(20 days)
These Powder Free, Nitrile Examination Gloves are a disposable device intended for medical purpose that is worn on the examiner's hands to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs as per ASTM D6978-05 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
US Glove Supply's Powder Free, Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) are Blue, Polymer coated, Nonsterile, Powder Free, Ambidextrous Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs. These are made up of 100% synthetic Nitrile Butadiene Latex. Its surface finish is finger textured with beaded cuff.
The provided text describes the acceptance criteria and performance data for Memorial™ Gloves, which are Powder Free, Nitrile Examination Gloves. The submission is a 510(k) premarket notification to the FDA, indicating a claim of substantial equivalence to already marketed predicate devices.
Here's an analysis of the provided information, framed by your questions:
1. Table of Acceptance Criteria and Reported Device Performance
The document presents several tables summarizing non-clinical tests. I will consolidate the key information from pages 15-17.
| Testing/Standards (Parameter) | Purpose of the Test | Acceptance Criteria | Reported Device Performance (Result) |
|---|---|---|---|
| Physical Properties | |||
| ASTM D-3767 (Dimensions: Length, Width, Thickness) | To determine the length, width and thickness of the gloves | US Glove Supply's Powder Free, Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) should meet the requirements of ASTM D6319. | Pass. Powder Free, Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) meets the requirements of ASTM D6319. (Specific values: Length Min 230mm, Width S 80, M 95, L 110, XL 120, Thickness (Cuff: 0.05 ± 0.02, Palm: 0.07 ± 0.02, Finger: 0.09 ± 0.02)) |
| ASTM D-412/D-573 (Tensile Strength & Elongation) | To determine the Tensile strength and elongation in gloves before aging and after aging | Before aging: Tensile Strength: 14MPa, min; Ultimate Elongation: 500%min. After aging: Tensile Strength: 14MPa, min; Ultimate Elongation: 400%min. | Pass. Powder Free, Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) meets the requirements of ASTM D6319. (Specific values are stated to meet these criteria, consistent with the acceptance criteria.) |
| ASTM D-5151 (Leakage/Detection of Holes) | Testing for freedom from holes as per ASTM D-5151. | The gloves should be free of holes (Meets with the requirement of ASTM D 5151, following ASTM D 6319 AQL 2.5/Inspection Level G-I). | Pass. Powder Free, Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) meets the requirements of ASTM D6319. (Stated as meeting ASTM D 5151, following ASTM D 6319 AQL 2.5/Inspection Level G-I) |
| ASTM D6124 (Powder Content) | To Determine the powder residue using Test Method D6124. | 2.0 mg Maximum | Pass. Powder Free, Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) meets the requirements of ASTM D6319. (Specific value stated as Max 1.38 mg/glove, which is < 2.0 mg) |
| Chemical Permeation | |||
| ASTM D6978-05 (2019) (Permeation Testing for Chemotherapy Drugs) | To determine the Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs | Should meet the requirements as per ASTM D 6978-05. (Specific minimum breakthrough detection times for listed drugs, e.g., No breakthrough for up to 240 minutes for most, Carmustine = 14.9 min, Thio-Tepa = 37.8 min). | Pass. Powder Free, Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) meets the requirements of ASTM D-6978-05. (Specific results include: Cyclophosphamide, Doxorubicin HCl, Etoposide, 5-Fluorouracil, Paclitaxel, Cisplatin, Dacarbazine, Methotrexate, Mitomycin C, Vincristine Sulfate: No breakthrough for up to 240 minutes. Carmustine (BCNU): Min minutes before breakthrough = 14.9. Thio-Tepa: Min minutes before breakthrough = 37.8. Warnings are noted for Carmustine and Thio-Tepa due to low permeation times.) |
| Biocompatibility | |||
| ISO 10993-23 (Primary Skin Irritation) | To evaluate the local dermal irritation of a test article extract following intracutaneous injection in rabbits. | Under the condition of study not an irritant. | Under the conditions of the study, the test article met the requirements of the test. |
| ISO 10993-10 (Dermal Sensitization) | To evaluate the test item, for the skin sensitization in Guinea pigs by maximization test. | Under the conditions of the study, not a sensitizer. | Under the conditions of the study, the test article was not considered a sensitizer. |
| ISO 10993-5 (In Vitro Cytotoxicity) | To determine the potential of a test article to cause cytotoxicity. | Under the conditions of the study, non-cytotoxic. | Based on the results obtained under laboratory testing conditions, test item extracts of Nitrile Examination Gloves was found to be "cytotoxic" at 100% and 50% extract and "non-cytotoxic" at 25%, 12.5% and 6.25% test item extracts to the subconfluent monolayer of L-929 mouse fibroblast cells. (This indicates partial cytotoxicity at higher concentrations). |
| ISO 10993-11 (Acute Systemic Toxicity) | To evaluate the acute systemic toxicity of a test article, extract following injection in mice. | Under the conditions of study, the device extracts do not pose a systemic toxicity concern. | Under the conditions of study, there was no mortality or evidence of acute systemic toxicity. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for each individual test (e.g., number of gloves tested for permeation, number of animals for biocompatibility). It generally states that the tests "meet the requirements of" the respective ASTM or ISO standards, which typically implies that the sample sizes specified by those standards were followed.
