(228 days)
The Halyard Purple Nitrile, Powder-Free Exam Gloves are disposable devices intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with the following chemotherapy drugs and Fentanyl Citrate and Gastric Acid as per ASTM -D6978-05 :
The following chemotherapy drugs and concentration had NO breakthrough detected up to 240 minutes:
Azacitidine (25 mg/ml)
Bendamustine HCl (5 mg/ml)
Bleomycin Sulfate (15 mg/ml)
Bortezomib (1 mg/ml)
Busulfan (6 mg/ml)
Capecitabine (26 mg/ml)
Carboplatin (10 mg/ml)
Carlzomib (2 mg/ml)
Cetuximab (2 mg/ml)
Chloroquine (50 mg/ml)
Cisplatin (1 mg/ml)
Cladribine (1 mg/ml)
Cyclophosphamide (20 mg/ml)
Cyclosporin A (100 mg/ml)
Cytarabine (Cytosine) (100 mg/ml)
Cytovene (Ganciclovir) (10 mg/ml)
Dacarbazine (DTIC) (10 mg/ml)
Dactinomycin (0.5 mg/ml)
Daunorubicin HCl (5 mg/ml)
Decitabine (5 mg/ml)
Docetaxel (10 mg/ml)
Doxorubicin HCl (2 mg/ml)
Epirubicin HCl (Ellence) (2 mg/ml)
Etoposide (Toposar) (20 mg/ml)
Fludarabine (25 mg/ml)
5-Fluorouracil (50 mg/ml)
Fulvestrant (50 mg/ml)
Gemcitabine (38 mg/ml)
Idarubicin (1 mg/ml)
Ifosfamide (50 mg/ml)
Irinotecan HCl (20 mg/ml)
Leuprolide Acetate Salt (5 mg/ml)
Mechlorethamine HCl (1 mg/ml)
Melphalan (5 mg/ml)
Methotrexate (25 mg/ml)
Mitomycin C (0.5 mg/ml)
Mitoxantrone (2 mg/ml)
Oxaliplatin (5 mg/ml)
Paclitaxel (6 mg/ml)
Pemetrexed (25 mg/ml)
Raltitrexed (0.5 mg/ml)
Retrovir (10 mg/ml)
Rituximab (10 mg/ml)
Temsirolimus (25 mg/ml)
Topotecan HCl (1 mg/ml)
Triclosan (2 mg/ml)
Trisenox (1 mg/ml)
Vinblastine Sulfate (1 mg/ml)
Vincristine (1 mg/ml)
Vinorelbine (10 mg/ml)
Zoledronic Acid (0.8 mg/ml)
The following chemotherapy drugs and concentration showed breakthrough detected in less than 90 minutes:
Carmustine (3.3 mg/ml) No breakthrough up to 55.3 minutes.
Thiotepa (10 mg/ml) No breakthrough up to 78.8 minutes.
Warning- Not for use with Carmustine and ThioTEPA
No breakthrough was detected up to 240 minutes for Fentanyl Citrate Injection (100 mcg/2 ml) and Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution
The Halyard Purple Powder-Free Nitrile Exam Glove tested with Chemotherapy Drugs, Fentanyl Citrate and simulated Gastric Acid is a disposable, nitrile, powder-free, textured fingertip, ambidextrous, non-sterile patient examination glove that are chlorinated on the donning side and are packed in a cardboard dispenser box.
The document describes the acceptance criteria and performance data for Halyard Purple Nitrile, Powder-Free Exam Gloves, which are medical gloves, not an AI-powered device. Therefore, many of the requested categories related to AI/algorithm performance (e.g., sample size for test set provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone algorithm performance, sample size for training set, ground truth for training set) are not applicable to this submission.
The information provided pertains to the physical and chemical performance of the gloves when exposed to certain substances.
