(218 days)
The SensiCare PI surgeon's glove is a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
The SensiCare PI Surgical Gloves are disposable powder-free surgical gloves that are intended to be worn by surgeons and/or operating room personnel to protect a surgical wound from contamination. The gloves are made with polyisoprene and are cream in color. The SensiCare PI Surgical Gloves are available in a smooth grip and are constructed with a beaded cuff. The gloves have been tested for use with chemotherapy drugs per ASTM D6978.
This document is a 510(k) Premarket Notification for the SensiCare PI Surgical Gloves. It outlines the device's characteristics, intended use, and a comparison to a predicate device. The primary performance testing described relates to the glove's resistance to chemotherapy drugs and its physical properties.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the SensiCare PI Surgical Gloves are based on compliance with specific ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization) standards, as well as FDA regulations.
| Acceptance Criteria Category | Standard / Reference | Acceptance Criterion | Reported Device Performance |
|---|---|---|---|
| Chemotherapy Drug Permeation (Breakthrough Detection Time) | ASTM D6978 | Not explicitly stated as a minimum "acceptance criteria" but rather as a performance benchmark compared to the predicate and intended use guidance (e.g., minimum breakthrough time of less than 30 minutes for certain drugs). The relevant criteria would be meeting or exceeding the performance of the predicate device. | Carmustine (BCNU) 3.3 mg/ml (3,300 ppm): 10.1 min. (10.1, 10.1, 10.1) |
| Cisplatin 1.0 mg/ml (1,000 ppm): 240 min. | |||
| Cyclophosphamide (Cytoxan) 20 mg/ml (20,000 ppm): 240 min. | |||
| Cytarabine 100 mg/ml (100,000 ppm): 240 min. | |||
| Dacarbazine (DTIC) 10.0 mg/ml (10,000 ppm): 240 min. | |||
| Doxorubicin Hydrochloride 2.0 mg/ml (2,000 ppm): 240 min. | |||
| Etoposide (Toposar) 20.0 mg/ml (20,000 ppm): 240 min. | |||
| Fluorouracil 50.0 mg/ml (50,000 ppm): 240 min. | |||
| Ifosfamide 50.0 mg/ml (50,000 ppm): 240 min. | |||
| Methotrexate 25 mg/ml (25,000 ppm): 240 min. | |||
| Mitomycin C 0.5 mg/ml (500 ppm): 240 min. | |||
| Mitoxantrone 2.0 mg/ml (2,000 ppm): 240 min. | |||
| Paclitaxel (Taxol) 6.0 mg/ml (6,000 ppm): 240 min. | |||
| Thiotepa 10.0 mg/ml (10,000 ppm): 11.6 min. (20.2, 21.5, 11.6) | |||
| Vincristine Sulfate 1.0 mg/ml (1,000 ppm): 240 min. | |||
| (Note: Carmustine and Thiotepa had breakthrough times less than 30 minutes, necessitating a warning in the intended use statement.) | |||
| Dimensions - Length | ASTM D3577 | 270mm min. | Meets ASTM D 3577 (270mm min.) |
| Dimensions - Width | ASTM D3577 | 5 ½ - 70±6mm, 6 - 76±6mm, 6 ½ - 83±6mm, 7 - 89±6mm, 7 ½ - 95±6mm, 8 - 102±6mm, 8 ½ - 108±6mm, 9 - 114±6mm | Meets ASTM D 3577 |
| Dimensions – Finger Thickness | ASTM D3577 | 0.10mm min. | Meets ASTM D3577 (0.10mm min.) |
| Dimensions – Palm Thickness | ASTM D3577 | 0.10mm min. | Meets ASTM D3577 (0.10mm min.) |
| Dimension – Cuff Thickness | ASTM D3577 | 0.10mm min. | Meets ASTM D3577 (0.10mm min.) |
| Physical Properties (Before Aging) - Tensile Strength | ASTM D3577 | 17 MPa min. | Meets ASTM D3577 (17 MPa min.) |
| Physical Properties (Before Aging) - Ultimate Elongation | ASTM D3577 | 650% min. | Meets ASTM D3577 (650% min.) |
| Physical Properties (Before Aging) - Stress at 500% Elongation | ASTM D3577 | 7.0 MPa min. | Meets ASTM D3577 (7.0 MPa min.) |
| Physical Properties (After Aging) - Tensile Strength | ASTM D3577 | 12 MPa min. | Meets ASTM D3577 (12 MPa min.) |
| Physical Properties (After Aging) - Ultimate Elongation | ASTM D3577 | 490% min. | Meets ASTM D3577 (490% min.) |
| Freedom from Holes | 21 CFR 800.20 & ASTM D3577 (tested per ASTM D5151) | Inspection Level 1, AQL 1.5 | Meets 21 CFR 800.20 and ASTM D3577 when tested in accordance with ASTM D5151 (Inspection Level 1, AQL 1.5) |
| Residual Powder | ASTM D3577 |
§ 878.4460 Non-powdered surgeon's glove.
(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's 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).