(125 days)
A Nitrile powder free examination glove is a disposable device intended for medical purposes, worn on the examiner's hand or finger to prevent contamination between examiner and patient. This specially glove has also been tested with Chemotherapy drugs and the Opioid Fentanyl citrate.
The K212613 gloves are produced as nitrile synthetic gloves. They are manufactured without natural rubber latex. The nitrile gloves are blue in color, disposable, single-use only, non-sterile, medical examination gloves. K212613 meets all the requirements of ASTM D6978-10(2019) Standard Specifications for Examination Gloves for Medical Applications. They have been tested for use with chemotherapy drugs and the opioid Fentanyl citrate, both of which were evaluated using ASTM D6378-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
The provided document describes the acceptance criteria and performance of Powder Free Nitrile Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs and Opioid Fentanyl Citrate (Blue). The evaluation is based on non-clinical performance tests, not clinical studies involving human or animal subjects. Therefore, sections related to human reader studies, ground truth establishment by experts, and training set information are not applicable.
Here's the information extracted from the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6978-2005 (2019) | Permeation by Chemotherapy Drugs | Minimum breakthrough detection time > 240 minutes for most drugs | All Chemotherapy Drugs & the Opioid passed >240 min except Carmustine (13.0 min) & ThioTepa (37.9 min) |
| ASTM D412-2016 | Physical properties (Tensile strength) | Minimum 14 Mpa | Pass |
| ASTM D412-2016 | Physical properties (Elongation) | Minimum 400% | Pass |
| ASTM D5151-19 | Water-leak test | AQL 1.5 (ISO 2859-1) | Pass |
| ASTM D6124-06 (2017) | Residual powder test | < 2mg/glove | Pass |
| ISO 10993-10:2010 (2016) | Dermal Irritation | Under conditions of this study, the subject device is non-irritating | Pass |
| ISO 10993-10:2010 (2016) | Skin Sensitization | Under conditions of this study, the subject device is non-sensitizing | Pass |
| ISO 10993-11: Tests for Systemic Toxicity | Systemic Toxicity (Biocompatibility) | Under the conditions of the Systemic Toxicity test, the predicate glove showed no adverse biological reaction. | Passes (Subject device used ISO 10993-11 as an accepted alternative to the predicate's ISO 10993-5) |
| ISO 10993-5 (Cytotoxicity) | Cytotoxicity (Biocompatibility) | Not explicitly stated for subject device, but predicate passed at certain concentrations | Not directly tested for subject device; ISO 10993-11 Acute Systemic Toxicity was used as an accepted alternative |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes (e.g., number of gloves) used for each non-clinical test. The tests are standard industry tests (e.g., ASTM, ISO standards) typically performed by manufacturers and independent labs. The data provenance is from the manufacturer's testing (Koon Seng Sdn. Bhd. located in Malaysia) or accredited laboratories performing these standard tests. These are non-clinical, controlled laboratory tests, not retrospective or prospective clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as the evaluation is based on objective, non-clinical laboratory tests according to specified standards, not expert interpretation of outputs like in AI/imaging studies.
4. Adjudication method for the test set
This is not applicable as the evaluation is based on objective, non-clinical laboratory tests.
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
No such study was done. This device is an examination glove, not an AI-assisted diagnostic tool.
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 (gloves), not an algorithm. The tests performed are standalone evaluations of the glove's physical and chemical resistance properties.
7. The type of ground truth used
The "ground truth" for the performance criteria is defined by established international and national standards for medical gloves (e.g., ASTM D6978, ASTM D412, ASTM D5151, ASTM D6124, ISO 10993). These standards specify the test methodologies and acceptable limits for physical properties, chemical permeation, and biocompatibility.
8. The sample size for the training set
This is not applicable as this is not a machine learning or AI device.
9. How the ground truth for the training set was established
This is not applicable as this is not a machine learning or AI device. The "ground truth" for the performance of the gloves is established by adherence to the objective criteria and methods outlined in the mentioned ASTM and ISO standards for medical devices and materials.
