(206 days)
A surgeon's glove is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:
Chemotherapy Drug Permeation
The following chemicals have been tested with these gloves.
Carmustine (BCNU) 3.3mg/ml 30.4
Cisplatin 1.0mg/ml > 240
Cyclophosphamide (Cytoxan) 20.0mg/ml > 240
Dacarbazine 10.0mg/ml > 240
Doxorubicin Hydrochloride 2.0mg/ml > 240
Etoposide (Toposar) 20.0mg/ml > 240
Fluorouracil 50.0mg/ml > 240
Ifosfamide 50.0mg/ml > 240
Mitoxantrone 2.0mg/ml > 240
Paclitaxel (Taxol) 6.0mg/ml > 240
Thiotepa 10.0mg/ml 59.0
Vincristine Sulfate 1.0mg/ml > 240
CAUTION: Testing showed an average breakthrough time of 30.4 minutes for Carmustine and an average breakthrough time of 59.0 minutes for Thiotepa.
Powder Free Nitrile Surgical Glove, Sterile meets all the requirements of ASTM standard D3577-09, D6978-05 and FDA 21 CFR 878.4460.
The powder free nitrile surgical glove is manufactured from synthetic rubber latex. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder on the glove surface. The glove is hand specific. The physical properties of glove i.e. tensile strength meet ASTM standard D3577-09.
This document describes the acceptance criteria and performance study for the Powder Free Nitrile Surgical Glove, Sterile, Tested for use with Chemotherapy Drugs (K161823).
1. Table of Acceptance Criteria and Reported Device Performance
The device's performance was evaluated against ASTM standards for various characteristics and against the ASTM D6978-05 standard for chemotherapy drug permeation.
| Characteristic | Standard / Acceptance Criteria | Reported Device Performance |
|---|---|---|
| General | ||
| Intended Use | Protection against surgical wound contamination, tested for chemotherapy drugs. | Meets intended use; tested for chemotherapy drugs per ASTM D6978. |
| Material | ASTM D3577-09 (for surgical gloves) | Nitrile (Synthetic Rubber Latex) |
| Color | - | Natural |
| Texture | - | Micro roughened |
| Dimensions | ASTM D3577-09 | Meets |
| Length | ASTM D3577-09: Min 270mm | Min 270mm |
| Width | ASTM D3577-09 | Meets (specific sizes listed: 5 ½ : 70±6mm, 6 : 76±6mm, etc.) |
| Thickness (Finger, Palm, Cuff) | ASTM D3577-09: Min 0.10mm | Meets: Min 0.10mm (for finger, palm, cuff) |
| Physical Properties Before Aging | ASTM D3577-09 | Meets |
| Tensile Strength | 7MPa min | 7MPa min |
| Ultimate Elongation | 650% min | 650% min |
| Stress at 500% Elongation | 7.0MPa min | 7.0MPa min |
| Physical Properties After Aging | ASTM D3577-09 | Meets |
| Tensile Strength | 12MPa min | 12MPa min |
| Ultimate Elongation | 490% min | 490% min |
| Watertight | ASTM D5151-06; 21CFR 800.20 & ASTM D3577 AQL 1.5 | Meets 21 CFR 800.20 and ASTM D3577 when tested in accordance with ASTM D5151 Inspection Level 1, AQL 1.5 |
| Powder Free | ASTM D6124-06 (≤ 2 mg/glove); ASTM D3577 requirements | Meets requirements of ≤2.0 mg/glove for Powder-Free designation per ASTM D3577 |
| Chemotherapy Drug Permeation (ASTM D6978-05) | ||
| Carmustine (BCNU) (3.3mg/ml) | Acceptance criteria not explicitly stated, but compared to predicates. | 30.4 minutes |
| Cisplatin (1.0mg/ml) | Acceptance criteria not explicitly stated, but compared to predicates. | > 240 minutes |
| Cyclophosphamide (Cytoxan) (20.0mg/ml) | Acceptance criteria not explicitly stated, but compared to predicates. | > 240 minutes |
| Dacarbazine (10.0mg/ml) | Acceptance criteria not explicitly stated, but compared to predicates. | > 240 minutes |
| Doxorubicin HCl (2.0mg/ml) | Acceptance criteria not explicitly stated, but compared to predicates. | > 240 minutes |
| Etoposide (Toposar) (20.0mg/ml) | Acceptance criteria not explicitly stated, but compared to predicates. | > 240 minutes |
| Fluorouracil (50.0mg/ml) | Acceptance criteria not explicitly stated, but compared to predicates. | > 240 minutes |
| Ifosfamide (50.0mg/ml) | Acceptance criteria not explicitly stated, but compared to predicates. | > 240 minutes |
