(87 days)
Non-sterile Powder Free Nitrile Examination Gloves (tested for use with Chemotherapy Drugs) is a non-sterile, single-use, disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves have been tested for use with chemotherapy drugs per ASTM D6978-05 (2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
The subject device, Non-sterile Powder Free Nitrile Examination Gloves (tested for use with Chemotherapy Drugs), is a single use, disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves have been tested for use with chemotherapy drugs per ASTM D6978-05 (2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. These gloves are made of synthetic copolymer of acrylonitrile and butadiene with a blue color additive. The gloves are provided in sizes XS, S. M, L and XL.
The provided text describes the acceptance criteria and performance of "Non-Sterile Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)" in comparison to a predicate device. This is a medical device submission, and the information is presented as part of a 510(k) summary to the FDA. As such, the "study" referred to is a series of non-clinical tests performed to demonstrate substantial equivalence, rather than a clinical study involving human patients.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document presents the acceptance criteria and results mainly in reference to established ASTM and ISO standards for medical gloves. The "Reported Device Performance" column directly reflects the results from the non-clinical tests.
| Standard | Testing | Acceptance Criteria (Requirements) | Reported Device Performance (Results) |
|---|---|---|---|
| ASTM D6319-19 | Standard Specification for Nitrile Examination Gloves for Medical Application | Product dimension:- Width: 70mm (±10mm) - XS, 80mm (±10mm) - S, 95mm (±10mm) - M, 110mm (±10mm) - L, 120mm (±10mm) - XL- Overall Length: 220 mm (Minimum) – S and XS, 230 mm (Minimum) – M, L and XL- Thickness: Finger - 0.05 mm (Minimum), Palm - 0.05mm (Minimum) | Pass (met listed dimension requirements) |
| ASTM D412-16 | Standards test method for Vulcanized Rubber and Thermoplastics Elastomer - Tension | Physical properties:- Before Aging: - Tensile strength: min 14MPa - Elongation: min 500%- After Aging: - Tensile strength: min 14MPa - Elongation: min 400% | Pass (met listed physical property requirements) |
| ASTM D5151-19 | Standard Test Method for detection of Holes in Medical Gloves | Pass Inspection Level G1, AQL 2.5 | Pass |
| ASTM D6124-06 | Standard Test Method for Residual Powder on Medical Gloves | Residual powder meets specification < 2.0 mg/glove | Pass |
| ASTM D6978-05 | Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs | An assessment is made based on the permeation (breakthrough) of nine chemotherapy drugs through the glove material over a certain period of time (maximum testing time is 240 minutes) | Carmustine (BCNU): 14.6 minutesCisplatin: > 240 minutesCyclophosphamide (Cytoxan®): > 240 minutesDacarbazine (DTIC): > 240 minutesDoxorubicin Hydrochloride: > 240 minutesEtoposide (Toposar®): > 240 minutesFluorouracil: > 240 minutesPaclitaxel (Taxol®): > 240 minutesThiotepa: 15.0 minutesWarning: Do not use with Carmustine and Thiotepa due to low permeation times. |
| ISO 10993-5 | Biological Evaluation on Medical Devices - Part 5: Test for In Vitro Cytotoxicity | Pass in vitro cytotoxicity | Exhibited "Severe" reactivity at 100% concentration and no cytotoxic effect at 10% concentration. (Note: A systemic toxicity study was performed to address the safety of materials given the cytotoxicity result). |
| ISO 10993-10 | Biological evaluation on medical device Part 10: Test for Irritation and Skin Sensitization | No irritating and sensitizing | Under the condition of study not an irritant or a sensitizer. |
| ISO 10993-11 | Biological Evaluation of Medical Devices - Part 11: Test for Systemic Toxicity | No systemic toxic | Under the condition of the test, not a systemic toxicity. |
2. Sample Sizes Used for the Test Set and Data Provenance:
- Sample Size for Test Set: The document does not explicitly state a consolidated sample size for all tests. However, for specific tests, it does provide some details:
- Freedom from Holes (ASTM D5151-19): AQL = 2.5, Inspection level G1. This standard outlines sampling plans, but the exact number of units tested is not provided in this summary. The predicate device mention "125 samples from batch of 35000", which gives a hint on the sample size used, but this is for the predicate not the subject device.
