(88 days)
Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. Additionally, the gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Medical Glove to Permeation by Chemotherapy Drugs.
The subject device in 510(K) notification is a blue nitrile examination gloves powder free tested for use with Chemotherapy drugs. The subject device is a patient examination glove made from acrylonitrile-butadiene copolymer dispersion, blue color, powder free and non sterile (as per 21CFR 880.6250, class I). The subject device meets all the current specifications listed under the ASTM Specification D 6319 -2019, Standard Specification for Nitrile Examination Gloves for Medical Application. This device also complies with requirements for standard practice for assessment of resistance of medical gloves to permeation by chemotherapy drugs as per ASTM D6978- 05(2019)
The provided document is a 510(k) Premarket Notification for "Blue Nitrile Examination Gloves Powder Free Tested for Use with Chemotherapy Drugs." This document clears a medical device (examination gloves) for market and is not an AI/ML device study. Therefore, most of the requested information about acceptance criteria and study design for AI/ML performance is not applicable within this context.
However, I can extract information related to the performance of these physical medical gloves as detailed in the provided document, specifically related to their physical properties and chemical resistance.
Here's the relevant information based on the document:
Study Purpose: To demonstrate that the "Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy Drugs" are as safe, effective, and perform as well as the legally marketed predicate device (Harbour Health Powder Free Nitrile Examination Glove, Blue (Tested for use with Chemotherapy Drugs) K210944).
Lack of AI/ML Study: This document does not describe a study involving an AI/ML device. It pertains to a physical medical device (examination gloves). Therefore, specific criteria and study details related to AI/ML device performance (such as sample size for test/training sets for AI, data provenance for AI, number of experts for AI ground truth, human reader improvement with AI assistance, standalone AI performance) are not present in this document and cannot be provided.
Acceptance Criteria and Device Performance (for Physical Device - Gloves):
The performance of the gloves was evaluated against ASTM standards for various physical properties and for resistance to chemotherapy drugs. The acceptance criteria and reported device performance are presented in the tables below.
Table 1: Physical Properties Acceptance Criteria and Device Performance
| Test Method (Standard) | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319-2019 | To determine the length of the gloves | Min 220 mm for Size Small & Min 230 mm for all other sizes | Small: 245 mm; Medium: 246 mm; Large: 248 mm; X-Large: 248 mm |
| ASTM D6319-2019 | To determine the width of the gloves | Small: 80+/-10 mm; Medium: 95+/-10 mm; Large: 110+/-10 mm; X-Large: 120+/-10 mm | Small: 80 mm; Medium: 92 mm; Large: 105 mm; X-Large: 115 mm |
| ASTM D6319-2019 | To determine the thickness of the gloves | Palm 0.05 mm min; Finger 0.05 mm min for all sizes | Palm: 0.09 mm (all sizes); Finger: 0.15mm (all sizes) |
| ASTM D6319-2019 | To Determine the physical properties - Tensile strength | Before Ageing: Tensile Strength 14Mpa Min for all sizes; After Ageing: Tensile Strength 14Mpa Min for all sizes | Before Ageing: >18.52 Mpa (all sizes); After Ageing: >17.54 Mpa (all sizes) |
| ASTM D6319-2019 | To Determine the physical properties - Ultimate Elongation | Before Ageing: Ultimate Elongation 500% Min for all sizes; After Ageing: Ultimate Elongation 400% Min for all sizes | Before Ageing: >690% (all sizes); After Ageing: >665% (all sizes) |
| ASTM D5151-2019 | To determine the holes in the gloves | AQL 2.5 | Gloves Passes AQL 1.5 |
| ASTM D6124-06 (Reapproved 2017) | To determine the residual powder in the gloves | 2 Mg/Glove Max | <0.22 mg/glove (all sizes) |
Table 2: Biocompatibility Testing Acceptance Criteria and Device Performance
| Test Method (Standard) | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ISO 10993-10 (Irritation) | To determine the potential of the material to produce dermal irritation in Rabbits | Under the condition of study not an irritant | Under the condition of study not an irritant |
| ISO 10993-10 (Skin Sensitization) | To determine the skin sensitization potential of the material in Guinea Pig. | Under the conditions of the study not a sensitizer | Under the conditions of the study not a sensitizer |
| ISO 10993-5:2009 (In vitro cytotoxicity) | To evaluate the in vitro cytotoxic potential of the test item extracts in L-929 mouse fibroblasts cells. | Under the conditions of study non cytotoxic | Under the conditions of the study cytotoxic. (Note: This indicates it did not meet the "non cytotoxic" criteria, but was still cleared due to other compensating factors or the nature of the cytotoxicity test that might be acceptable for the device's use) |
| ISO 10993-11:2017 (Acute systemic toxicity) | To determine the acute systemic toxicity potential of the test item extracts in Swiss Albino mice. | Under the conditions of study the device extracts do not pose a systemic toxicity concern | Under the conditions of study the device extracts do not pose a systemic toxicity concern |
| ISO 10993-11:2017 / USP 41<151> (Material Mediated Pyrogenicity) | To determine the pyrogenic potential of the test item extract following intravenous injection in New Zealand white Rabbits. | Under the conditions of the study, the device did not demonstrate a material mediated pyrogenicity response. | Under the conditions of the study, the device did not demonstrate a material mediated pyrogenicity response. |
Table 3: Chemotherapy Drug Permeation Acceptance Criteria and Device Performance
(Note: The "acceptance criteria" here is implied by the predicate device's performance for comparison, and the requirement to report the minimum breakthrough detection time. A longer time generally indicates better performance.)
| Tested Chemotherapy Drug Name & Concentration | Predicate Device Minimum Breakthrough Detection Time | Proposed Device Minimum Breakthrough Detection Time |
|---|---|---|
| Carmustine (BCNU) (3.3 mg/ml) | 14.5 Minutes | 34.3 Minutes |
| Carboplatin (10 mg/ml) | >240 Minutes | >240 Minutes |
| Cisplatin (1 mg/ml) | >240 Minutes | >240 Minutes |
| Cyclophosphamide (Cytoxan) (20 mg/ml) | >240 Minutes | >240 Minutes |
| Dacarbazine (10.0 mg/ml) | >240 Minutes | >240 Minutes |
| Doxorubicin HCl (2 mg/ml) | >240 Minutes | >240 Minutes |
| Etoposide (20 mg/ml) | >240 Minutes | >240 Minutes |
| Fluorouracil (50 mg/ml) | >240 Minutes | >240 Minutes |
| Ifosfamide (50 mg/ml) | >240 Minutes | >240 Minutes |
| Methotrexate (25 mg/ml) | >240 Minutes | >240 Minutes |
| Mitomycin C (0.5 mg/ml) | >240 Minutes | >240 Minutes |
| Mitoxantrone (2 mg/ml) | >240 Minutes | >240 Minutes |
| Paclitaxel (6 mg/ml) | >240 Minutes | >240 Minutes |
| Thiotepa (10 mg/ml) | 47.4 Minutes | 87.3 Minutes |
| Vincristine Sulfate (1 mg/ml) | >240 Minutes | >240 Minutes |
| Drugs tested by Predicate but NOT Proposed: | Busulfan (6mg/ml) (>240 min), Cytarabine (100 mg/ ml) (>240 min), Docetaxel (10 mg/ml) (>240 min), Mechlorethamine HCL (1 mg/ml) (>240 min) | Not Tested |
| Note on warnings: | Warning: Do not use with Carmustine (BCNU) & Thiotepa |
2. Sample Size Used for the Test Set and Data Provenance:
- The document primarily refers to testing done in accordance with ASTM standards. These standards specify sample sizes for testing (e.g., for AQL testing for pinholes, or for physical properties). The exact number of samples for each specific test (e.g., how many gloves for tensile strength or how many for chemical permeation) is not explicitly stated in the summary, but it would be prescribed by the referenced ASTM standards (e.g., ASTM D6319-2019, ASTM D5151-2019, ASTM D6124-06, ASTM D6978-05).
- Data Provenance: The applicant for the device is Aspen Glove Sdn. Bhd., located in Malaysia. The testing would presumably have been conducted there or by a certified lab, but specific country of origin for the data (i.e., where the tests were physically performed) is not explicitly stated beyond the applicant's location. The testing would be prospective in nature as it evaluates the manufactured product.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- This is not applicable as this is a physical medical device and not an AI/ML device requiring establishment of "ground truth" by clinical experts for image interpretation or similar tasks. The "ground truth" for the physical properties and chemical resistance is established by validated laboratory testing methods conforming to recognized international standards (ASTM, ISO).
4. Adjudication Method for the Test Set:
- Not applicable. This is not a study requiring adjudication of expert interpretations but rather laboratory testing against established physical and chemical standards.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:
- Not applicable. This is a physical medical device, not an AI/ML device that assists human readers.
6. Standalone (Algorithm Only) Performance:
- Not applicable. This is a physical medical device, not an algorithm.
7. Type of Ground Truth Used:
- For physical and biocompatibility properties: Ground truth is established by validated laboratory testing methods against recognized industry standards (ASTM, ISO) with numerical or pass/fail criteria.
- For chemotherapy drug permeation: Ground truth is established by laboratory testing per ASTM D6978-05 (2019), measuring the minimum breakthrough detection time.
8. Sample Size for the Training Set:
- Not applicable. This is not an AI/ML device requiring a training set.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. This is not an AI/ML device.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
December 20, 2021
Aspen Glove Sdn. Bhd. Manoj Zacharias Consultant Liberty Management Group Ltd. 75 Executive Dr. STE 114 Aurora, Illinois 60504
Re: K213076
Trade/Device Name: Blue Nitrile Examination Gloves Powder Free Tested for Use with Chemotherapy Drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC Dated: September 18, 2021 Received: September 23, 2021
Dear Manoj Zacharias:
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 mediation-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 Clarence W. Murray, III, Ph.D. 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) K213076
Device Name
Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs
Indications for Use (Describe)
Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Additionally, the gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Medical Glove to Permeation by Chemotherapy Drugs.
The tested chemotherapy drugs and their breakthrough detection times are as follows:
| Tested Chemotherapy Drug Name & Concentration | Minimum Breakthrough Detection Time |
|---|---|
| Carmustine (BCNU) (3.3 mg/ml) | 34.3 Minutes |
| Carboplatin (10 mg/ml) | >240 Minutes |
| Cisplatin (1 mg/ml) | >240 Minutes |
| Cyclophosphamide (Cytoxan) (20 mg/ml) | >240 Minutes |
| Dacarbazine (10.0 mg/ml) | >240 Minutes |
| Doxorubicin HCl (2 mg/ml) | >240 Minutes |
| Etoposide (20 mg/ml) | >240 Minutes |
| Fluorouracil (50 mg/ml) | >240 Minutes |
| Ifosfamide (50 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 (6 mg/ml) | >240 Minutes |
| Thiotepa (10 mg/ml) | 87.3 Minutes |
| Vincristine Sulfate (1 mg/ml) | >240 Minutes |
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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K213076 510(K) SUMMARY As required by: 21CFR§807.92(c)
A. APPLICANTINFORMATION
| 510(K) Owner's Name | Aspen Glove Sdn. Bhd. |
|---|---|
| Address | Aspen House, 300, JLN Macalister,10450 Georgetown, Pulau Pinang,Malaysia |
| Phone | +604- 227 5000 |
| Fax | +604- 227 5000 |
| corporate@aspen.com.my | |
| Contact Person | Mr. Iskandar Basha bin Abdul Kadir |
| Designation | Managing Director |
| Contact Number | 017-550 0577 |
| Contact Email | Iskandar@aspenglove.com.my |
| Date Submitted | 18 September 2021 |
B. DEVICE IDENTIFICATION
| Name of the device | Blue Nitrile Examination Gloves Powder Free testedfor use with Chemotherapy drugs |
|---|---|
| Product proprietary or trade name | AspenMed+ |
| Common or usual name | Exam Gloves |
| Classification name | Patient Examination Gloves, Specialty |
| Device Classification | Class- I |
| Product Code | LZA, LZC |
| Regulation Number | 21 CFR 880.6250 |
| Review Panel | General Hospital |
C. PREDICATE DEVICE
| Predicate Device | Harbour HealthPowder Free Nitrile Examination Glove, Blue (Tested foruse with Chemotherapy Drugs) |
|---|---|
| 510( K) Number | K210944 |
| Regulatory Class | I |
| Product code | LZA, LZC, OPJ |
D. DESCRIPTION OF THEDEVICE:
The subject device in 510(K) notification is a blue nitrile examination gloves powder free tested for use with Chemotherapy drugs.
The subject device is a patient examination glove made from acrylonitrile-butadiene copolymer dispersion, blue color, powder free and non sterile (as per 21CFR 880.6250, class I).
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The subject device meets all the current specifications listed under the ASTM Specification D 6319 -2019, Standard Specification for Nitrile Examination Gloves for Medical Application. This device also complies with requirements for standard practice for assessment of resistance of medical gloves to permeation by chemotherapy drugs as per ASTM D6978- 05(2019)
E. INTENDED USE OF THE DEVICE:
Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. Additionally, the gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Medical Glove to Permeation by Chemotherapy Drugs.
| Tested Chemotherapy Drug Name &Concentration | Minimum Breakthrough DetectionTime (Minutes) |
|---|---|
| Carmustine (BCNU) (3.3 mg/ml) | 34.3 Minutes |
| Carboplatin (10 mg/ml) | >240 Minutes |
| Cisplatin (1 mg/ml) | >240 Minutes |
| Cyclophosphamide (Cytoxan) (20 mg/ml) | >240 Minutes |
| Dacarbazine (10.0 mg/ml) | >240 Minutes |
| Doxorubicin HCl (2 mg/ml) | >240 Minutes |
| Etoposide (20 mg/ml) | >240 Minutes |
| Fluorouracil (50 mg/ml) | >240 Minutes |
| Ifosfamide (50 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 (6 mg/ml) | >240 Minutes |
| Thiotepa (10 mg/ml) | 87.3 Minutes |
| Vincristine Sulfate (1 mg/ml) | >240 Minutes |
The tested chemotherapy drugs and their breakthrough detection times are as follows:
hat the following drugs have low permeation times Carmustine (BCNU) (3.3 mg/ml) 34.3 Minutes Thiotepa (10 mg/ml) 87.3 Minutes
Warning: Do not use with Carmustine (BCNU) & Thiotepa
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F. SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE
| CHARACTERSTICS | STANDARDS | DEVICE PERFORMANCE | REMARKS | |
|---|---|---|---|---|
| PREDICATE | PROPOSEDDEVICE | |||
| 510(K) Number | K210944 | K213076 | ||
| Name of device | Harbour HealthPowder FreeNitrileExaminationGlove, Blue(Tested for usewithChemotherapyDrugs) | Blue NitrileExamination GlovesPowder Free testedfor use withChemotherapy drugs | Similar | |
| Product Code | LZA, LZC, OPJ | LZA, LZC | Similar | |
| Intended use | Harbour HealthPowderFreeNitrileExaminationGlove, Blue(Tested for usewithChemotherapyDrugs) disposabledeviceintendedformedicalpurpose that isworn on theexaminer's handtopreventcontaminationbetween patientand examiner.Theproposeddevice was testedforusewithchemotherapydrugs as perASTM D6978-05(2019), StandardPracticeforAssessmentofMedical Gloves toPermeation byChemotherapyDrugs | Blue NitrileExamination GlovesPowder Free testedfor use withChemotherapy drugsis a disposabledevice intended formedical purpose thatis worn on theexaminer's hand topreventcontaminationbetween patient andexaminer.Additionally,thegloves were testedfor use withchemotherapy drugsin accordance withASTM D6978-05(2019) StandardPracticeforAssessmentofMedical Glove toPermeation byChemotherapyDrugs. | Similar | |
| CHARACTERSTICS | STANDARDS | DEVICE PERFORMANCEPREDICATEK210944 | DEVICE PERFORMANCEPROPOSEDDEVICE | REMARKS |
| Regulation Number | - | 21 CFR880.6250 | 21 CFR880.6250 | Same |
| Material | - | Nitrile | Nitrile | Same |
| Color | - | Blue | Blue | Same |
| Texture | - | Finger Texture | Finger texture | Same |
| Size | ASTM D6319-2019 | Small, LargeMedium, Large,Extra | Small, Medium,Large, ExtraLarge | Same |
| Single Use | Medical GloveGuidanceManual- Labeling | Single Use | Single Use | Same |
| Sterile/non sterile | - | Non sterile | Non sterile | Same |
| Dimensions | ASTM D6319-2019 | Length: Small-Min 220 mm &Medium, Large& Extra large-Min 230 mmWidth Min95+/-10 mm(Medium Size) | Length > 230mmWidth Min95+/-10 mm(formedium size) | Similar |
| Physical Properties | ASTM D6319-2019 | Before AgeingTensile Strengthmin 14 MpaUltimateElongationMin 500%After AgeingTensile Strengthmin 14 MpaUltimateElongationMin 400% | Before AgeingTensile Strength> 14 MpaUltimateElongation>500%After AgeingTensile Strength>14 MpaUltimateElongation> 400% | Same |
| Thickness | ASTM D6319-2019 | Palmmin 0.05 mmFingermin 0.05 mm | Palm >0.05 mmFinger > 0.05mm | Same |
| Powder FreeResidue | ASTM D6319-2019 | <2 mg/glove | <2 mg/glove | Same |
| Watertight(1000 ml) | ASTM D5151-2019 | Passes AQL-2.5 | Passes AQL-1.5 | Similar |
| Label and Labeling | FDA Labelrequirements | Meets FDA'srequirements | Meets FDA'srequirements | Same |
| CHARACTERSTICS | STANDARDS | DEVICE PERFORMANCE | REMARKS | |
| PREDICATEK210944 | PROPOSEDDEVICE | |||
| Bio-compatibility | Primary Skin Irritation-ISO 10993-10:2010(E) | Under the conditionof study not anirritant | Under the conditionof study not anirritant | Same |
| Dermal Sensitization-ISO 10993-10:2010(E) | Under the conditionsof the study not asensitizer | Under the conditionsof the study not asensitizer | Same | |
| In vitro cytotoxicityISO10993-5 :2009(E) | Under theconditions of thestudy, potentiallycytotoxic | Under theconditions of thestudy, cytotoxic | Similar | |
| MaterialMediatedPyrogenicityISO 10993-11:2017(E) /USP 41<151> | No Data Available | Under theconditions of thestudy nonpyrogenic | ---- | |
| Acute Systemic ToxicityTest ISO 10993-11:2017(E) | Under the conditionsof the study, thedevice does notelicit a systemictoxicity response inthe model animal | Under the conditionof study does notinduce any systemictoxic concern | Similar | |
| Bacterial EndotoxintestUSP 42<85> | No data available | <20EU/pair ofgloves | ---- | |
| Chemotherapy Drugs Tested with Minimum Breakthrough Detection Time as tested per ASTMD6978-05 (2019) | ||||
| Busulfan (6mg/ml) | >240 Minutes | Not Tested | Different | |
| Carmustine (BCNU) (3.3 mg/ml) | 14.5 Minutes | 34.3 Minutes | Different | |
| Carboplatin (10 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Cisplatin (1 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Cyclophosphamide (Cytoxan) (20 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Cytarabine (100 mg/ ml) | >240 Minutes | Not Tested | Different | |
| Dacarbazine (10.0 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Docetaxel (10 mg/ml) | >240 Minutes | Not Tested | Different | |
| Doxorubicin HCl (2 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Etoposide (20 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Fluorouracil (50 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Ifosfamide (50 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Mechlorethamine HCL (1 mg/ml) | >240 Minutes | Not Tested | Different | |
| Methotrexate (25 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Mitomycin C (0.5 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Mitoxantrone (2 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Paclitaxel (6 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Thiotepa (10 mg/ml) | 47.4 Minutes | 87.3 Minutes | Different | |
| Vincristine Sulfate (1 mg/ml) | >240 Minutes | >240 Minutes | Same |
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| G. NON-CLINICAL TESTING SUMMARY PERFORMANCE DATA | ||||
|---|---|---|---|---|
| -- | -- | -- | -- | -------------------------------------------------- |
| Test Method | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| ASTM D6319-2019 StandardSpecification for NitrileExamination Gloves forMedical Application | To determine thelength of the gloves | Min 220 mm for Size Small& Min 230 mm for allother sizes | Small:- 245 mmMedium:- 246 mmLarge:- 248 mmX-Large:- 248 mm |
| ASTM D6319-2019 StandardSpecification for NitrileExamination Gloves forMedical Application | To determine thewidth of the gloves | Small:- 80+/-10 mmMedium:- 95+/-10 mmLarge:- 110+/-10 mmX-Large:- 120+/-10 mm | Small:- 80 mmMedium:- 92 mmLarge:- 105 mmX-Large:- 115 mm |
| Test Method | Purpose | Acceptance Criteria | Result | ||
|---|---|---|---|---|---|
| ASTM D6319-2019 StandardSpecification for NitrileExamination Gloves forMedical Application | To determine thethickness of thegloves | Palm 0.05 mm minFinger 0.05 mm minfor all sizes | SizeSmallMediumLargeX-Large | Palm0.09 mm0.09 mm0.09 mm0.09 mm | Finger0.15mm0.15mm0.15mm0.15mm |
| ASTM D6319-2019 StandardSpecification for NitrileExamination Gloves forMedical Application | To Determine thephysicalproperties-Tensile strength | Before AgeingTensile Strength 14MpaMin for all sizesAfter Ageing TensileStrength 14MpaMinfor all sizes | SizeSmallMediumLargeX-Large | Beforeageing18.52 Mpa18.61 Mpa18.67 Mpa18.72 Mpa | Afterageing17.54 Mpa17.68 Mpa17.74 Mpa17.80 Mpa |
| ASTM D6319-2019 StandardSpecification for NitrileExamination Gloves forMedical Application | To Determine thephysicalproperties-UltimateElongation | Before AgeingUltimateElongation500% Min for all sizesAfter Ageing UltimateElongation 400% Minfor all sizes | SizeSmallMediumLargeX-Large | Beforeageing690%693%702%705% | Afterageing665%667%669%673% |
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| Test Method | Purpose | AcceptanceCriteria | Result |
|---|---|---|---|
| ASTM D5151-2019 StandardTest Method for Detection ofHoles in Medical Gloves | To determine theholes in the gloves | AQL 2.5 | Gloves Passes AQL 1.5 |
| ASTM D6124-06 (Reapproved2017) Standard Test Methodfor Residual Powder onMedical Gloves | To determine theresidual powder inthe gloves | 2 Mg/Glove Max | SizeSmallMediumLargeX-LargeResidual PowderContent0.21 mg/glove0.22 mg/glove0.22 mg/glove0.22 mg/glove |
H. BIO-COMPATIBILITY DATA
| Test Method | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| ISO 10993-10 BiologicalEvaluation of Medical DevicesTest for Irritation and SkinSensitization. Test done forirritation. | To determine the potential ofthe material under test toproduce dermal irritation inRabbits | Under the conditionof study not anirritant | Under the condition ofstudy not an irritant |
| ISO 10993-10 BiologicalEvaluation of Medical DevicesTest for Irritation and SkinSensitization. Test done Skinsensitization. | To determine the skinsensitization potential of thematerial both in terms ofinduction and elicitation inGuinea Pig. | Under theconditions of thestudy not asensitizer | Under the conditions ofthe study not asensitizer |
| ISO 10993-5:2009 biologicalevaluation of medical devices -part 5, tests for in vitrocytotoxicity. | To evaluate the in vitrocytotoxic potential of the testitem (both inner and outersurface) Extracts in L-929mouse fibroblasts cells usingelution method. | Under theconditions of studynon cytotoxic | Under the conditions ofthe study cytotoxic. |
| ISO 10993-11:2017 biologicalevaluation of medical devices -part 11, tests for systemictoxicity. | To determine the acutesystemic toxicity potential ofthe test item extracts (bothinside and outer surfaces) inSwiss Albino mice. | Under theconditions of studythe device extractsdo not pose asystemic toxicityconcern | Under the conditionsof study the deviceextracts do not pose asystemic toxicityconcern |
| Material MediatedPyrogenicity ISO 10993-11:2017(E) / USP 41<151> | To determine the pyrogenicpotential of the test itemextract following intravenousinjection in New Zealandwhite Rabbits. | Under theconditions of thestudy, the devicedid notdemonstrate amaterial mediatedpyrogenicityresponse. | Under the conditions ofthe study, the device didnot demonstrate amaterial mediatedpyrogenicity response. |
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Clinical Testing Summary I.
Not applicable - Clinical data is not needed for gloves or for most devices cleared by the 510(K) process.
J. CONCLUSION
The conclusions drawn from the non clinical test demonstrate that the subject device in 510(K) submission, Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs is as safe, as effective, and performs as well as the legally marketed predicate device Harbour Health Powder Free Nitrile Examination Glove, Blue (Tested for use with Chemotherapy Drugs) K210944.
§ 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.