The data provenance is non-clinical testing, performed to meet specific international and US standards. The document doesn't specify the country of origin of the data beyond the standards themselves. The tests are prospective in the sense that they were specifically conducted for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable in the context of this device submission. This is a 510(k) for examination gloves, which relies on well-established performance standards (ASTM, ISO) for physical, chemical, and biocompatibility properties, not on expert adjudication of subjective results (like image interpretation).
4. Adjudication Method for the Test Set
This is not applicable. The tests performed are objective, quantitative measurements (e.g., tensile strength, breakthrough time, cytotoxicity levels) against predefined acceptance criteria from international standards. There is no expert adjudication process for these types of tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This device is not an AI/ML-enabled medical device. Therefore, a MRMC comparative effectiveness study is not applicable and was not performed. The device is a physical product (gloves) whose performance is evaluated against material and barrier properties.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable, as the device is not an algorithm or AI.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The "ground truth" for this product is derived from established international and laboratory standards (ASTM, ISO). These standards define the scientific methods and criteria for evaluating the physical, chemical resistance, and biocompatibility of medical gloves. For example:
- Physical properties: Measured parameters (length, width, thickness, tensile strength, elongation, freedom from holes, powder content) are compared against the numerical specifications in ASTM D6319 and D5151/D6124.
- Chemotherapy drug permeation: Breakthrough times are objectively measured according to ASTM D6978-05.
- Biocompatibility: In vitro and in vivo tests (irritation, sensitization, cytotoxicity, systemic toxicity) follow ISO 10993 series to assess biological responses, with predefined criteria for "irritant," "sensitizer," "cytotoxic," etc.
8. The Sample Size for the Training Set
This is not applicable. The device is not an AI/ML product and does not involve training data sets.
9. How the Ground Truth for the Training Set Was Established
This is not applicable, as there is no training set for this type of 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 is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 4, 2023
US Glove Supply % Prithul Bom Accredited Person, Reviewer Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114
Re: K231740
Trade/Device Name: Memorial™ Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-powdered patient examination glove Regulatory Class: Class I. reserved Product Code: LZA, LZC, OPJ Dated: June 14, 2023 Received: June 14, 2023
Dear Prithul Bom:
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.
