(87 days)
The Nitrile Powder Free patient examination glove is non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid.
KIMTECH™ Purple Nitrile™ Examination Gloves, Powder Free, Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric acid and Fentanyl in Simulated Gastric acid are single use only, non-sterile, disposable gloves. The powder-free gloves are made of a synthetic copolymer of acrylonitrile and butadiene with a purple color additive. The gloves are available in extra small, medium, large, and extra-large sizes.
This document is a 510(k) Premarket Notification for KIMTECH™ Purple Nitrile™ Powder Free Examination Gloves. It focuses on demonstrating that the proposed device is substantially equivalent to legally marketed predicate devices, particularly concerning its resistance to permeation by chemotherapy drugs, fentanyl citrate, simulated gastric acid, and fentanyl in simulated gastric acid.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the permeation resistance of the gloves are defined by the "Minimum Breakthrough Detection Time" for each substance. For other characteristics, the acceptance criteria are generally "Complies with" or "Pass" based on recognized ASTM and ISO standards.
| Attribute/Test | Standard/Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Chemotherapy Drugs (Permeation Time) | ASTM D6978-05 (Re-approved 2013): Minimum Breakthrough Detection Time (implied requirement is to demonstrate significant barrier, often >240 min for most drugs but with specific exceptions) | Reported Breakthrough Detection Time (minutes) |
| Blenoxane | >240 | >240 |
| Busulfan | >240 | >240 |
| Carmustine (BiCNU) | (Note: Extremely low permeation time reported) | >3.6 (Warning: Do Not Use With) |
| Cisplatin | >240 | >240 |
| Cyclophosphamide/cytoxan | >240 | >240 |
| Cytarabine | >240 | >240 |
| Dacarbazine (DTIC) | >240 | >240 |
| Daunorubicin | >240 | >240 |
| Docetaxel | >240 | >240 |
| Doxorubicin | >240 | >240 |
| Ellence | >240 | >240 |
| Etoposide/Toposar | >240 | >240 |
| Fludarabine | >240 | >240 |
| Fluorouracil | >240 | >240 |
| Gemcitabine | >240 | >240 |
| Idarubicin | >240 | >240 |
| Ifosfamide | >240 | >240 |
| Irinotecan | >240 | >240 |
| Mechlorethamine HCL | >240 | >240 |
| Melphalan | >240 | >240 |
| Methotrexate | >240 | >240 |
| Mitomycin C | >240 | >240 |
| Mitoxantrone | >240 | >240 |
| Paclitaxel | >240 | >240 |
| Paraplatin | >240 | >240 |
| Rituximab | >240 | >240 |
| Thiotepa | (Note: Extremely low permeation time reported) | >15.9 (Warning: Do Not Use With) |
| Trisenox | >240 | >240 |
| Vincristine Sulfate | >240 | >240 |
| Opioid Fentanyl Citrate (Permeation Time) | ||
| Fentanyl Citrate | >240 | >240 |
| Simulated Gastric Acid (Permeation Time) | ||
| Gastric Acid (simulated) | >240 | >240 |
| Fentanyl in Simulated Gastric Acid (Permeation Time) | ||
| Fentanyl in Gastric Acid | >240 | >240 |
| Dimensions: Overall Length | ASTM D6319 Minimum: 230mm | All sizes comply with length dimensions |
| Dimensions: Width (mean) | ASTM D6319 Minimum: 70 + 10mm (implied range based on standard) | All sizes comply with length dimensions |
| Dimensions: Palm & Finger Thickness | ASTM D6319 Min. Palm: 0.05mm, Finger: 0.05mm | All sizes comply with length dimensions |
| Tensile Strength: Before Aging | ASTM D6319 Min: 14MPa | Complies both before and after accelerated aging |
| Tensile Strength: After Aging | ASTM D6319 Min: 14MPa | Complies both before and after accelerated aging |
| Ultimate Elongation: Before Aging | ASTM D6319 Minimum: 500% | Complies both before and after accelerated aging |
| Ultimate Elongation: After Aging | ASTM D6319 Minimum: 400% | Complies both before and after accelerated aging |
| Freedom from Holes | ASTM D6319 G1, AQL 2.5 (7 Accept, 8 Reject) | Pass |
| Powder-Free | ASTM D6319 Maximum <2mg/glove | Less than 2.0mg per glove; Pass |
| Biocompatibility: Systemic Toxicity | ISO 10993-11: No systemic response in model animal | Under conditions of the study, the device extracts did not elicit a systemic response in the model animal. |
| Biocompatibility: Primary Skin Irritation | ISO 10993-10: Not irritant to animal model | Under conditions of this study, the polar and non-polar device extracts were found not to be an irritant to the animal model. |
| Biocompatibility: Sensitization (Guinea pig Maximization) | ISO 10993-10: Not sensitizers to animal model | Under Conditions of this study, the polar and non-polar device extracts were found not to be sensitizers to the animal model. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the sample sizes used for each specific test (e.g., how many gloves were tested for permeation for each drug). However, it references standards like ISO 2859 Sampling Procedures and Tables for Inspection by Attributes, indicating that sampling was conducted according to recognized statistical methods for quality control.
The data provenance is not explicitly stated in terms of country of origin or retrospective/prospective. However, considering it's a 510(k) submission, the data would typically be derived from laboratory tests conducted for the purpose of the submission. The "Test Results Follow" tables imply that the data presented is the result of direct testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable to this type of device submission. The "ground truth" for glove performance (like permeation, tensile strength, or freedom from holes) is established through physical and chemical testing against defined standards (ASTM, ISO), not through expert consensus or interpretation of complex medical images/data. There are no "experts" establishing a clinical ground truth for these performance tests.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among human readers or experts when establishing a clinical ground truth, often in image-based diagnostic studies. For physical device testing, the results are typically quantitative measurements or pass/fail determinations against scientific standards, not subject to human adjudication in that manner.
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. MRMC studies are relevant for AI-powered diagnostic tools where human readers are interpreting medical images or data. This document describes a physical medical device (examination gloves) and its performance against chemical permeation and physical characteristics; it does not involve AI or human readers for diagnostic purposes.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. This device is not an algorithm or AI. It is a physical product, and its performance is measured independently in a laboratory setting.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The "ground truth" for the performance claims of these gloves is based on objective measurements and adherence to established industry standards (ASTM D6978-05 for permeation, ASTM D6319 for physical properties, ISO 10993 for biocompatibility). The results are direct measurements of physical and chemical resistance, not subjective interpretations or clinical outcomes data.
8. The Sample Size for the Training Set
This information is not applicable. There is no "training set" in the context of this device. Training sets are used for machine learning algorithms. The performance of these gloves is determined through physical testing, not by training a model.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reason stated in point 8.
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April 10, 2020
Kimberly-Clark Corporation % Wava Truscott Consultant Truscott MedSci Associates, LLC 180 Burkemeade Ct Roswell, Georgia 30075
Re: K200072
Trade/Device Name: KIMTECH Purple Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs, the Opioid Fentanyl Citrate, Simulated Gastric acid, and Fentanyl in Simulated Gastric acid Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC, QDO Dated: January 15, 2020 Received: January 16, 2020
Dear Wava Truscott:
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/cfpmp/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.
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
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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 (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,
David Krause
for CAPT 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
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Indications for Use
510(k) Number (if known) K200072
Device Name
KIMTECH™ Purple Nitrile™ Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentany1 Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid
Indications for Use (Describe)
The Nittile Powder Free patient examination glove is non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. Test Results Follow:
| Chemotherapy Drug | Concentration | Minimum Breakthrough Detection Time |
|---|---|---|
| Blenoxane | (15mg/mL),(15,000 ppm) | >240 |
| Busulfan | (6mg/mL),(6,000 ppm) | >240 |
| Carmustine (BiCNU) | (3.3mg/mL),(3,300 ppm) | >3.6 |
| Cisplatin | (1mg/mL),(1,000 ppm) | >240 |
| Cyclophosphamide/cytoxan | (20mg/mL),(20,000 ppm) | >240 |
| Cytarabine | (100mg/mL),(100,000 ppm) | >240 |
| Dacarbazine(DTIC) | (10mg/mL),(10,000 ppm) | >240 |
| Daunorubicin | (5mg/mL),(5,000 ppm) | >240 |
| Docetaxel | (10mg/mL),(10,000ppm) | >240 |
| Doxorubicin | (2mg/mL),(2,000 ppm) | >240 |
| Ellence | (2mg/mL),(2,000 ppm) | >240 |
| Etoposide/Toposar | (20mg/mL,(20,000 ppm) | >240 |
| Fludarabine | (25mg/mL),(25,000 ppm) | >240 |
| Fluorouracil | (50mg/mL),(50,000 ppm) | >240 |
| Gemcitabine | (38mg/mL),(38,000 ppm) | >240 |
| Idarubicin | (1mg/mL),(1,000 ppm) | >240 |
| Ifosfamide | (50mg/mL),(50,000 ppm) | >240 |
| Irinotecan | (20mg/mL),(20,000 ppm) | >240 |
| Mechlorethamine HCL | (1 mg/mL),(1,000 ppm) | >240 |
| Melphalan | (5mg/mL),(5,000 ppm) | >240 |
| Methotrexate | (25mg/mL),(25,000 ppm) | >240 |
| Mitomycin C | (0.5mg/mL),(500 ppm) | >240 |
| Mitoxantrone | (2mg/mL),(2,000 ppm) | >240 |
| Paclitaxel | (6mg/mL),(6,000 ppm) | >240 |
| Paraplatin | (10mg/mL),(10,000 ppm) | >240 |
| Rituximab | (10mg/mL),(10,000 ppm) | >240 |
| Thiotepa | (10mg/mL),(10,000 ppm) | >15.9 |
| Trisenox | (0.1 mg/mL),(100 ppm) | >240 |
| Vincristine Sulfate | (1 mg/ m ),(1,000 ppm) | >240 |
| Fentanyl Citrate | 100mcg/2mL | >240 |
| Gastric Acid (simulated) | 0.2% NaCl in 0.7% HCL | >240 |
| Fentanyl in Gastric Acid | 50/50 Mix | >240 |
Note: Carmustine and Thiotepa have extremely low permeation times of 3.6 and 15.9 minutes respectively Warning: Do Not Use With: Carmustine, Thiotepa
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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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The information contained herein is being provided in accordance with the requirements of 21 CFR 807.92(c).
510(k) Number: K200072
Preparation Date: April 6, 2020 510(k) Summary
KIMTECH™ Purple Nitrile™ Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid
1. Submitter:
| Company Name:Address:Country:Phone: | Kimberly-Clark Corporation1400 Holcomb Bridge RoadRoswell, GA 30076United States of America+1 770 587 8000 |
|---|---|
| Contact Person: | Juan M. MarquezDirector, Regulatory AffairsKimberly-Clark Corporation1400 Holcomb Bridge RoadRoswell, GA 30076 |
| Phone | +1 678-352-6069 |
| Fax | +1920-969-4863 |
| E-mail: | Juan.M.Marquez@kcc.com |
2. Correspondent:
| Correspondent: | Wava Truscott, PhD. |
|---|---|
| Company Name: | Truscott MedSci Associates, LLC |
| Address: | 180 Burkemeade Ct.Roswell, GA 30075 |
| Phone: | +1 (678) 860-1550 |
| Fax: | +1 (770) 552-2887 |
| Email: | Wava.Truscott@gmail.com |
3. Device information:
| Device Trade Name: | KIMTECH™ Purple Nitrile™ Powder free Examination Gloves Tested forUse with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated GastricAcid, and Fentanyl in Simulated Gastric Acid |
|---|---|
| Classification Name: | Patient Examination Glove |
| Classification: | Class I (general controls) |
| Regulation Number: | 21 CFR 880-6250 |
| Common name: | Powder-free Nitrile Exam Glove for use with Chemotherapy drugs andFentanyl |
| Product Code: | LZC, LZA, QDO |
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4. Predicate Device:
K170686: Brightway Non-Powdered Nitrile Examination Glove Tested for use with Chemotherapy gloves: LZA, LZC (Subject Glove is exactly the same glove, but seeking the additional QDO claim)
K182241: Non-Sterile Powder-Free Nitrile Examination Glove Black Tested for use with Chemotherapy gloves: LZA, LZC, QDO
5. Description of the Device:
KIMTECH™ Purple Nitrile™ Examination Gloves, Powder Free, Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric acid and Fentanyl in Simulated Gastric acid are single use only, non-sterile, disposable gloves. The powder-free gloves are made of a synthetic copolymer of acrylonitrile and butadiene with a purple color additive. The gloves are available in extra small, medium, large, and extra-large sizes.
6. Indications for Use:
The Nitrile Powder Free patient examination glove is non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
| Test Results Follow:Chemotherapy Drug | Concentration | Minimum Breakthrough Detection Time |
|---|---|---|
| Blenoxane | (15mg/mL),(15,000 ppm) | >240 |
| Busulfan | (6mg/mL),(6,000 ppm) | >240 |
| Carmustine(BiCNU) | (3.3mg/mL),(3,300 ppm) | >3.6 |
| Cisplatin | (1mg/mL),(1,000 ppm) | >240 |
| Cyclophosphamide/cytoxan | (20mg/mL),(20,000 ppm) | >240 |
| Cytarabine | (100mg/mL),(100,000 ppm) | >240 |
| Dacarbazine(DTIC) | (10mg/mL),(10,000 ppm) | >240 |
| Daunorubicin | (5mg/mL),(5,000 ppm) | >240 |
| Docetaxel | (10mg/mL),(10,000ppm) | >240 |
| Doxorubicin | (2mg/mL),(2,000 ppm) | >240 |
| Ellence | (2mg/mL),(2,000 ppm) | >240 |
| Etoposide/Toposar | (20mg/mL),(20,000 ppm) | >240 |
| Fludarabine | (25mg/mL),(25,000 ppm) | >240 |
| Fluorouracil | (50mg/mL),(50,000 ppm) | >240 |
| Gemcitabine | (38mg/mL),(38,000 ppm) | >240 |
| Idarubicin | (1mg/mL),(1,000 ppm) | >240 |
| Ifosfamide | (50mg/mL),(50,000 ppm) | >240 |
| Irinotecan | (20mg/mL),(20,000 ppm) | >240 |
| Mechlorethamine HCL | (1 mg/mL),(1,000 ppm) | >240 |
| Melphalan | (5mg/mL),(5,000 ppm) | >240 |
| Methotrexate | (25mg/mL),(25,000 ppm) | >240 |
| Mitomycin C | (0.5mg/mL),(500 ppm) | >240 |
| Mitoxantrone | (2mg/mL),(2,000 ppm) | >240 |
| Paclitaxel | (6mg/mL),(6,000 ppm) | >240 |
| Paraplatin | (10mg/mL),(10,000 ppm) | >240 |
| Rituximab | (10mg/mL),(10,000 ppm) | >240 |
| Thiotepa | (10mg/mL),(10,000 ppm) | >15.9 |
| Trisenox | (0.1 mg/mL),(100 ppm) | >240 |
| Vincristine Sulfate | (1 mg/m),(1,000 ppm) | >240 |
| Fentanyl Opioid and Gastric acid tested as follows: | ||
| Fentanyl Citrate | 100mcg/2mL | >240 |
| Gastric Acid (simulated) | 0.2% NaCl in 0.7% HCL | >240 |
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Fentanyl in Gastric Acid 50/50 Mix >240 Note: Carmustine and Thiotepa have extremely low permeation times of 3.6 and 15.9 minutes respectively Warning: Do Not Use With: Carmustine, Thiotepa
| Attributes | StandardWhere TestSets Limits | a) PredicateDevice:K182241 | b) PredicateDevice: K170686 | Subject Device Glove | How Does SubjectGlove Compare toPredicates |
|---|---|---|---|---|---|
| Common Nameof Device Type | NA | ExaminationGlove | ExaminationGlove | ExaminationGlove | a) Sameb) Same |
| Base Material | NA | Nitrile | Nitrile | Nitrile | c) Samed) Same |
| Color | NA | Black | Purple | Purple | a) Different thanK182241; but,biocompatibility, &physical attributes,show difference incolor has notaltered glove safetyor performanceb) Identical toK170686 |
| Gloveformulation | NA | Owners ownproprietaryformula | KC Purple Nitrile9.5 ChemoFormulation | KC Purple Nitrile9.5 ChemoFormulation | a) Different thanK182241, actualformula unknownb) Identical toK170686 |
| Product Codes | NA | LZA, LZC, QDO | LZA, LZC | LZA, LZC, QDO | a) Sameb) Similar-no QDO |
| Sterile vs Non-Sterile | NA | Non-Sterile | Non-Sterile | Non-Sterile | a) Sameb) Same |
| Prescription orOTC | NA | OTC | OTC | OTC | a) Sameb) Same |
| Attributes | StandardWhereLimitsTestLimits Set | a) PredicateDevice: K182241 | b) PredicateDevice: K170686 | Subject DeviceGlove | How DoesSubject GloveCompare toPredicates |
| Single Use-Disposable | NA | Yes | Yes | Yes | a) Sameb) Same |
| Intended Use | NA | The device is adisposable deviceintended formedical purposesthat is worn on theexaminer's hand orfinger to preventcontaminationbetween patientand examiner. | The device is adisposable deviceintended formedical purposesthat is worn on theexaminer's hand orfinger to preventcontaminationbetween patientand examiner. | The device is adisposable deviceintended formedical purposesthat is worn on theexaminer's hand orfinger to preventcontaminationbetween patientand examiner. | a) Sameb) Same |
| Indications foruse (summary) | NA | In addition toroutineexaminationglove's intendeduse, the SubjectGlove was Testedfor use withchemotherapydrugs and theopioid FentanylSEE Below forspecifics | In addition toroutineexaminationglove's intendeduse, the SubjectGlove was Testedfor use withChemotherapydrugsSEE Below forspecifics | KIMTECHTMPurple NitrileTMPowder FreeExaminationGloves Tested forUse withChemotherapyDrugs, theFentanyl Citrate,Gastric acid, andFentanyl inGastric acidSEE Below forspecifics | a) Similar: Bothtested withChemotherapy drugsbut some drugsdifferent. Both alsotested for Fentanyl,but Subject glovealso tested withgastric acid andFentanyl in gastricacidb) similar: Becausethey are same glove,same Chemo drugstest breakthroughtimes identical toK170686; becausesame test data, butsubject glove alsotested for Fentanylcitrate, gastric acid,and Fentanyl ingastric acid to becleared for QDOclaims |
| Attributes | StandardTestsWhereLimits Set | a) PredicateDevice: K182241Chemotherapydrugs tested: | b) PredicateDevice: K170686Chemotherapydrugs tested: | Subject Device GloveChemotherapydrugs tested: | How DoesSubject GloveCompare toPredicates |
| Indicationsfor UseClaims | ASTMD6978 -05Re -approved2013 | • Carmustine(BCN U)• Cisplatin,• Cyclophosphamide(Cytoxan),• Dacarbazine(DTIC)• DoxorubicinHydrochloride,• Etoposide(Toposar)• Fluorouracil,• Methotrexate• Paclitazel (Taxol),• Thiotepa• Vincristine SulfateNote Carmustine(BCN U) andThiotepa havelow permeationtimesIn Addition:• Fentanyl | • Blenoxane• Busulfan• Carmustine• Cisplatin• Cyclophosphamide/Cytoxan• Cytarabine• Dacarbazine• Daunorubicin• Docetaxel• Doxorubicin• Ellence• Etoposide/Toposar• Fluorouracil• Gemcitabine• Idarubicin• Ifosfamide• Mechlorethamine HCL• Melphalan• Methotrexate• Mitomycin C• Mitoxantrone• Paclitaxel• Paraplatin• Rituxmab• Thiotepa• Trisenox• Vincristine SulfateAll >240min exceptThioTEPA;Ca1mustine | • Blenoxane• Busulfan• Carmustine• Cisplatin• Cyclophosphamide/Cytoxan• Cytarabine• Dacarbazine• Daunorubicin• Docetaxel• Doxorubicin• Ellence• Etoposide/Toposar• Fluorouracil• Gemcitabine• Idarubicin• Ifosfamide• Mechlorethamine HCL• Melphalan• Methotrexate• Mitomycin C• Mitoxantrone• Paclitaxel• Paraplatin• Rituximab• Thiotepa• Trisenox• Vincristine SulfateAll >240min exceptThioTEPA; Carmustine• Fentanyl Citrate• Gastric acid• Fentanyl Citrate inGastric acid | a) Similar: bothtested CHEMODrugs forpem1eation, butSubject glovetested more. Bothtested Fentanyl, butSubject glove alsotested Gastricacidb) Similar: Thesubject glove haslisted the same29Chemotherapydrugs as (b) becausesame glove andthe data fromK170686 used forSubject glove datasubmission, but theglove has now alsobe e n tested withadditional Fentanyland Gastric Acid toacquire the QDOcode. |
| Attributes | StandardWhere LimitsTestLimits Set | a) Predicate Device:K182241 | b) Predicate Device:K170686 | Subject Device Glove | How Does SubjectGlove Compare toPredicates |
| Caution/WarningStatements | NA | Note Carmustine(BCNU) andThiotepa havelow permeationtimes | Note: Carmustineand Thiotepahave extremelylow permeationtimes of 3.6 and15.9 minutesrespectively.WARNING:Not for usewith:Carmustine,Thiotepa | Note: Carmustineand Thiotepahave extremelylow permeationtimes of 3.6 and15.9 minutesrespectively.WARNING:Not for Use With:Carmustine,Thiotepa | a) Similar:PredicateK182241 doesnot list thebreakthroughtimes in the"Note," nor doesit instruct wearernot to use withCarmustine,Thiotepa. SubjectGlove is moreinformativeb) Same |
| Dimensions:Overall length | ASTM D6319Minimum:230mm | All sizes comply withlength dimensions | All sizes comply withlength dimensions | All sizes comply withlength dimensions | Same |
| Dimensions:Width (mean) | ASTM D6319Minimum: 70+10mm | All sizes comply withlength dimensions | All sizes comply withlength dimensions | All sizes comply withlength dimensions | Same |
| Dimensions:Palm & FingerThickness | ASTM D6319Min.Palm:0.05mmFinger:0.05mm | All sizes comply withlength dimensions | All sizes comply withlength dimensions | All sizes comply withlength dimensions | Same |
| Tensilestrength:Before &After Aging | ASTM D6319Min Before:14MPaAfter: 14Mpa | Complies bothbefore and afteraccelerated aging | Complies bothbefore and afteraccelerated aging | Complies bothbefore and afteraccelerated aging | Same |
| Attributes | Standard WhereLimits TestLimits Set | a) Predicate Device: K182241 | b) Predicate Device:K170686 | Subject Device Glove | How DoesSubject GloveCompare toPredicates |
| UltimateelongationBefore & Afteraging | ASTMD6319Minimum:Before: 500%After:400% | Complies bothbefore and afteraccelerated aging | Complies bothbefore and afteraccelerated aging | Complies both beforeand after acceleratedaging | Same |
| Freedom fromholes: | ASTMD6319 G1,AQL 2.57 Accept8 Reject | Pass | Pass | Pass | Same |
| Powder-Free | ASTMD6319Maximum<2mg/glove | Less than 2.0mgper glove;Pass | Less than 2.0mgper glove;Pass | Less than 2.0mgper glove;Pass | Same |
| Biocompatibility | ISO10993- 11SystemicToxicityTest | Under conditionsof the study, thedevice extracts didnot elicit asystemicresponse in themodel animal. | Under conditionsof the study, thedevice extracts didnot elicit asystemicresponse in themodel animal. | Under conditionsof the study, thedevice extracts didnot elicit asystemicresponse in themodel animal. | Same |
| ISO10993-10PrimarySkinIrritationon Rabbits | Under Condit ionsof this study, thepolar and non-polar deviceextracts werefound not to be anirritant to theanimal model. | Under Condit ionsof this study, thepolar and non-polar deviceextracts werefound not to be anirritant to theanimal model. | Under Condit ionsof this study, thepolar and non-polar deviceextracts werefound not to be anirritant to theanimal model. | Same | |
| ISO10993-10Magnusson& KligmanGuinea pigMaximization | Under Conditions of thisstudy, the polarand non- polardevice extractswere found notto besensitizers tothe animalmodel. | Under Conditionsof this study, thepolar and non-polar deviceextracts werefound not to besensitizers to theanimal model. | Under Conditions ofthis study, the polarand non- polardevice extractswere found not tobe sensitizers to theanimal model. | Same |
7. Predicate & Subject Technological Characteristics Comparison Table
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8. Summary of Non-Clinical Performance Tests:
Non-Clinical Testing was conducted to demonstrate that the proposed device met all required design specifications. The test results demonstrated that the proposed device met the performance criteria as specified utilizing the following test methods, standards, and specifications:
ASTM D6319-10 Standard D6319-10 Standard Specification for Nitrile Examination Gloves for Medical Application
ASTM D412-2006a (Reapproved 2013) Standard Test Method for Vulcanized Rubber and Thermoplastic Elastomers-Tension
ASTM D573-2004 (Reapproved 2010) Standard Test Method for Rubber-Deterioration in an Air Oven
ASTM D3767-03 Standard Practice for Rubber Measurement of Dimensions
ASTM D5151-2006 (Reapproved 2015) Standard Test Method for Detection of holes in Medical Gloves
ASTM D6124-2006 (Reapproved 2015) Standard Tested Method for Residual Powder on Medical Gloves
ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs
ISO 2859 Sampling Procedures and Tables for Inspection by Attributes
ISO 10993-10 Biological Evaluation of medical Devices-Part 10: Tests for Irritation and Sensitization
ISO 10993-11 Biological Evaluation of Medical Devices-Part 11: Tests for Systemic Toxicity
9. Conclusion:
The conclusions drawn is that the physical attributes and the nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as, or better than, the legally marketed predicate devices.
§ 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.