Here's a breakdown of the applicable information from the provided document, restructured to address the closest relevant aspects of your request:
1. A table of acceptance criteria and the reported device performance
| Test | Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Dimensions | ASTM D6319 | Length: 230 – 258 mm; Palm Width Size: 85 – 105 mm; Finger thickness: 0.05-0.09 mm; Palm thickness: 0.05-0.09 mm | Meets requirements |
| Physical Properties (Tensile Strength) | ASTM D6319 | Before aging: ≥14 MPa (Tensile Strength), ≥500% (Ultimate elongation); After aging: ≥14 MPa (Tensile Strength), ≥400% (Ultimate elongation) | Meets requirements |
| Freedom from Pinholes (Leakage) | ASTM D6319, ASTM D5151 | AQL 2.5%, No leakage | Meets requirements (Testing of the subject device shows it meets the 2.5% AQL requirement in the standards for leakage.) |
| Powder Free | ASTM D6124, ASTM D6319 | ≤ 2 mg / glove (maximum powder) | Meets requirements (Average of 0.4 mg/glove, within the powder-free limit) |
| ISO Indirect Irritation Study | ISO 10993, Part 10 | Primary Irritation Index ≤ 2.0 | Device is not an irritant under the study conditions. |
| ISO Systemic Toxicity Study | ISO 10993, Part 11 | No animals treated with test extracts exhibit greater reaction than control animals | No evidence of systemic toxicity. |
| ISO Dermal Sensitization | ISO 10993, Part 10 | Grade < 1 | Device is not a sensitizer under the study conditions. |
| Resistance to Permeation by Chemotherapy Drugs | ASTM D6978-05 | No breakthrough detected for up to 240 minutes for the specified drugs. | 50 chemotherapy drugs: No breakthrough detected up to 240 minutes. Carmustine (3.3 mg/ml): No breakthrough up to 55.3 minutes.Thiotepa (10 mg/ml): No breakthrough up to 78.8 minutes. (Warning: Not for use with Carmustine and ThioTEPA)Fentanyl Citrate Injection (100 mcg/2 ml): No breakthrough detected up to 240 minutes.Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution: No breakthrough detected up to 240 minutes. |
2. Sample size used for the test set and the data provenance
The document does not specify exact sample sizes for each test beyond indicating adherence to standard AQLs (Acceptable Quality Levels) for tests like leakage and powder content, which imply a defined statistical sampling plan according to the respective ASTM standards. The provenance of the data is from laboratory testing conducted by the manufacturer, O & M Halyard, Inc., in the context of a 510(k) premarket notification to the FDA. This is inherently prospective testing for a new device submission. Country of origin of the data is not explicitly stated but is implicitly tied to the submitting company (Alpharetta, Georgia, USA).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable, as this is a physical product being tested against chemical permeation and physical properties, not an AI/algorithm where expert consensus on interpretations is required for ground truth. The "ground truth" here is the objective measurement of chemical breakthrough time, physical dimensions, and material properties according to standardized laboratory protocols.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study involving human interpretation or adjudication. The tests are objective measurements.
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
Not applicable. No AI component is described in this medical device submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical product, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth used for these tests is based on objective laboratory measurements in accordance with established ASTM and ISO standards for:
- Chemical permeation (breakthrough time of specific drugs through the glove material).
- Physical properties (tensile strength, elongation, dimensions).
- Freedom from defects (pinholes, residual powder).
- Biocompatibility (irritation, systemic toxicity, sensitization).
8. The sample size for the training set
Not applicable. There is no "training set" as this is not an AI/machine learning model.
9. How the ground truth for the training set was established
Not applicable.
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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: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 1, 2022
O & M Halyard, Inc. Angela L. Bunn Director, Global Regulatory Affairs 1 Edison Drive Alpharetta, Georgia 30005
Re: K213929
Trade/Device Name: Halyard Purple Nitrile, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, OPJ, QDO Dated: June 28, 2022 Received: June 30, 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,
Clarence W. Murray, III, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: 0MB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known)
K213929
Device Name
Halyard Purple Nitrile, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, and Simulated Gastric Acid Indications for Use (Describe)
The Halvard Purple Nitrile, Powder-Free Exam Gloven intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were the following chemotherapy drugs and Fentany Citrate and Gastric Acid as per ASTM-26978-05
The following chemotherapy drugs and concentration had NO breakthrough detected up to 240 minutes: Azacitidine (25 mg/ml) Bendamustine HCl (5 mg/ml) Bleomycin Sulfate (15 mg/ml) Bortezomib (1 mg/ml) Busulfan (6 mg/ml) Capecitabine (26 mg/ml) Carboplatin (10 mg/ml) Carlzomib (2 mg/ml) Cetuximab (2 mg/ml) Chloroquine (50 mg/ml) Cisplatin (1 mg/ml) Cladribine (1 mg/ml) Cyclophosphamide (20 mg/ml) Cyclosporin A (100 mg/ml) Cytarabine (Cytosine) (100 mg/ml) Cytovene (Ganciclovir) (10 mg/ml) Dacarbazine (DTIC) (10 mg/ml) Dactinomvcin (0.5 mg/ml) Daunorubicin HCl (5 mg/ml) Decitabine (5 mg/ml) Docetaxel (10 mg/ml) Doxorubicin HCl (2 mg/ml) Epirubicin HCl (Ellence) (2 mg/ml) Etoposide (Toposar) (20 mg/ml) Fludarabine (25 mg/ml) 5-Fluorouracil (50 mg/ml) Fulvestrant (50 mg/ml) Gemcitabine (38 mg/ml) Idarubicin (1 mg/ml) Ifosfamide (50 mg/ml) Irinotecan HCl (20 mg/ml) Leuprolide Acetate Salt (5 mg/ml) Mechlorethamine HCl (1 mg/ml) Melphalan (5 mg/ml) Methotrexate (25 mg/ml) Mitomycin C (0.5 mg/ml) Mitoxantrone (2 mg/ml) Oxaliplatin (5 mg/ml) Paclitaxel (6 mg/ml) Pemetrexed (25 mg/ml) Raltitrexed (0.5 mg/ml) Retrovir (10 mg/ml) Rituximab (10 mg/ml) Temsirolimus (25 mg/ml) Topotecan HCl (1 mg/ml) Triclosan (2 mg/ml) Trisenox (1 mg/ml) Vinblastine Sulfate (1 mg/ml) Vinorelbine (10 mg/ml) Vincristine (1 mg/ml) Zoledronic Acid (0.8 mg/ml) The following chemotherapy drugs and concentration showed breakthrough detected in less than 90 minutes:
Carmustine (3.3 mg/ml) No breakthrough up to 55.3 minutes.
Thiotepa (10 mg/ml) No breakthrough up to 78.8 minutes.
Warning- Not for use with Carmustine and ThioTEPA
No breakthrough was detected up to 240 minutes for Fention (100 mg/2 ml) and Simulated Gastric Acid Fluid/Fentany Citrate hijection Mix 50/50 Solution
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
IX] Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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Image /page/4/Picture/0 description: The image shows the logo for Owens & Minor. The logo consists of the letters "OM" in a dark red color on the left side of the image. To the right of the letters is the name "Owens & Minor" in gray.
510(k) Summary
| Date Summarywas Prepared | July 28, 2022 |
|---|---|
| 510(k) Clearance Number | K213929 |
| 510(k) Submitter | O & M Halyard, Inc.1 Edison DriveAlpharetta, GA 30005 |
| Primary Contact forthis 510(k) Submission | Angela L. Bunn, RACTel: 470-364-7147Email: angela.bunn@owens-minor.com |
| Marketed Common Name | Halyard Purple Nitrile Powder-Free Exam Gloves |
| Device Submission Trade Nameand Description | Halyard Purple Nitrile, Powder-Free Exam Gloves Tested for Use withChemotherapy Drugs, Fentanyl Citrate, and Simulated Gastric Acid |
| Device Common Name | Medical Exam Gloves |
| Device Product Codeand Classification Name | LZA Class I, 21 CFR §880.6250 Patient Examination GloveOQD Class I, 21 CFR §880.6250 Fentanyl and other opioid protection gloveOPJ, Class 1, 21 CFR §880.6250 Medical Gloves With Chemotherapy LabelingClaims - Test For Use With Chemotherapy Drugs |
