(97 days)
The PureZero MARIN Nitrile Powder-Free Exam Gloves with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid claim and PureZero MARIN-XTRA Nitrile Powder-Free Exam Gloves with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid claim is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
The following chemotherapy drugs and concentration had NO breakthrough detected up to 240 minutes:
Cisplatin (1 mg/ml) Cyclophosphamide (20 mg/ml) Dacarbazine (10 mg/ml) Doxorubicin HCI (2 mg/ml) Etoposide (20 mg/ml) Fluorouracil (50 mg/ml) Ifosfamide (50 mg/ml) Methotrexate (25 mg/ml) Mitomycin C (0.5 mg/ml) Mitoxantrone HCI (2 mg/ml) Paclitaxel (6 mg/ml) Vincrinstine Sulfate (1 mg/ml) Fentanyl Citrate Injection (100 mcg/2 mL) Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution
The following chemotherapy drugs and concentration showed breakthrough detected in less than 90 minutes:
ThioTEPA (10 mg/ml), breakthrough detected at 88.6 minutes
Carmustine (3.3 mg/ml), breakthrough detected at 55.2 minutes
Warning: Not for Use With: Carmustine, ThioTEPA
The subject device is a dark blue colored, chlorinated, nitrile, powder-free, textured fingertip, ambidextrous, patient examination gloves.
The provided document is a 510(k) summary for medical examination gloves and does not relate to AI/ML powered medical devices. Therefore, many of the requested categories (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, sample size for training set, how training set ground truth was established) are not applicable and are not present in this type of submission.
However, I can extract the acceptance criteria and performance data for the device itself (the gloves).
Here's the relevant information based on the provided document:
1. A table of acceptance criteria and the reported device performance
| Test | Standard(s) | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Chemotherapy Drugs Permeation Resistance | ASTM D6978-05 | No breakthrough for specific drugs up to 240 minutes. | No breakthrough detected up to 240 minutes for: Cisplatin (1 mg/ml), Cyclophosphamide (20 mg/ml), Dacarbazine (10 mg/ml), Doxorubicin HCI (2 mg/ml), Etoposide (20 mg/ml), Fluorouracil (50 mg/ml), Ifosfamide (50 mg/ml), Methotrexate (25 mg/ml), Mitomycin C (0.5 mg/ml), Mitoxantrone HCI (2 mg/ml), Paclitaxel (6 mg/ml), Vincristine Sulfate (1 mg/ml), Fentanyl Citrate Injection (100 mcg/2 mL), Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution. Breakthrough detected in less than 90 minutes for: ThioTEPA (10 mg/ml) at 88.6 minutes. Breakthrough detected in less than 60 minutes for: Carmustine (3.3 mg/ml) at 55.2 minutes. Warning: Do not use with Carmustine or ThioTEPA. |
| Freedom from Pinholes (Leakage) | ASTM D5151-06, ASTM D6319 | 2.5% AQL requirement for leakage. No leakage. | Meets the 2.5% AQL requirement for leakage. Meets the acceptance criteria. |
| Residual Powder | ASTM D6124-06, ASTM D6319 | < 2 mg maximum powder per glove. | Average of 0.4 mg/glove, within the powder-free limit. Meets acceptance criteria. |
| Physical Dimensions (Length) | ASTM D6319 | PureZero MARIN Nitrile: 235 - 250 mm. PureZero MARIN-XTRA Nitrile: 295 - 325 mm. | Meets requirements. |
| Physical Dimensions (Palm Width) | ASTM D6319 | XSmall: 60 – 80 mm; Small: 70 - 90 mm; Med: 85–105 mm; Large: 100 - 120 mm; X-Large: 110-130 mm. | Meets requirements. |
| Physical Dimensions (Thickness - Finger, Palm, Cuff) | ASTM D6319 | Finger: 0.10-0.19 mm; Palm: 0.10-0.16 mm; Cuff: 0.10-0.13 mm. | Meets requirements. |
| Physical Properties (Tensile Strength & Ultimate Elongation - Before Aging) | ASTM D6319 | Tensile Strength: ≥14 MPa; Ultimate Elongation: ≥500%. | Meets requirements. |
| Physical Properties (Tensile Strength & Ultimate Elongation - After Aging) | ASTM D6319 | Tensile Strength: ≥14 MPa; Ultimate Elongation: ≥400%. | Meets requirements. |
| Biocompatibility - Indirect Irritation Study | ISO 10993, Part 10 | Primary Irritation Index ≤2.0. | Test article was considered nonirritating. Meets acceptance criteria. |
| Biocompatibility - Systemic Toxicity Study | ISO 10993, Part 11 | No animals treated with test extracts exhibit greater reaction than control animals. | No evidence of systemic toxicity. Test article considered non-toxic. Meets acceptance criteria. |
| Biocompatibility - Dermal Sensitization | ISO 10993, Part 10 | Grade < 1. | Under the conditions of the study, the device is not a sensitizer. Meets acceptance criteria. |
2. Sample sized used for the test set and the data provenance:
The document refers to various ASTM and ISO standards for testing. These standards define the sample sizes and testing methodologies. For example, ASTM D5151-06 (Detection of Holes) typically involves a water leak test on a statistically significant sample based on AQL (Acceptable Quality Level). ASTM D6978-05 (Chemotherapy Permeation) involves testing multiple gloves for each drug. The specific sample sizes for each test are not explicitly stated in the 510(k) summary, but adherence to these standards implies standard sampling appropriate for the tests.
