(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.
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March 20, 2020
Sri Trang Gloves (Thailand) Public Company Limited % Jordan Smith Quality Assurance and Regulatory Affairs Leader Sri Trang USA, Inc. 5820 West Cypress Street, Suite H Tampa, Florida 33607-1785
Re: K193581
Trade/Device Name: Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Lilac, Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Orchid, Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Oyster Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove
Regulatory Class: Class I, reserved Product Code: LZA, LZC, QDO Dated: November 27, 2019 Received: December 23, 2019
Dear Jordan Smith:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Elizabeth Claverie, M.S. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K193581
Device Name
Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Lilac, Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Orchid, Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Oyster
Indications for Use (Describe)
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.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) Summary
K193581
[As Required by 21 section 807.92 (c)]
Summary prepared: March 17, 2020
A. APPLICANT INFORMATION
Submitter Name: Sri Trang Gloves (Thailand) Public Company Limited Address: 10 Soi 10 Phetkasem Rd. Hatyai Songkhla. Thailand 90110 Phone: (+66) 74 344 663 Fax: (+66) 74 344 677 Contact Person: Mr. Anan Pruksanusak, Managing Director
B. US AGENT & CONTACT PERSON INFORMATION
Official Correspondent: Sri Trang USA, Inc. Address: 5820 West Cypress Street, Suite Tampa, Florida 33607-1785 Phone: +1 (813) 606-4301 Fax: +1 (813) 606-4314 Contact person: Mr. M. Jordan Smith, Quality Assurance and Regulatory Affairs Leader
C. DEVICE IDENTIFICATION
Device Trade or Proprietary Name: Non-Sterile. Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Lilac, Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Orchid, Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Oyster
Device Common or Usual Name: Examination glove
Device Classification Name: Nitrile Patient Examination Glove (21 CFR 880.6250)
Device Product Codes: LZA, LZC, QDO
Device Class: Class I
D.PREDICATE DEVICE INFORMATION
510(k) Number: K182241
Trade Name: Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with Chemotherapy Drugs
Common Name: Examination Glove
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Classification Name: Nitrile Patient Examination Glove Device Product Codes: LZA, LZC, QDO Device Class: Class I Regulation Number: 21 CFR 880.6250
E. DESCRIPTION OF THE DEVICE
Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with Chemotherapy Drugs and Fentanyl.
F. INTENDED USE OF THE DEVICE
This device is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
G. Technological Characteristics Comparison Table
| TECHNOLOGICALCHARACTERISTICS | STANDARD | PREDICATE DEVICEK182241 | SUBJECT DEVICEK193581 | COMPARISON |
|---|---|---|---|---|
| 510(k) Number | K182241 | K193581 | ||
| Trade Name | Non-sterile, Powder-FreeNitrile ExaminationGlove Black Tested foruse with ChemotherapyDrugs | Non-sterile, Powder FreeNitrile ExaminationGloves | Different | |
| Common Name | Examination Glove | Examination Glove | Identical | |
| Classification Name | Nitrile PatientExamination Glove | Nitrile PatientExamination Glove | Identical | |
| Device Product Codes | LZA, LZC, QDO | LZA, LZC, QDO | Identical | |
| Device Class | Class I | Class I | Identical | |
| Regulation Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Identical | |