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December 21, 2021
Koon Seng Sdn Bhd % Wava Truscott President Truscott MedSci Associates, LLC. 180 Burkemeade Ct. Roswell, Georgia 30075
Re: K212613
Trade/Device Name: Powder Free Nitrile Examination Gloves, Non-sterile,Tested For Use with Chemotherapy Drugs and Opioid Fentanyl Citrate (Blue) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-powdered patient examination glove Regulatory Class: Class I. reserved Product Code: LZA, LZC, OPJ, QPO Dated: November 15, 2021 Received: November 22, 2021
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/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.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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.
Clarence W. Murray, III, PhD 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)
K212613
Device Name
Trade Name: Powder Free Nitrile Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs and the Opiod Fentanyl Citrate (Blue)
Indications for Use (Describe) A Nitrile powder free examination glove is a disposable device intended for medical purposes, worn on the examiner's hand or finger to prevent contamination between examiner and patient. This specially glove has also been tested with Chemotherapy drugs and the Opioid Fentanyl citrate.
| Chemotherapy Drugs and the opioid Fentanyl citrate were tested for breakthrough detection times: | |||
|---|---|---|---|
| -- | -- | -- | -------------------------------------------------------------------------------------------------- |
| TESTCHEMOTHERAPY DRUG | CONCENTRATIONTESTED | MINIMUM BREAKTHROUGHDETECTION TIME (MINUTES) |
|---|---|---|
| Carmustine (BCNU) | 3.3 mg/ml | 13.0 |
| Cisplatin | 1.0 mg/ml | No Breakthrough Up To 240 minutes |
| Cyclophosphamide (Cyloxan) | 20.0 mg/ml | No Breakthrough Up To 240 minutes |
| Cytarabine | 100.0 mg/ml | No Breakthrough Up To 240 minutes |
| Dacarbazine (DTIC) | 10.0 mg/ml | No Breakthrough Up To 240 minutes |
| Doxorubicin Hydrochloride | 2.0 mg/ml | No Breakthrough Up To 240 minutes |
| Etoposide (Toposar) | 20.0 mg/ml | No Breakthrough Up To 240 minutes |
| Fluorouracil | 50.0 mg/ml | No Breakthrough Up To 240 minutes |
| Ifosfamide | 50.0 mg/ml | No Breakthrough Up To 240 minutes |
| Methotrexate | 25.0 mg/ml | No Breakthrough Up To 240 minutes |
| Mitomycin C | 0.5 mg/ml | No Breakthrough Up To 240 minutes |
| Mitoxantrone | 2.0 mg/ml | No Breakthrough Up To 240 minutes |
| Pacitaxel (Taxol) | 6.0 mg/ml | No Breakthrough Up To 240 minutes |
| Thiotepa | 10.0 mg/ml | 37.9 |
| Vincristine Sulfate | 1.0 mg/ml | No Breakthrough Up To 240 minutes |
Important: Carmustine and Thiolepa have extremely low minimal breakthrough times of 13.0 minutes and 37.9 minutes respectively. Warning: Do not use with Carmusline or Thiotepa.
| TEST OPIOID DRUG | CONCENTRATIONTESTED | MINIMUM BREAKTHROUGHDETECTION TIME (MINUTES) |
|---|---|---|
| Fentanyl Citrate (Injectable) | 100.0 mg/2ml | No Breakthrough up to 240 minutes |
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image is a logo featuring two golden hands overlapping each other, set against a black background. The logo is encircled by a golden ring, and the text "Delivering Quality Excellence in Gloves" is written around the ring. The text is in a smaller font size and follows the curve of the circle.
QUALITY, TRANSPARENCY, PARTNER
OON SENG SDN. BHD = (107051-H)
(A member of the KS Group) Corporate Sales Office: 1321, 13th Floor, BlockA, Lift Lobby &, Damancara Intan No.1,
Jin. SS 20/27, 47400 Petaling Jaya, Selangor. Factory 1 : PTD 3274, Batu 41/2, Jalan Bakri, 84000 Muar, Johor, Factory 2 : PTD 16058, Kaw. Perindustrian Tangkak, 84900 Tangkak, Johor.