Data Provenance: Not explicitly stated, but assumed to be from laboratory testing conducted according to relevant international standards. This is a pre-market submission, so it represents performance characteristics of the manufactured device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. These are physical and chemical property tests, not expert-opinion-based assessments like image interpretation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. These are objective laboratory tests.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No, not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, not applicable.
7. The type of ground truth used:
For most tests (e.g., physical dimensions, tensile strength, powder content, pinholes), the "ground truth" is directly measured by calibrated instruments and procedures as defined by the referenced ASTM and ISO standards.
For chemotherapy drug permeation, the "ground truth" is the empirically observed breakthrough time using analytical methods.
For biocompatibility, the "ground truth" is established through standardized biological evaluations using animal models as per ISO 10993 guidelines, assessing for specific adverse reactions (irritation, toxicity, sensitization).
8. The sample size for the training set: Not applicable (no AI/ML model being trained).
9. How the ground truth for the training set was established: Not applicable (no AI/ML model being trained).
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 2, 2022
O&M Halyard, Inc. Angela Bunn Director, Global Regulatory Affairs 1 Edison Drive Alpharetta, Georgia 30005
Re: K220547
Trade/Device Name: PureZero MARIN Nitrile Powder-Free Exam Gloves, PureZero MARIN-XTRA Nitrile Powder-Free Exam Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC, QDO Dated: April 28, 2022 Received: May 3, 2022
Dear Angela Bunn:
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.
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
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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 (OS) 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 Bifeng Qian, Ph D Acting 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)
K220547
Device Name
The PureZero MARIN Nitrite Powder-Free Exam Gloves with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid claim and PureZero MARIN-XTRA Nitrile Powder-Free Exam Gloves
Indications for Use (Describe)
The PureZero MARIN Nitrile Powder-Free Exam Gloves with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid claim and PureZero MARIN-XTRA Nitrile Powder-Free Exam Gloves with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid claim is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
The following chemotherapy drugs and concentration had NO breakthrough detected up to 240 minutes:
Cisplatin (1 mg/ml) Cyclophosphamide (20 mg/ml) Dacarbazine (10 mg/ml) Doxorubicin HCI (2 mg/ml) Etoposide (20 mg/ml) Fluorouracil (50 mg/ml) Ifosfamide (50 mg/ml) Methotrexate (25 mg/ml) Mitomycin C (0.5 mg/ml) Mitoxantrone HCI (2 mg/ml) Paclitaxel (6 mg/ml) Vincrinstine Sulfate (1 mg/ml) Fentanyl Citrate Injection (100 mcg/2 mL) Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution
The following chemotherapy drugs and concentration showed breakthrough detected in less than 90 minutes:
ThioTEPA (10 mg/ml), breakthrough detected at 88.6 minutes
Carmustine (3.3 mg/ml), breakthrough detected at 55.2 minutes
Warning: Not for Use With: Carmustine, ThioTEPA
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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510(k) Summary
K220547
| Date Summarywas Prepared | February 1, 2022 |
|---|---|
| 510(k) Submitter | O & M Halyard, Inc.1 Edison DriveAlpharetta, GA 30005 |
| Primary Contact forthis 510(k) Submission | Angela L. Bunn, RACTel: 470-347-7147Email: angela.bunn@owens-minor.com |
| Marketed Common Name | Nitrile Powder-Free Exam Gloves |
