(137 days)
No
The device is a medical examination glove, and the description focuses on material properties, testing standards, and physical characteristics. There is no mention of AI or ML capabilities.
No.
The device is a patient examination glove, intended to prevent contamination between patient and examiner, not to treat a condition or restore function.
No
Explanation: The device is a patient examination glove, intended to prevent contamination between patient and examiner. It is not designed to diagnose any medical condition.
No
The device is a physical examination glove, which is a hardware medical device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. They are used outside the body.
- Device's Intended Use: The intended use of these gloves is to be worn on the examiner's hand to prevent contamination between the patient and the examiner. This is a barrier function, not a diagnostic function performed on a specimen.
- Device Description: The description focuses on the physical characteristics and performance as a barrier (powder-free, ambidextrous, material, testing for chemotherapy drug permeation).
- Performance Studies: The performance studies listed are related to biocompatibility and physical performance as a barrier (dimensions, holes, breakthrough time), not diagnostic accuracy or analysis of biological specimens.
The testing for chemotherapy drugs is about the glove's ability to protect the wearer from exposure, not about diagnosing anything in the patient or a specimen.
N/A
Intended Use / Indications for Use
A patient examination 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 chemotherapy drugs as per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Blenoxane (Bleomycin) 15.0 mg/ml >240 minutes Bortezomib 1.0 mg/ml >240 minutes Busulfan 6.0 mg/ml >240 minutes Carboplatin 10.0 mg./ml >240 minutes Carmustine (BCNU) 3.3 mg/ml 13.2 minutes Cetuximab (Eributux) 2.0 mg/ml >240 minutes Cisplatin 1.0 mg/ml >240 minutes Cyclophosphamide (Cytoxan) 20.0 mg/ml >240 minutes Dacarbazine (DTIC)10.0 mg/ml >240 minutes Docetaxel 10.0 mg/ml >240 minutes Doxorubicin Hydrochloride 2.0 mg/ml >240 minutes Epirubicin (Ellence) 2.0 mg/ml >240 minutes Etoposide (Toposar) 20.0 mg/ml >240 minutes Fludarabine 25.0 mg/ml >240 minutes Fluorouracil 50.0 mg/ml >240 minutes Gemcitabine (Gemzar) 38.0 mg/ml >240 minutes Idarubicin 1.0 mg/ml >240 minutes Ifosfamide 50.0 mg/ml >240 minutes Irinotecan 50.0 mg/ml >240 minutes Mechlorethamine HCl 1.0 mg/ml >240 minutes Melphalan 5.0 mg/ml >240 minutes Methotrexate 25.0 mg/ml >240 minutes Mitomycin C 0.5 mg/ml >240 minutes Mitoxantrone 2.0 mg/ml >240 minutes Oxaliplatin 5.0 mg/ml >240 minutes Paclitaxel (Taxol) 6.0 mg/ml >240 minutes Paraplatin 10.0 mg/ml >240 minutes Pemetrexed 25.0 mg/ml >240 minutes Raltitrexed 0.5 mg/ml >240 minutes Rituximab 10.0 mg/ml >240 minutes Thiotepa 10.0 mg/ml 44 minutes Trisonex (Arsenic Trioxide) 1.0 mg/ml >240 minutes Vidaza (Azacitidine) 25.0 mg/ml >240 minutes Vinblastine 1.0 mg/ml >240 minutes Vincristine Sulfate 1.0 mg/ml >240 minutes Vinorelbine 10.0 mg/ml >240 minutes
Please note that the following drug has extremely low permeation time: Carmustine (BCNU) (3.3 mg/ml) 13.2 minutes Please note that the following drug has extremely low permeation time: Thiotepa (10.0 mg/ml) 44.0 minutes
Product codes (comma separated list FDA assigned to the subject device)
LZA, LZC
Device Description
There have been no changes to the Medline Green Ambidextrous Powder-Free Nitrile Examination Gloves with Colloidal Oatmeal USP (Tested for Use with Chemotherapy Drugs). The materials of construction, colorant, sizes and product specifications have not changed and are identical to what was cleared under K180696. The only change is to the Indications for Use.