Bifeng Qian -S
Bifeng Qian, M.D., 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
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Indications for Use
510(k) Number (if known)
K231740
Device Name
Memorialтм Gloves
Indications for Use (Describe)
These Powder Free, Nitrile Examination Gloves are a disposable device intended for medical purpose that is worn on the examiner's hands to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs as per ASTM D6978-05 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
Chemotherapy Drug Permeation
The following chemicals have been tested with these gloves:
| Tested Chemotherapy Drug and Concentration | Minimum Breakthrough Detection time |
|---|---|
| Cyclophosphamide (20.0 mg/ml) | No breakthrough for up to 240 minutes |
| Doxorubicin Hydrochloride (2.0 mg/ml) | No breakthrough for up to 240 minutes |
| Etoposide (20.0 mg/ml) | No breakthrough for up to 240 minutes |
| 5-Fluorouracil (50.0 mg/ml) | No breakthrough for up to 240 minutes |
| Paclitaxel (Taxol) (6.0 mg/ml) | No breakthrough for up to 240 minutes |
| Cisplatin (1.0 mg/ml) | No breakthrough for up to 240 minutes |
| Dacarbazine (10.0 mg/ml) | No breakthrough for up to 240 minutes |
| Methotrexate (25 mg/ml) | No breakthrough for up to 240 minutes |
| Mitomycin C (0.5 mg/ml) | No breakthrough for up to 240 minutes |
| Vincristine Sulfate (1.0 mg/ml) | No breakthrough for up to 240 minutes |
| Carmustine (BCNU) (3.3 mg/ml) | Min minutes before breakthrough =14.9 |
| Thio-Tepa (10.0 mg/ml) | Min minutes before breakthrough =37.8 |
Warning Not For use with Carmustine
Warning Not For use with Thio-Tepa
*Please note that the following drugs have low permeation times:
Carmustine (BCNU): 14.9 Minutes and Thio-Tepa: 37.8 Minutes
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | X Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| -------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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Powder Free, Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)
510 (k) Summary - K231740
5.1 Submission Sponsor Information
US Glove Supply 300 Commerce Drive, Buffalo NY, 14218 United States Cell Phone Number: 516-456-3642 E-mail: jacomo@glovesupply.us Website: www.glovesupply.us Primary Contact: Mr Jacomo Hakim Secondary Contact: Rose Robbins E-mail: Rose@glovesupply.us Cell Phone Number:212-771-8822
5.2 Date Prepared
6/29/2023
5.3 Device Identification
| Trade/Proprietary Name | MemorialTM Gloves |
|---|---|
| Common Name | Powder Free, Nitrile Examination Gloves (Tested for Usewith Chemotherapy Drugs) |
| Classification Name | Non-Powdered Patient Examination Glove Specialty |
| Regulation Number | 21 CFR 880.6250 |
| Product Code | LZC, LZA, OPJ |
| Device Class | Class I, reserved |
| Classification Panel | General Hospital and Personal Use Devices |
Legally marketed device(s) to which equivalence is claimed 5.4
Predicate Device:
| 510(k) | K172525 |
|---|---|
| Trade/Proprietary Name | Blue Non-Sterile Powder Free Nitrile Examination Gloves |
| Tested for Use with Chemotherapy Drugs | |
| Common Name | Chemotherapy Gloves, Exam Gloves |
| Classification Name | Patient Examination Gloves Specialty |
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| Regulation Number | 21 CFR 880.6250 |
|---|---|
| Product Code | LZC, LZA |
| Device Class | Class I |
| Classification Panel | General Hospital and Personal Use Devices |
Reference device:
| 510(k) | K223559 |
|---|---|
| Trade/Proprietary Name | Nephron Nitrile |
| Common Name | Nitrile Examination Gloves (Tested for Use withChemotherapy drugs) |
| Classification Name | Non-Powdered Patient Examination Glove Specialty |
| Regulation Number | 21 CFR 880.6250 |
| Product Code | LZC, LZA, OPJ |
| Device Class | Class I, reserved |
| Classification Panel | General Hospital and Personal Use Devices |
ર્ રંડ Device Description
US Glove Supply's Powder Free, Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) are Blue, Polymer coated, Nonsterile, Powder Free, Ambidextrous Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs. These are made up of 100% synthetic Nitrile Butadiene Latex. Its surface finish is finger textured with beaded cuff.
The device is designed and tested as per its device specific guidance; "Medical Glove Guidance Manual".
Image /page/5/Picture/7 description: The image shows two blue nitrile gloves. The gloves are clean and appear to be new. The gloves are positioned side by side, with the fingers pointing upwards. The gloves are likely intended for medical or industrial use.
Figure 5.1: US Glove Supply's Powder Free, Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)
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Over the counter use: Yes
Single use disposable device: Yes
Sterile: No
User Profile/Population: Adults
Use Environment:
- Examination and Medical (Hospitals, Dental Clinics, Chemotherapy Centers, Home-care -Centers)
Indications for Use 5.6
These Powder Free, Nitrile Examination Gloves are a disposable device intended for medical purpose that is worn on the examiner's hands to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs as per ASTM D6978-05 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
Chemotherapy Drug Permeation
The following chemicals have been tested with these gloves:
| Tested Chemotherapy Drug andConcentration | Minimum Breakthrough Detection Time |
|---|---|
| Carmustine (BCNU) 3.3 mg/ml | Min minutes before breakthrough =14.9 |
| Cyclophosphamide 20.0 mg/ml | No breakthrough for up to 240 minutes |
| Cisplatin (1.0 mg/ml) | No breakthrough for up to 240 minutes |
| Dacarbazine 10.0 mg/ml | No breakthrough for up to 240 minutes |
| Doxorubicin Hydrochloride 2.0 mg/ml | No breakthrough for up to 240 minutes |
| Etoposide 20.0 mg/ml | No breakthrough for up to 240 minutes |
| Fluorouracil 50.0 mg/ml | No breakthrough for up to 240 minutes |
| Methotrexate 25 mg/ml | No breakthrough for up to 240 minutes |
| Mitomycin C 0.5 mg/ml | No breakthrough for up to 240 minutes |
| Paclitaxel (Taxol) 6.0 mg/ml | No breakthrough for up to 240 minutes |
| Thio-Tepa 10.0 mg/ml | Min minutes before breakthrough =37.8 |
| Vincristine Sulfate 1.0 mg/ml | No breakthrough for up to 240 minutes |
*Please note that the following drugs have low permeation times: Carmustine (BCNU): 14.9 Minutes and Thio-Tepa: 37.8 Minutes Warning: Not for use with Carmustine (BCNU) and Thio-Tepa.
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5.7 Comparison of the technological characteristics with the predicate device
The comparison chart below provides evidence to facilitate the substantial equivalence determination between US Glove Supply Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) and the predicate device (K172525) & with reference device (K223559) with respect to the intended use, technological characteristics, and principles of operation.
Reference device (K223559) has been included in the 510K to support substantial equivalence with respect to the use of additionally claimed chemotherapy drugs than that of Predicate device.
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Powder Free, Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)
| Comparisonparameters | STANDARDS | (Proposed Device) | (Predicate Device) | (Reference device) | Comparison |
|---|---|---|---|---|---|
| 510(K)Number | -- | K231740 | K172525 | K223559 | Different |
| ManufacturerName | -- | US Glove Supply | Central Medicare SDN. BHD | Nephron PharmaceuticalsCorporation | Different |
| Name of device | -- | Powder Free, NitrileExamination Gloves (Testedfor Use with ChemotherapyDrugs) | Blue Non-Sterile Powder FreeNitrile Examination Gloves Testedfor Use with Chemotherapy Drugs | Nephron Nitrile Powder-FreeNitrile Examination Gloves(Tested for Use withChemotherapy Drugs) | Different |
| Product Code | -- | LZC, LZA, OPJ | LZA, LZC | LZA, LZC, OPJ | Same withPredicateDevice |