| Device Submission Trade Nameand Description | PureZero MARIN Nitrile Powder-Free Exam Gloves with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid claimPureZero MARIN-XTRA Nitrile Powder-Free Exam Gloves with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid claim |
| Device Common Name | Medical Exam Gloves |
| Device Product Codeand Classification Name | LZA Class I, 21 CFR §880.6250 Patient Examination GloveLZC Class I, 21 CFR §880.6250 Patient Examination Glove, SpecialtyQDO Class 1, 21 CFR §880.6250 Fentanyl and Other Opioid Protection Glove |
| Predicate Device | Halyard Purple Nitrile Powder-Free Exam Glove with Chemotherapy Drug and Fentanyl Citrate Claim (K200633) |
| Subject Device Description | The subject device is a dark blue colored, chlorinated, nitrile, powder-free, textured fingertip, ambidextrous, patient examination gloves. The devices follow consensus standards:ASTM D5151-06 Standard Test Method for Detection of Holes in Medical GlovesASTM D6319-10 Standard Specification for Nitrile Examination Gloves for Medical ApplicationsASTM D6124-06 Standard Test Method for Residual Powder on Medical GlovesASTM D6978-05 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy DrugsISO 10993-11:2017, Biological evaluation of medical devices - Part 11: Tests for Systemic ToxicityISO 10993-10: 2010: Biological evaluation of medical devices - Part 10: |
| Tests for Irritation and Skin Sensitization | |
| Indications for Use | The PureZero MARIN Nitrile Powder-Free Exam Gloves with ChemotherapyDrugs, Fentanyl Citrate and Gastric Acid claim and PureZero MARIN-XTRA NitrilePowder-Free Exam Gloves with Chemotherapy Drugs, Fentanyl Citrate andGastric Acid claim is a disposable device intended for medical purposes that isworn on the examiner's hand to prevent contamination between patient andexaminer. |
| The following chemotherapy drugs and concentration had NO breakthroughdetected up to 240 minutes: | |
| Cisplatin (1 mg/ml)Cyclophosphamide (20 mg/ml)Dacarbazine (10 mg/ml)Doxorubicin HCI (2 mg/ml)Etoposide (20 mg/ml)Fluorouracil (50 mg/ml)Ifosfamide (50 mg/ml)Methotrexate (25 mg/ml)Mitomycin C (0.5 mg/ml)Mitoxantrone HCI (2 mg/ml)Paclitaxel (6 mg/ml)Vincrinstine Sulfate (1 mg/ml)Fentanyl Citrate Injection (100 mcg/2 mL)Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution | |
| The following chemotherapy drugs and concentration showed breakthroughdetected in less than 90 minutes:ThioTEPA (10 mg/ml), breakthrough detected at 88.6 minutes | |
| The following chemotherapy drugs and concentration showed breakthroughdetected in less than 60 minutes: | |
| Carmustine (3.3 mg/ml), breakthrough detected at 55.2 minutes | |
| Warning: Do not use with Carmustine or ThioTEPA |
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| Technological Characteristics Comparison Table | |||
|---|---|---|---|
| Subject DeviceK220547 | Predicate DeviceHalyard Purple Nitrile Powder-Free Exam GloveK200633 | Comparison | |
| FDA Product Code | LZC, LZA, QDO | LZC, LZA, QDO | Added QDO for theFentanyl Claim |
| FDA Classification | Class I | Class I | Same |
| Regulation Number | 880.6250 | 880.6250 | Same |
| Common Name | Medical Exam Glove | Medical Exam Glove | Same |
| Device Trade Name | PureZero MARIN Nitrile Powder-Free Exam Gloves withChemotherapy Drugs, FentanylCitrate and Gastric Acid claimPureZero MARIN-XTRA NitrilePowder-Free Exam Gloves withChemotherapy Drugs, FentanylCitrate and Gastric Acid claim | Halyard Purple Nitrile Powder-Free Exam Gloves withChemotherapy Drugs andFentanyl Citrate claim | Similar |
| Intended Use | The device is a disposable deviceintended for medical purposesthat is worn on the examiner'shand to prevent contaminationbetween patient and examiner.These gloves were tested for usewith chemotherapy drugs,fentanyl citrate and gastric acidas listed on the label. | The device is a disposabledevice intended for medicalpurposes that is worn on theexaminer's hand to preventcontamination between patientand examiner.These gloves were tested foruse with chemotherapy drugsand fentanyl citrate listed onthe label. | SimilarAdding Gastric AcidClaim |