| Mitoxantrone (2.0mg/ml) | Acceptance criteria not explicitly stated, but compared to predicates. | > 240 minutes |
| Paclitaxel (Taxol) (6.0mg/ml) | Acceptance criteria not explicitly stated, but compared to predicates. | > 240 minutes |
| Thiotepa (10.0mg/ml) | Acceptance criteria not explicitly stated, but compared to predicates. | 59.0 minutes |
| Vincristine Sulfate (1.0mg/ml) | Acceptance criteria not explicitly stated, but compared to predicates. | > 240 minutes |
| Biocompatibility | ||
| Primary Skin Irritation | ISO 10993-10:2010(E) & Consumer Product Safety Commission, Tittle 16, Chapter II, Part 1500 | Passes; Not a primary skin irritant |
| Dermal Sensitization | ISO 10993-10:2010(E) & Consumer Product Safety Commission, Tittle 16, Chapter II, Part 1500.3(c)(4) | Passes; Not a contact sensitizer |
| Labeling | Medical Glove Guidance Manual - Labeling | Meets (Sizes: 5 ½, 6.0, 6 ½, 7.0, 7 ½, 8.0, 8 ½, 9.0) |
| Single Use | Medical Glove Guidance Manual - Labeling | Single use |
| Sterility Status | Medical Glove Guidance Manual - Labeling | Sterile |
Note regarding Chemotherapy Drug Permeation: For Carmustine and Thiotepa, a "CAUTION" statement is included, indicating average breakthrough times of 30.4 minutes and 59.0 minutes, respectively. This implies that while the glove offers some protection, it is not indefinitely resistant to these specific drugs, and users should be aware of these breakthrough times. The other listed drugs showed breakthrough times greater than 240 minutes, indicating high resistance under the tested conditions.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each specific test (e.g., number of gloves tested for watertightness, number of samples for chemotherapy permeation). However, it indicates adherence to relevant ASTM standards (D3577-09, D6978-05, D5151-06, D6124-06) and ISO standards (ISO 10993-10), which would dictate appropriate sample sizes for these types of tests.
The data provenance is not explicitly stated in terms of country of origin for the testing, but the submitter is WRP Asia Pacific Sdn Bhd, located in Malaysia. The testing adheres to international and US standards (ASTM, ISO, 21 CFR), suggesting a globally recognized testing methodology. The studies are non-clinical performance tests.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not applicable as the ground truth for medical gloves is established through objective physical, chemical, and biological testing against established international and national standards (ASTM, ISO, FDA regulations). There is no mention of human expert assessment or consensus being used to establish a "ground truth" for the device's performance characteristics in the way it might be for diagnostic AI.
4. Adjudication Method for the Test Set
This is not applicable as the evaluation relies on objective measurements and compliance with predefined standards, not on human interpretation or adjudication of subjective data.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
This is not applicable. An MRMC study is relevant for evaluating the impact of an AI system on human reader performance, typically in diagnostic imaging. This document describes the testing of a medical device (surgical glove) based on its physical properties and resistance to chemicals, which does not involve human readers interpreting data alongside an AI.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
This is not applicable. The device is a physical product (surgical glove), not an AI algorithm. Its performance is measured directly through laboratory tests.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established by:
- Performance against established standards: This includes physical property measurements (tensile strength, elongation, dimensions), impermeability (watertightness), chemical resistance (chemotherapy drug permeation), cleanliness (powder-free), and biocompatibility (skin irritation, sensitization) as defined by ASTM and ISO standards and FDA regulations.