- The other non-clinical tests (e.g., physical properties, biocompatibility, chemotherapy permeation) would also have specific sample sizes as per their respective standards, but these are not enumerated in this summary.
- Data Provenance: The document does not explicitly state the country-of-origin for the "data" or whether the tests were retrospective or prospective. Given that this is a 510(k) summary for a device manufactured by "RUBBEREX ALLIANCE SDN BHD" in Malaysia, it is highly probable that the testing was performed in conjunction with the manufacturer or by contract labs. The tests are prospective as they are conducted specifically for the device submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This section is not applicable as the described "study" consists of non-clinical, laboratory-based tests of physical properties and chemical resistance of gloves against established standards (ASTM, ISO). There is no "ground truth" derived from expert interpretation of medical images or patient outcomes data in this context. The "ground truth" is adherence to the objective criteria defined by the test methods and standards.
4. Adjudication Method for the Test Set:
This section is not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical studies or studies involving subjective human interpretation (e.g., reviewing medical images) to resolve discrepancies. The tests described here are objective laboratory measurements against defined standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
This section is not applicable. An MRMC study assesses the effectiveness of a diagnostic device or AI with and without human readers. The device in question is a medical glove, for which such a study design is irrelevant.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
This section is not applicable. "Standalone" performance usually refers to the performance of an AI algorithm without human interaction. This document describes the performance of a physical medical device (gloves) through laboratory tests, not an AI algorithm. The performance described is "standalone" in the sense that it's the intrinsic performance of the glove material.
7. Type of Ground Truth Used:
The "ground truth" for the performance of these gloves is based on:
- Established Standard Specifications: e.g., ASTM D6319-19 for dimensions, tensile strength, elongation.
- Standardized Test Methods and Protocols: e.g., ASTM D5151-19 for holes, ASTM D6124-06 for residual powder, ASTM D6978-05 for chemotherapy drug permeation, ISO 10993 series for biocompatibility.
- The results are quantitative measurements interpreted against pre-defined thresholds or criteria derived from these standards.
8. Sample Size for the Training Set:
This section is not applicable. There is no "training set" as this is not an AI/ML device. The tests performed are to evaluate manufactured products against predefined specifications.
9. How the Ground Truth for the Training Set Was Established:
This section is not applicable for the same reason as point 8.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
August 5, 2022
Rubberex Alliance Products Sdn Bhd % Kewin Tham Official Correspondent Mdi Consultants, Inc. 55 Northern Blvd. Suite 200 Great Neck, New York 11021
Re: K221350
Trade/Device Name: Non-Sterile Powder Free Nitrile Examination Gloves (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, OPJ Dated: May 9, 2022 Received: May 10, 2022
Dear Kewin Tham:
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, 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
Enclosure
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Indications for Use
510(k) Number (if known) K221350
Device Name
Non-Sterile Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)
Indications for Use (Describe)
Non-sterile Powder Free Nitrile Examination Gloves (tested for use with Chemotherapy Drugs) is a non-sterile, singleuse, disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves have been
tested for use with chemotherapy drugs per ASTM D6978-05 (2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
List of Drugs tested concentration and breakthrough detection time in maximum testing time is 240 minutes.
| Drug Tested | Concentration | Breakthrough Detection Time in Minutes |
|---|---|---|
| Carmustine (BCNU) | 3.3 mg/mL (3300 ppm) | 14.6 |
| Cisplatin | 1.0 mg/mL (1000 ppm) | > 240 |
| Cyclophosphamide (Cytoxan®) | 20 mg/mL (20000 ppm) | > 240 |
| Dacarbazine (DTCI) | 10 mg/mL (10000 ppm) | > 240 |
| Doxorubicin Hydrochloride | 2.0 mg/mL (2000 ppm) | > 240 |
| Etoposide (ToposarⓇ) | 20 mg/mL (20000 ppm) | > 240 |
| Fluorouracil | 50 mg/mL (50000 ppm) | > 240 |
| Paclitaxel (Taxol®) | 6.0 mg/mL (6000 ppm) | > 240 |
| Thiotepa | 10 mg/mL (10000 ppm) | 15.0 |
Warning: Do not use with Carmustine and Thiotepa.
Please note that the following drugs have low permeation times:
| Camustine (BCNU) | 3.3 mg/mL (3300 ppm) | 14.6 minutes |
|---|---|---|
| Thiotepa | 10.0 mg/mL (10000 ppm) | 15.0 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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510(k) SUMMARY
K221350 Date Summary Prepared: 29 July 2022
1. Submitter's Identification:
| a. Applicant: | RUBBEREX ALLIANCE SDN BHDLot 138201 Off ¾ Mile, Jalan BerchamKawasan Perindustrian Bercham31400 Ipoh, Perak, Malaysia |
|---|---|
| b. Applicant Contact Person: | Sabri Bin Abdul HamidLot 138201 Off ¾ Mile, Jalan BerchamKawasan Perindustrian Bercham31400 Ipoh, Perak, Malaysia |
| c. Official 510k Correspondent: | Ms. Kewin ThamOfficial Contact for RUBBEREX ALLIANCE SDN BHD |
| d. Official 510k Correspondent Firm | Mdi Consultants, Inc55 Northern Blvd. Suite 200Great Neck, New York 11021(516) 482-9001Fax: (516) 482-0186Email: kewin@mdiconsultants.com |
2. Name of the Device:
Non-Sterile Powder Free Nitrile Examination Gloves (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, OPJ |
3. Information for the 510(k) Cleared Device (Predicate Device):
| Predicate device: | K213227 |
|---|---|
| Trade/Device Name: | Uweport Powder-Free Nitrile Examination Gloves Tested for Use |
| with Chemotherapy Drugs | |
| Device Classification Name: | Non-Powdered Patient Examination gloves |
| Regulation Number: | 21 CFR 880.6250 |
| Device Class: | Class I |
| Product Code: | LZA, LZC, OPJ |
| Applicant name: | Uweport LLC. |
4. Device Description:
The subject device, Non-sterile Powder Free Nitrile Examination Gloves (tested for use with Chemotherapy Drugs), is a single use, disposable device intended for medical purposes that is worn
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on the examiner's hand to prevent contamination between patient and examiner. These gloves have been tested for use with chemotherapy drugs per ASTM D6978-05 (2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. These gloves are made of synthetic copolymer of acrylonitrile and butadiene with a blue color additive. The gloves are provided in sizes XS, S. M, L and XL.
ട. Indications for Use:
Non-sterile Powder Free Nitrile Examination Gloves (tested for use with Chemotherapy Drugs) is a non-sterile, single-use, disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves have been tested for use with chemotherapy drugs per ASTM D6978-05 (2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
List of Drugs tested concentration and breakthrough detection time in minutes. The maximum testing time is 240 minutes.
| Drug Tested | Concentration | BreakthroughDetection Timein Minutes |
|---|---|---|
| Carmustine (BCNU) | 3.3 mg/mL (3300 ppm) | 14.6 |
| Cisplatin | 1.0 mg/mL (1000 ppm) | > 240 |
| Cyclophosphamide (Cytoxan®) | 20 mg/mL (20000 ppm) | > 240 |
| Dacarbazine (DTCI) | 10 mg/mL (10000 ppm) | > 240 |
| Doxorubicin Hydrochloride | 2.0 mg/mL (2000 ppm) | > 240 |
| Etoposide (Toposar®) | 20 mg/mL (20000 ppm) | > 240 |
| Fluorouracil | 50 mg/mL (50000 ppm) | > 240 |
| Paclitaxel (Taxol®) | 6.0 mg/mL (6000 ppm) | > 240 |
| Thiotepa | 10 mg/mL (10000 ppm) | 15.0 |
Warning: Do not use with Carmustine and Thiotepa.
