(88 days)
This device is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
The tested chemotherapy drugs and permeation times are as follows:
Bleomycin Sulfate 15 mg/mL, >240 minutes Busulfan 6 mg/mL. >240 minutes Carboplatin (Paraplatin) 10 mg/mL, >240 minutes Carmustine (BCNU) 3.3 mg/mL, 17.1 minutes Cisplatin 1.0 mg/mL, >240 minutes Cyclophosphamide (Cytoxan) 20 mg/mL, >240 minutes Cytarabine 100 mg/mL, >240 minutes Dacarbazine (DTIC) 10 mg/mL, >240 minutes Daunorubicin 5 mg/mL, >240 minutes Docetaxel 10 mg/mL, >240 minutes Doxorubicin Hydrochloride 2 mg/mL, >240 minutes Epirubicin (Ellence) 2 mg/mL. >240 minutes Etoposide (Toposar) 20 mg/mL, >240 minutes Fludarabine 25 mg/mL, >240 minutes Fluorouracil 50 mg/mL, >240 minutes Gemcitabine 38 mg/mL, >240 minutes Idarubicin 1 mg/mL, >240 minutes
Ifosfamide 50 mg/mL, >240 minutes Irinotecan 20 mg/mL, >240 minutes Mechlorethamine 1 mg/mL, >240 minutes Melphalan 5 mg/mL, >240 minutes Methotrexate 25 mg/mL, >240 minutes Mitomycin C 0.5 mg/mL, >240 minutes Mitoxantrone 2 mg/mL, >240 minutes Paclitaxel (Taxol) 6 mg/mL, >240 minutes Rituximab 10 mg/mL, >240 minutes Thiotepa 10 mg/mL, 27.9 minutes Trisenox 1 mg/mL , >240 minutes Vincristine Sulfate 1 mg/mL, >240 minutes
Fentanyl tested as follows: Fentanyl citrate 100 mcg/2mL. >240 minutes
WARNING: Not for use with Carmustine or Thiotepa.
Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with Chemotherapy Drugs and Fentanyl.
This document is a 510(k) Premarket Notification from the FDA, detailing the substantial equivalence of a new medical device (nitrile exam gloves) to a legally marketed predicate device. It contains a section on non-clinical performance testing which describes the "acceptance criteria" and the "study that proves the device meets the acceptance criteria" for various physical and chemical properties of the gloves.
1. Table of Acceptance Criteria and Reported Device Performance:
The document provides a comprehensive table for various physical and chemical properties of the gloves under "H. Summary of Non-Clinical Performance Testings". The device is presented in three models: NOF_SD Orchid, NOF_SL Lilac, and NOF_EL Oyster.
| Measurement | Standard Criteria | Reported Device Performance (NOF_SD Orchid) | Reported Device Performance (NOF_SL Lilac) | Reported Device Performance (NOF_EL Oyster) |
|---|---|---|---|---|
| Tensile strength (Before aging) | 14 MPa Min (per ASTM D 6319-10) | 33 MPa | 34 MPa | 37 MPa |
| Tensile strength (After aging) | 14 MPa Min (per ASTM D 6319-10) | 37 MPa | 38 MPa | 41 MPa |
| Ultimate elongation (Before aging) | 500% Min (per ASTM D 6319-10) | 630% | 570% | 564% |
| Ultimate elongation (After aging) | 400% Min (per ASTM D 6319-10) | 625% | 535% | 551% |
| Length | 230 mm Min (M) | 240 mm | 238 mm | 240 mm |
| Thickness (Single wall Finger) | 0.05 mm Min | 0.14 mm | 0.08 mm | 0.08 mm |
| Thickness (Single wall Palm) | 0.05 mm Min | 0.10 mm | 0.06 mm | 0.05 mm |
| Width | 110 +/- 10 mm (M) | 111 mm | 110 mm | 110 mm |
| Freedom from holes | GI, AQL 2.5 (Accept - 7, Reject - 8) | 0 | 1 | 1 |
| Powder Residue | 2.0 mg/glove | 0.5 mg/glove | 0.3 mg/glove | 0.5 mg/glove |
| Chemotherapy Drug Permeation (Various drugs) | No breakthrough up to 240 minutes (for most drugs listed) | (See detailed table below for each drug) | (See detailed table below for each drug) | (See detailed table below for each drug) |
Chemotherapy Drug Permeation (Minimum Breakthrough Detection Time):
| Test Drug and Concentration | Standard Criteria (Minimum Breakthrough Detection Time) | NOF_SD Orchid | NOF_SL Lilac | NOF_EL Oyster | Steady State Perm. Rate (for some) |
|---|---|---|---|---|---|
| Bleomycin Sulfate 15,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Busulfan 6,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Carboplatin 10,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Carmustine (BCNU) 3,300 ppm | Not explicitly stated as "accepted", but tested | 17.1 minutes | 22.8 minutes | 22.3 minutes | 0.4, 0.4, 0.3 |
| Cisplatin 1,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Cytoxan 20,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Cytarabine 100,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| DTIC 10,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Daunorubicin 2,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Docetaxel 10,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Doxorubicin hydrochloride 2,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Epirubicin 2,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Etoposide (Toposar) 20,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Fludarabine 25,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Fluorouracil 50,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Gemcitabine 38,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Idarubicin 1,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Ifosfamide 50,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Irinotecan 20,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Mechlorethamine 1,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Melphalan 5,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Methotrexate 25,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Mitomycin C 500 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Mitoxantrone 2,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Taxol 6,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Rituximab 10,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Thiotepa 10,000 ppm | Not explicitly stated as "accepted", but tested | 27.9 minutes | 39.1 minutes | 39 minutes | 0.3, 0.3, 0.2 |