- The metrics are objective and quantitatively measured (e.g., length in mm, breakthrough time in minutes, mg/glove for powder, MPa for tensile strength).
8. The Sample Size for the Training Set
This is not applicable. The device is a physical product, not an AI model. Therefore, there is no "training set" in the context of machine learning. The manufacturing process is likely subject to quality control and statistical process control, which involves ongoing testing and process adjustments, but this is distinct from an AI training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the reason stated in point 8.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a series of interconnected human profiles.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 23, 2017
WRP Asia Pacific Sdn Bhd Sarala Jayaraman Regulatory Affairs Manager Lot 1, Jalan 3, Kaw Perusahaan Bandar Baru Salak Tinggi Sepang, 43900 MY
Re: K161823
Trade/Device Name: Powder Free Nitrile Surgical Glove, Sterile, Tested for use with Chemotherapy Drugs Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: Class I Product Code: KGO, LZC
Dated: December 15, 2016
Received: December 19, 2016
Dear Sarala Jayaraman:
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
{1}------------------------------------------------
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.
Michael J. Ryan -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known) K161823
Device Name
Powder Free Nitrile Surgical Glove, Sterile, Tested for use with Chemotherapy Drugs
Indications for Use (Describe)
A surgeon's glove is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:
Chemotherapy Drug Permeation
The following chemicals have been tested with these gloves.
| Chemotherapy Drug | Concentration | Breakthrough Detection Time in Minutes |
|---|---|---|
| *Carmustine (BCNU) | 3.3mg/ml | 30.4 |
| Cisplatin | 1.0mg/ml | > 240 |
| Cyclophosphamide (Cytoxan) | 20.0mg/ml | > 240 |
| Dacarbazine | 10.0mg/ml | > 240 |
| Doxorubicin Hydrochloride | 2.0mg/ml | > 240 |
| Etoposide (Toposar) | 20.0mg/ml | > 240 |
| Fluorouracil | 50.0mg/ml | > 240 |
| Ifosfamide | 50.0mg/ml | > 240 |
| Mitoxantrone | 2.0mg/ml | > 240 |
| Paclitaxel (Taxol) | 6.0mg/ml | > 240 |
| *Thiotepa | 10.0mg/ml | 59.0 |
| Vincristine Sulfate | 1.0mg/ml | > 240 |
CAUTION: Testing showed an average breakthrough time of 30.4 minutes for Carmustine and an average breakthrough time of 59.0 minutes for Thiotepa.
Type of Use (Select one or both, as applicable)
[] Prescription Use (Part 21 CFR 801 Subpart D)
区 Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
{3}------------------------------------------------
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{4}------------------------------------------------
1.0 Submitter:
| Name: | Sarala Devi Jayaraman |
|---|---|
| Address: | WRP Asia Pacific Sdn BhdLot 1, Jalan 3, Kawasan Perusahaan Bandar Baru Salak Tinggi,43900 Sepang, Selangor Darul Ehsan, MALAYSIA |
| Phone No.: | +60 3 8706 1486 |
| Fax No.: | +60 3 8706 1485 |
Date of Summary Prepared: 12 January 2017
2.0 Name of the modified device Identification:
Powder Free Nitrile Surgical Glove, Sterile, Tested for use with Chemotherapy Drugs 510(k) Number: K161823 Common Name: Surgical Gloves Classification Name: Surgeon's Gloves (21 CFR 878.4460 product code KGO) Patient Examination Gloves Specialty (21 CFR 880.6250 product code LZC)
3.0 Identification of The Legally Marketed Devices that equivalency is claimed:
| Predicate 1 | Predicate 2 | |
|---|---|---|
| Manufacturer | Cardinal Health200, LLC | MedlineIndustries,Incorporated |
| Device name | Cardinal Health™Sterile NeoprenePowder-freeSurgical Gloveswith NitrileCoating andTested for UsewithChemotherapyDrugs(Yellow) | SensiCare PISurgical Gloves |
| 510(k) Number | K153316 | K152428 |
| Regulatory Class | I | I |
| Product Code | KGO, LZC | KGO, LZC |
4.0 Description of The Device:
Powder Free Nitrile Surgical Glove, Sterile meets all the requirements of ASTM standard D3577-09, D6978-05 and FDA 21 CFR 878.4460.
