(218 days)
The SensiCare PI surgeon's glove is a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
The SensiCare PI Surgical Gloves are disposable powder-free surgical gloves that are intended to be worn by surgeons and/or operating room personnel to protect a surgical wound from contamination. The gloves are made with polyisoprene and are cream in color. The SensiCare PI Surgical Gloves are available in a smooth grip and are constructed with a beaded cuff. The gloves have been tested for use with chemotherapy drugs per ASTM D6978.
This document is a 510(k) Premarket Notification for the SensiCare PI Surgical Gloves. It outlines the device's characteristics, intended use, and a comparison to a predicate device. The primary performance testing described relates to the glove's resistance to chemotherapy drugs and its physical properties.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the SensiCare PI Surgical Gloves are based on compliance with specific ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization) standards, as well as FDA regulations.
| Acceptance Criteria Category | Standard / Reference | Acceptance Criterion | Reported Device Performance |
|---|---|---|---|
| Chemotherapy Drug Permeation (Breakthrough Detection Time) | ASTM D6978 | Not explicitly stated as a minimum "acceptance criteria" but rather as a performance benchmark compared to the predicate and intended use guidance (e.g., minimum breakthrough time of less than 30 minutes for certain drugs). The relevant criteria would be meeting or exceeding the performance of the predicate device. | Carmustine (BCNU) 3.3 mg/ml (3,300 ppm): 10.1 min. (10.1, 10.1, 10.1)Cisplatin 1.0 mg/ml (1,000 ppm): 240 min.Cyclophosphamide (Cytoxan) 20 mg/ml (20,000 ppm): 240 min.Cytarabine 100 mg/ml (100,000 ppm): 240 min.Dacarbazine (DTIC) 10.0 mg/ml (10,000 ppm): 240 min.Doxorubicin Hydrochloride 2.0 mg/ml (2,000 ppm): 240 min.Etoposide (Toposar) 20.0 mg/ml (20,000 ppm): 240 min.Fluorouracil 50.0 mg/ml (50,000 ppm): 240 min.Ifosfamide 50.0 mg/ml (50,000 ppm): 240 min.Methotrexate 25 mg/ml (25,000 ppm): 240 min.Mitomycin C 0.5 mg/ml (500 ppm): 240 min.Mitoxantrone 2.0 mg/ml (2,000 ppm): 240 min.Paclitaxel (Taxol) 6.0 mg/ml (6,000 ppm): 240 min.Thiotepa 10.0 mg/ml (10,000 ppm): 11.6 min. (20.2, 21.5, 11.6)Vincristine Sulfate 1.0 mg/ml (1,000 ppm): 240 min.(Note: Carmustine and Thiotepa had breakthrough times less than 30 minutes, necessitating a warning in the intended use statement.) |
| Dimensions - Length | ASTM D3577 | 270mm min. | Meets ASTM D 3577 (270mm min.) |
| Dimensions - Width | ASTM D3577 | 5 ½ - 70±6mm, 6 - 76±6mm, 6 ½ - 83±6mm, 7 - 89±6mm, 7 ½ - 95±6mm, 8 - 102±6mm, 8 ½ - 108±6mm, 9 - 114±6mm | Meets ASTM D 3577 |
| Dimensions – Finger Thickness | ASTM D3577 | 0.10mm min. | Meets ASTM D3577 (0.10mm min.) |
| Dimensions – Palm Thickness | ASTM D3577 | 0.10mm min. | Meets ASTM D3577 (0.10mm min.) |
| Dimension – Cuff Thickness | ASTM D3577 | 0.10mm min. | Meets ASTM D3577 (0.10mm min.) |
| Physical Properties (Before Aging) - Tensile Strength | ASTM D3577 | 17 MPa min. | Meets ASTM D3577 (17 MPa min.) |
| Physical Properties (Before Aging) - Ultimate Elongation | ASTM D3577 | 650% min. | Meets ASTM D3577 (650% min.) |
| Physical Properties (Before Aging) - Stress at 500% Elongation | ASTM D3577 | 7.0 MPa min. | Meets ASTM D3577 (7.0 MPa min.) |
| Physical Properties (After Aging) - Tensile Strength | ASTM D3577 | 12 MPa min. | Meets ASTM D3577 (12 MPa min.) |
| Physical Properties (After Aging) - Ultimate Elongation | ASTM D3577 | 490% min. | Meets ASTM D3577 (490% min.) |
| Freedom from Holes | 21 CFR 800.20 & ASTM D3577 (tested per ASTM D5151) | Inspection Level 1, AQL 1.5 | Meets 21 CFR 800.20 and ASTM D3577 when tested in accordance with ASTM D5151 (Inspection Level 1, AQL 1.5) |
| Residual Powder | ASTM D3577 | <2mg of residual powder | <2mg of residual powder when tested in accordance with ASTM D3577 |
| Biocompatibility - Primary Skin Irritation | ISO 10993-10 | Device is not an irritant (Under the conditions of the study) | Under the conditions of the study (per ISO 10993-10), the device is not an irritant |
| Biocompatibility - Sensitization | ISO 10993-10 | Device is not a sensitizer (Under the conditions of the study) | Under the conditions of the study (per ISO 10993-10), the device is not a sensitizer |
| Sterility Assurance Level (SAL) | ISO 11137 | 10-6 | Gamma 10-6 (This implies the SAL was met; the method used was gamma irradiation to achieve this level) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not explicitly state the exact "sample size" in terms of number of gloves tested for each individual performance test (e.g., how many gloves for tensile strength, how many for permeation). Instead, it references adherence to specific ASTM and ISO standards, which inherently include their own sampling plans and acceptance criteria. For example, ASTM D5151 for freedom from holes specifies "Inspection Level 1, AQL 1.5," which dictates the sample size based on the lot size.
- Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective. Given the nature of medical device testing for regulatory submission, these are typically prospective, controlled bench tests conducted in a laboratory setting.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable to this type of device. The ground truth for surgical gloves, especially regarding physical properties and chemotherapy permeation, is established through objective, standardized laboratory testing against established physical and chemical metrics defined in national and international standards (ASTM, ISO). It does not involve expert consensus on subjective interpretations like image analysis or clinical outcomes.
4. Adjudication Method for the Test Set
This information is not applicable to this type of device. Adjudication methods (like 2+1, 3+1) are typically used in studies where human expert review is involved to establish a "ground truth" (e.g., in medical image analysis). For physical device testing, the results are objectively measured from the device directly.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable to this device. An MRMC study is relevant for diagnostic devices, particularly those involving human interpretation of data (e.g., radiologists interpreting images, often with AI assistance). This device is a surgical glove, which is a physical barrier device, and does not involve "human readers" or "AI assistance" in its direct function for diagnosis or interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable to this device, as it is a physical device and does not involve algorithms or AI.
7. The Type of Ground Truth Used
The ground truth used for this device is based on objective, quantitative measurements compliant with standardized test methods. These include:
- Standardized Physical Properties: Measurements of dimensions (length, width, thickness), tensile strength, and ultimate elongation as defined by ASTM D3577.
- Permeation Resistance: Measurement of breakthrough detection time for chemotherapy drugs as defined by ASTM D6978-05.
- Freedom from Holes: Determined by water leak tests according to ASTM D5151, with acceptance based on AQL (Acceptable Quality Level) specified in 21 CFR 800.20 and ASTM D3577.
- Biocompatibility: Results from validated in vitro or in vivo tests (like primary skin irritation and sensitization) as per ISO 10993-10 standards.
8. The Sample Size for the Training Set
This information is not applicable to this device. "Training set" refers to data used to train machine learning models. This device is a physical product and does not involve AI/ML models. Development and manufacturing of surgical gloves rely on engineering specifications and materials science, not data training.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable to this device for the same reason as point 8.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 31, 2016
Medline Industries, Inc. Jennifer Mason Senior Regulatory Affairs Specialist One Medline Place Mundelein, Illinois 60060
Re: K152428
Trade/Device Name: SensiCare PI Surgical Gloves Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO, LZC Dated: March 3, 2016 Received: March 4, 2016
Dear Jennifer Mason:
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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin Keith, M.S. Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K152428
Device Name SensiCare PI Surgical Gloves
Indications for Use (Describe)
The SensiCare PI surgeon's glove is a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
The following chemicals have been tested with these gloves.
Chemotherapy Drug Permeation (Breakthrough Detection Time) in Minutes
Carmustine (BCNU) 3.3 mg/ml (3,300 ppm) 10.1 min. (10.1, 10.1) Cisplatin 1.0 mg/ml (1,000 ppm) 240 min. Cyclophosphamide (Cytoxan) 20 mg/ml (20,000 ppm) 240 min. Cytarabine 100 mg/ml (100,000 ppm) 240 min. Dacarbazine (DTIC) 10.0 mg/ml (10,000 ppm) 240 min. Doxorubicin Hydrochloride 2.0 mg/ml (2.000 ppm) 240 min. Etoposide (Toposar) 20.0 mg/ml (20,000 ppm) 240 min. Fluorouracil 50.0 mg/ml (50,000 ppm) 240 min. Ifosfamide 50.0 mg/ml (50,000 ppm) 240 min. Methotrexate 25 mg/ml (25,000 ppm) 240 min. Mitomycin C 0.5 mg/ml (500 ppm) 240 min. Mitoxantrone 2.0 mg/ml (2,000 ppm) 240 min. Paclitaxel (Taxol) 6.0 mg/ml (6.000 ppm) 240 min. Thiotepa 10.0 mg/ml (10,000 ppm) 11.6 min. (20.2, 21.5, 11.6) Vincristine Sulfate 1.0 mg/ml (1,000 ppm) 240 min.