As previously described in K180696, the Medline Green Ambidextrous Powder-Free Nitrile Examination Gloves with Colloidal Oatmeal USP (Tested for use with Chemotherapy Drugs) are non-sterile, single use, disposable gloves intended for medical purposes to be worn on the hands of examiners to prevent contamination between a patient and an examiner. The gloves are powder-free, ambidextrous with beaded cuff, green colored nitrile gloves featuring an inner coating of colloidal oatmeal USP. The gloves are offered in five sizes, extra-small, small, medium, large and extra-large.
The gloves are designed and manufactured in accordance with the ASTM D6319-10 standard and are tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2013).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hands
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Examiner (medical purposes)
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)
Non-Clinical Testing:
Biocompatibility:
- Primary Skin Irritation per ISO 10993-10: No skin reactions observed, not a skin irritant.
- Dermal Sensitization per ISO 10993-10: No positive allergic reactions observed, not a skin sensitizer.
- Cytotoxicity per ISO 10993-5: At the neat extraction, the test article is considered cytotoxic.
- Acute Systemic Toxicity per ISO 10993-11: No signs of toxicity at any of the observation periods were observed.
Performance Testing (Bench):
- ASTM D6319-10: Standard Specification for Nitrile Examination Gloves for Medical Application. Result: All device dimensions meet the standard.
- ASTM D6124-06 (Reaffirmation 2011): Standard Test Method for Residual Powder on Medical Gloves. Result: Complies with standard (
§ 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.
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Image /page/0/Picture/0 description: The image shows 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.
January 10, 2020
Medline Industries, Inc. Claire Pigman Associate Manager, Regulatory Affairs Three Lakes Drive Northfield, Illinois 60093
Re: K192315
Trade/Device Name: Medline Green Ambidextrous Power-Free Nitrile Examination Gloves with Colloidal Oatmeal USP (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: December 6, 2019 Received: December 10, 2019
Dear Claire Pigman:
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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For Elizabeth Claverie, M.S. 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) K192315
Device Name
Medline Green Ambidextrous Powder-Free Nitrile Examination Gloves with Colloidal Oatmeal USP (Tested for use with Chemotherapy Drugs)
Indications for Use (Describe)
A patient examination 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 chemotherapy drugs as per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Blenoxane (Bleomycin) 15.0 mg/ml >240 minutes Bortezomib 1.0 mg/ml >240 minutes Busulfan 6.0 mg/ml >240 minutes Carboplatin 10.0 mg./ml >240 minutes Carmustine (BCNU) 3.3 mg/ml 13.2 minutes Cetuximab (Eributux) 2.0 mg/ml >240 minutes Cisplatin 1.0 mg/ml >240 minutes Cyclophosphamide (Cytoxan) 20.0 mg/ml >240 minutes Dacarbazine (DTIC)10.0 mg/ml >240 minutes Docetaxel 10.0 mg/ml >240 minutes Doxorubicin Hydrochloride 2.0 mg/ml >240 minutes Epirubicin (Ellence) 2.0 mg/ml >240 minutes Etoposide (Toposar) 20.0 mg/ml >240 minutes Fludarabine 25.0 mg/ml >240 minutes Fluorouracil 50.0 mg/ml >240 minutes Gemcitabine (Gemzar) 38.0 mg/ml >240 minutes Idarubicin 1.0 mg/ml >240 minutes Ifosfamide 50.0 mg/ml >240 minutes Irinotecan 50.0 mg/ml >240 minutes Mechlorethamine HCI 1.0 mg/ml >240 minutes Melphalan 5.0 mg/ml >240 minutes Methotrexate 25.0 mg/ml >240 minutes Mitomycin C 0.5 mg/ml >240 minutes Mitoxantrone 2.0 mg/ml >240 minutes Oxaliplatin 5.0 mg/ml >240 minutes Paclitaxel (Taxol) 6.0 mg/ml >240 minutes Paraplatin 10.0 mg/ml >240 minutes Pemetrexed 25.0 mg/ml >240 minutes Raltitrexed 0.5 mg/ml >240 minutes Rituximab 10.0 mg/ml >240 minutes Thiotepa 10.0 mg/ml 44 minutes Trisonex (Arsenic Trioxide) 1.0 mg/ml >240 minutes Vidaza (Azacitidine) 25.0 mg/ml >240 minutes Vinblastine 1.0 mg/ml >240 minutes Vincristine Sulfate 1.0 mg/ml >240 minutes Vinorelbine 10.0 mg/ml >240 minutes
3
Please note that the following drug has extremely low permeation time: Carmustine (BCNU) (3.3 mg/ml) 13.2 minutes Please note that the following drug has extremely low permeation time: Thiotepa (10.0 mg/ml) 44.0 minutes
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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Image /page/4/Picture/0 description: The image shows the Medline logo. The logo is set against a blue background. The word "MEDLINE" is in white, block letters, and to the right of the word is a white, stylized star shape. The star has four points, with the bottom point extending further down than the other three.
