(97 days)
The PureZero LIMON Nitrile Powder-Free Exam Gloves with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid claim and PureZero LIMON-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 87.6 minutes
Carmustine (3.3 mg/ml), breakthrough detected at 34.3 minutes
Warning: Not for Use With: Carmustine, ThioTEPA
The subject device is a green colored, chlorinated, nitrile, powder-free, textured fingertip, ambidextrous, patient examination gloves.
This document, K220541, is a 510(k) Premarket Notification from the FDA regarding "PureZero LIMON Nitrile Powder-Free Exam Gloves" and "PureZero LIMON-XTRA Nitrile Powder-Free Exam Gloves." It focuses on the substantial equivalence of these gloves to a predicate device and their resistance to permeation by various substances.
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:
Important Note: This document describes the testing performed for medical gloves to demonstrate their chemical resistance and physical properties, rather than an AI/ML powered medical device. Therefore, questions 2, 3, 4, 5, 8, and 9, which apply specifically to AI/ML device studies (test set sample size, data provenance, expert adjudication, MRMC studies, training set details), are not directly applicable to this document's content.
1. Table of Acceptance Criteria and Reported Device Performance
The document presents several key performance metrics for the gloves, tested against specific ASTM and ISO standards.
| Test | Standard(s) | Acceptance Criteria | Reported Device Performance (Subject Device) |
|---|---|---|---|
| Resistance to Permeation by Chemotherapy Drugs, Fentanyl Citrate, and Gastric Acid | ASTM D6978-05 | For "NO Breakthrough detected up to 240 minutes": Cisplatin (1 mg/ml), Cyclophosphamide (20 mg/ml), Dacarbazine (10 mg/ml), Doxorubicin HCl (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 HCl (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. For "breakthrough detected in less than 90 minutes": ThioTEPA (10 mg/ml), Carmustine (3.3 mg/ml). (Note: Specific breakthrough times would be the acceptance criteria for these, implied to be under 90 minutes, with a warning not to use for these specific chemicals). | PureZero LIMON / LIMON-XTRA Gloves: • 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), Vincrinstine 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 87.6 minutes, Carmustine (3.3 mg/ml) at 34.3 minutes. • Warning: Not for Use With: Carmustine or ThioTEPA. |
| Detection of Holes (Leakage) | ASTM D5151-06, ASTM D6319 | 2.5% AQL (Acceptable Quality Level) (or implied to meet this general glove standard), No leakage. | Testing shows it meets the 2.5% AQL requirement in the standards for leakage. The device meets the acceptance criteria of the standard. |
| Residual Powder | ASTM D6124-06, ASTM D6319 | < 2 mg maximum powder per glove. | Residual powder is an average of 0.4 mg/glove, which is within the powder-free limit of < 2 mg, meeting acceptance criteria. |
| Physical Dimensions and Properties (Tensile Strength, Elongation) | ASTM D6319-10 | Dimensions: • Length: 235-250 mm (PureZero LIMON), 295-325 mm (PureZero LIMON-XTRA)• Palm Width: XSmall: 60-80 mm, Small: 70-90 mm, Med: 85-105 mm, Large: 100-120 mm, X-Large: 110-130 mm• Finger thickness: 0.10-0.19 mm• Palm thickness: 0.10-0.16 mm• Cuff thickness: 0.10-0.13 mmPhysical Properties:• Before Aging: Tensile Strength: ≥14 MPa, Ultimate elongation: ≥500%• After Aging: Tensile Strength: ≥14 MPa, Ultimate elongation: ≥400% | The physical dimensions of the subject device are within the limits of the standard. The physical properties met the requirements for tensile strength before and after aging. (Results: Meets requirements for dimensions and physical properties). |
| Biocompatibility - Systemic Toxicity | ISO 10993-11 | No animals treated with test extracts exhibit greater reaction than control animals. | No evidence of systemic toxicity. Meets acceptance criteria. The test article was considered non-toxic. |
| Biocompatibility - Irritation (Skin) | ISO 10993-10 | Primary Irritation Index ≤ 2.0. | Under the conditions of the study, the device is not an irritant. Meets acceptance criteria. The test article was considered nonirritating. |
| Biocompatibility - Sensitization (Skin) | ISO 10993-10 | Grade < 1. | Under the conditions of the study, the device is not a sensitizer. Meets acceptance criteria. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample sizes for each specific test (e.g., number of gloves tested for permeation, number of gloves for physical properties). However, it refers to standard testing methods (ASTM and ISO), which typically specify minimum sample sizes for statistical validity. The provenance of the data is not mentioned in terms of country of origin or whether it was retrospective or prospective. Given the nature of physical product testing, it would be prospective laboratory testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable. The device is a physical barrier (glove), not an AI/ML diagnostic or image interpretation tool. Ground truth is established through standardized laboratory tests measuring physical and chemical properties as per ASTM and ISO guidelines, not through expert human interpretation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This question is not applicable. Adjudication methods are relevant for subjective interpretations (e.g., medical image reads), not for objective physical and chemical testing of a medical device like a glove.
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 question is not applicable. This is not an AI-powered device, nor is it a device that directly assists human readers in medical interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable. This device is a physical product (glove), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for this device's performance is established by standardized laboratory testing procedures and industry consensus standards (ASTM and ISO). These standards define the methodologies and acceptable performance thresholds for properties like chemical permeation, physical dimensions, tensile strength, and biocompatibility. For example:
- Chemical Permeation: Breakthrough time is objectively measured using analytical techniques.
- Hole Detection: Based on a quantitative water leak test.
- Physical Properties: Measured using calibrated equipment (e.g., tensile tester for strength and elongation, calipers for dimensions).
- Biocompatibility: In-vitro or in-vivo biological assays with defined endpoints.
8. The sample size for the training set
This question is not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
This question is not applicable. This is not an AI/ML device that requires a training set.
{0}------------------------------------------------
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.
June 2, 2022
೦&M Halyard, Inc. Angela Bunn Director. Global Regulatory Affairs 1 Edison Drive Alpharetta, Georgia 30005
Re: K220541
Trade/Device Name: PureZero LIMON Nitrile Powder-Free Exam Gloves, PureZero LIMON-XTRA Nitrile Powder-Free Exam Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: 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
{1}------------------------------------------------
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Bifeng Oian, 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 Ouality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known)
K220541
Device Name
The PureZero LIMON Nitrile Powder-Free Exam Gloves with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid claim and PureZero LIMON-XTRA Nitrile Powder-Free Exam Gloves
Indications for Use (Describe)
The PureZero LIMON Nitrile Powder-Free Exam Gloves with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid claim and PureZero LIMON-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 87.6 minutes
Carmustine (3.3 mg/ml), breakthrough detected at 34.3 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)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
{3}------------------------------------------------
{4}------------------------------------------------
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{5}------------------------------------------------
510(k) Summary
K220541
| Date Summarywas Prepared | February 10, 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 LIMON Nitrile Powder-Free Exam Gloves with Chemotherapy Drugs,Fentanyl Citrate and Gastric Acid claim |
| PureZero LIMON-XTRA Nitrile Powder-Free Exam Gloves with ChemotherapyDrugs, Fentanyl Citrate and Gastric Acid claim | |
| Device Common Name | Patient Examination 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 Sterling* Nitrile Powder-Free Exam Glove with Chemotherapy Drugand Fentanyl Citrate Claim (K191230) |
| Subject Device Description | The subject device is a green colored, chlorinated, nitrile, powder-free,textured fingertip, ambidextrous, patient examination gloves. The devicesfollow consensus standards:ASTM D5151-06 Standard Test Method for Detection of Holes in MedicalGloves |
| ASTM D6319-10 Standard Specification for Nitrile Examination Gloves forMedical Applications | |
| ASTM D6124-06 Standard Test Method for Residual Powder on MedicalGloves | |