Email : koonseng@koonseng.com Website : www.koonseng.com Tel : 603- 7733 1388
Tel : 606-9868446 , 606-986 9257 Fax: 606-986 6908 Tel: 606-979 1778 , 606-978 2780 Fax: 606-979 1779
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K212613: 510(k) Summary
| 1.0 | Submitter | |||
|---|---|---|---|---|
| Name | : | Koon Seng, Sdn. Bhd. | ||
| Address | : | PTD 16058, Kawasan Perindustrian Tangkak,84900 Tangkak, Johor, Malaysia | ||
| Contact | : | Yeo Pai Shuang | ||
| Phone No. | : | +603-7733 1388 | ||
| Fax No. | : | +603-7733 6499 | ||
| Date of Preparation | : | June 29, 2021 | ||
| 2.0 | Name of the Device | |||
| Common Name | : | Nitrile Powder Free Examination Glove | ||
| Trade Name | : | Powder Free Nitrile Examination Gloves, Non-sterile,Tested for Usewith Chemotherapy Drugs and the Opioid Fentanyl Citrate (Blue) | ||
| Classification Name | : | Patient Examination Glove Specialty (21CFR 880.6250) | ||
| Product Codes | : | LZA, LZC, OPJ, QDO | ||
| Device Class | : | Class I | ||
| 3.0 | Predicate: Identification of Legally Marketed Device | |||
| Predicate 510(k) No. | : | K192954 | ||
| Trade Name | : | Blue Colored, Powder Free Nitrile Examination Gloves Tested for Use withChemotherapy Drugs and Fentanyl Citrate | ||
| Owner | : | Comfort Rubber Gloves Industries Sdn. Bhd. | ||
| Product Codes | : | LZA, LZC, QDO | ||
| Device Class | : | Class I |
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Image /page/4/Picture/0 description: The image shows the logo for Koon Seng. Above the name is the text "Quality - Transparency - Partnership". Below the name is the text "Since 1987".
4.0 Description of Subject Device
The K212613 gloves are produced as nitrile synthetic gloves. They are manufactured without natural rubber latex. The nitrile gloves are blue in color, disposable, single-use only, non-sterile, medical examination gloves. K212613 meets all the requirements of ASTM D6978-10(2019) Standard Specifications for Examination Gloves for Medical Applications. They have been tested for use with chemotherapy drugs and the opioid Fentanyl citrate, both of which were evaluated using ASTM D6378-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
5.0 Indications for Use
A Nitrile powder free examination glove is a disposable device intended for medical purposes, worn on the examiner's hand or finger to prevent contamination between examiner and patient. This specialty glove has also been tested for use with Chemotherapy drugs and the Opioid Fentanyl citrate.
| Test Chemotherapy Drug | Concentration | Minimum Breakthrough Detection Time(minutes) |
|---|---|---|
| Carmustine (BCNU) | 3.3 mg/mL | 13 min. |
| Cisplatin | 1.0 mg/mL | >240 min. |
| Cyclophosphamide (Cytoxan) | 20.0 mg/mL | >240 min. |
| Cytarabine | 100 mg/mL | >240 min. |
| Dacarbazine | 10.0 mg/mL | >240 min. |
| Doxorubicin | 2.0 mg/mL | >240 min. |
| Etoposide | 20.0 mg/mL | >240 min. |
| Fluorouracil | 50.0 mg/mL | >240 min. |
| Ifosfamide | 50.0 mg/mL | >240 min. |
| Methotrexate | 25.0 mg/mL | >240 min. |
| Mitomycin C | 0.5 mg/mL | >240 min. |
| Mitoxantrone | 2.0 mg/mL | >240 min. |
| Paclitaxel | 6.0 mg/mL | >240 min. |
| ThioTepa | 10.0 mg/mL | 37.9 min |
| Vincristine Sulfate | 1.0 mg/mL | >240 min. |
| Important: Carmustine and ThioTepa have extremely low minimum breakthrough times of13.0 minutes and 37.9 minutes respectively. | ||
| Warning: Do not use with Carmustine or ThioTepa. | ||
| Test Opioid Drug | Concentration | Minimum Breakthrough Detection Time(minutes) |
| Fentanyl Citrate Injection | 100mcg/2mL | >240 min. |
| Please Note: Glove used for protection against possible Chemotherapy Drug exposureshould be selected specifically for the type of drugs used. Users should review drug labelingor material safety data sheets for the drugs being used to determine an adequate level ofprotection. |
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Image /page/5/Picture/0 description: The image shows the logo for Koon Seng. The logo includes the words "Quality • Transparency • Partnership" at the top. Below that is the name "KOON SENG" in large, bold letters. Finally, the words "Since 1987" are at the bottom of the logo.
