ 14MPa; Elongation ≥400%) |
| Materials | N/A (Compared to predicate) | Flexible Nitrile |
| Color | N/A (Compared to predicate) | Synthetic Glove with embedded BLUE Biocompatible Colorant |
| Technology of Glove Design (Coatings/Donning Aid) | N/A (Compared to predicate) | Ambidextrous; Inner Glove Surface Chlorine Treated to Facilitate Donning; Fingertips Textured to Improve Tactility and Grip |
| Powder-Free | Applicable Definition for Powder Free (
§ 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.