| Predicate Device | Halyard Purple , Powder-Free Exam Gloves Tested for Use withChemotherapy Drugs (K200633) |
| Subject Device Description | The Halyard Purple Powder-Free Nitrile Exam Glove tested withChemotherapy Drugs, Fentanyl Citrate and simulated Gastric Acid is adisposable, nitrile, powder-free, textured fingertip, ambidextrous, non-sterile patient examination glove that are chlorinated on the donning sideand are packed in a cardboard dispenser box.The devices follow consensus standards:ASTM D5151-06 Standard Test Method for Detection of Holes in MedicalGlovesASTM D6319-10 Standard Specification for Nitrile Examination Gloves forMedical ApplicationsASTM D6124-06 Standard Test Method for Residual Powder on MedicalGlovesASTM D6978-05 Standard Practice for Assessment of Resistance of MedicalGloves to Permeation by Chemotherapy DrugsISO 10993-11:2017, Biological evaluation of medical devices - Part 11: Testsfor Systemic Toxicity |
| ISO 10993-10: 2010: Biological evaluation of medical devices - Part 10: | |
| Tests for Irritation and Skin Sensitization | |
| Indications for Use | |
| The Halyard Purple Nitrile, Powder-Free Exam Gloves are disposable devices intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with the following chemotherapy drugs and Fentanyl Citrate and Gastric Acid as per ASTM -D6978-05 : | |
| The following chemotherapy drugs and concentration had NO breakthrough detected up to 240 minutes: | |
| Azacitidine (25 mg/ml) | |
| Bendamustine HCl (5 mg/ml) | |
| Bleomycin Sulfate (15 mg/ml) | |
| Bortezomib (1 mg/ml) | |
| Busulfan (6 mg/ml) | |
| Capecitabine (26 mg/ml) | |
| Carboplatin (10 mg/ml) | |
| Carlzomib (2 mg/ml) | |
| Cetuximab (2 mg/ml) | |
| Chloroquine (50 mg/ml) | |
| Cisplatin (1 mg/ml) | |
| Cladribine (1 mg/ml) | |
| Cyclophosphamide (20 mg/ml) | |
| Cyclosporin A (100 mg/ml) | |
| Cytarabine (Cytosine) (100 mg/ml) | |
| Cytovene (Ganciclovir) (10 mg/ml) | |
| Dacarbazine (DTIC) (10 mg/ml) | |
| Dactinomycin (0.5 mg/ml) | |
| Daunorubicin HCl (5 mg/ml) | |
| Decitabine (5 mg/ml) | |
| Docetaxel (10 mg/ml) | |
| Doxorubicin HCl (2 mg/ml) | |
| Epirubicin HCl (Ellence) (2 mg/ml) | |
| Etoposide (Toposar) (20 mg/ml) | |
| Fludarabine (25 mg/ml) | |
| 5-Fluorouracil (50 mg/ml) | |
| Fulvestrant (50 mg/ml) | |
| Gemcitabine (38 mg/ml) | |
| Idarubicin (1 mg/ml) | |
| Ifosfamide (50 mg/ml) | |
| Irinotecan HCl (20 mg/ml) | |
| Leuprolide Acetate Salt (5 mg/ml) | |
| Mechlorethamine HCl (1 mg/ml) | |
| Melphalan (5 mg/ml) | |
| Methotrexate (25 mg/ml) | |
| Mitomycin C (0.5 mg/ml) | |
| Mitoxantrone (2 mg/ml) | |
| Oxaliplatin (5 mg/ml) | |
| Paclitaxel (6 mg/ml) | |
| Pemetrexed (25 mg/ml) | |
| Raltitrexed (0.5 mg/ml) | |
| Retrovir (10 mg/ml) | |
| Rituximab (10 mg/ml) | |
| Temsirolimus (25 mg/ml) | |
| Topotecan HCl (1 mg/ml) | |
| Triclosan (2 mg/ml) | |
| Trisenox (1 mg/ml) | |
| Vinblastine Sulfate (1 mg/ml) | |
| Vincristine (1 mg/ml) | |
| Vinorelbine (10 mg/ml) | |
| Zoledronic Acid (0.8 mg/ml) | |
| The following chemotherapy drugs and concentration showed breakthrough detected in less than 90 minutes: | |
| Carmustine (3.3 mg/ml) No breakthrough up to 55.3 minutes. | |
| Thiotepa (10 mg/ml) No breakthrough up to 78.8 minutes. | |
| Warning- Not for use with Carmustine and ThioTEPA | |
| No breakthrough was detected up to 240 minutes for Fentanyl Citrate Injection (100 mcg/2 ml) and Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution |
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| Subject Device K213929 | Predicate Device K200633 | Comparison | |
|---|---|---|---|
| FDA Product Code | OPJ, LZA, OQD | LZC, LZA, OQD | Same |
| FDA Classification | Class I | Class I | Same |
| Regulation Number | 880.6250 | 880.6250 | Same |
| Common Name | Purple Nitrile Exam Glove | Purple Nitrile Exam Glove | Same |
| Device Trade Name | Halyard Purple Nitrile, Powder-FreeExam Gloves Tested for Use withChemotherapy Drugs, FentanylCitrate, Simulated Gastric Acid andFentanyl in Simulated Gastric Acid | Halyard Purple Nitrile, Powder-FreeExam Gloves Tested for Use withChemotherapy Drugs and FentanylCitrate | Similar |