Please note that the following drugs have extremely low permeation time of less than 30 minutes: Carmustine (3.3 mg/ ml) has a minimum breakthrough time of 10.1 minutes; Thiotepa (10.0 mg/ml) has a minimum breakthrough time of 11.6 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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SECTION 5 510(k) SUMMARY [AS REQUIRED BY 21CFR807.92(c)]
Submitter / 510(k) Sponsor
Medline Industries, Inc. 1 Medline Place Mundelein, IL 60060
Registration Number: 1417592
Contact Person
Jennifer Mason Senior Regulatory Affairs Specialist Phone: 847-643-3652 Email: jamason@medline.com
Summary Preparation Date March 31, 2016
Type of 510(k) Submission Traditional
Device Name / Classification
Name of Device: SensiCare PI Surgical Gloves Proprietary Name: SensiCare PI Surgical Gloves Common Name: Surgeon's gloves Classification Name: Surgeon's gloves Product Code: KGO, LZC Regulatory Class: Class I Regulation #: 21 CFR 878.4460 Classification Panel: General Hospital
Predicate Device
Sterile Polyisoprene Powder-Free Surgical Gloves Tested for Use with Chemotherapy Drugs K110272
Device Description
The SensiCare PI Surgical Gloves are disposable powder-free surgical gloves that are intended to be worn by surgeons and/or operating room personnel to protect a surgical wound from contamination. The gloves are made with
CONFIDENTIAL
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polyisoprene and are cream in color. The SensiCare PI Surgical Gloves are available in a smooth grip and are constructed with a beaded cuff. The gloves have been tested for use with chemotherapy drugs per ASTM D6978.
Indications for Use:
The SensiCare PI surgeon's glove is a disposable device made of synthetic rubber intended to be worn by onerating room personnel to protect a surgical wound from contamination. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
The following chemicals have been tested with these gloves.
Chemotherapy Drug Permeation (Breakthrough Detection Time) in Minutes
| Carmustine (BCNU) 3.3 mg/ml (3,300 ppm) | 10.1 min. (10.1, 10.1, 10.1) |
|---|---|
| Cisplatin 1.0 mg/ml (1,000 ppm) | 240 min. |
| Cyclophosphamide (Cytoxan) 20 mg/ml (20,000 ppm) | 240 min. |
| Cytarabine 100 mg/ml (100,000 ppm) | 240 min. |
| Dacarbazine (DTIC) 10.0 mg/ml (10,000 ppm) | 240 min. |
| Doxorubicin Hydrochloride 2.0 mg/ml (2,000 ppm) | 240 min. |
| Etoposide (Toposar) 20.0 mg/ml (20,000 ppm) | 240 min. |
| Fluorouracil 50.0 mg/ml (50,000 ppm) | 240 min. |
| Ifosfamide 50.0 mg/ml (50,000 ppm) | 240 min. |
| Methotrexate 25 mg/ml (25,000 ppm) | 240 min. |
| Mitomycin C 0.5 mg/ml (500 ppm) | 240 min. |
| Mitoxantrone 2.0 mg/ml (2,000 ppm) | 240 min. |
| Paclitaxel (Taxol) 6.0 mg/ml (6,000 ppm) | 240 min. |
| Thiotepa 10.0 mg/ml (10,000 ppm) | 11.6 min. (20.2, 21.5, 11.6) |
| Vincristine Sulfate 1.0 mg/ml (1,000 ppm) | 240 min. |
Please note that the following drugs have extremely low permeation time of less than 30 minutes: Carmustine (3.3 mg/ml) has a minimum breakthrough time of 10.1 minutes; Thiotepa (10.0 mg/ml) has a minimum breakthrough time of 11.6 minutes.
Summary of Technological Characteristics
The SensiCare PI Surgical Glove is substantially equivalent to the predicate, K110272, Sterile Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs. Both gloves have intended use, same material and the same device performance.
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TABLE 1: COMPARISON OF PROPOSED AND PREDICATE DEVICES
| DeviceCharacteristic | Proposed Device | Predicate Device | ComparisonAnalysis |
|---|---|---|---|
| Product Name | SensiCare PI Surgical Gloves | Sterile Polyisoprene Powder-Free Surgical Gloves Tested forUse with Chemotherapy Drugs | N/A |
| 510(k) Reference | K110272 | N/A | |
| Product Owner | Medline Industries, Inc. | Cardinal Health | Different |
| Product Code | KGO | KGO | SubstantiallyEquivalent |
| Regulation Number | 21 CFR 878.4460 | 21 CFR 878.4460 | SubstantiallyEquivalent |
| Intended Use | The SensiCare PI surgeon'sglove is a disposable devicemade of synthetic rubberintended to be worn by operatingroom personnel to protect asurgical wound fromcontamination. In addition, thesegloves were tested for use withchemotherapy drugs inaccordance with ASTM D6978Standard Practice for Assessmentof Medical Gloves to Permeationby Chemotherapy Drugs.Warning: Do not use withCarmustine and Thiotepa | This powder-free surgeon'sglove is a disposable devicemade of synthetic rubberintended to be worn by operatingroom personnel to protect asurgical wound fromcontamination. In addition, thesegloves were tested for use withchemotherapy drugs inaccordance with ASTM D 6978Standard Practice for Assessmentof Medical Gloves to Permeationby Chemotherapy Drugs. | SubstantiallyEquivalent |
| Sizes | 5 ½ , 6, 6 ½ , 7, 7 ½ , 8, 8 ½, 9 | 5 ½ , 6, 6 ½ , 7, 7 ½ , 8, 8 ½, 9 | SubstantiallyEquivalent |
| Materials | Polyisoprene | Polyisoprene | SubstantiallyEquivalent |
| Colorant | Yes - cream colored. Contains ablend of three colorants(naphthos AS red, azo yellowand carbon black) | Yes - cream colored | SubstantiallyEquivalent |
| Dimensions -Length | Meets ASTM D 3577270mm min. | Meets ASTM D 3577270mm min. | SubstantiallyEquivalent |
| Dimensions - Width | Meets ASTM D 35775 ½ - 70±6mm6 - 76±6mm6 ½ - 83±6mm7 - 89±6mm7 ½ - 95±6mm | Meets ASTM D 35775 ½ - 70±6mm6 - 76±6mm6 ½ - 83±6mm7 - 89±6mm7 ½ - 95±6mm | SubstantiallyEquivalent |
| 8 - 102±6mm | 8 - 102±6mm | ||
| 8 ½ - 108±6mm | 8 ½ - 108±6mm | ||
| 9 - 114±6mm | 9 - 114±6mm | ||
| Dimensions –Finger Thickness | Meets ASTM D35770.10mm min | Meets ASTM D35770.10mm min | SubstantiallyEquivalent |
| Dimensions – PalmThickness | Meets ASTM D35770.10mm min | Meets ASTM D35770.10mm min | SubstantiallyEquivalent |
| Dimension – CuffThickness | Meets ASTM D35770.10mm min | Meets ASTM D35770.10mm min | SubstantiallyEquivalent |
| Physical Properties | Meets ASTM D3577Before AgingTensile Strength - 17 MPa minUltimate Elongation – 650% minStress at 500% Elongation – 7.0MPa min | Meets ASTM D3577Before AgingTensile Strength - 17 MPa minUltimate Elongation – 650% minStress at 500% Elongation –7MPa min | SubstantiallyEquivalent |
| Meets ASTM 3577After AgingTensile Strength – 12 MPa minUltimate Elongation - 490% min | Meets ASTM 3577After AgingTensile Strength – 12 MPa minUltimate Elongation – 490% min | SubstantiallyEquivalent | |
| Freedom fromHoles | Meets 21 CFR 800.20 andASTM D3577 when tested inaccordance with ASTM D5151Inspection Level 1, AQL 1.5 | Meets 21 CFR 800.20 andASTM D3577 when tested inaccordance with ASTM D5151Inspection Level 1, AQL 1.5 | SubstantiallyEquivalent |
| Powder or Powder-free | Powder-free | Powder-free | SubstantiallyEquivalent |
| Residual Powder | <2mg of residual powder whentested in accordance with ASTMD3577 | <2mg of residual powder whentested in accordance with ASTMD3577 | SubstantiallyEquivalent |
| Tested for Use withChemotherapyDrugs | Yes | Yes | SubstantiallyEquivalent |
| ChemotherapyDrugs Tested | Blenoxane (15mg/ml)>240Busulfan (6mg/ml) >240Carmustine (3.3mg/ml) 0.37Cisplatin (1.0mg/ml) >240Cytarabine (100mg/ml) >240Cyclophosphamide (20mg/ml)>240Dacarbazine (10mg ml) >240Doxorubicin (2.0mg ml) >240Ellence (25mg/ml) >240Etoposide (20mg/ml) >Fludarabine (25mg.ml) >240Fluorouracil (50mg ml) >240 | Similar | |
| Carmustine 10.1 | |||
| Cisplatin >240 | |||
| Cytarabine >240 | |||
| Cyclophosphamide >240 | |||
| Dacarbazine >240 | |||
| Doxorubicin >240 | |||
| Etoposide >240 | |||
| Fluorouracil >240 | |||
| Ifosfamide >240 | Idarubicin (1mg/ml) >240 | ||
| Ifosfamide (50mg/ml) >240 | |||
| Mechlorethamine HCI (1mg.ml) >240 | |||
| Methotrexate >240 | Melphalan (5mg.ml) >240 | ||
| Mitoxantrone >240 | Methotrexate (25 mg.ml) >240 | ||
| Mitomycin C >240 | Mitoxantrone (2mg.ml) >240 | ||
| Paclitaxel >240 | Mitomycin C (0.5mg.ml) >240 | ||
| Paclitaxel (6.0 mg/ml) >240 | |||
| Paraplatin (10mg.ml) >240 | |||
| Rituximab (10mg/ml) >240 | |||
| Thiotepa 11.6 | Thiotepa (10mg/ml) 0.44 | ||
| Trisenox (0.1mg.ml) >240 | |||
| Vincristine sulfate >240 | Vincristine sulfate (1mg/ml) >240 | ||
| Sterile or Non-sterile | Sterile | Sterile | Substantially Equivalent |
| Sterilization Method | Gamma 10-6 | Gamma | Substantially Equivalent |
| Primary Skin Irritation | Under the conditions of the study (per ISO 10993-10), the device is not an irritant | Meets ISO 10993-10 | Substantially Equivalent |
| Sensitization (Guinea Pig Maximization Test) | Under the conditions of the study (per ISO 10993-10), the device is not a sensitizer | Meets ISO 10993-10 | Substantially Equivalent |
| Elements Contained on Product Labeling | |||
| • Product Identifier | Yes | Yes | Substantially Equivalent |
| • Material | Yes | Yes | Substantially Equivalent |
| • Product Characteristics | Yes | Yes | Substantially Equivalent |
| • Size | Yes | Yes | Substantially Equivalent |
| • Manufacturer Name and Address | Yes | Yes | Substantially Equivalent |
| • Single Use Only | Yes | Yes | Substantially Equivalent |
| • In Pairs, Left/Right | Yes | Yes | Substantially Equivalent |
| • Country ofManufacturing | Yes | Yes | SubstantiallyEquivalent |
| • List ofChemotherapyDrugs andBreakthroughTimes | Yes | Yes | SubstantiallyEquivalent |
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Summary of Non-Clinical Testing
The biocompatibility evaluation for the SensiCare PI Surgical Glove was conducted in accordance with ANSI/AAMI/ISO 10993-1:2009 Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process, as recognized by FDA. The SensiCare PI Surgical Gloves are classified as a surface contacting device with a limited contact duration of less than 24 hours.
The following tests were performed to evaluate the biocompatibility of the SensiCare PI Surgical Gloves:
- ISO 10993-10: Irritation Intracutaneous reactivity ●
- . ISO 10993-10: Delayed-Type Hypersensitivity (Sensitization) - Guinea Pig Maximization Test
Performance Testing (Bench)
Permeation testing was conducted on the SensiCare PI Surgical Glove per ASTM D6978-05, Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. The gloves were tested against fifteen chemotherapy drugs.
Physical performance qualities were evaluated per ASTM D3577, Standard Specification for Rubber Surgical Gloves.
Summary of Clinical Testing
This section does not apply. No clinical testing was performed.
Conclusion
In accordance with 21 CFR Part 807, and based on the information provided in this premarket notification, Medline Industries, Inc. concludes that the SensiCare PI Surgical Glove is as safe and as effective and performs as well as the predicate, Sterile Polyisoprene Powder-Free Surgical Gloves Tested for Use with Chemotherapy Drugs (K110272). Therefore, the SensiCare PI Surgical Glove is substantially equivalent to the predicate.
§ 878.4460 Non-powdered surgeon's glove.
(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's 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).