| Indications for Use | N/A | This device is adisposable deviceintended for medicalpurpose that is worn onthe examiner's hand toprevent contaminationbetween patient andexaminer. The testedchemotherapy drugs areas follows: Carmustine(BCNU) Cisplatin,Cyclophosphamide,Dacarbzine (DTIC),DoxorubicinHydrochloride,Etoposide (Toposar), | This device is adisposable deviceintended for medicalpurpose that is worn onthe examiner's hand toprevent contaminationbetween patient andexaminer.Bleomycin Sulfate,15mg/mL, >240 minutesIfosfamide 50 mg/mL,>240 minutesBusulfan 6mg/mL, >240minutesIrinotecan 20 mg/mL | Similar |
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| >240 minutes | |
|---|---|
| Carboplatin (Paraplatin) 10 mg/mL, >240 minutes | |
| Mechlorethamine 1mg/mL, >240 minutes | |
| Carmustine (BCNU) 3.3 mg/mL, 17.1 minutes, 22.8 minutes, and 22.3 minutesminutes | |
| Melphalan 5 mg/mL, >240 minutes | |
| Cisplatin 1.0 mg/mL, >240 minutes | |
| Methotrexate 25 mg/mL, >240 minutes | |
| Cyclophosphamide (Cytoxan) 20 mg/mL, | |
| Fluorouracil,Methotrexate, Paclitaxel (Taxol), Thiotepa,Vincristine SulfateNote Carmustine (BCNU) and Thiotepa have low permeation timesFentanyl tested as follows: Fentanyl Citrate | >240 minutesMitomycin C 0.5 mg/mL, >240 minutesCytarabine 100 mg/mL, >240 minutesMitoxantrone 2 mg/mL, >240 minutesDacarbazine (DTIC) 10 mg/mL, >240 minutesPaclitaxel (Taxol) 6 mg/mL, >240 minutesDaunorubicin 5 mg/mL, >240 minutesRituximab 10 mg/mL, >240 minutesDocetazel 10 mg/mL, >240 minutesThiotepa 10 mg/mL, 27.9 minutesDoxorubicin Hydrochloride 2 mg/mL, >240 minutesTrisenox mg/mL, >240 minutesEpirubicin (Ellence) 1 mg/mL, >240 minutesVincristine Sulfate 1 mg/mL, >240 minutesEtoposide (Toposar) 20 mg/mL, >240 minutesFludarabine 25 mg/mL, >240 minutesFluorouracil 50 mg/mL, >240 minutesGemcitabine 38 mg/mL, >240 minutesIdarubicin 1 mg/mL, >240 minutesWARNING – Not for use with Carmustine and ThiotepaFentanyl tested as follows:Fentanyl Citrate 100 |
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| mcg/2mL, >240 minutes | ||||
|---|---|---|---|---|
| Dimensions: overalllength | ASTM D 6319-10,Minimum 230 mm | 238 mm | 238 mm (NOF_SL) | Similar |
| 238 mm | 240 mm (NOF_EL) | |||
| 238 mm | 240 mm (NOF_SD) | |||
| Dimensions: width | ASTM D 6319-10,110 ± 10 mm | Size Large | Size Large | Similar |
| 114 mm | 110 mm | |||
| 115 mm | 110 mm | |||
| 114 mm | 111 mm | |||
| Dimensions: palm andfinger thickness | ASTM D 6319-10,Minimum 0.05 mm | Palm | Palm | Similar |
| 0.07 mm | 0.05mm (NOF_SL) | |||
| 0.07 mm | 0.05mm (NOF_EL) | |||
| 0.07 mm | 0.10 mm (NOF_SD) | |||
| Finger | Finger | |||
| 0.07 mm | 0.08 mm (NOF_SL) | |||
| 0.08 mm | 0.08 mm (NOF_EL) | |||
| 0.09 mm | 0.14 mm (NOF_SD) | |||
| Tensile strength: beforeand after aging | ASTM D 6319-10 | Before35 MPa | Before34 MPa (NOF_SL) | Similar |
| 33 MPa | 37 MPa (NOF_EL) | |||
| 35 MPa | 33 MPa (NOF_SD) | |||
| After31 MPa | After38 MPa (NOF_SL) | |||
| 32 MPa | 41 MPa (NOF_EL) | |||
| 34 MPa | 37 MPa (NOF_SD) | |||
| Ultimate elongation:before and after aging | ASTM D 6319-10 | Before538% | Before570 (NOF_SL) | Similar |
| 534% | 564% (NOF_EL) | |||
| 535% | 630% (NOF_SD) | |||
| After518% | After535% (NOF_SL) | |||
| 493% | 551% (NOF_EL) | |||
| 503% | 625% (NOF_SD) | |||
| Powder Free Residue | ASTM D 6319-10 | 0.7 mg/glove | 0.3 mg/glove (NOF_SL) | Similar |
| 0.8 mg/glove | 0.5 mg/glove (NOF_EL) | |||
| 0.8 mg/glove | 0.5 mg/glove (NOF_SD) | |||
| Biocompatibility | ISO 10993-10Primary SkinIrritation in Rabbits | Under the conditions ofthe study, the polar andnon- polar deviceextracts were found notto be an irritant to theanimal model. | Under the conditions ofthe study, the polar andnon-polar device extractswere found not to be anirritant to the animalmodel. | Same |
