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510(k) Data Aggregation
(145 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
These gloves were tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
The subject device in this 510(k) Notification is a Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs
The subject device is a patient examination glove made from nitrile compound, blue in color, powder free and non-sterile (as per 21 CFR 880.6250, class I).
The principle operation of the medical device to provide single use barrier protection for the wearer and the device meets all the requirement specifications for Barrier Protection, tensile properties as defined in ASTM D6319-10, Standard specification for Nitrile Examination Gloves.
This document describes the acceptance criteria and performance study for the Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs (K171873).
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimension | ASTM standard D 6319-10 | Meets |
| Physical Properties | ASTM standard D 6319-10 | Meets |
| Freedom from pinholes | 21 CFR 800.20, ASTM D5151-11 | Meets |
| Powder Residual | ASTM D6319-10 and D6124-06 (Reapproved 2011) | Meets |
| Biocompatibility (Skin Irritation) | ISO 10993-10:2010 Primary Skin Irritation | Not a primary skin irritant under the conditions of the study |
| Biocompatibility (Sensitization) | ISO 10993-10:2010 Dermal sensitization in the guinea pig | Not a contact sensitizer under the conditions of the study |
| Chemotherapy Drug Permeation | ASTM D6978-05 (Reapproved 2013) - Minimum Breakthrough Detection Time (drug specific) | See table below for specific drug performance |
Chemotherapy Drug Permeation Performance:
| Drug and Concentration | Minimum Breakthrough Detection Time in Minutes (Acceptance Criteria per ASTM D6978-05) | Reported Device Performance (Minimum Breakthrough Detection Time in Minute) |
|---|---|---|
| Carmustine (BCNU) 3.3 mg/ml | Not explicitly stated as a minimum in the document, but assessed against predicate. | 14.7 |
| Cisplatin 1.0 mg/ml | Not explicitly stated as a minimum in the document, but assessed against predicate. | >240 |
| Cyclophosphamide (Cytoxan) 20 mg/ml | Not explicitly stated as a minimum in the document, but assessed against predicate. | >240 |
| Cytarabine 100 mg/ml | Not explicitly stated as a minimum in the document, but assessed against predicate. | >240 |
| Dacarbazine (DTIC) 10.0 mg/ml | Not explicitly stated as a minimum in the document, but assessed against predicate. | >240 |
| Doxorubicin Hydrochloride 2.0 mg/ml | Not explicitly stated as a minimum in the document, but assessed against predicate. | >240 |
| Etoposide (Toposar) 20.0 mg/ml | Not explicitly stated as a minimum in the document, but assessed against predicate. | >240 |
| Fluorouracil 50.0 mg/ml | Not explicitly stated as a minimum in the document, but assessed against predicate. | >240 |
| Ifosfamide 50.0 mg/ml | Not explicitly stated as a minimum in the document, but assessed against predicate. | >240 |
| Methotrexate 25 mg/ml | Not explicitly stated as a minimum in the document, but assessed against predicate. | >240 |
| Mitomycin C 0.5 mg/ml | Not explicitly stated as a minimum in the document, but assessed against predicate. | >240 |
| Mitoxantrone 2.0 mg/ml | Not explicitly stated as a minimum in the document, but assessed against predicate. | >240 |
| Paclitaxel (Taxol) 6.0 mg/ml | Not explicitly stated as a minimum in the document, but assessed against predicate. | >240 |
| Thiotepa 10.0 mg/ml | Not explicitly stated as a minimum in the document, but assessed against predicate. | 58.8 |
| Vincristine Sulfate 1.0 mg/ml | Not explicitly stated as a minimum in the document, but assessed against predicate. | >240 |
Note: The document highlights that Carmustine (BCNU) and Thiotepa have "extremely low permeation times" and a warning statement is to be included in labeling for these specifically.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" in terms of a dataset of items being classified or evaluated by an algorithm or human readers. Instead, it refers to bench tests conducted on the device itself.
- Sample Size: Not explicitly stated for each specific test (e.g., number of gloves tested for pinholes, physical properties, or chemotherapy permeation). The general statement is "Bench tests were conducted to verify that the proposed device met all specifications."
- Data Provenance: The tests are described as "Bench tests" which are typically laboratory-based and prospective in nature for a new device. The country of origin for the data is not specified, but the applicant company is Zhonghong Pulin Medical Products Co., Ltd. located in China.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable to this type of device submission. The "ground truth" for glove performance is established through adherence to recognized international standards (e.g., ASTM, ISO) and regulatory requirements (e.g., 21 CFR 800.20), not through expert consensus on a test set of data. The performance is objectively measured against predefined criteria in these standards.
4. Adjudication Method for the Test Set
Not applicable. As noted above, performance is measured against objective standards, not through consensus or adjudication of expert interpretations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This type of study is not relevant for a medical device like an examination glove. MRMC studies are typically used for evaluating diagnostic imaging or AI algorithms where human interpretation plays a significant role.
6. Standalone Performance Study (Algorithm Only Without HIL)
No. This device is a physical medical glove and does not involve AI algorithms or human-in-the-loop performance evaluation in the context of an algorithm. The "device performance" refers to the physical and chemical properties of the glove itself.
7. Type of Ground Truth Used
The "ground truth" for evaluating the glove's performance is based on established industry standards and regulatory requirements. This includes:
- ASTM D6319-10: Standard Specification for Nitrile Examination Gloves for Medical application (Dimension, Physical Properties, Powder Residual).
- 21 CFR 800.20 & ASTM D5151-06 (2011): Freedom from pinholes.
- ASTM D6124-06 (2011): Standard Test Method for Residual Powder on Medical Gloves.
- ISO 10993-10:2010: Biocompatibility (Primary Skin Irritation, Dermal Sensitization).
- ASTM D6978-05 (Reapproved 2013): Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
8. Sample Size for the Training Set
Not applicable. This device is not an AI algorithm that requires a training set. Its performance is evaluated through physical and chemical testing.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
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