Technological Characteristic Comparison:
Shown below is a comparison of The Powder Free Nitrile Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs and Opioid Fentanyl Citrate (Blue) and Blue Colored, Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate.
Glove Comparison Table":
| Subject | Standards | Koon Seng SubjectDevice510(k): K212613 | Predicate Device:510(k): K192954 | Comparison K212613Subject glove toPredicate K192954 |
|---|---|---|---|---|
| Manufacturers | NA | Koon Seng Sdn. Bhd. | Comfort Rubber GlovesIndustries Sdn. Bhd. | Different |
| Trade Name | NA | Powder Free NitrileExamination Gloves, Non-Sterile, Tested for Use withChemotherapy Drugs and theOpiod Fentanyl Citrate (Blue) | Blue Colored, Powder FreeNitrile Examination GloveTested for Use withChemotherapy Drugs andFentanyl Citrate | Different |
| CommonName | ASTM D6319 -10(2019) | Nitrile Powder free PatientExamination Glove | Nitrile PatientExamination Glove | Similar |
| Device Class | 21 CFR880.6250 | Class 1 | Class 1 | Same |
| Base Material | NA | Nitrile | Nitrile | Same |
| Color | NA | Blue | Blue | Same |
| Product Codes | 21 CFR880.6250 | LZA, LZC, OPJ, QDO | LZA, LZC, QDO | Similar OPJ is new: denotestested with Chemotherapydrugs to further define theLZC specialty designation |
| Sizes offered | ASTM D3767 | Extra SmallSmallMediumLargeExtra Large | Extra SmallSmallMediumLargeExtra Large | Same |
| Dimensions: | ASTM D6319 -10(2019) | Meets | Meets | Same |
| Sterile v.Non-Sterile | NA | Non-Sterile | Non-Sterile | Same |
| Prescription orOTC | NA | OTC | OTC | Same |
| Single Use-Disposable | NA | Single use-Disposable | Single use-Disposable | Same |
| Thickness:Finger & palm | ASTM D6319 -10(2019) | Meets | Meets | Same |
| Before agingPhysicalProperties | ASTM D412ASTM D6319 -10(2019) | Meets | Meets | Same |
| After agingPhysicalProperties | ASTM D412ASTM D6319 | Meets | Meets | Same |
| Freedom fromHoles | ASTM D5151ASTM D6319 | Meets AQL 1.5 | Meets AQL 1.5 | Same |
| Subject | Standards | Koon Seng SubjectDevice510(k): K212613 | Predicate Device:510(k): K192954 | Comparison K212613Subject glove toPredicate K192954 |
| Powder-Free | ASTM D6124< 2mg/glove | Meets | Meets | Same |
| Intended Use(part ofIndications forUse) | A Nitrile powder freeexamination glove is adisposable device intendedfor medical purposes, wornon the examiner's hand orfinger to preventcontamination betweenexaminer and patient. Thisspecialty glove has also beentested for use withChemotherapy drugs and theOpioid Fentanyl citrate. | A patient examinationglove is a disposabledevice intended formedical purpose that isworn on the examiner'shand to preventcontamination betweenpatient and examiner. | Similar | |