| ISO 10993-5In vitro cytotoxicity | Cytotoxic | Cytotoxic | Same | |
| ISO 10993-11Tests for systemictoxicity | the device extracts didnot elicit a systemicresponse in the animalmodel. | the device extracts didnot elicit a systemicresponse in the animalmodel. | Same | |
| ISO 10993-10Guinea PigSensitization | Under the conditions ofthe study, the polar andnon- polar deviceextracts were found notto be sensitizers to theanimal model. | Under the conditions ofthe study, the polar andnon-polar device extractswere found not to besensitizers to the animalmodel. | Same |
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H. Summary of Non-Clinical Performance Testings
Non-clinical tests were conducted to demonstrate that the proposed device met all design specifications. The test results demonstrated that the proposed device met the performance criteria with the following standards:
| Measurement | Standard Criteria | Subject Device Model | Results | |
|---|---|---|---|---|
| Before aging | 14 MPa Min | Tensile strength per ASTM D 6319-10 | ||
| Model - NOF_SD Orchid | 33 | |||
| Model - NOF_SL Lilac | 34 | |||
| Model - NOF_EL Oyster | 37 | |||
| After aging (70C, 168hrs.) | 14 MPa Min | Model - NOF_SD Orchid | 37 | |
| Model - NOF_SL Lilac | 38 | |||
| Model - NOF_EL Oyster | 41 | |||
| Before aging | 500% Min | Ultimate elongation per ASTM D 6319-10 | ||
| Model - NOF_SD Orchid | 630 | |||
| Model - NOF_SL Lilac | 570 | |||
| Model - NOF_EL Oyster | 564 | |||
| After aging (70C, 168hrs.) | 400% Min | Model - NOF_SD Orchid | 625 | |
| Model - NOF_SL Lilac | 535 | |||
| Model - NOF_EL Oyster | 551 | |||
| Length (mm) | 230 mm Min (M) | Model - NOF_SD Orchid | 240 mm | |
| Model - NOF_SL Lilac | 238 mm | |||
| Model - NOF_EL Oyster | 240 mm | |||
| Thickness(mm) Singlewall Finger | 0.05 mm Min | Model - NOF_SD Orchid | 0.14 | |
| Model - NOF_SL Lilac | 0.08 | |||
| Model - NOF_EL Oyster | 0.08 | |||
| Thickness (mm) Singlewall Palm | 0.05 mm Min | Model - NOF_SD Orchid | 0.10 | |
| Model - NOF_SL Lilac | 0.06 | |||
| Model - NOF_EL Oyster | 0.05 | |||
| Width | 110+/-10 mm (M) | Model - NOF_SD Orchid | 111 | |
| Model - NOF_SL Lilac | 110 | |||
| Model - NOF_EL Oyster | 110 | |||
| Freedom from holes per ASTM D5151-2006 | ||||
| Freedom from holes | GI, AQL 2.5 | Model - NOF_SD Orchid: 125 | 0 | |
| Accept - 7 | Model - NOF_SL Lilac: 125 | 1 | ||
| Reject - 8 | Model - NOF_EL Oyster: 125 | 1 | ||
| Powder Residue, ASTM D6124-2006 | ||||
| Powder Residue | 2.0 mg/glove | Model - NOF_SD Orchid | 0.5 mg/glove | |
| Model - NOF_SL Lilac | 0.3 mg/glove | |||
| Model - NOF_EL Oyster | 0.5 mg/glove | |||
| Resistance of Medical Gloves to Permeation by Chemotherapy Drugs per ASTM D6978 | ||||
| Test Drug andConcentration | Minimum BreakthroughDetection Time Model –NOF_SD Orchid | Minimum BreakthroughDetection Time Model –NOF_SL Lilac | Minimum BreakthroughDetection Time Model –NOF_EL Oyster | Steady StatePerm. Rate |
| BleomycinSulfate15,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Busulfan6,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Carboplatin10,000 ppm | 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 | 17.1 minutes | 22.8 minutes | 22.3 minutes | 0.40.40.3 |
| Cisplatin1,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Cytoxan20,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Cytarabine100,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| DTIC10,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Daunorubicin2,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Docetaxel10,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Doxorubicinhydrochloride2,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Epirubicin2,000 ppm | 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 | N/A |