| Indication foruse | -- | These Powder Free, NitrileExamination Gloves are adisposable device intended formedical purpose that is wornon the examiner's hands toprevent contaminationbetween patient and examiner.These gloves were tested foruse with chemotherapy drugsas per ASTM D6978-05Standard Practice forAssessment of Resistance ofMedical Gloves to Permeationby Chemotherapy Drugs. | Blue Non-Sterile Powder FreeNitrile Examination Gloves Testedfor Use with Chemotherapy Drugsis a disposable device intended formedical purposes that is worn onthe examiner's hand to preventcontamination between patient andexaminer.Gloves have been tested for usewith chemotherapy drugs usingASTM D6978-05 and will belabelled with a statement ofcompliance and a summary of thetesting results | Nephron Nitrile Powder-FreeNitrile Examination Gloves(Tested for Use withChemotherapy Drugs) is adisposable device intended formedical purpose that is worn onthe examiner's hand to preventcontamination between patientand examiner. In addition, thesegloves were tested for use withchemotherapy drugs inaccordance with ASTMD6978-05 (2019) StandardPractice for Assessment ofResistance of Medical Glovesto Permeation byChemotherapy Drugs. | Similar;difference interminology |
| RegulationNumber | -- | 21 CFR 880.6250 | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Material | -- | Nitrile | Nitrile | Nitrile | Same |
| Colour | -- | Blue | Blue | Blue | Same |
| Size | -- | Small, Medium, Large, X Large | Extra Small, Small, Medium, Large, Extra Large | M, L, XL, XXL | Similar; predicate device has additional sizes |
| Single use | -- | Single use | Single use | Single use | Same |
| Sterile/non sterile | -- | Non-sterile | Non-sterile | Non-sterile | Same |
| Rx Only or OTC | -- | OTC | OTC | OTC | Same |
| Dimensions - Length | ASTM D6319-2019 | Minimum 230 | Minimum 230 | Minimum 230 | Same |
| Dimensions - Width | ASTM D6319-2019 | S 80M 95L 110XL 120 | XS 70S 80M 95L 110XL 120 | M 95L 113XL 121XXL 129 | Same |
| Physical PropertiesTensile Strength | ASTM D6319-2019 | Before aging: 14MPa, minAfter aging: 14MPa, min | Before aging: 14MPa, minAfter aging: 14MPa, min | Same | |
| Physical PropertiesUltimate Elongation | ASTM D6319-2019 | Before aging: 500%, minAfter aging: 400%, min | Before aging: 500%, minAfter aging: 400%, min | Same | |
| Thickness (mm) | ASTM D6319-19 | Cuff: 0.05 ± 0.02Palm: 0.07 ± 0.02Finger: 0.09 ± 0.02 | Cuff: 0.06 ± 0.03Palm: 0.08 ± 0.03Finger: 0.10 ± 0.03 | Similar; meets ASTM D6319 -19 requirements | |
| Powder FreeResidue | ASTMD6319-19 | Max 1.38 mg/glove | Max. 0.52 mg per glove | < 2 mg per glove Averagevalue = 0.3516 mg/glove(Medium) | Similar,meets thestandardASTMD6124requirementof maximum2.0 mg |
| Freedom fromholes | ASTM D5151-2019 | Meets with the requirement ofASTM D 5151, followingASTM D 6319 AQL2.5/Inspection Level G-I | Meets with the requirement ofASTM D 5151, followingASTM D 6319 AQL2.5/Inspection Level G-I | In accordance withASTM D 5151-19,following ASTMD6319- 19,G-I, AQL 2.5 | Same |
| ChemotherapyDrugsTested withMinimumBreakthroughDetection Time | ASTM D6978-05 (2019) | Carmustine (3.3mg/ml)Min minutesbefore breakthrough =14.9 | Carmustine (3.3mg/ml)Min minutes before breakthrough=12.4 | Carmustine (3.3mg/ml)Min minutesbefore breakthrough =33.8 | Similar |
| Cisplatin (1.0 mg/ml)No breakthrough for up to240minutes | Cisplatin (1.0 mg/ml)No breakthrough for up to240minutes | Cisplatin (1.0 mg/ml)No breakthrough for up to240minutes | Same | ||
| Cyclophosphamide (20mg/ml)No breakthrough for up to240minutes | Cyclophosphamide (20mg/ml)No breakthrough for up to240minutes | Cyclophosphamide (20mg/ml)No breakthrough for up to240minutes | Same | ||
| Dacarbazine (10.0 mg/ml)No breakthrough for up to240minutes | Dacarbazine (10.0 mg/ml)No breakthrough for up to240minutes | Dacarbazine (10.0 mg/ml)No breakthrough for up to240minutes | Same | ||
| Doxorubicin HCI (2.0mg/ml)No breakthrough for up to240minutes | Doxorubicin HCI (2.0mg/ml)No breakthrough for up to240minutes | Doxorubicin HCI (2.0mg/ml)No breakthrough for up to240minutes | Same | ||
| Etoposide (20.0 mg/ml)No breakthrough for up to240minutes | Etoposide (20.0 mg/ml)No breakthrough for up to240minutes | Etoposide (20.0 mg/ml)No breakthrough for up to240minutes | Same |
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Powder Free, Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)