| Indications forUseChemotherapy | ASTM D6978 | Chemotherapy drugs:All >240min BreakthroughTimes except Carmustine &ThioTEPA• Cisplatin, 1mg/ml• Cyclophosphamide(Cytoxan), 20mg/ml• Cytarabine, 100mg/ml• Dacarbazine, 10mg/ml• Doxorubicin HCL, 2mg/ml• Etoposide, 20mg/ml• Fluorouracil, 50mg/ml• Ifosfamide, 50mg/ml• Methotrexate, 25mg/ml• Mitomycin C, 0.5mg/ml• Mitoxantrone, 2mg/ml• Paclitaxel, 6mg/ml• Vincristine Sulfate,mg/ml• Carmustine (BCNU), 3.3mg/ml:Breakthrough: 13 min.• ThioTepa, 10mg/mlBreakthrough: 37.9 min. | Chemotherapy drugs:All>240min BreakthroughTimes except Carmustine &ThioTEPA•Cisplatin 1mg/ml• Cyclophosphamide(Cytoxan) 20mg/ml• Dacarbazine (DTIC) 10mg/ml• Doxorubicin HCL, 2mg/ml• Hydrochloride 2mg/ml• Etoposide (Toposar)20mg/ml• FluorouracilS0mg/ml• Paclitaxel (Taxol)6mg/ml• Carmustine (BCNU) 3.3mg/ml:Breakthrough: 18.2 min.• ThioTepa (THT) 10mg/ml:Breakthrough: 57.3 min. | Similar |
| Subject | Standards | Koon Seng SubjectDevice510(k): K212613 | Predicate Device:510(k): K192954 | Comparison K212613Subject glove toPredicate K192954 |
| Cautions &Warnings | Important: Carmustine andThioTEPA have extremely lowminimal breakthrough times of13.0 minutes and37.9 minutes respectively.Warning: Do not use withCarmustine or ThioTepa | Please note that thefollowing drugs haveextremely low permeationtimes: Carmustine (BCNU):18.2minutes and Thiotepa:57.3 minutes. Warning:Do not use withCarmustine. | Similar: except Subjectdevice added ThioTepa tothe " Warning: Do not usewith..." listing. Technically,it is not required to do soas the cut-off to requirethe warning is below 30minutes. | |
| Indications forUse: Fentanyl | ASTM D6978 | Fentanyl Citrate (Injectable)100mg/2ml:Minimumbreakthrough time: >240 | Fentanyl Citrate 100mg/2ml:Minimum breakthrough time:>240 | Similar: Fentanyl Citrateconcentration & diluentsame. US DEA requiredtesting street injectableterm by test lab in testresults |
| Biocompatibility | ISO 10993-11: Testsfor SystemicToxicity | PassesUnder the conditions of TheSystemic Toxicity test thepredicate glove showed noadverse biological reaction. | (Used Accepted Alternative:ISO 10993-5 (Cytotoxicity) | Similar: Used Differentalternativebiocompatibilitytest method: Bothacceptable |
| ISO 10993-5Cytotoxicity | (Used Accepted Alternative:ISO 10993-11 Acute SystemicToxicity) | Passed at: Exhibits severecytotoxicity reactivity at100%, and 66% extractconcentrations and nocytotoxicity reactivity at44%, 30%, 20% and 15%extract concentrationsunder the condition of thistest. | Similar: Used DifferentAccepted AlternativeBiocompatibility test | |
| ISO 10993-10SkinIrritation | PassesUnder conditions of thisstudy, subject glove is non-irritating | PassesUnder conditions of thestudy, the device is non-irritating | Same | |
| ISO 10993-10DermalSensitization | PassesUnder conditions of thisstudy, subject glove is anon-sensitizer | PassesUnder conditions of thestudy, the device is non-sensitization | Same |
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Summary of Non-Clinical Performance Tests conducted
| Test Method | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ASTM D6978-2005(2019) | Permeation byChemotherapy Drugs | Minimum detection time >240minute | All Chemotherapy Drugs & theOpioid Passed >240min. exceptCarmustine & ThioTepa |
| ASTM D412-2016ASTM D573-04(2019) | Physical properties | Tensile strength(min=14Mpa); Elongation (min400%) | