(119 days)
The Halyard Lavender Nitrile, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and Fentany1 Citrate 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 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 60 minutes: Carmustine (3.3 mg/ml) No breakthrough up to 0.3 minutes. Thiotepa (10 mg/ml) No breakthrough up to 30.9 minutes.
The following hazardous drugs (opioids) and concentration had NO breakthrough detected up to 240 minutes: Fentanyl Citrate Injection (100 mcg/2 ml)
Warning: Not for Use With: Carmustine, ThioTEPA
Halyard Lavender Nitrile, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate are disposable, lavender colored, chlorinated, nitrile, powder-free, textured fingertip, ambidextrous, patient examination gloves.
Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) summary:
Device: Halyard Lavender Nitrile, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Regulatory Class: Class I (Non-Powdered Patient Examination Glove, Specialty; Fentanyl and other opioid protection glove)
Study Design Overview:
This appears to be a non-clinical performance study focusing on the physical characteristics and chemical permeation resistance of the gloves. It is a comparative study against a previously cleared predicate device (Halyard Lavender, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs). The primary method used for evaluating chemical permeation was ASTM D6978-05.
1. Table of Acceptance Criteria & Reported Device Performance
| Test/Characteristic | Standard | Acceptance Criteria | Reported Device Performance and Remarks |
|---|---|---|---|
| Chemical Permeation | ASTM D6978-05 | No breakthrough detected for up to 240 minutes for listed drugs. | Chemotherapy Drugs (NO Breakthrough 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)Chemotherapy Drugs (Breakthrough < 60 minutes, with specific breakthrough times): Carmustine (3.3 mg/ml) - No breakthrough up to 0.3 minutes. Thiotepa (10 mg/ml) - No breakthrough up to 30.9 minutes.Hazardous Drugs (Opioids) (NO Breakthrough up to 240 minutes): Fentanyl Citrate Injection (100 mcg/2 ml)Warning: Not for Use With: Carmustine, ThioTEPA. The device meets the acceptance criteria for those drugs where no breakthrough was detected for up to 240 minutes and explicitly warns for those with early breakthrough. |
| Dimensions | ASTM D6319 | Length: 295 – 325 mmPalm Width (Sizes XS-XL): 60 – 130 mm (range)Finger thickness: 0.10-0.19 mmPalm thickness: 0.10-0.16 mmCuff thickness: 0.10-0.13 mm | Meets requirements. (Specific values not provided in this summary, but stated as meeting standard). |
| Physical Properties | ASTM D6319 | AQL 4.0Before Aging: Tensile Strength: ≥14 MPa, Ultimate elongation: ≥500%After Aging: Tensile Strength: ≥14 MPa, Ultimate elongation: ≥400% | Meets requirements. The physical properties met the requirements for tensile strength and elongation before and after aging. |
| Freedom from Pinholes | ASTM D6319, ASTM D5151 | AQL 2.5%, No leakage | Meets requirements. Testing showed it meets the 2.5% AQL requirement in the standards for leakage. |
| Powder Free | ASTM D6124, ASTM D6319 | ≤ 2 mg / glove | Meets requirements. Residual powder was an average of 0.4 mg/glove, which is within the powder-free limit. |
| Biocompatibility (Irritation) | ISO 10993, Part 10 | Primary Irritation Index ≤ 2.0 | Meets acceptance criteria. Under the conditions of the study, the device is not an irritant. |
| Biocompatibility (Systemic Toxicity) | ISO 10993, Part 11 | No animals treated with test extracts exhibit greater reaction than control animals. | Meets acceptance criteria. No evidence of systemic toxicity under the conditions of the study. |
| Biocompatibility (Dermal Sensitization) | ISO 10993, Part 10 | Grade < 1 | Meets acceptance criteria. Under the conditions of the study, the device is not a sensitizer. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not explicitly state the specific sample sizes (number of gloves or individual tests) for each test. However, it references conformity to various ASTM and ISO standards (e.g., ASTM D6978-05, ASTM D5151-06, ASTM D6319-10, ISO 10993 parts 10 and 11), which implicitly define the required sample sizes for such tests.
- Data Provenance: The data appears to be from non-clinical, prospective laboratory testing conducted by the manufacturer (O & M Halyard, Inc.) to demonstrate compliance with recognized industry standards for medical gloves. The country of origin of the data is not explicitly stated but is implicitly associated with the manufacturer's location (Alpharetta, Georgia, USA), and the testing would adhere to international standards (ASTM, ISO).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- This detailed information is not provided in the 510(k) summary. For non-clinical performance and biocompatibility studies of this type (testing against standard specifications), "experts" in the traditional sense of clinical adjudication are not typically involved. The "ground truth" is established by the standardized test methods themselves and the specified acceptance criteria. The lab personnel conducting the tests would be qualified per the relevant test standards (e.g., trained technicians, chemists, biologists).
4. Adjudication Method for the Test Set:
- None in the sense of clinical image review or multi-reader evaluation. The ground truth is determined directly by the quantitative and qualitative results of the standardized physical, chemical, and biological tests as per the ASTM and ISO standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC study was not done. This device is a medical glove, and its performance evaluation relates to physical, chemical, and biological properties, not diagnostic or interpretive clinical effectiveness by human readers. Therefore, an MRMC study is not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, a "standalone" performance evaluation was done in the sense that the glove's resistance to chemical permeation and its physical/biological properties were tested directly, independent of human interaction during clinical use for the purpose of the test. The "algorithm" here is the glove itself and its material properties, tested in a laboratory setting.
7. The Type of Ground Truth Used:
- The ground truth is based on objective, standardized laboratory test results as defined by:
- Consensus Standards: ASTM D6978-05 (chemical permeation), ASTM D5151-06 (pinholes), ASTM D6319-10 (physical properties, dimensions, powder), and ISO 10993 parts 10 and 11 (biocompatibility).
- Predefined Acceptance Criteria specified in these standards (e.g., breakthrough time, AQL levels, mechanical property thresholds, irritation indices).
8. The Sample Size for the Training Set:
- Not applicable. This submission is for a physical medical device (gloves), not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The "development" of the glove material and design would have involved iterative testing and refinement, but this is distinct from an AI training set.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable (as explained in point 8).
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January 7, 2021
O & M Halyard, Inc. Steven Dowdley Associate Director 1 Edison Drive Alpharetta, Georgia 30005
Re: K202622
Trade/Device Name: Halyard Lavender, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, Product Code: LZC, LZA, QDO Dated: December 4, 2020 Received: December 10, 2020
Dear Steven Dowdley:
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.
For: Elizabeth F. Claverie-Williams, MS 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) K202622
Device Name
Halyard Lavender Nitrile, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Indications for Use (Describe)
The Halyard Lavender Nitrile, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and Fentany1 Citrate 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 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)
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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 60 minutes: Carmustine (3.3 mg/ml) No breakthrough up to 0.3 minutes. Thiotepa (10 mg/ml) No breakthrough up to 30.9 minutes.
The following hazardous drugs (opioids) and concentration had NO breakthrough detected up to 240 minutes: Fentanyl Citrate Injection (100 mcg/2 ml)
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)
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510(k) Summary for K202622 Halyard Lavender Nitrile, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
| Date Summarywas Prepared | December 4, 2020 | ||
|---|---|---|---|
| 510(k) Submitter | O & M Halyard, Inc.1 Edison DriveAlpharetta, GA 30005 | ||
| Primary Contact forthis 510(k) Submission | Steven Dowdley, RACTel: 678-451-8062Email: steven.dowdley@hyh.com | ||
| Marketed Common Name | Halyard Lavender Nitrile Powder-Free Exam Gloves | ||
| Device Submission Trade Nameand Description | Halyard Lavender Nitrile, Powder-Free Exam Gloves Tested for Use | ||
| 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, Specialty;QDO Class I, 21 CFR §880.6250 Fentanyl and other opioid protection glove | ||
| Predicate Device | Halyard Lavender, Powder-Free Exam Gloves Tested for Use withChemotherapy Drugs (K180646) | ||
| Subject Device Description | Halyard Lavender Nitrile, Powder-Free Exam Gloves Tested for Use withChemotherapy Drugs and Fentanyl Citrate are disposable, lavender colored,chlorinated, nitrile, powder-free, textured fingertip, ambidextrous, patientexamination gloves. 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:Tests for Systemic ToxicityISO 10993-10: 2010: Biological evaluation of medical devices - Part 10:Tests for Irritation and Skin Sensitization | ||
| for medical purposes that is worn on the examiner's hand to preventcontamination between patient and examiner. These gloves were tested foruse with the following chemotherapy drugs and Fentanyl Citrate as per ASTM-D6978-05 :The following chemotherapy drugs and concentration had NO breakthroughdetected 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) | Indications for Use | The Halyard Lavender Nitrile, Powder-Free Exam Gloves Tested for Use withChemotherapy Drugs and Fentanyl Citrate are disposable devices intended | |
| 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 breakthroughdetected in less than 60 minutes: | |||
| Carmustine (3.3 mg/ml) No breakthrough up to 0.3 minutes. | |||
| Thiotepa (10 mg/ml) No breakthrough up to 30.9 minutes. | |||
| The following hazardous drugs (opioids) and concentration had NObreakthrough detected up to 240 minutes: | |||
| Fentanyl Citrate Injection (100 mcg/2 ml) | |||
| Warning: Do not use with Carmustine or Thiotepa. | |||
| Technological Characteristics Comparison Table | |||
| Subject Device K202622 | Predicate Device K180646 | Comparison | |
| FDA Product Code | LZC, LZA, QDO | LZC, LZA | Same |
| 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 | Halyard Lavender Nitrile, Powder-Free Exam Gloves Tested for Usewith Chemotherapy Drugs andFentanyl Citrate | Halyard Lavender, Powder-FreeExam Gloves Tested for Use withChemotherapy Drugs | |
| Intended Use | Halyard Lavender Nitrile, Powder-Free Exam Gloves Tested for Usewith Chemotherapy Drugs andFentanyl Citrate are disposabledevices intended for medicalpurposes that is worn on theexaminer's hand to preventcontamination between patientand examiner.These gloves were tested for usewith chemotherapy drugs listed onthe label. | The Halyard Lavender, Powder-Free Exam Gloves Tested for Usewith Chemotherapy Drugs aredisposable device intended formedical purposes that is worn onthe examiner's hand to preventcontamination between patientand examiner.These gloves were tested for usewith chemotherapy drugs listedon the label. | Same |
| 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, patientexamination glove. | 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 –Test for Systemic Injection, the testarticle was considered non-toxic.Meets the acceptance criteria. | Based 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 deviceextracts were not found to cause asystemic response in the animalmodel. Meets the acceptancecriteria. | 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. | ||
| Performance Data for Chemotherapy Drugs | |||
| Standard | ResultsSubject Devices | ResultsPredicate Devices K180646 | Remarks |
| ASTM D6978-05Standard Practicefor Assessment ofResistance ofMedical Gloves toPermeation byChemotherapyDrugs | The following chemotherapy drugsand concentration had NObreakthroughdetected 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)Car-lzomib (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) | The following chemotherapy drugsand concentration had NObreakthroughdetected up to 240 minutes:• Cyclophosphamide (20.0 mg/ml) Nobreakthrough up to 240 minutes• Doxorubicin HCl (2.0 mg/ml) Nobreakthrough up to 240 minutes• Etoposide (20.0 mg/ml) Nobreakthrough up to 240 minutes• 5-Fluorouracil (50.0 mg/ml) Nobreakthrough up to 240 minutes• Paclitaxel (Taxol) (6.0 mg/ml) Nobreakthrough up to 240 minutes• Cisplatin (1.0 mg/ml) Nobreakthrough up to 240 minutes• Dacarbazine (10.0 mg/ml) Nobreakthrough up to 240 minutes• Ifosfamide (50.0 mg/ml) Nobreakthrough up to 240 minutes• Mitoxantrone (2.0 mg/ml) Nobreakthrough up to 240 minutes• Vincristine sulfate (1.0 mg/ml) Nobreakthrough up to 240 minutes• Carmustine (3.3 mg/ml) Nobreakthrough up to 0.3 minutes• ThioTEPA (10.0 mg.ml) Nobreakthrough up to 30.9 minutesWarning: Not for Use With:Carmustine, ThioTEPA | Similar |
| 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 than60 minutes:Carmustine (3.3 mg/ml) Nobreakthrough up to 0.3 minutes.Thiotepa (10 mg/ml) Nobreakthrough up to 30.9 minutes. | |||
| Performance Data for Hazardous Drugs (opioids) | |||
| ASTM D6978-05Standard Practicefor Assessment ofResistance ofMedical Gloves toPermeation byChemotherapyDrugs | The following hazardous drugs(opioids) and concentration had NObreakthrough detected up to 240minutes:Fentanyl Citrate Injection (100mcg/2 ml) | Not Tested | Different |
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| Performance Data | Same | ||
|---|---|---|---|
| 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 |
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| 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 subject device also met therequirement for elongation beforeand after aging. | 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. | Same |
|---|---|---|---|
| ISO 10993 Biologicalevaluation ofmedical devices | Meets acceptance criteria | Meets acceptance criteria | Same |
PERFORMANCE CHARACTERISTICS OF THE SUBJECT DEVICE
| PERFORMANCE CHARACTERISTICS OF THE SUBJECT DEVICEBrief descriptionof non-clinicaltests: | Test | Standard | Acceptance Criteria | Results |
|---|---|---|---|---|
| Dimensions | ASTM D 6319 | Meetsrequirements | ||
| Length | 295 – 325 mm | |||
| Palm Width Size | XSmall: 60 – 80 mmSmall: 70 - 90 mmMed: 85–105 mmLrge: 100 - 120 mmX-Lrge: 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 4.0 | Meetsrequirements | |
| BeforeTensile Strength: $≥14$ MPaUltimate elongation: $≥500%$ | ||||
| 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 |
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| ISO SystemicToxicityStudy | ISO 10993, Part 11 | No animals treatedwith testextractsexhibit greaterreaction 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 50chemotherapy drugs.And for FentanylCitrate Injection (100mcg/2ml) | |
| Conclusion: | The conclusions drawn from the nonclinical and clinical tests demonstrate that thesubject device (Halyard Lavender Nitrile, Powder-Free Exam Gloves Tested for Use withChemotherapy Drugs and Fentanyl Citrate) are as safe, as effective, and performs as wellas or better than the legally marketed devices cleared under K180646. |
§ 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.