K192315 510(k) SUMMARY [AS REQUIRED BY 21CFR807.92]
Submitter / 510(k) Sponsor
Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093 Registration Number: 1417592
Contact Person
Claire Pigman Associate Manager, Regulatory Affairs Phone: 847-643-4071 Email: cpigman@medline.com
Summary Preparation Date January 9, 2020
Type of 510(k) Submission Traditional
Device Name / Classification
Name of Device: Patient Examination Glove (Tested for Use with Chemotherapy Drugs) Proprietary Name: Medline Green Ambidextrous Powder-Free Nitrile Examination Gloves with Colloidal Oatmeal USP (Tested for use with Chemotherapy Drugs) Common Name: Patient Examination Glove Classification Name: Patient Examination Glove Product Code: LZA, LZC Classification Panel: General Hospital Regulation #: 21 CFR 880.6250
Predicate Device
Medline Green Ambidextrous Powder-Free Nitrile Examination Gloves with Colloidal Oatmeal USP (Tested for Use with Chemotherapy Drugs) - K180696
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Image /page/5/Picture/0 description: The image shows the Medline logo. The logo is set against a blue background. The word "MEDLINE" is written in white, with a stylized white starburst symbol above it. The starburst has four points, resembling a compass rose.
Device Description
There have been no changes to the Medline Green Ambidextrous Powder-Free Nitrile Examination Gloves with Colloidal Oatmeal USP (Tested for Use with Chemotherapy Drugs). The materials of construction, colorant, sizes and product specifications have not changed and are identical to what was cleared under K180696. The only change is to the Indications for Use.
As previously described in K180696, the Medline Green Ambidextrous Powder-Free Nitrile Examination Gloves with Colloidal Oatmeal USP (Tested for use with Chemotherapy Drugs) are non-sterile, single use, disposable gloves intended for medical purposes to be worn on the hands of examiners to prevent contamination between a patient and an examiner. The gloves are powder-free, ambidextrous with beaded cuff, green colored nitrile gloves featuring an inner coating of colloidal oatmeal USP. The gloves are offered in five sizes, extra-small, small, medium, large and extra-large.
The gloves are designed and manufactured in accordance with the ASTM D6319-10 standard and are tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2013).
Indications for Use
A patient examination 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 chemotherapy drugs per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Blenoxane (Bleomycin) 15.0 mg/ml >240 minutes Bortezomib 1.0 mg/ml >240 minutes Busulfan 6.0 mg/ml >240 minutes Carboplatin 10.0 mg./ml >240 minutes Carmustine (BCNU) 3.3 mg/ml 13.2 minutes Cetuximab (Eributux) 2.0 mg/ml >240 minutes Cisplatin 1.0 mg/ml >240 minutes Cyclophosphamide (Cytoxan) 20.0 mg/ml >240 minutes Dacarbazine (DTIC)10.0 mg/ml >240 minutes Docetaxel 10.0 mg/ml >240 minutes Doxorubicin Hydrochloride 2.0 mg/ml >240 minutes Epirubicin (Ellence) 2.0 mg/ml >240 minutes Etoposide (Toposar) 20.0 mg/ml >240 minutes Fludarabine 25.0 mg/ml >240 minutes Fluorouracil 50.0 mg/ml >240 minutes Gemcitabine (Gemzar) 38.0 mg/ml >240 minutes Idarubicin 1.0 mg/ml >240 minutes Ifosfamide 50.0 mg/ml >240 minutes Irinotecan 50.0 mg/ml >240 minutes
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Image /page/6/Picture/0 description: The image shows the Medline logo. The logo is set against a blue background. The word "MEDLINE" is written in white, block letters. A white, stylized starburst symbol is behind the text, with the word "MEDLINE" centered on the starburst.