| TechnologicalCharacteristics | The glove is a colored, nitrile,powder-free, textured fingertip,ambidextrous, patientexamination glove. | The glove is a colored, nitrile,powder-free, textured fingertip,ambidextrous, patientexamination glove. | Same |
| Sizes of gloves | XS, S, M, L, XL | XS, S, M, L, XL | Same |
| Glove Length | PureZero MARIN Nitrile Powder-Free Exam Gloves withChemotherapy Drugs, FentanylCitrate and Gastric Acid claim is9.5 inches in lengthPureZero MARIN-XTRA NitrilePowder-Free Exam Gloves withChemotherapy Drugs, FentanylCitrate and Gastric Acid claimis 12 inches in length | Halyard Purple Nitrile Powder-Free Exam Glove withChemotherapy Drugs andFentanyl Citrate is 9.5 inches inlength | SimilarAdding a longerlength glove |
| Texture | Textured fingertips | Textured fingertips | Same |
| Sterility | Non-Sterile | Non-Sterile | Same |
| Shelf Life | 5 years | N/A | Different |
| Biocompatibility | Based on ISO 10993 Biologicalevaluation of Medical devices –Test for Systemic Injection, thetest article was considered non-toxic. Meets the acceptancecriteria. | Based on ISO 10993 Biologicalevaluation of Medical devices –Test for Systemic Injection, thetest article was considered non-toxic. Meets the acceptancecriteria. | Same |
| Based on ISO 10993- Biologicalevaluation of Medical Devices –Test for Skin Irritation, the testarticle was considerednonirritating. Meets theacceptance criteria. | Based on ISO 10993- Biologicalevaluation of Medical Devices –Test for Skin Irritation, the testarticle was considerednonirritating. Meets theacceptance criteria. |
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| Performance Data for Chemotherapy Drugs | |||
|---|---|---|---|
| Standard | Results Subject Device(s)K220547PureZero MARIN Nitrile Powder-Free Exam Gloves withChemotherapy Drugs, FentanylCitrate and Gastric Acid claimPureZero MARIN-XTRA NitrilePowder-Free Exam Gloves withChemotherapy Drugs, FentanylCitrate and Gastric Acid claim | Results Predicate Device K200633Halyard Purple Nitrile Powder-FreeExam Glove with ChemotherapyDrugs and Fentanyl Citrate claim | Remarks |
| ASTM D6978-05Standard Practicefor Assessment ofResistance ofMedical Gloves toPermeation byChemotherapyDrugs | The following chemotherapydrugs and concentration had NObreakthroughdetected up to 240 minutes:Cisplatin (1 mg/ml)Cyclophosphamide (20 mg/ml)Dacarbazine (10 mg/ml)Doxorubicin HCI (2 mg/ml)Etoposide (20 mg/ml)Fluorouracil (50 mg/ml)Ifosfamide (50 mg/ml)Methotrexate (25 mg/ml)Mitomycin C (0.5 mg/ml)Mitoxantrone HCI (2 mg/ml)Paclitaxel (6 mg/ml)Vincrinstine Sulfate (1 mg/ml)Fentanyl Citrate Injection (100mcg/2 mL)Simulated Gastric AcidFluid/Fentanyl Citrate InjectionMix 50/50 SolutionThe following chemotherapydrugs and concentrationshowed breakthrough detectedin less than 90 minutes: | The following chemotherapy drugsand concentration had NObreakthroughdetected up to 240 minutes:Bleomycin (15.0 mg/ml)Busulfan (6.0 mg/ml)Carboplatin (10.0 mg/ml)Cisplatin (1.0 mg/ml)Cyclophosphamide (20.0 mg/ml)Cytarabine (100.0 mg/ml)Dacarbazine (DTIC) (10.0 mg/ml)Daunorubicin (5.0 mg/ml)Docetaxel (10.0 mg/ml)Doxorubicin Hydrochloride (2.0mg/ml)Ellence (2.0 mg/ml)Etoposide (Toposar) (20.0 mg/ml)Fludarabine (25.0 mg/ml)Fluorouracil (50.0 mg/ml)Gemcitabine (Gemzar) (38.0 mg/ml)Idarubicin (1.0 mg/ml)Ifosfamide (50.0 mg/ml)Irinotecan (20.0 mg/ml)Mechlorethamine HCl (1.0 mg/ml)Melphalan (5.0 mg/ml)Methotrexate (25.0 mg/ml)Mitomycin C (0.5 mg/ml)Mitoxantrone (2.0 mg/ml)Paclitaxel (Taxol) (6.0 mg/ml) | Similar |
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| ThioTEPA (10 mg/ml),breakthrough detected at 88.6minutesThe following chemotherapydrugs and concentrationshowed breakthrough detectedin less than 60 minutes:Carmustine (3.3 mg/ml),breakthrough detected at 55.2minutesWarning: Do not use withCarmustine or ThioTEPA | Paraplatin (10.0 mg/ml)Rituximab (10.0 mg/ml)Trisonex (1.0 mg/ml)Vincrinstine (1mg/ml)Fentanyl Citrate, 100 mcg/2mlThe following drugs showedbreakthrough detected in less than30 minutes:Carmustine (3.3mg/ml) 1.8 minutesThioTEPA (10.0mg/ml): 1.7 minutes.Warning- Not for use withCarmustine and ThioTEPA |
|---|---|
| -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Performance Data | |||
|---|---|---|---|
| ASTM D5151-06Standard TestMethod forDetection of Holesin Medical Gloves | Testing of the subject device showsit meets the 2.5% AQL requirementin the standards for leakage. Thedevice meets the acceptancecriteria of the standard. | Testing of the subject device showsit meets the 2.5% AQL requirementin the standards for leakage. Thedevice meets the acceptancecriteria of the standard. | Same |
| ASTM D6124-06Standard TestMethod for ResidualPowder on MedicalGloves | Residual powder on the subjectdevice is an average of 0.4mg/glove within the powder-freelimit of $< 2$ mg maximum powderper glove and meets theacceptance criteria for powder-free. | Residual powder on the subjectdevice is an average of 0.4 mg/glovewithin the powder-free limit of $< 2$mg maximum powder per glove andmeets the acceptance criteria forpowder- free. | Same |
| ASTM D6319-10StandardSpecification forNitrile ExaminationGloves for MedicalApplications | The physical dimensions of thesubject device are within the limitsof the standard and the physicalproperties of the subject devicemet the requirements for tensilestrength before and after aging. | The physical dimensions of thepredicate device are within thelimits of the standard and thephysical properties of the subjectdevice met the requirements fortensile strength before and afteraging. | Same |
| ISO 10993 Biologicalevaluation ofmedical devices | Meets acceptance criteria | Meets acceptance criteria | Same |
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PERFORMANCE CHARACTERISTICS OF THE SUBJECT DEVICE
| Brief descriptionof non-clinicaltests: | Test | Standard | Acceptance Criteria | Results |
|---|---|---|---|---|
| Dimensions | ASTM D 6319 | Meetsrequirements | ||
| Length | 235 -250 mm (PureZeroMARIN Nitrile) | |||
| 295- 325 mm (PureZeroMARIN-XTRA Nitrile) | ||||
| Palm Width Size | XSmall: 60 – 80 mmSmall: 70 - 90 mmMed: 85–105 mmLarge: 100 - 120 mmX-Large: 110-130 mm | |||
| Finger thicknessPalm thicknessCuff thickness | 0.10-0.19 mm0.10-0.16 mm0.10-0.13 mm | |||
| Physical Properties | ASTM D 6319 | AQL 4.0BeforeTensile Strength: ≥14 MPaUltimate elongation: ≥500%AfterTensile Strength: ≥14 MPaUltimate elongation: ≥400% | ||
| Freedom fromPinholes | ASTM D 6319ASTM D 5151 | AQL 2.5%No leakage | ||
| Power Free | ASTM D 6124ASTM D 6319 | ≤ 2 mg / glove | ||
| ISO IndirectIrritationStudy | ISO 10993, Part 10 | Primary Irritation Index≤2.0 | ||
| ISO SystemicToxicityStudy | ISO 10993, Part 11 | No animals treated withtest extracts exhibitgreater reaction thancontrol animals | No evidence ofsystemictoxicity | |
| ISO DermalSensitization | ISO 10993, Part 10 | Grade < 1 | Under theconditionsof the studythe device isnot asensitizer |
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| Conclusion: | The conclusions drawn from the nonclinical and clinical tests demonstrate that thesubject device PureZero MARIN Nitrile Powder-Free Exam Gloves with Chemotherapy |
|---|---|
| Drugs, Fentanyl Citrate and Gastric Acid claim and PureZero MARIN-XTRA Nitrile Powder- | |
| Free Exam Glove with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid claim, are as | |
| safe, as effective, and performs as well as or better than the legally marketed devices | |
| cleared under K200633. |
§ 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.