| ASTM D6978-05 Standard Practice for Assessment of Resistance of MedicalGloves to Permeation by Chemotherapy Drugs | |
| ISO 10993-11:2017, Biological evaluation of medical devices - Part 11:Tests for Systemic Toxicity | |
| ISO 10993-10: 2010: Biological evaluation of medical devices - Part 10: | |
| Indications for Use | Tests for Irritation and Skin SensitizationThe PureZero LIMON Nitrile Powder-Free Exam Gloves with ChemotherapyDrugs, Fentanyl Citrate and Gastric Acid claim and PureZero LIMON-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 87.6 minutesCarmustine (3.3 mg/ml), breakthrough detected at 34.3 minutesWarning: Not for Use With: Carmustine or ThioTEPA |
{6}------------------------------------------------
| Technological Characteristics Comparison Table | |||
|---|---|---|---|
| Subject DeviceK220541 | Predicate DeviceHalyard Sterling* NitrilePowder-Free Exam GloveK191230 | Comparison | |
| FDA Product Code | LZC, LZA, QDO | LZC | Added LZA andQDO for theFentanyl Claim |
| FDA Classification | Class I | Class I | Same |
| Regulation Number | 880.6250 | 880.6250 | Same |
| Common Name | Patient Examination Glove | Patient Examination Glove | Same |
{7}------------------------------------------------
| Device Trade Name | PureZero LIMON Nitrile Powder-Free Exam Gloves withChemotherapy Drugs, FentanylCitrate and Gastric Acid claimPureZero LIMON-XTRA NitrilePowder-Free Exam Gloves withChemotherapy Drugs, FentanylCitrate and Gastric Acid claim | Halyard Sterling* NitrilePowder-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 LIMON Nitrile Powder-Free Exam Gloves withChemotherapy Drugs, FentanylCitrate and Gastric Acid claim is9.5 inches in lengthPureZero LIMON-XTRA NitrilePowder-Free Exam Gloves withChemotherapy Drugs, FentanylCitrate and Gastric Acid claimis 12 inches in length | Halyard Sterling* NitrilePowder-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 | 3-year | None | Different |
| Biocompatibility | Based ISO 10993-11 Biologicalevaluation of Medical devices -Test for Systemic Toxicity, thetest article was considered non-toxic. Meets the acceptancecriteria. | Based ISO 10993-11 Biologicalevaluation of Medical devices -Test for Systemic Toxicity, thetest article was considered non-toxic. Meets the acceptancecriteria. | Same |
| Based on ISO 10993-10Biological evaluation of MedicalDevices - Test for SkinIrritation, the test article wasconsidered nonirritating. Meetsthe acceptance criteria. | Based on ISO 10993-10Biological evaluation of MedicalDevices - Test for SkinIrritation, the test article wasconsidered nonirritating. Meetsthe acceptance criteria. | ||
| Based on ISO 10993-10Biological evaluation of MedicalDevices - Test for SkinSensitization. Under theconditions of the studythe device is not a sensitizer.Meets the acceptance criteria. | Based on ISO 10993-10Biological evaluation of MedicalDevices - Test for SkinSensitization. Under theconditions of the studythe device is not a sensitizer.Meets the acceptance criteria. |
{8}------------------------------------------------
{9}------------------------------------------------
| Standard | Results Subject Device(s) | Results Predicate Device K191230 | Remarks |
|---|---|---|---|
| Standard | PureZero LIMON Nitrile Powder-Free Exam Gloves withChemotherapy Drugs, FentanylCitrate and Gastric Acid claimPureZero LIMON-XTRA NitrilePowder-Free Exam Gloves withChemotherapy Drugs, FentanylCitrate and Gastric Acid claim | Halyard Sterling* Nitrile Powder-Free Exam Glove withChemotherapy Drugs and FentanylCitrate claim | |
| ASTM D6978-05Standard Practicefor Assessment ofResistance ofMedical Gloves toPermeation byChemotherapyDrugs | The following chemotherapy drugsand 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 (100 mcg/2 mL)Simulated Gastric AcidFluid/Fentanyl Citrate InjectionMix 50/50 Solution | The following chemotherapy drugsand concentration had NObreakthroughdetected up to 240 minutes:Arsenic Trioxide (1 mg/ml)Doxorubicin HCL (2 mg/ml)Paclitaxel (6 mg/ml)Azacitidine (Vidaza) (25 mg/ml)Epirubicin (Ellence) (2 mg/ml)Paraplatin (10 mg/ml)Bendamustine (5 mg/ml)Eribulin Mesylate (0.5 mg/ml)Pemetrexed (25 mg/ml)Bortezomib (Velcade) (1 mg/ml)Etoposide (20 mg/ml)Pertuzumab (30 mg/ml)Bleomycin sulfate (15 mg/ml)Fludarabine (25 mg/ml)Raltitrexed (0.5 mg/ml)Busulfan (6 mg/ml)Fluorouracil (50 mg/ml)Retrovir (10 mg/ml)Carboplatin (10 mg/ml)Fulvestrant (50 mg/ml)Rituximab (10 mg/ml)Carfilzomib (2 mg/ml)Gemcitabine (38 mg/ml)Temsirolimus (25 mg/ml)Cetuximab (Erbitux) (2 mg/ml)Idarubicin (1 mg/ml)Trastuzumab (21 mg/ml)Cisplatin (1 mg/ml)Ifosfamide (50 mg/ml) | Similar |
| The following chemotherapy drugsand concentration showedbreakthrough detected in less than90 minutes:ThioTEPA (10 mg/ml), breakthroughdetected at 87.6 minutesCarmustine (3.3 mg/ml),breakthrough detected at 34.3minutes. |
{10}------------------------------------------------
| Cyclophosphamide (20 mg/ml) | |
|---|---|
| Irinotecan (20 mg/ml) | |
| Triclosan (2 mg/ml) | |
| Cytarabine HCL (100 mg/ml) | |
| Mechlorethamine HCL (1 mg/ml) | |
| Trisonex (1 mg/ml) | |
| Cytovene (10 mg/ml) | |
| Melphalan (5 mg/ml) | |
| Vincrinstine Sulfate (1 mg/ml) | |
| Dacarbazine (10 mg/ml) | |
| Methotrexate (25 mg/ml) | |
| Vinblastine (1 mg/ml) | |
| Daunorubicin HCL (5 mg/ml) | |
| Mitomycin-C (0.5 mg/ml) | |
| Vinorelbine (10 mg/ml) | |
| Decitabine (5 mg/ml) | |
| Mitoxantrone (2 mg/ml) | |
| Zoledronic Acid (0.8 mg/ml) | |
| Docetaxel (10 mg/ml) | |
| Oxaliplatin (2 mg/ml) | |
| ThioTEPA (10 mg/ml), breakthroughdetected at 37.1 minutes | |
| Carmustine (3.3 mg/ml),breakthrough detected at 22.9minutes |
| 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 < 2mg maximum powder per glove andmeets the acceptance criteria forpowder- free. | Same |
{11}------------------------------------------------
| 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 |
performance characteristics of the subject device
| Brief descriptionof non-clinicaltests: | Test | Standard | Acceptance Criteria | Results |
|---|---|---|---|---|
| Dimensions | ASTM D 6319 | Meetsrequirements | ||
| Length | 235 -250 mm (PureZeroLIMON Nitrile) | |||
| Palm Width Size | 295- 325 mm (PureZeroLIMON-XTRA Nitrile)XSmall: 60 – 80 mmSmall: 70 - 90 mmMed: 85–105 mmLarge: 100 - 120 mmX-Large: 110-130 mm | |||
| Finger thickness | 0.10-0.19 mm | |||
| Palm thickness | 0.10-0.16 mm | |||
| Cuff thickness | 0.10-0.13 mm | |||
| Physical Properties | ASTM D 6319 | AQL 4.0BeforeTensile Strength: ≥14MPaUltimate elongation:≥500%After | Meetsrequirements | |
{12}------------------------------------------------
| Tensile Strength: ≥14 MPaUltimate elongation: ≥400% | |||
|---|---|---|---|
| Freedom fromPinholes | ASTM D 6319ASTM D 5151 | AQL 2.5%No leakage | Meetsrequirements |
| Power Free | ASTM D 6124ASTM D 6319 | ≤ 2 mg / glove | Meetsrequirements |
| ISO IndirectIrritationStudy | ISO 10993, Part 10 | Primary Irritation Index≤ 2.0 | Under theconditions ofThe study thedevice is notan irritant |
| 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 |
| Conclusion: | The conclusions drawn from the nonclinical tests demonstrate that the subject devicePureZero LIMON Nitrile Powder- Free Exam Gloves with Chemotherapy Drugs, FentanylCitrate and Gastric Acid claim and PureZero LIMON-XTRA Nitrile Powder-Free Exam Gloveswith 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 clearedunder K191230. |
|---|---|
| ------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
§ 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.