| Fludarabine25,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Fluorouracil50,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Gemcitabine38,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Idarubicin1,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Ifosfamide50,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Irinotecan20,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Mechlorethamine1,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Melphalan5,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Methotrexate25,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Mitomycin C500 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Mitoxantrone2,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Taxol6,000 ppm | No breakthrough up to240 minutes | No breakthrough up to 240minutes | No breakthrough up to240 minutes | N/A |
| Rituximab10,000 ppm | No breakthroughup to 240 minutes | No breakthroughup to 240 minutes | No breakthroughup to 240 minutes | N/A |
| Thiotepa 10,000ppm | 27.9 minutes | 39.1 minutes | 39 minutes | 0.30.30.2 |
| Trisenox1,000 ppm | No breakthrough up to240 minutes | No breakthrough up to 240minutes | No breakthrough up to240 minutes | N/A |
| Vincristinefulfate 1,000 ppm | No breakthrough up to240 minutes | No breakthrough up to 240minutes | No breakthrough up to240 minutes | N/A |
| Fentanyl Citrate100 mcg/2mL | No breakthrough up to240 minutes | No breakthrough up to 240minutes | No breakthrough up to240 minutes | N/A |
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The test results demonstrated that the proposed device complies with following standards:
ASTM D6319-10 Standard Specification for Nitrile Examination Gloves for Medical Application
ASTM D5151-2006 (Reapproved 2015) Standard Test Method for Detection of Holes in Medical Gloves
ASTM D6124-2006 (Reapproved 2001) Standard Test Method for Residual Powder on Medical Gloves
ASTM D6978 - Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs
ASTM D412-2006a (reapproved 2013) Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers-Tension
ASTM D573-2004 (Reapproved 2010) Standard Test Method for Rubber-Deterioration in an Air Oven
ASTM D3767-03 Standard Practice for Rubber-Measurement of Dimensions
ISO 2859 Sampling Procedures and Tables for Inspection by Attributes
- · Tested according to ASTM D5151 for pinholes and freedom from holes, Inspection Level: GI, AQL = 2.5
- · Tested according to ASTM D6124 for powder residue, Inspection Level: N =5, AQL = N/A
- · Tested according to ASTM D412 for tensile strength and ultimate elongation before and after aging, Inspection Level: S-2, AQL 4.0
- · Tested according to ASTM D3767 for length, thickness, and width, Inspection Level: S-2. AOL 4.0
ISO 10993-5 Biological evaluation of medical devices-Part5 Tests for in vivo cytotoxicity Minimal Essential Media Elution Test:
ISO 10993-10 Biological evaluation of medical devices-Part 10 Test for irritation and delayedtype hypersensitivity
ISO 10993-11 Biological evaluation of medical devices-Part 11 Tests for systemic toxicity Acute Systemic Toxicity Test.
I. Conclusion
The conclusions drawn from the nonclinical tests demonstrate that Non-Sterile. Powder Free Nitrile
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Exam Glove Tested for use with Chemotherapy Drugs - Lilac, Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Orchid, Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs – Oyster are as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K182241.
§ 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.