| Trisenox 1,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Vincristine sulfate 1,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Fentanyl Citrate 100 mcg/2mL | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Biocompatibility | (No specific numerical criteria, qualitative result) | Not an irritant | Not an irritant | Not an irritant | N/A |
| In vitro cytotoxicity | (No specific numerical criteria, qualitative result) | Cytotoxic | Cytotoxic | Cytotoxic | N/A |
| Systemic toxicity | (No specific numerical criteria, qualitative result) | No systemic response | No systemic response | No systemic response | N/A |
| Guinea Pig Sensitization | (No specific numerical criteria, qualitative result) | Not a sensitizer | Not a sensitizer | Not a sensitizer | N/A |
Important Note: The document explicitly states "WARNING: Not for use with Carmustine or Thiotepa" in the Indications for Use section (page 2), despite reporting specific breakthrough times for these drugs, indicating that these shorter permeation times (17.1-22.8 minutes for Carmustine and 27.9-39.1 minutes for Thiotepa) are below an acceptable level for safe use with these particular chemotherapy drugs.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document specifies sample sizes for a few tests:
- Freedom from holes: 125 samples for each model (NOF_SD Orchid, NOF_SL Lilac, NOF_EL Oyster) (page 8).
- Powder Residue: N=5 (number of gloves tested, AQL=N/A) (page 10).
- Tensile strength and ultimate elongation: Inspection Level: S-2 (page 10).
- Length, thickness, and width: Inspection Level: S-2 (page 10).
- Data Provenance: The tests are described as "Non-Clinical Performance Testings" conducted to demonstrate the device met design specifications. The submitting entity is Sri Trang Gloves (Thailand) Public Company Limited, with a US agent in Tampa, Florida. The location where the testing occurred is not explicitly stated as a country or specific lab in this document. The data is retrospective in nature, as it's being presented to the FDA for review of a finished product.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This document describes performance testing of physical and chemical properties of gloves against established industry standards (e.g., ASTM, ISO). It does not involve human expert interpretation of medical images or clinical data to establish a "ground truth" in the way an AI medical device submission would. Therefore, the concept of "number of experts" and their "qualifications" for ground truth establishment does not apply here. The "ground truth" for these tests is defined by the objective measurement criteria of the specified ASTM and ISO standards.
4. Adjudication Method for the Test Set:
Not applicable, as this is objective device performance testing against established standards, not a review of clinical or imaging data requiring adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:
No, this is a 510(k) submission for a Class I medical device (nitrile exam gloves). MRMC studies are typically performed for high-risk diagnostic devices, particularly those involving AI, to assess the impact of the AI on human reader performance. This document details non-clinical laboratory testing of the glove's material properties and chemical resistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI/algorithm device. The "performance" described is the physical and chemical integrity of the glove itself.
7. The Type of Ground Truth Used:
The ground truth used for these tests is based on objective, standardized measurements according to established international and national standards for medical gloves, specifically:
- ASTM D 6319-10 (Standard Specification for Nitrile Examination Gloves for Medical Application)
- ASTM D 5151-2006 (Reapproved 2015) (Standard Test Method for Detection of Holes in Medical Gloves)
- ASTM D 6124-2006 (Reapproved 2001) (Standard Test Method for Residual Powder on Medical Gloves)
- ASTM D 6978 (Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs)
- ASTM D 412-2006a (reapproved 2013) (Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers-Tension)
- ASTM D 573-2004 (Reapproved 2010), (Standard Test Method for Rubber-Deterioration in an Air Oven)
- ASTM D 3767-03 (Standard Practice for Rubber-Measurement of Dimensions)
- ISO 2859 (Sampling Procedures and Tables for Inspection by Attributes)
- ISO 10993-5 (Biological evaluation of medical devices-Part5 Tests for in vitro cytotoxicity)
- ISO 10993-10 (Biological evaluation of medical devices-Part 10 Test for irritation and delayed-type hypersensitivity)
- ISO 10993-11 (Biological evaluation of medical devices-Part 11 Tests for systemic toxicity)
For the biocompatibility tests (cytotoxicity, irritation, systemic toxicity, sensitization), the ground truth is established through animal model studies, where specific observed reactions (or lack thereof) are assessed against established biological response criteria for those ISO standards.
8. The Sample Size for the Training Set:
Not applicable. This is a manufactured product (physical medical device), not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as no machine learning model or training set is involved.
§ 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.