(119 days)
Not Found
No
The device is a physical medical glove and the summary focuses on its material properties and resistance to chemicals, with no mention of software, algorithms, or data processing.
No
This device, Halyard Lavender Nitrile, Powder-Free Exam Gloves, is intended to prevent contamination between patient and examiner and protect the examiner from certain chemotherapy drugs and fentanyl citrate. It is a barrier device for protection and does not provide therapy or treatment for a disease or condition.
No
Explanation: The device is an exam glove intended to prevent contamination. It does not diagnose any condition or disease.
No
The device is a physical glove, not software. The description details its material, physical properties, and testing against chemical permeation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the gloves are "disposable devices intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner." This describes a barrier device used for protection during medical examinations.
- IVD Definition: An In Vitro Diagnostic device is defined as a medical device that is used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Lack of Diagnostic Function: The description of the gloves and their testing focuses on their barrier properties and resistance to permeation by certain drugs. There is no mention of the gloves being used to analyze samples or provide diagnostic information about a patient's health.
The testing for chemotherapy drugs and Fentanyl Citrate is related to the safety and performance of the barrier function of the gloves when exposed to these substances, not for diagnosing anything.
N/A
Intended Use / Indications for Use
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
Product codes (comma separated list FDA assigned to the subject device)
LZC, LZA, QDO
Device Description
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. The devices follow consensus standards: ASTM D5151-06 Standard Test Method for Detection of Holes in Medical Gloves ASTM D6319-10 Standard Specification for Nitrile Examination Gloves for Medical Applications ASTM D6124-06 Standard Test Method for Residual Powder on Medical Gloves ASTM D6978-05 Standard Practice for Assessment of Resistance of Medical Gloves 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: Tests for Irritation and Skin Sensitization
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
ASTM D6978-05 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs:
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), 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), 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).
ASTM D5151-06 Standard Test Method for Detection of Holes in Medical Gloves:
Testing of the subject device shows it meets the 2.5% AQL requirement in the standards for leakage. The device meets the acceptance criteria of the standard.
ASTM D6124-06 Standard Test Method for Residual Powder on Medical Gloves:
Residual powder on the subject device is an average of 0.4 mg/glove within the powder-free limit of
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a sans-serif font.
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.
1
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
2
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)
3
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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4
510(k) Summary for K202622 Halyard Lavender Nitrile, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
| Date Summary
| was Prepared | December 4, 2020 | ||
|---|---|---|---|
| 510(k) Submitter | O & M Halyard, Inc. | ||
| 1 Edison Drive | |||
| Alpharetta, GA 30005 | |||
| Primary Contact for | |||
| this 510(k) Submission | Steven Dowdley, RAC | ||
| Tel: 678-451-8062 | |||
| Email: steven.dowdley@hyh.com | |||
| Marketed Common Name | Halyard Lavender Nitrile Powder-Free Exam Gloves | ||
| Device Submission Trade Name | |||
| and Description | Halyard Lavender Nitrile, Powder-Free Exam Gloves Tested for Use | ||
| Device Common Name | Medical Exam Gloves | ||
| Device Product Code | |||
| and Classification Name | LZA Class I, 21 CFR §880.6250 Patient Examination Glove | ||
| LZC 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 with | ||
| Chemotherapy Drugs (K180646) | |||
| Subject Device Description | 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. The devices follow consensus standards: | |||
| ASTM D5151-06 Standard Test Method for Detection of Holes in Medical | |||
| Gloves | |||
| ASTM D6319-10 Standard Specification for Nitrile Examination Gloves for | |||
| Medical Applications | |||
| ASTM D6124-06 Standard Test Method for Residual Powder on Medical | |||
| Gloves | |||
| ASTM D6978-05 Standard Practice for Assessment of Resistance of Medical | |||
| Gloves 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: | |||
| Tests for Irritation and Skin Sensitization | |||
| 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) | Indications for Use | The Halyard Lavender Nitrile, Powder-Free Exam Gloves Tested for Use with | |
| Chemotherapy 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 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: 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 Use | |||
| with Chemotherapy Drugs and | |||
| Fentanyl Citrate | Halyard Lavender, Powder-Free | ||
| Exam Gloves Tested for Use with | |||
| Chemotherapy Drugs | |||
| Intended Use | Halyard Lavender Nitrile, Powder-Free Exam Gloves Tested for Use | ||
| with Chemotherapy Drugs and | |||
| Fentanyl 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 chemotherapy drugs listed on | |||
| the label. | The Halyard Lavender, Powder-Free Exam Gloves Tested for Use | ||
| with Chemotherapy Drugs are | |||
| 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 chemotherapy drugs listed | |||
| on the label. | Same | ||
| Technological | |||
| Characteristics | The glove is a colored, nitrile, | ||
| powder-free, textured fingertip, | |||
| ambidextrous, patient examination | |||
| glove. | The glove is a colored, nitrile, | ||
| powder-free, textured fingertip, | |||
| ambidextrous, patient | |||
| examination 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 Biological | ||
| evaluation of Medical devices – | |||
| Test for Systemic Injection, the test | |||
| article was considered non-toxic. | |||
| Meets the acceptance criteria. | Based ISO 10993 Biological | ||
| evaluation of Medical devices – | |||
| Test for Systemic Injection, the | |||
| test article was considered non-toxic. | |||
| Meets the acceptance | |||
| criteria. | Same | ||
| Based on ISO 10993- Biological | |||
| evaluation of Medical Devices – | |||
| Test for Skin Irritation, the device | |||
| extracts were not found to cause a | |||
| systemic response in the animal | |||
| model. Meets the acceptance | |||
| criteria. | Based on ISO 10993- Biological | ||
| evaluation of Medical Devices – | |||
| Test for Skin Irritation, the device | |||
| extracts were not found to cause a | |||
| systemic response in the animal | |||
| model. Meets the acceptance | |||
| criteria. | |||
| Performance Data for Chemotherapy Drugs | |||
| Standard | Results | ||
| Subject Devices | Results | ||
| Predicate Devices K180646 | Remarks | ||
| ASTM D6978-05 | |||
| Standard Practice | |||
| for Assessment of | |||
| Resistance of | |||
| Medical Gloves to | |||
| Permeation by | |||
| Chemotherapy | |||
| Drugs | 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) | |||
| 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 drugs | ||
| and concentration had NO | |||
| breakthrough | |||
| detected up to 240 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 0.3 minutes | |||
| • ThioTEPA (10.0 mg.ml) No | |||
| breakthrough up to 30.9 minutes | |||
| Warning: 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 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. | |||
| Performance Data for Hazardous Drugs (opioids) | |||
| ASTM D6978-05 | |||
| Standard Practice | |||
| for Assessment of | |||
| Resistance of | |||
| Medical Gloves to | |||
| Permeation by | |||
| Chemotherapy | |||
| Drugs | The following hazardous drugs | ||
| (opioids) and concentration had NO | |||
| breakthrough detected up to 240 | |||
| minutes: | |||
| Fentanyl Citrate Injection (100 | |||
| mcg/2 ml) | Not Tested | Different |
5
6
7
8
9
| Performance Data | Same | ||
|---|---|---|---|
| ASTM D5151-06 | |||
| Standard Test | |||
| Method for | |||
| Detection of Holes | |||
| in Medical Gloves | Testing of the subject device shows | ||
| it meets the 2.5% AQL requirement | |||
| in the standards for leakage. The | |||
| device meets the acceptance | |||
| criteria of the standard. | Testing of the subject device shows | ||
| it meets the 2.5% AQL requirement | |||
| in the standards for leakage. The | |||
| device meets the acceptance | |||
| criteria of the standard. | Same | ||
| ASTM D6124-06 | |||
| Standard Test | |||
| Method for Residual | |||
| Powder on Medical | |||
| Gloves | Residual powder on the subject | ||
| device is an average of 0.4 | |||
| mg/glove within the powder-free | |||
| limit of |