| Intended Use | Halyard Purple Nitrile, Powder-FreeExam Gloves are disposable devicesintended for medical purposes thatis worn on the examiner's hand toprevent contamination betweenpatient and examiner.These gloves were tested for usewith chemotherapy drugs listed onthe label. | Halyard Purple Nitrile, Powder-FreeExam Gloves are disposable devicesintended for medical purposes thatis worn on the examiner's hand toprevent contamination betweenpatient and examiner.These gloves were tested for usewith chemotherapy drugs listed onthe label. | Same |
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| TechnologicalCharacteristics | The glove is a colored, nitrile,powder-free, textured fingertip,ambidextrous, patient examinationglove. | The glove is a colored, nitrile,powder-free, textured fingertip,ambidextrous, patient examinationglove. | Same |
|---|---|---|---|
| Sizes of gloves | XS, S, M, L, XL | XS, S, M, L, XL | Same |
| Texture | Textured fingertips | Textured fingertips | Same |
| Sterility | Non-Sterile | Non-Sterile | Same |
| Biocompatibility | Based ISO 10993 Biologicalevaluation of Medical devices – Testfor Systemic Injection, the testarticle was considered non-toxic.Meets the acceptance criteria.Based on ISO 10993– Biologicalevaluation of Medical Devices — Testfor Skin Irritation, the deviceextracts were not found to cause asystemic response in the animalmodel. Meets the acceptancecriteria. | Based ISO 10993 Biologicalevaluation of Medical devices –Test for Systemic Injection, the testarticle was considered non-toxic.Meets the acceptance criteria.Based on ISO 10993– Biologicalevaluation of Medical Devices -Test for Skin Irritation, the deviceextracts were not found to cause asystemic response in the animalmodel. Meets the acceptancecriteria. | Same |
| Performance Data for Chemotherapy Drugs | |||
|---|---|---|---|
| Standard | ResultsSubject Device K213929 | ResultsPredicate Devices K200633 | Remarks |
| ASTM D6978-05Standard Practice forAssessment ofResistance ofMedical Gloves toPermeation byChemotherapyDrugs | No signs of breakthrough after 4 hours for 50 chemotherapy drugs.The following drugs showed not breakthrough at 240 minutes:Azacitidine (25 mg/ml)Bendamustine HCl (5 mg/ml)Bleomycin Sulfate (15 mg/ml)Bortezomib (1 mg/ml)Busulfan (6 mg/ml)Capecitabine (26 mg/ml)Carboplatin (10 mg/ml)Carlzomib (2 mg/ml)Cetuximab (2 mg/ml)Chloroquine (50 mg/ml)Cisplatin (1 mg/ml)Cladribine (1 mg/ml)Cyclophosphamide (20 mg/ml)Cyclosporin A (100 mg/ml)Cytarabine (Cytosine) (100 mg/ml)Cytovene (Ganciclovir) (10 mg/ml)Dacarbazine (DTIC) (10 mg/ml)Dactinomycin (0.5 mg/ml) | No signs of breakthrough after 4 hours for chemotherapy drugs.The following drugs showed not breakthrough at 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 (2.0 mg/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) | Similar |
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| Daunorubicin HCl (5 mg/ml) | Ifosfamide (50.0 mg/ml) |
|---|---|
| Decitabine (5 mg/ml) | Irinotecan (20.0 mg/ml) |
| Docetaxel (10 mg/ml) | Mechlorethamine HCl (1.0 mg/ml) |
| Doxorubicin HCl (2 mg/ml) | Melphalan (5.0 mg/ml) |
| Epirubicin HCl (Ellence) (2 mg/ml) | Methotrexate (25.0 mg/ml) |
| Etoposide (Toposar) (20 mg/ml) | Mitomycin C (0.5 mg/ml) |
| Fludarabine (25 mg/ml) | Mitoxantrone (2.0 mg/ml) |
| 5-Fluorouracil (50 mg/ml) | Paclitaxel (Taxol) (6.0 mg/ml) |
| Fulvestrant (50 mg/ml) | Paraplatin (10.0 mg/ml) |
| Gemcitabine (38 mg/ml) | Rituximab (10.0 mg/ml) |
| Idarubicin (1 mg/ml) | Trisonex (1.0 mg/ml) |
| Ifosfamide (50 mg/ml) | Vincrinstine (1mg/ml) |
| Irinotecan HCl (20 mg/ml) | Fentanyl Citrate, 100 mcg/2ml |
| Leuprolide Acetate Salt (5 mg/ml) | The following drugs showedbreakthrough detected in less than30 minutes: |
| Mechlorethamine HCl (1 mg/ml) | Carmustine (3.3mg/ml) 1.8minutes |
| Melphalan (5 mg/ml) | ThioTEPA (10.0mg/ml): 1.7 minutes |
| Methotrexate (25 mg/ml) | Warning- Not for use withCarmustine and ThioTEPA. |
| Mitomycin C (0.5 mg/ml) | |
| Mitoxantrone (2 mg/ml) | |
| Oxaliplatin (5 mg/ml) | |
| Paclitaxel (6 mg/ml) | |