| Please note that the following drugs have low permeation times: | ||
|---|---|---|
| Camustine (BCNU) | 3.3 mg/mL (3300 ppm) | 14.6 minutes |
| Thiotepa | 10.0 mg/mL (10000 ppm) | 15.0 minutes |
6. Comparison to the 510(k) Cleared Devices (Predicate Devices):
Table 1: Comparison to Predicate Device
| Characteristic | Predicate Device | Subject Device | ComparisonAnalysis |
|---|---|---|---|
| Manufacturer | Uweport LLC | Rubberex Alliance SdnBhd | N/A |
| Device Name | Nitrile Exam Glove (testedfor use with ChemotherapyDrugs) | Non-sterile Powder FreeNitrile Examination Gloves(tested for use withChemotherapy Drugs) | Similar |
| 510(k) Reference | K213227 | K221350 | N/A |
| Product Code | LZA, LZC, OPJ | LZA, LZC, OPJ | Same |
| Characteristic | Predicate Device | Subject Device | ComparisonAnalysis |
| Indication for Use | Uweport Powder-FreeNitrile Exam Gloves Testedfor Use with ChemotherapyDrugs is a non-sterile,disposable device intendedfor medical purposes that isworn on the examiner'shand to preventcontamination. The Gloveshave been tested for usewith chemotherapy drugsper ASTM D6978-05(2019)Standard Practice forAssessment of Resistance ofMedical Gloves toPermeation byChemotherapy Drugs. | Non-sterile Powder FreeNitrile Examination Gloves(Tested for Use withChemotherapy Drugs) is anon-sterile, disposabledevice intended formedical purposes that isworn on the examiner'shand to preventcontamination. The gloveshave been tested for usewith chemotherapy drugsper ASTM D6978-05(2019) Standard Practicefor Assessment ofResistance of MedicalGloves to Permeation byChemotherapy Drugs. | Similar |
| Regulation Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Material | Nitrile | Nitrile | Same |
| Color | Blue | Blue | Same |
| Design Features | AmbidextrousTextured fingertipsBeaded cuffStraight fingers | AmbidextrousTextured fingertipsBeaded cuffStraight fingers | Same |
| Sizes | Small, Medium, Large,Extra Large | Extra Small, Small,Medium, Large, ExtraLarge | Different(1) See Below |
| Dimension-Thickness | Complies with ASTMD6319-19Palm: 0.07S; 0.08M; 0.08L;0.08XL all ± 0.03mmFinger: 0.09 ± 0.03mm | Complies with ASTMD6319-19Palm: min 0.05mmFinger: min 0.05mm | DifferentSee Below(2) |
| Dimension-Width | Complies with ASTMD6319-19Small: 85 ± 5mmMedium: 96 ± 5mmLarge: 108 ± 5mmExtra Large: 115 ± 5mm | Complies with ASTMD6319-19Extra Small: 70 ± 10mmSmall: 80 ± 10mmMedium: 95 ± 10mmLarge: 110 ± 10mmExtra Large: 120 ± 10mm | DifferentSee Below(3) |
| Dimension-Length | Complies with ASTMD6319-19Small: ≥ 220mmMedium/Large/Extra Large:≥ 240mm | Complies with ASTMD6319-19Extra Small/Small: ≥220mmMedium/Large/ExtraLarge: ≥ 230mm | DifferentSee Below(4) |
| Rx vs OTC | OTC | OTC | Same |
| Sterile vs Non-SterileDisposable vs Non-Disposable | Non-SterileDisposable | Non-SterileDisposable | SameSame |
| BiocompatibilityCytotoxicity ISO10993-5 | At 100% extraction the cellviability was 17.1%. | Exhibited "Severe"reactivity at 100%concentration and no | DifferentSee Below(5) |
| Characteristic | Predicate Device | Subject Device | ComparisonAnalysis |
| BiocompatibilitySensitization ISO10993-10 | The test article passed bothextracts with a 0 score. | The test article passed bothextracts with a 0 score. | Same |
| BiocompatibilityIrritation ISO 10993-10 | The test article from bothextracts was categorized asnegligible under the testconditions. | The test article from bothextracts was categorized asnegligible under the testconditions. | Same |
| BiocompatibilityAcute SystemicToxicity ISO 10993-11:2017 | Under the conditions of thestudy the test article extractmet the requirements of thestudy; Body weight data andanimal appearance wasnormal throughout the study. | Under the conditions of thestudy the test article extractmet the requirements of thestudy; Body weight dataand animal appearance wasnormal throughout thestudy. | Same |
| Single Use | Yes | Yes | Same |
| Physical Properties -Tensile Strength | Complies with ASTMD6319-19 at nominalconditions ≥ 14MPa | Complies with ASTMD6319-19 at nominalconditions ≥ 14MPa | Same |
| Physical Properties -Elongation | Complies with ASTMD6319-19 at nominalconditions; ≥ 500% | Complies with ASTMD6319-19Before aging: min 500%After aging: min 400% | Different(6) See Below |
| Freedom from Holes | Complies with ASTMD5151-19; AQL = 2.5, 125samples from batch of35000, inspection level 1,criterion ≤ 7Zero nonconforming | Complies with ASTMD5151-19; AQL = 2.5,Inspection level G-1 | Similar |
| Residual Powder | ASTM D6124 Standard TestMethod for Residual Powderon Medical Gloves; residualpowder 0.15; 0.18 and 0.19mg/ glove | Complies with ASTMD6124 Standard TestMethod for ResidualPowder on MedicalGloves; residual powder ≤2.0 mg/ glove | Similar |
| ChemotherapyPermeationASTM D6978-05(2019) Assessmentof Resistance ofMedical Gloves toPermeation byChemotherapy Drugs | Carmustine (BCNU) 3.3mg/mL (3300 ppm): 22.6minutes | Carmustine (BCNU) 3.3mg/mL (3300 ppm): 14.6minutes | Similar |
| Cisplatin 1.0 mg/mL (1000ppm): > 240 minutes | Cisplatin 1.0 mg/mL (1000ppm): > 240 minutes | Same | |
| Cyclophosphamide(Cytoxan®) 20 mg/mL(20000 ppm): > 240 minutes | Cyclophosphamide(Cytoxan®) 20 mg/mL(20000 ppm): > 240minutes | Same | |
| Dacarbazine (DTIC) 10mg/mL (10000 ppm): > 240minutes | Dacarbazine (DTIC) 10mg/mL (10000 ppm): >240 minutes | Same | |
| Doxurubicin Hydrochloride2.0 mg/mL (2000 ppm): >240 minutes | DoxurubicinHydrochloride 2.0 mg/mL(2000 ppm): > 240 minutes | Same | |
| Characteristic | Predicate Device | Subject Device | ComparisonAnalysis |
| Etoposide (Toposar®) 20mg/mL (20000 ppm): > 240minutes | Etoposide (Toposar®) 20mg/mL (20000 ppm): >240 minutes | Same | |
| Fluorouracil 50 mg/mL(50000 ppm): > 240 minutes | Fluorouracil 50 mg/mL(50000 ppm): > 240minutes | Same | |
| Paclitaxel (Taxol®) 6.0mg/mL (6000 ppm): > 240minutes | Paclitaxel (Taxol®) 6.0mg/mL (6000 ppm): > 240minutes | Same | |
| Thiotepa 10 mg/mL (10000ppm): 46.8 minutes | Thiotepa 10 mg/mL(10000 ppm): 15.0 minutes | Similar |
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1. Sizes
The subject device sizes ranges from Extra Small, Small, Medium, Large, Extra Large, whereas the predicate device size ranges from Small, Medium, Large, Extra Large. This does not introduce any new risk to the device.
2. Dimension-Thickness
The subject device dimension thickness Palm: measures at a min of 0.05mm and Finger: measures at a min of 0.05mm, whereas the predicate device Palm: measures at 0.07 Small; 0.08 Medium; 0.08 Large; 0.08 Extra Large all ± 0.03m and Finger measures at: 0.09 ± 0.03mm. These differences do not affect the performance nor introduce any new risk to the device.
3. Dimension-Width
The subject device which complies with ASTM D6319-19 measures for: Extra Small: 70 ± 10mm Small: 80 ± 10mm Medium: 95 ± 10mm Large: 110 ± 10mm Extra Large: 120 ± 10mm Whereas, the predicate device which complies with ASTM D6319-19 measures for: Small: 85 ± 5mm Medium: 96 ± 5mm Large: 108 ± 5mm Extra Large: 115 ± 5mm These differences do not affect the device's performance or safety and effectiveness.
4. Dimension-Length
The subject device which complies with ASTM D6319-19 measures for: Extra Small/Small: ≥ 220mm Medium/Large/Extra Large: ≥ 230mm Whereas, the predicate which complies with ASTM D6319-19 measures for: Small: ≥ 220mm Medium/Large/Extra Large: ≥ 240mm
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These dimensional differences does not introduce any new risk to the device. Nor does it affect the device's safety and effectiveness.
5. Biocompatibility- Cytotoxicity ISO 10993-5
The subject device exhibited "severe" reactivity at 100% concentration and no cytotoxic effect at 10% concentration. Whereas, for the predicate device, at 100% extraction the cell viability was 17.1%.. To demonstrate the safety of the materials the sponsor elected to perform a systemic toxicity study in which the device was found to be non-toxic.
6. Physical Properties - Elongation
The subject device which complies with ASTM D6319-19 was found to be Before aging: min 500% After aging: min 400% Whereas, the predicate device which complies with ASTM D6319-19 at nominal conditions was ≥ 500%
These differences do not affect the device's performance or safety and effectiveness.
7. Summary of Non-Clinical Tests Performed
Non-sterile Powder Free Nitrile Examination Gloves (tested for use with Chemotherapy Drugs) was tested and found in conformance with the following standards.
| Standard | Testing | Requirements | Results |
|---|---|---|---|
| ASTM D6319-19 | Standard Specificationfor NitrileExamination Glovesfor MedicalApplication | Product dimension pass (between thetolerance gaps) | Pass |
| Width: | |||
| 70 mm (±10mm) - XS | |||
| 80 mm (±10mm) - S | |||
| 95 mm (±10mm) - M | |||
| 110 mm (±10mm) - L | |||
| 120 mm (±10mm) - XL | |||
| Overall Length:220 mm (Minimum) – S and XS230 mm (Minimum) – M, L andXL | |||
| Thickness: (for all sizes)Finger -0.05 mm (Minimum)Palm -0.05mm (Minimum) | |||
| ASTM D412-16 | Standards test methodfor Vulcanized Rubberand ThermoplasticsElastomer - Tension | Physical properties:Before Aging:Tensile strength: min 14MPaElongation: min 500% | Pass |
| After Aging:Tensile strength: min 14MPa |
Table 2: Summary Non-Clinical Tests
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| Standard | Testing | Requirements | Results |
|---|---|---|---|
| Elongation: min 400% | |||
| ASTM D5151-19 | Standard Test Methodfor detection of Holesin Medical Gloves | Pass Inspection Level G1, AQL 2.5 | Pass |
| ASTM D6124-06 | Standard Test Methodfor Residual Powderon Medical Gloves | Residual powder meets specification<2.0mg/glove | Pass |
| ASTM D6978-05 | Standard Practice forAssessment ofResistance of MedicalGloves to Permeationby ChemotherapyDrugs | An assessment is made based on thepermeation (breakthrough) of ninechemotherapy drugs through theglove material over a certain periodof time | See Table 1 above |
| ISO 10993-5 | Biological Evaluationon Medical Devices-Part 5: Test for InVitro Cytotoxicity | Pass in vitro cytotoxicity | Exhibited "Severe"reactivity at 100%concentration and nocytotoxic effect at10% concentration. |
| ISO 10993-10 | Biological evaluationon medical device Part10: Test for Irritationand Skin Sensitization | No irritating and sensitizing | Under the conditionof study not anirritant or asensitizer. |
| ISO 10993-11 | Biological Evaluationof Medical Devices -Part 11: Test forSystemic Toxicity | No systemic toxic | Under the conditionof the test, not asystemic toxicity. |
The following National and International Standards were utilized for testing the subject device:
| ASTM D6319-19 | Standard Specification for Nitrile Examination Glovesfor Medical Application |
|---|---|
| ASTM D412-16 | Standard Test Methods for Volcanized Rubber andThermoplastic Elastomers - Tension |
| ASTM D5151-19 | Standard Test Method for detection of Holes in MedicalGloves |
| ASTM D6124-06 | Standard Test Method for Residual Powder on MedicalGloves |
| ASTM D6978-05 | Standard Practice for Assessment of Resistance ofMedical Gloves to Permeation by Chemotherapy Drugs |
| ISO 10993-5 | Biological Evaluation on Medical Devices- Part 5: Testfor In Vitro Cytotoxicity |
| ISO 10993-10 | Biological Evaluation on Medical Devices- Part 10: Testfor Irritation and Skin Sensitization |
| ISO 10993-11 | Biological Evaluation of Medical Devices – Part 11:Testfor Systemic Toxicity |
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Summary of Clinical Testing: 8.
Clinical Testing is not required for the subject gloves.
9. Conclusions:
The conclusion drawn from the non-clinical tests demonstrates that the subject device, Non-sterile Powder Free Nitrile Examination Glove (tested for use with Chemotherapy Drugs) is as safe, as effective, and performs as well as or better than the legally marketed Predicate device cleared under K213227.
§ 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.