The powder free nitrile surgical glove is manufactured from synthetic rubber latex. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder on the glove surface. The glove is hand specific. The physical properties of glove i.e. tensile strength meet ASTM standard D3577-09.
{5}------------------------------------------------
5.0 Intended Use of the Device:
A surgeon's glove is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. The device has also been tested for use with chemotherapy drugs.
These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:
| Chemotherapy Drug Permeation | ||
|---|---|---|
| The following chemicals have been tested with these gloves. | ||
| Chemotherapy Drug | Concentration | Breakthrough DetectionTime in Minutes |
| *Carmustine (BCNU) | 3.3mg/ml | 30.4 |
| Cisplatin | 1.0mg/ml | > 240 |
| Cyclophosphamide (Cytoxan) | 20.0mg/ml | > 240 |
| Dacarbazine | 10.0mg/ml | > 240 |
| Doxorubicin Hydrochloride | 2.0mg/ml | > 240 |
| Etoposide (Toposar) | 20.0mg/ml | > 240 |
| Fluorouracil | 50.0mg/ml | > 240 |
| Ifosfamide | 50.0mg/ml | > 240 |
| Mitoxantrone | 2.0mg/ml | > 240 |
| Paclitaxel (Taxol) | 6.0mg/ml | > 240 |
| *Thiotepa | 10.0mg/ml | 59.0 |
| Vincristine Sulfate | 1.0mg/ml | > 240 |
CAUTION: Testing showed an average breakthrough time of 30.4 minutes for Carmustine and an average breakthrough time of 59.0 minutes for Thiotepa.
6.0 Summary of the Technological Characteristics of the Device:
The Powder Free Nitrile Surgical Glove, Sterile are summarized with the following technological characteristics compared to ASTM D3577 or equivalent standards as shown in Table 1
Compliant to chemotherapy claim whereby glove thickness and length meets minimal thickness of 0.10 mm and minimal length of 270 respectively.
{6}------------------------------------------------
Table 1
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | ||
|---|---|---|---|---|
| Predicate 1 | Predicate 2 | Current | ||
| Manufacturer(s) | Cardinal Health200, LLC | Medline Industries,Incorporated | WRP Asia PacificSdn Bhd | |
| 510(k) Number | K153316 | K152428 | K161823 | |
| Intended use | - | A powder-freesterile surgeon'sglove isa disposable devicemade of syntheticrubber intended tobe worn byoperatingroom personnel toprotect a surgicalwound fromcontamination.In addition, thesegloves were testedforuse withchemotherapydrugs inaccordance withASTM D6978Standard Practicefor Assessment ofMedical Gloves toPermeation byChemotherapyDrugs. | The SensiCare PIsurgeon'sglove is adisposable devicemade of syntheticrubberintended to beworn by operatingroom personnel toprotect asurgical woundfromcontamination. Inaddition, thesegloves were testedfor use withchemotherapydrugs inaccordance withASTM D6978Standard Practicefor Assessmentof Medical Gloves toPermeationby ChemotherapyDrugs.Warning: Do notuse withCarmustine andThiotepa | A powder-freesterile surgeon'sglove is adisposable devicemade of syntheticrubber intended tobe worn byoperating roompersonnel toprotect a surgicalwound fromcontamination. Inaddition, thesegloves were testedforuse withchemotherapydrugs inaccordance withASTM D6978Standard Practicefor Assessment ofMedical Gloves toPermeation byChemotherapyDrugs.*CAUTION: Testingshowed an averagebreakthrough timeof 30.4 minutes forCarmustine and anaveragebreakthrough timeof 59.0 minutes forThiotepa. |
| Material | ASTM D3577-09 | Synthetic NeoprenePolymer coated withNitrile | SyntheticPolyisoprene | Nitrile |
| Color | - | Yellow | Cream colored.Contains ablend of threecolorants(naphthos AS red, azoyellow and carbonblack) | Natural |
| Texture | - | Micro roughened | ||
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | ||
| 510(k) Number | ASTM D3577-09 | Predicate 1K153316 | Predicate 2K152428 | CurrentK161823 |
| Dimensions | ASTM D3577-09 | Meets | Meets | Meets |
| Length | ASTM D3577-09 | Min 270mm | Min 270mm | Min 270mm |
| Width | ASTM D3577-09 | Meets | Meets5 ½ : 70±6mm6 : 76±6mm6 ½ : 83±6mm7 : 89±6mm7 ½ : 95±6mm8 : 102±6mm8 ½ : 108±6mm9 : 114±6mm | Meets5 ½ : 70±6mm6 : 76±6mm6 ½ : 83±6mm7 : 89±6mm7 ½ : 95±6mm8 : 102±6mm8 ½ : 108±6mm9 : 114±6mm |
| Thickness- Finger- Palm- Cuff | ASTM D3577-09 | Meets | MeetsMin 0.10mmMin 0.10mmMin 0.10mm | MeetsMin 0.10mmMin 0.10mmMin 0.10mm |
| Physical PropertiesBefore AgingTensile Strength :UltimateElongation :Stress at 500%Elongation : | ASTM D3577-09 | Meets | Meets7MPa min650% min7.0MPa min | Meets7MPa min650% min7.0MPa min |
| Physical PropertiesAfter AgingTensile Strength :UltimateElongation : | ASTM D3577-09 | Meets | Meets12MPa min490% min | Meets12MPa min490% min |
| Watertight(1000ml) | ASTM D5151-06 | Meets 21CFR800.20 & ASTMD3577requirements ofAQL 1.5 | Meets 21 CFR800.20 andASTM D3577when tested inaccordance withASTM D5151Inspection Level1, AQL 1.5 | Meets 21 CFR800.20 andASTM D3577when tested inaccordance withASTM D5151Inspection Level1, AQL 1.5 |
| Powder Free | ASTM D6124-06(≤ 2 mg/glove) | Meetsrequirements of≤2.0 mg/glovefor Powder-Freedesignation perASTM D3577 | <2mg of residualpowder whentested inaccordance withASTM D3577 | Meetsrequirements of≤2.0 mg/glovefor Powder-Freedesignation perASTM D3577 |
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | ||
| Predicate 1 | Predicate 2 | Current | ||
| 510(k) Number | K153316 | K152428 | K161823 | |
| Chemotherapy DrugPermeation Test | ASTM D6978-05 | |||
| TestChemotherapyDrug | Concentration | Minimum Breakthrough Detection Time (min) | ||
| *Carmustine (BCNU) | 3.3mg/ml | 60.1 | 10.1 | 30.4 |
| Cisplatin | 1.0mg/ml | > 240 | > 240 | > 240 |
| Cytarabine | 100.0mg/ml | > 240 | - | |
| Cyclophosphamide(Cytoxan) | 20.0mg/ml | > 240 | > 240 | > 240 |
| Dacarbazine | 10.0mg/ml | - | > 240 | > 240 |
| DoxorubicinHydrochloride | 2.0mg/ml | > 240 | > 240 | > 240 |
| Etoposide (Toposar) | 20.0mg/ml | > 240 | > 240 | > 240 |
| Fluorouracil | 50.0mg/ml | > 240 | > 240 | > 240 |
| Ifosfamide | 50.0mg/ml | - | > 240 | > 240 |
| Methotrexate | 25.0mg/ml | > 240 | > 240 | - |
| Mitoxantrone | 2.0mg/ml | - | > 240 | > 240 |
| Mitomycin C | 0.5mg/ml | > 240 | > 240 | - |
| Paclitaxel (Taxol) | 6.0mg/ml | > 240 | > 240 | > 240 |
| *Thiotepa | 10.0mg/ml | 110.5 | 11.6 | 59.0 |
| Vincristine Sulfate | 1.0mg/ml | > 240 | > 240 | > 240 |
| Warning Statement | Under the testconditionsprescribed by thetest, theminimumnormalizedbreakthroughdetection timesfor each of the 11chemotherapydrugs testedexceeded themaximumtesting time of240 minutesexcept forCarmustine(BCNU) (3.3mg/ml), whichshowedpermeation timeof60.1 minutes, andThiotepa(10 mg/ml), whichshowedpermeation timeof 110.5minutes. | Please note thatthe followingdrugs haveextremely lowpermeation timeof less than 30minutes:Carmustine(3.3 mg/ml) has aminimumbreakthrough timeof 10.1 minutes;Thiotepa (10.0mg/ml) has aminimumbreakthroughtime of 11.6minutes. | CAUTION: Testingshowed anaveragebreakthrough timeof 30.4 minutesfor Carmustineand an averagebreakthrough timeof 59.0 minutesfor Thiotepa. | |
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | ||
| Predicate 1 | Predicate 2 | Current | ||
| 510(k) Number | K153316 | K152428 | K161823 | |
| Biocompatibility | Primary SkinIrritation -ISO 10993-10:2010(E) &Consumer ProductSafety Commission,Tittle 16, ChapterII, Part 1500 | Non-Irritating,under theconditions ofthe study | Under theconditions of thestudy(per ISO 10993-10), the device isnot an irritant | PassesNot a primaryskin irritantunder theconditions of thestudy. |
| Biocompatibility | DermalSensitization -ISO 10993-10:2010(E) &Consumer ProductSafety Commission,Tittle 16, ChapterII, Part1500.3(c)(4) | Non-sensitizing,under theconditions ofthe study | Under theconditions of thestudy(per ISO 10993-10), the device isnot a sensitizer | PassesNot a contactsensitizer underthe conditions ofthe study. |
| Size | Medical GloveGuidance Manual -Labeling | - | 5½6.06½7.07½8.08½9.0 | 5½6.06½7.07½8.08½9.0 |
| Single Use | Medical GloveGuidance Manual -Labeling | Single use | Single use | Single use |
| Sterility Status | Medical GloveGuidance Manual -Labeling | Sterile | Sterile | Sterile |
{7}------------------------------------------------
{8}------------------------------------------------
{9}------------------------------------------------
{10}------------------------------------------------
7.0 Substantial Equivalence Based on Assessment of Non-Clinical Performance Data
The performance test data of the non-clinical tests that support a determination of substantial equivalence is the same as mentioned immediately above (ASTM Requirements).
The device and the predicates share the same intended use, same material, same specifications for thickness and length, similar labeling according to the glove guidance, and same compliance with standards for physical properties, powder free, biocompatibility and water tightness. Thus, the device is substantially equivalent to the predicates.
Current device compliant to chemotherapy claim whereby glove thickness and length meets minimal thickness of 0.10 mm and minimal length of 270 respectively.
Substantial Equivalent Based on Assessment of Clinical Performance Data 8.0
Not applicable - Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.
9.0 Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the leqally marketed predicate devices.
§ 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).