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| Fluorouracil (50.0 mg/ml)No breakthrough for up to240minutes | Fluorouracil (50.0 mg/ml)No breakthrough for up to240minutes | Fluorouracil (50.0 mg/ml)No breakthrough for up to240minutes | Same |
|---|---|---|---|
| Methotrexate (25.0 mg/ml)No breakthrough for up to240minutes | Not tested | Methotrexate (25.0 mg/ml)No breakthrough for up to240minutes | *Same asReferencePredicateDevice |
| Mitomycin C (0.5 mg/ml)No breakthrough for up to240minutes | Not tested | Mitomycin C (0.5 mg/ml)No breakthrough for up to240minutes | *Same asReferencePredicateDevice |
| Paclitaxel (6.0 mg/ml)No breakthrough for up to240minutes | Paclitaxel (6.0 mg/ml)No breakthrough for up to240minutes | Paclitaxel (6.0 mg/ml)No breakthrough for up to240minutes | Same |
| Thiotepa (10.0 mg/ml)Min minutes beforebreakthrough =37.8 | Thiotepa (10.0 mg/ml)Min minutes beforebreakthrough =4.4 | Thiotepa (10.0 mg/ml)Min minutes beforebreakthrough =128.1 | Similar |
| Vincristine Sulfate (1.0mg/ml)No breakthrough for up to240minutes | Vincristine Sulfate (1.0mg/ml)No breakthrough for up to240minutes | Vincristine Sulfate (1.0mg/ml)No breakthrough for up to240minutes | Same |
| Ifosfamide (50.0 mg/ml)Not tested | Ifosfamide (50.0 mg/ml)No breakthrough for up to240minutes | Ifosfamide (50.0 mg/ml)No breakthrough for up to240minutes | *Will not beclaimed byUS Gloves |
| Mitoxantrone (2.0 mg/ml)Not tested | Mitoxantrone (2.0 mg/ml)No breakthrough for up to240minutes | Mitoxantrone (2.0 mg/ml)No breakthrough for up to240minutes | *Will not beclaimed byUS Gloves |
| Mechlorethamine HCL(1.0mg/ml)Not tested | Mechlorethamine HCL(1.0mg/ml)Not tested | Mechlorethamine HCL(1.0 mg/ml)Not tested | *Will not beclaimed byUS Gloves |
| Irinotecan (20.0 mg/ml)Not tested | Irinotecan (20.0 mg/ml)Not tested | Irinotecan (20.0 mg/ml)No breakthrough for up to240minutes | *Will not beclaimed byUS Gloves |
| Carboplatin (10.0 mg/ml)Not tested | Carboplatin (10.0 mg/ml)Not tested | Carboplatin (10.0 mg/ml)No breakthrough for up to240minutes | *Will not beclaimed byUS Gloves |
| Docetaxel (10.0 mg/ml)Not tested | Docetaxel (10.0 mg/ml)Not tested | Docetaxel (10.0 mg/ml)Not tested | *Will not beclaimed byUS Gloves |
| Bleomycin Sulfate(15 mg/ml)Not Tested | Bleomycin Sulfate(15 mg/ml)Not Tested | Bleomycin Sulfate(15 mg/ml)No breakthrough for up to240minutes | *Will not beclaimed byUS Gloves |
| Busulfan (6 mg/ml)Not tested | Busulfan (6 mg/ml)Not tested | Busulfan (6 mg/ml)No breakthrough for up to240minutes | *Will not beclaimed byUS Gloves |
| Chloroquine 50mg/mlNot tested | Chloroquine50mg/mlNot tested | Chloroquine50mg/mlNot tested | *Will not beclaimed byUS Gloves |
| Cyclosporin 100 mg/mlNot tested | Cyclosporin 100 mg/mlNot tested | Cyclosporin 100 mg/mlNot tested | *Will not beclaimed byUS Gloves |
| Cytarabine HCL 100 mg/mlNot tested | Cytarabine HCL 100 mg/mlNot tested | Cytarabine HCL 100 mg/mlNot tested | *Will not beclaimed byUS Gloves |
| Cytarabine 100 mg/mlNot tested | Cytarabine 100 mg/mlNot tested | Cytarabine 100 mg/mlNo breakthrough for up to240minutes | *Will not beclaimed byUS Gloves |
| Daunorubicin HCl5 mg/mlNot tested | Daunorubicin HCl5 mg/mlNot tested | Daunorubicin HCl5 mg/mlNo breakthrough for up to240minutes | *Will not beclaimed byUS Gloves |
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| Docetaxel HCL 10 mg/mlNot tested | Docetaxel HCL 10 mg/mlNot tested | Docetaxel HCL 10 mg/mlNot tested | *Will not beclaimed byUS Gloves | ||
|---|---|---|---|---|---|
| Docetaxel 10 mg/mlNot tested | Docetaxel 10 mg/mlNot tested | Docetaxel 10 mg/mlNo breakthrough for up to240minutes | *Will not beclaimed byUS Gloves | ||
| Epirubicin HCl 2 mg/mlNot tested | Epirubicin HCl 2 mg/mlNot tested | Epirubicin HCl 2 mg/mlNo breakthrough for up to240minutes | *Will not beclaimed byUS Gloves | ||
| Fludarabine 25 mg/mlNot tested | Fludarabine 25 mg/mlNot tested | Fludarabine 25 mg/mlNo breakthrough for up to240minutes | *Will not beclaimed byUS Gloves | ||
| Gemcitabine 38 mg/mlNot tested | Gemcitabine 38 mg/mlNot tested | Gemcitabine 38 mg/mlNo breakthrough for up to240minutes | *Will not beclaimed byUS Gloves | ||
| Idarubicin HCl 1 mg/mlNot tested | Idarubicin HCl 1 mg/mlNot tested | Idarubicin HCl 1 mg/mlNo breakthrough for up to240minutes | *Will not beclaimed byUS Gloves | ||
| Melphalan 5 mg/mlNot tested | Melphalan 5 mg/mlNot tested | Melphalan 5 mg/mlNo breakthrough for up to240minutes | *Will not beclaimed byUS Gloves | ||
| Rituximab 10 mg/mlNot tested | Rituximab 10 mg/mlNot tested | Rituximab 10 mg/mlNo breakthrough for up to240minutes | *Will not beclaimed byUS Gloves | ||
| Trisenox 1 mg/mlNot tested | Trisenox 1 mg/mlNot tested | Trisenox 1 mg/mlNo breakthrough for up to240minutes | *Will not beclaimed byUS Gloves | ||
| Biocompatibility | Primary skinirritation- ISO10993 Part23:2021 | Under the conditions of thestudy, not an irritant | Under the conditions of the study,not an irritant | Under the conditions of thestudy, not an irritant | Same |
| DermalSensitization- | Under the conditions of thestudy, not a sensitizer | Under the conditions of the study,not a sensitizer | Under the conditions of thestudy, not a sensitizer | Same | |
| ISO 10993-10:2021 | --- | ||||
| In vitroCytotoxicity-ISO 10993-5:2009 | Based on the results obtainedunder laboratory testingconditions, test item extracts ofNitrile Examination Gloves wasfound to be "cytotoxic" at 100%and 50% extract and "non-cytotoxic" at 25%, 12.5% and6.25% test item extracts to thesubconfluent monolayer of L-929 mouse fibroblast cells. | --- | Under the conditions of thestudy, the undiluted test articleextract and 50% test articleextract dilution did not meetthe requirements of the testand the 25%, 12.5%, 6.25%,and 3.13% test article extractdilutions met the requirementsof the test | Same as theReferencePredicateDevice | |
| AcuteSystemicToxicity- ISO10993-11:2017 | Under the conditions of thisstudy, there was no evidence ofacute systemic toxicity | --- | Under the conditions of thestudy, there was no mortalityor evidence of acute systemictoxicity | Same as theReferencePredicateDevice |
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*Predicate device/reference device perform additional chemotherapy drug test.
*Reference device has been included in the 510K to support substantial equivalence for the subject device with respect to the use of chemotherapy drugs Mitomycin C (0.5 mg/ml) and Methotrexate (25.0 mg/ml) which was not tested in case of the predicate device.
There are no significant differences between the products and are identical in terms of intended use, materials, design and manufacturing methods. The devices meet the ASTM standard D6319 and D6978-05 (2019).
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5.8 Performance Data: Summary of non-clinical tests conducted for determination of substantial equivalence
The proposed device and its predicate devices share the same intended use, are made of the same material, are within the same minimum specifications of thickness and length by meeting ASTM D6319-19, similar permeation rates for chemotherapy drugs as per ASTM D6978-05, similar labelling, physical properties, freedom from powder, biocompatibility and water tightness.
Permeation rates for additionally claimed chemotherapy drugs Mitomycin C (0.5 mg/ml) and Methotrexate (25.0 mg/ml) which was not tested in case of the predicate device are similar to Reference device as per ASTM D6978-05. It supports substantial equivalence for the subject device with respect to the use of additionally claimed chemotherapy drugs than that of Predicate device.
Biocompatibility studies were performed on the proposed device. Under the conditions of the study, the proposed device is not a sensitizer, or an irritant.
