SkyBreeze Zero Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. June 26, 2019 O & M Halyard, Inc. Angela Bunn Director Regulatory Affairs 5405 Windward Parkway Alpharetta, Georgia 30004 Re: K182851 Trade/Device Name: SkyBreeze Zero Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I Product Code: LZA, LZC Dated: May 23, 2019 Received: May 24, 2019 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). 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Assistant Director THT4B2: Disinfection, Reprocessing and Personal Protection Acting Assistant Director. THT4B1: Sterility Devices 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 {2}------------------------------------------------ ## Indications for Use #### 510(k) Number (if known) K182851 #### Device Name SkyBreeze Zero Nitrile Powder-Free Exam Gloves, Tested for Use with Chemotherapy Drugs #### Indications for Use (Describe) The Skybreeze Zero Nitrile Powder-Free Exam Glove is a disposable device 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: | Tested Chemotherapy Drugs and Concentration | Average Breakthrough Detection Time (Minutes) | |-------------------------------------------------|-----------------------------------------------| | • Cyclophosphamide (20.0 mg/ml) | No breakthrough up to 240 minutes | | • Doxorubicin HCl (2.0 mg/ml) | No breakthrough up to 240 minutes | | • Etoposide (20.0 mg/ml) | No breakthrough up to 240 minutes | | • 5-Fluorouracil (50.0 mg/ml) | No breakthrough up to 240 minutes | | • Paclitaxel (Taxol) (6.0 mg/ml) | No breakthrough up to 240 minutes | | • Cisplatin (1.0 mg/ml) | No breakthrough up to 240 minutes | | • Dacarbazine (10.0 mg/ml) | No breakthrough up to 240 minutes | | • Ifosfamide (50.0 mg/ml) | No breakthrough up to 240 minutes | | • Mitoxantrone (2.0 mg/ml) | No breakthrough up to 240 minutes | | • Vincristine sulfate (1.0 mg/ml) | No breakthrough up to 240 minutes | | • Carmustine (3.3 mg/ml) | No breakthrough up to 18.6 minutes | | • ThioTEPA (10.0 mg.ml) | No breakthrough up to 48.3 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) X Over-The-Counter Use (21 CFR 801 Subpart C) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Bunn, Director Regulatory Affairs<br>O & M Halyard, Inc.<br>5405 Windward Parkway, Alpharetta, GA 30004 US<br>(470) 448-5158 [voice]<br>angela.bunn@hyh.com | | Device Trade Name | SkyBreeze Zero Nitrile Powder-Free Exam Gloves, Tested for Use<br>with Chemotherapy Drugs | | Device Common Name | Medical Exam Gloves | | Device Product Code<br>and Classification Name | LZA, LZC<br>Class I, 21 CFR §880.6250<br>Patient Examination Glove | | Predicate Device | K180646<br>Halyard Lavender Nitrile Powder-Free Exam Gloves Tested for Use<br>with Chemotherapy Drugs | | Subject Device Description | The SkyBreeze Zero Nitrile Powder-Free Exam Gloves, Tested for<br>Use with Chemotherapy Drugs are disposable, blue-colored,<br>chlorinated, nitrile, powder-free, textured fingertip, ambidextrous,<br>non-sterile patient examination gloves packed in a cardboard<br>dispenser box. The Device follows consensus standards:<br>· ASTM D5151-06 Standard Test Method for Detection of Holes in<br>Medical Gloves | | | · ASTM D6319-10 Standard Specification for Nitrile Examination<br>Gloves for Medical Applications | | | · ASTM D6124-06 Standard Test Method for Residual Powder on<br>Medical Gloves | | | · ASTM D6978-05 Standard Practice for Assessment of Resistance<br>of Medical Gloves to Permeation by Chemotherapy Drugs | | | · ISO 10993-11:2017, Biological evaluation of medical devices -<br>Part 11: Tests for Systemic Toxicity | | | · ISO 10993-10: 2010: Biological evaluation of medical devices -<br>Part 10: Tests for Irritation and Skin Sensitization | | Indications for Use | The Skybreeze Zero Nitrile Powder-Free Exam Glove is a disposable device<br>intended for medical purposes that is worn on the examiner's hand to prevent<br>contamination between patient and examiner. These gloves were tested for use<br>with the following chemotherapy drugs:<br>Cyclophosphamide (20.0 mg/ml) No breakthrough up to 240 minutes Doxorubicin HCI (2.0 mg/ml) No breakthrough up to 240 minutes Etoposide (20.0 mg/ml) No breakthrough up to 240 minutes 5-Fluorouracil (50.0 mg/ml) No breakthrough up to 240 minutes Paclitaxel (Taxol) (6.0 mg/ml) No breakthrough up to 240 minutes Cisplatin (1.0 mg/ml) No breakthrough up to 240 minutes Dacarbazine (10.0 mg/ml) No breakthrough up to 240 minutes Ifosfamide (50.0 mg/ml) No breakthrough up to 240 minutes Mitoxantrone (2.0 mg/ml) No breakthrough up to 240 minutes Vincristine sulfate (1.0 mg/ml) No breakthrough up to 240 minutes Carmustine (3.3 mg/ml) No breakthrough up to 18.6 minutes ThioTEPA (10.0 mg.ml) No breakthrough up to 48.3 minutes Warning: Not for Use with: Carmustine, ThioTEPA | | Summary of comparison of<br>technological characteristics | Both the subject device and the predicate device are powder-free non-sterile<br>nitrile exam gloves tested for resistance to permeation by chemotherapy<br>drugs. | {4}------------------------------------------------ | Technological Characteristics Comparison Table | | | | |------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------| | | Subject Device | Predicate Device K180646 | Comparison | | | | | | | FDA Product Code | LZC, LZA | 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 | SkyBreeze Zero Nitrile Powder-<br>Free Exam Gloves Tested for<br>Use with Chemotherapy Drugs | Halyard Lavender Nitrile Powder-<br>Free Exam Gloves Tested for Use<br>with Chemotherapy Drugs | Similar | | Intended Use | The Skybreeze Zero Nitrile<br>Powder-Free Exam Glove is a<br>disposable device intended for<br>medical purposes that is worn on<br>the examiner's hand to prevent<br>contamination between patient<br>and examiner. These gloves<br>were tested for use with<br>chemotherapy drugs listed on the<br>label. | The Halyard Lavender Nitrile-<br>Powder-Free Exam Glove is a<br>disposable device intended for<br>medical purposes that is worn on<br>the examiner's hand to prevent<br>contamination between patient<br>and examiner. These gloves were<br>tested for use with chemotherapy<br>drugs listed on the label. | Same | | Technological<br>Characteristics | Blue-colored, 9.5-inch, 0.07 mm<br>thick at palm, nitrile, powder-free,<br>textured fingertip, ambidextrous,<br>non- sterile patient examination<br>glove. | Lavender-colored, 9.5-inch, .058<br>mm thick at palm, nitrile, powder-<br>free, textured fingertip,<br>ambidextrous, non- sterile patient<br>examination glove. | Similar | | Sizes of gloves | Extra Small (XS)<br>Small (S)<br>Medium (M)<br>Large (L)<br>Extra Large (XL) | Extra Small (XS)<br>Small (S)<br>Medium (M)<br>Large (L)<br>Extra Large (XL) | Similar<br>dimensions<br>with minor<br>differences in<br>fingers and<br>palm<br>thickness. | | Thickness at Fingers | 0.10 mm (XS)<br>0.10 mm (S)<br>0.10 mm (MS)<br>0.10 mm (L)<br>0.10 mm (XL) | 0.078 mm (XS)<br>0.078 (S)<br>0.078 mm (MS)<br>0.078 mm (L)<br>0.078 mm (XL) | thickness. | | Thickness at Palm | 0.07 mm (XS)<br>0.07 mm (S)<br>0.07 mm (M)<br>0.07 mm (L)<br>0.07 mm (XL) | 0.058 (XS)<br>0.058 (S)<br>0.058 (M)<br>0.058 (L)<br>0.058 (XL) | | | Width of Palm | 70 mm (XS)<br>80 mm (S)<br>95 mm (M)<br>110 mm (L)<br>120 mm (XL) | 70 mm (XS)<br>80 mm (S)<br>95 mm (M)<br>110 mm (L)<br>120 mm (XL) | | | Length of Palm | 240 mm (XS)<br>240 mm (S)<br>240 mm (M)<br>240 mm (L)<br>240 mm (XL) | 242 mm (XS)<br>242 mm (S)<br>242 mm (M)<br>242 mm (L)<br>242 mm (XL) | | | Texture | Textured fingertips | Textured fingertips | Same | | Sterility | Non-Sterile | Non-Sterile | Same | | Shelf life | No Shelf life is being claimed at<br>this time. | No Shelf life is being claimed at<br>this time. | Same | | Biocompatibility | Based ISO 10993 – 11 (2017)<br>Biological evaluation of Medical<br>devices - Test for Systemic<br>Toxicity, the test article was<br>considered non-toxic. | Based ISO 10993 – 11 (2017)<br>Biological evaluation of Medical<br>devices - Test for Systemic<br>Toxicity, the test article was<br>considered non-toxic. | Same | | | Based on ISO 10993 – 10<br>(2010): Under the conditions of<br>the study, not a primary skin<br>irritant;<br>Under conditions of the study,<br>not a contact sensitizer. | Based on ISO 10993 – 10 (2010):<br>Under the conditions of the study,<br>not a primary skin irritant;<br>Under conditions of the study, not<br>a contact sensitizer. | | {5}------------------------------------------------ {6}------------------------------------------------ {7}------------------------------------------------ | Performance