Mechlorethamine HCI 1.0 mg/ml >240 minutes Melphalan 5.0 mg/ml >240 minutes Methotrexate 25.0 mg/ml >240 minutes Mitomycin C 0.5 mg/ml >240 minutes Mitoxantrone 2.0 mg/ml >240 minutes Oxaliplatin 5.0 mg/ml >240 minutes Paclitaxel (Taxol) 6.0 mg/ml >240 minutes Paraplatin 10.0 mg/ml >240 minutes Pemetrexed 25.0 mg/ml >240 minutes Raltitrexed 0.5 mg/ml >240 minutes Rituximab 10.0 mg/ml >240 minutes Thiotepa 10.0 mg/ml 44 minutes Trisonex (Arsenic Trioxide) 1.0 mg/ml >240 minutes Vidaza (Azacitidine) 25.0 mg/ml >240 minutes Vinblastine 1.0 mg/ml >240 minutes Vincristine Sulfate 1.0 mg/ml >240 minutes Vinorelbine 10.0 mg/ml >240 minutes
Please note that the following drug has extremely low permeation time: Carmustine (BCNU) (3.3 mg/ml) 13.2 minutes Please note that the following drug has extremely low permeation time: Thiotepa (10.0 mg/ml) 44.0 minutes
Summary of Technological Characteristics
| Device Characteristic | Proposed Device | Predicate Device | Comparison Analysis |
|---|---|---|---|
| Product Name | Medline Green Ambidextrous | ||
| Powder-Free Nitrile Examination | |||
| Gloves with Colloidal Oatmeal | |||
| USP (Tested for use with | |||
| Chemotherapy Drugs) | Medline Green Ambidextrous | ||
| Powder-Free Nitrile Examination | |||
| Gloves with Colloidal Oatmeal | |||
| USP (Tested for use with | |||
| Chemotherapy Drugs) | Same | ||
| 510(k) Reference | K192315 | K180696 | N/A |
| Product Owner | Medline Industries, Inc. | Medline Industries, Inc. | Same |
| Product Code | LZA, LZC | LZA, LZC | Same |
| Intended Use | A patient examination glove is a | ||
| disposable device intended for | |||
| medical purposes that is worn on | |||
| the examiner's hand to prevent | A patient examination glove is a | ||
| disposable device intended for | |||
| medical purposes that is worn on | |||
| the examiner's hand to prevent | Same | ||
| contamination between patient and examiner. | |||
| These gloves were tested for use with chemotherapy drugs as per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs | contamination between patient and examiner. | ||
| These gloves were tested for use with chemotherapy drugs as per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs | |||
| Regulation Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Materials | Nitrile | ||
| Colloidal oatmeal | Nitrile | ||
| Colloidal oatmeal | Same | ||
| Color | Green | Same | |
| Sizes | x- small, small, medium, large, x-large | x-small, small, medium, large, x-large | Same |
| Dimensions - Length | Complies with ASTM D6319-10 | ||
| 220mm min. | Complies with ASTM D6319-10 | ||
| 230mm min. | Same | ||
| Dimensions - Width | Complies with ASTM D6319-10 | ||
| X-small – 70±10mm | |||
| Small – 80±10mm | |||
| Medium – 95±10mm | |||
| Large – 110±10mm | |||
| X-large – 120±10mm | Complies with ASTM D6319-10 | ||
| X-small – 70±10mm | |||
| Small – 80±10mm | |||
| Medium – 95±10mm | |||
| Large – 110±10mm | |||
| X-large – 120±10mm | Same | ||
| Dimensions - Thickness | Complies with ASTM D6319-10 | ||
| Palm – 0.05mm min. | |||
| Finger – 0.05mm min. | Complies with ASTM D6319-10 | ||
| Palm – 0.05mm min. | |||
| Finger – 0.05mm min. | Same | ||
| Physical Properties | Complies with ASTM D6319-10 minimum: | ||
| Tensile Strength: | |||
| Before Aging ≥14 MPa, min. | |||
| After Aging ≥14 MPa, min. | |||
| Elongation: | |||
| Before Aging 500%, min. | |||
| After Aging 400%, min. | Complies with ASTM D6319-10 minimum: | ||
| Tensile Strength: | |||
| Before Aging ≥14 MPa, min. | |||
| After Aging ≥14 MPa, min. | |||
| Elongation: | |||
| Before Aging 500% min. | |||
| After Aging 400% min. | Same | ||
| Freedom from Holes | Complies with ASTM D6319-10 and ASTM D5151-06 G-1, AQL 1.5 | Complies with ASTM D6319-10 and ASTM D5151-06 G-1, AQL 1.5 | Same |
| Powder or Powder-Free | Powder-Free | Powder-Free | Same |
| Residual Powder | Complies with ASTM D6319-10 | ||
| 240 min. | Similar | ||
| Bortezomib 1 mg/ml |
240 min. | | Similar |
| | Busulfan 6 mg/ml
240 min. | | Similar |
| | Carboplatin 10 mg/ml
240 min. | | Similar |
| | Carmustine (BCNU) 3.3 mg/ml
240 min. | Carmustine (BCNU) 3.3 mg/ml
13.2 min. | Same |
| | Cetuximab (Erbitux) 2 mg/ml >240
min. | | Similar |
| | Cisplatin 1.0 mg/ml
240 min. | Cisplatin 1.0 mg.ml
240 min. | Same |
| | Cyclophosphamide (Cytoxan) 20
mg/ml
240 min. | Cyclophosphamide (Cytoxan) 20.0
mg/ml
240 min. | Same |
| | Dacarbazine (DTIC)10.0 mg/ml
240 min. | Dacarbazine (DTIC)10.0 mg/ml
240 min. | Same |
| | Docetaxel 10.0 mg/ml
240 min. | | Similar |
| | Doxorubicin Hydrochloride 2.0
mg/ml >240 min. | Doxorubicin Hydrochloride 2.0
mg/ml >240 min. | Same |
| | Epirubicin (Ellence) 2.0 mg/ml
240 min. | | Similar |
| | Etoposide (Toposar) 20.0 mg/ml
240 min. | Etoposide (Toposar) 20.0 mg/ml
240 min. | Same |
| | Fludarabine 25 mg/ml
240 min. | | Similar |
| | Fluorouracil 50.0 mg/ml
240 min. | Fluorouracil 50.0 mg/ml
240 min. | Same |
| Gemcitabine (Gemzar) 38 mg/ml
240 min. | | Similar | |
| Idarubicin 1 mg/ml
240 min. | | Similar | |
| Ifosfamide 50.0 mg/ml
240 min. | | Similar | |
| Irinotecan 20.0 mg/ml
240 min. | | Similar | |
| Mechlorethamine HCI 1.0 mg/ml
240 min. | | Similar | |
| Melphalan 5 mg/ml
240 min. | | Similar | |
| Methotrexate 25 mg/ml
240 min. | Methotrexate 25 mg/ml
240 min. | Same | |
| Mitromycin C. 0.5 mg/ml >240 | Mitromycin C. 0.5 mg/ml >240 | Same | |
| Mitoxantrone 2.0 mg/ml
240 min. | | Similar | |
| Oxaliplatin 5 mg/ml
240 min. | | Similar | |
| Paclitaxel (Taxol) 6.0 mg/ml
240 min. | Paclitaxel (Taxol) 6.0 mg/ml
240 min. | Same | |
| Paraplatin 10 mg/ml
240 min. | | Similar | |
| Pemetrexed Disodium 25 mg/ml
240 min. | | Similar | |
| Raltitrexed 0.5 mg/ml
240 min. | | Similar | |
| Rituximab 10 mg/ml
240 min. | | Similar | |
| Thiotepa 10.0 mg/ml
44.0 min. | Thiotepa 10.0 mg/ml
44.0 min. | Same | |
| Trisonex 0.1 mg/ml
240 min. | | Similar | |
| Vidaza (5-Azacytidine) 25 mg/ml
240 min | | Similar | |
| Vinblastine 1 mg/ml
240 min. | | Similar | |
| Vinorelbine 10 mg/ml
240 min. | | Similar | |
| Vincristine Sulfate 1.0 mg/ml >240
min. | Vincristine Sulfate 1.0 mg/ml
240 min. | Same | |
Table 1 Comparison of Proposed and Predicate Device
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Image /page/7/Picture/0 description: The image shows the Medline logo. The logo is set against a blue square background. The word "MEDLINE" is written in white, block letters on the left side of the square. To the right of the word is a white, stylized starburst symbol.