| Pemetrexed (25 mg/ml) | |
| Raltitrexed (0.5 mg/ml) | |
| Retrovir (10 mg/ml) | |
| Rituximab (10 mg/ml) | |
| Temsirolimus (25 mg/ml) | |
| Topotecan HCl (1 mg/ml) | |
| Triclosan (2 mg/ml) | |
| Trisenox (1 mg/ml) | |
| Vinblastine Sulfate (1 mg/ml) | |
| Vincristine (1 mg/ml) | |
| Vinorelbine (10 mg/ml) | |
| Zoledronic Acid (0.8 mg/ml) | |
| The following chemotherapy drugsand concentration showedbreakthrough detected in less than90 minutes: | |
| Carmustine (3.3 mg/ml) Nobreakthrough up to 55.3 minutes. | |
| Thiotepa (10 mg/ml) Nobreakthrough up to 78.8 minutes. | |
| Warning- Not for use withCarmustine and ThioTEPA | |
| No breakthrough was detected upto 240 minutes for Fentanyl |
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| and Simulated Gastric AcidFluid/Fentanyl Citrate InjectionMix 50/50 Solution | |||
|---|---|---|---|
| Performance Data for Hazardous Drugs (opioids) | |||
| ASTM D6978-05Standard Practice forAssessment ofResistance ofMedical Gloves toPermeation byChemotherapyDrugs | The following hazardous drugs(opioids) and concentration had NObreakthrough detected up to 240minutes:Fentanyl Citrate Injection (100mcg/2 ml)Simulated Gastric AcidFluid/Fentanyl Citrate Injection Mix50/50 Solution | The following hazardous drugs(opioids) and concentration had NObreakthrough detected up to 240minutes:Fentanyl Citrate Injection (100 mcg/2ml) | Different |
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| Performance Data | |||
|---|---|---|---|
| ASTM D5151-06Standard TestMethod forDetection of Holes inMedical Gloves | Testing of the subject device showsit meets the 2.5% AQL requirementin the standards for leakage. Thedevice meets the acceptance criteriaof the standard. | Testing of the subject device shows itmeets the 2.5% AQL requirement inthe standards for leakage. The devicemeets the acceptance criteria of thestandard. | Same |
| ASTM D6124-06Standard TestMethod for ResidualPowder on MedicalGloves | 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. | 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 |
| 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 device metthe requirements for tensilestrength before and after aging. Thesubject device also met therequirement for elongation beforeand after aging. | The physical dimensions of thesubject device are within the limits ofthe standard and the physicalproperties of the subject device metthe requirements for tensile strengthbefore and after aging. The subjectdevice also met the requirement forelongation before and after aging. | 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 | 230 – 258 mm | |||
| Palm Width Size | 85 – 105mm | |||
| Finger thickness | 0.05-0.09 mm | |||
| Palm thickness | 0.05-0.09 mm | |||
| Physical Properties | ASTM D 6319 | AQL 4.0 | Meetsrequirements | |
| BeforeTensile Strength: ≥14MPaUltimate elongation: |
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| ≥500% | |||
|---|---|---|---|
| AfterTensile 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 IrritationIndex≤ 2.0 | Under theconditions ofthestudy the device isnot an irritant |
| ISO SystemicToxicityStudy | ISO 10993, Part 11 | No animals treatedwith testextracts exhibitgreaterreaction than controlanimals | No evidence ofsystemic toxicity |
| ISO DermalSensitization | ISO 10993, Part 10 | Grade < 1 | Under theconditionsof the study thedevice is not asensitizer |
| Standard PracticeforAssessment ofResistance ofMedicalGloves toPermeationby ChemotherapyDrugs | ASTM D6978-05 | No breakthrough wasdetectedfor up to 240 minutesfor the drugs listedabove. | Acceptance criteria:No signs ofbreakthrough for thesubject device after 4hours for the testedchemotherapy drugs,FentanylCitrate Injection (100mcg/2ml), andGastric Acid. |
| Conclusion: | The conclusions drawn from the nonclinical and clinical tests demonstrate that thesubject device (Halyard Purple Nitrile, Powder-Free Exam Gloves Tested for Use withChemotherapy Drugs, Fentanyl Citrate and Gastric Acid) are as safe, as effective, andperforms 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.