Data | | | | |-----------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------| | Standard | Results<br>Subject Device | Results<br>K180646 | Remarks | | ASTM D6978-05<br>Standard Practice for<br>Assessment of Resistance of<br>Medical Gloves to<br>Permeation by<br>Chemotherapy Drugs | Result: Meets acceptance<br>criteria for 10 drugs. | Result: Meets acceptance<br>criteria for 10 drugs. | Similar with different<br>breakthrough times<br>for Carmustine and<br>Thiotepa. | | | No breakthrough up to 240<br>minutes: | No breakthrough up to<br>240 minutes: | | | | Cisplatin (1 mg/ml) No<br>breakthrough up to 240<br>minutes | Cisplatin (1 mg/ml) No<br>breakthrough up to 240<br>minutes | | | | Cyclophosphamide (20<br>mg/ml) No breakthrough up<br>to 240 minutes | Cyclophosphamide (20<br>mg/ml) No breakthrough<br>up to 240 minutes | | | | Dacarbazine (10 mg/ml)<br>No breakthrough up to 240<br>minutes | Dacarbazine (10 mg/ml)<br>No breakthrough up to<br>240 minutes | | | | Doxorubicin HCL (2 mg/ml)<br>No breakthrough up to 240<br>minutes | Doxorubicin HCL (2<br>mg/ml) No breakthrough<br>up to 240 minutes | | | | Etoposide (20 mg/ml) No<br>breakthrough up to 240<br>minutes | Etoposide (20 mg/ml) No<br>breakthrough up to 240<br>minutes | | | | Fluorouracil (50 mg/ml) No<br>breakthrough up to 240<br>minutes | Fluorouracil (50 mg/ml)<br>No breakthrough up to<br>240 minutes | | | | Ifosfamide (50 mg/ml) No<br>breakthrough up to 240<br>minutes | Ifosfamide (50 mg/ml) No<br>breakthrough up to 240<br>minutes | | | | Mitoxantrone (2 mg/ml) No<br>breakthrough up to 240<br>minutes | Mitoxantrone (2 mg/ml)<br>No breakthrough up to<br>240 minutes | | | | Paclitaxel (6 mg/ml) No<br>breakthrough up to 240<br>minutes | Paclitaxel (6 mg/ml) No<br>breakthrough up to 240<br>minutes | | | | Vincrinstine Sulfate (1<br>mg/ml) No breakthrough up<br>to 240 minutes | Vincrinstine Sulfate (1<br>mg/ml) No breakthrough<br>up to 240 minutes | | | | Carmustine (3.3 mg/ml)<br>showed no signs of<br>breakthrough until 18.6<br>minutes | Carmustine (3.3 mg/ml)<br>showed no signs of<br>breakthrough until 0.3<br>minutes | | | | Thiotepa (10 mg/ml)<br>showed no signs of<br>breakthrough until 48.3<br>minutes | Thiotepa (10 mg/ml)<br>showed no signs of<br>breakthrough until 30.9<br>minutes. | | | ASTM D5151-06<br>Standard Test Method for<br>Detection of Holes in Medical<br>Gloves | Testing of the subject<br>device shows it meets the<br>2.5% AQL requirement in<br>the standards for leakage.<br>The device meets the<br>acceptance criteria of the<br>standard. | Testing of the subject<br>device shows it meets the<br>2.5% AQL requirement in<br>the standards for leakage.<br>The device meets the<br>acceptance criteria of the<br>standard. | Same | | ASTM D6124-06<br>Standard Test Method for<br>Residual Powder on Medical<br>Gloves | Residual powder on the<br>subject device is an<br>average of 0.4 mg/glove<br>within the powder-free limit<br>of < 2 mg maximum<br>powder per glove and<br>meets the acceptance<br>criteria for powder- free. | Residual powder on the<br>subject device is an<br>average of 0.4 mg/glove<br>within the powder-free<br>limit of < 2 mg maximum<br>powder per glove and<br>meets the acceptance<br>criteria for powder- free. | Same | | ASTM D6319-10<br>Standard Specification for<br>Nitrile Examination Gloves for<br>Medical Applications | The physical dimensions of<br>the subject device are<br>within the limits of the<br>standard and the physical<br>properties of the subject<br>device meet the<br>requirements for tensile<br>strength with an average<br>before aging of 26.17 MPa<br>and after aging of 34.37<br>MPa and elongation of<br>580% before aging and<br>554% after aging. | The physical dimensions<br>of the predicate device<br>are within the limits of the<br>standard and the physical<br>properties meet the<br>requirements for tensile<br>strength with an average<br>before aging of 30.56<br>MPa and after aging of<br>37.53 MPa and elongation<br>of 593% before aging and<br>533% after aging. | Similar | | Conclusion: | The conclusions drawn from the nonclinical tests demonstrate that the proposed<br>device is as safe, as effective, and performs as well as or better than the legally<br>marketed predicated device. | | | {8}------------------------------------------------