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Image /page/8/Picture/0 description: The image features the Medline logo, which is set against a blue square background. The word "MEDLINE" is prominently displayed in white, sans-serif font, positioned to the left of a stylized white starburst symbol. The starburst has four points, resembling a compass rose, and it is oriented diagonally within the square.
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Image /page/9/Picture/0 description: The image features the Medline logo against a blue background. The logo consists of the word "MEDLINE" in a sans-serif font, positioned to the left of a stylized starburst symbol. The starburst is composed of four white, elongated triangles converging at a central point, creating a dynamic and modern design.
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Image /page/10/Picture/0 description: The image features the Medline logo against a blue background. The logo consists of the word "MEDLINE" in a sans-serif font, positioned to the left of a stylized white starburst symbol. The starburst is oriented diagonally, with its points extending beyond the text, creating a dynamic and recognizable brand mark.
Summary of Non-Clinical Testing
Biocompatibility
The biocompatibility evaluation for Medline Green Ambidextrous Powder-Free Nitrile Examination Glove with Colloidal Oatmeal USP (Tested for Use with Chemotherapy Drugs) was conducted in accordance with ANSI/AAMI/ISO 10993-1:2018 Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing Within a Risk Management Process, as recognized by FDA.
The following tests were performed to evaluate the biocompatibility of Medline Green Ambidextrous Powder-Free Nitrile Examination Glove with Colloidal Oatmeal USP (Tested for Use with Chemotherapy Drugs):
| Test
Standard | Test Standard
Description | Acceptance Criteria | Result |
|------------------|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|
| ISO 10993-10 | Primary Skin Irritation | Cutaneous macroscopical examinations are
performed after removal of test material. The
appearance of each application site and skin
reaction observed are scored. | No skin reactions
observed. Not a skin
irritant. |
| ISO 10993-10 | Dermal Sensitization | Challenge sites are visually assessed for allergic
reactions and the intensity of the reaction is
scored. | No positive allergic
reactions observed. Not
a skin sensitizer |
| ISO 10993-5 | Cytotoxicity | Test articles scoring '0', '1', or '2' are
considered 'non-cytotoxic.' Test articles
scoring '3' or '4' are considered 'cytotoxic.' | At the neat extraction,
the test article is
considered cytotoxic. |
| ISO 10993-11 | Acute Systemic Toxicity | Abnormal clinical signs indicative of toxicity
during the 72 hours test period are observed and
reported. | No signs of toxicity at
any of the observation
periods were observed. |
Table 2 Biocompatibility Testing Summary
Performance Testing (Bench)
Physical performance qualities of the proposed device were evaluated per ASTM D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application. Additionally, permeation testing was conducted to support the addition of the labeling claim: Tested for use with chemotherapy drugs. In addition, the proposed device was tested according to ASTM D6978-05 (Reapproved 2013), Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs, in which minimum breakthrough times were determined for a wide range of chemotherapy drugs. To summarize, the following tests were performed to evaluate the functional performance of the subject device:
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Table 3 Performance Testing Summary
| Test Standard | Test Standard Description | Acceptance Criteria | Result |
|---|---|---|---|
| ASTM D6319-10 | Standard Specification for | ||
| Nitrile Examination Gloves for | |||
| Medical Application | Samples shall meet specified | ||
| physical dimensions in accordance | |||
| with the standard. | All device dimensions | ||
| meet the standard. | |||
| ASTM D6124-06 | |||
| (Reaffirmation |
- | Standard Test Method for
Residual Powder on Medical
Gloves |