The above test results demonstrated that the proposed device complies with the following standards: ASTM D6319-19
The results of the performance testing demonstrate fulfilment of requirements as per device specific guidance "Medical Glove Guidance Manual" as well as substantial equivalence with predicate. The minor differences in the product does not affect the products safety and efficacy.
| Testing/Standards | Purpose of the Test | Acceptance Criteria | Result |
|---|---|---|---|
| ASTM D-3767Dimensions(Length, Width &thickness) | To determine thelength, width andthickness of thegloves | US Glove Supply's PowderFree, Nitrile ExaminationGloves (Tested for Use withChemotherapy Drugs) shouldmeet the requirements ofASTM D6319. | Pass. Powder Free, NitrileExamination Gloves(Tested for Use withChemotherapy Drugs)meets the requirements ofASTM D6319 |
| ASTM D-412/D-573Tensile Strength &Elongation | To determine theTensile strength andelongation in glovesbefore aging andafter aging | Before agingTensile Strength: 14MPa,minUltimate Elongation:500%minAfter agingTensile Strength: 14MPa,min | Pass. Powder Free, NitrileExamination Gloves(Tested for Use withChemotherapy Drugs)meets the requirements ofASTM D6319. |
Table 5.2. Non-Clinical Performance Tests
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Powder Free, Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)
| Ultimate Elongation:400%min | |||
|---|---|---|---|
| ASTM D-5151Leakage/Detectionof Holes | Testing for freedomfrom holes as perASTM D-5151. | The gloves should be free ofholes | Pass. Powder Free, NitrileExamination Gloves(Tested for Use withChemotherapy Drugs)meets the requirements ofASTM D6319 |
| ASTM D6124Powder Content | To Determine thepowder residue usingTest Method D6124. | 2.0 mg Maximum | Pass. Powder Free, NitrileExamination Gloves(Tested for Use withChemotherapy Drugs)meets the requirements ofASTM D6319 |
| Permeation Testingper ASTM D6978-05 (2019) | To determine theAssessment ofResistance ofMedical Gloves toPermeation byChemotherapy Drugs | Should meet the requirementsas per ASTM D 6978-05 | Pass. Powder Free, NitrileExamination Gloves(Tested for Use withChemotherapy Drugs)meets the requirements ofASTM D-6978-05. |
BIOCOMPATIBILTIY DATA
| TEST DATA | PURPOSE | ACCEPTANCECRITERIA | RESULT |
|---|---|---|---|
| ISO 10993-23 Firstedition2021-01 BiologicalEvaluation of MedicalDevices - Part 23, TestsforIrritation. | To evaluate the localdermal irritation of a testarticle extract followingintracutaneous injectionin rabbits. | Under the condition ofstudy not an irritant | Under the conditionsof the study, the testarticle met therequirements of thetest |
| 10993-10 Fourthedition 2021-11Biological Evaluationof Medical Devices -Part 10, Tests for SkinSensitization. | To evaluate the testitem, for the skinsensitization in Guineapigs by maximizationtest. | Under the conditions ofthe study, not a sensitizer | Under the conditionsof the study, the testarticle was notconsidered asensitizer |
| ISO 10993-5 Thirdedition2009-06-01 BiologicalEvaluation of MedicalDevices - Part 5, Testsfor | To determine thepotentialof a test article to causecytotoxicity | Under the conditions ofthe study, non-cytotoxic | Based on the resultsobtained underlaboratory testingconditions, test itemextracts of NitrileExamination Gloves |
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| In Vitro Cytotoxicity. | was found to be"cytotoxic" at 100%and 50% extract and"non-cytotoxic" at25%, 12.5% and6.25% test itemextracts to thesubconfluentmonolayer of L-929mouse fibroblastcells. | ||
|---|---|---|---|
| ISO 10993-11 Thirdedition 2017-09BiologicalEvaluation of MedicalDevices - Part 11, Testsfor Systemic Toxicity. | To evaluate the acutesystemic toxicity of atest article, extractfollowing injection inmice. | Under the conditions ofstudy, the device extractsdo not pose a systemictoxicity concern. | Under the conditionsof study, there wasno mortality orevidence of acutesystemic toxicity. |
5.9 Summary of clinical tests conducted for determination of substantial equivalence or of clinical information
No clinical testing is required for this device.
5.10 Conclusions
The conclusions drawn from the non-clinical tests demonstrate that the subject device, US Glove Supply's Powder Free, Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) is as safe, as effective, and performs as well as or better than the legally marketed Predicate device (K172525).
§ 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.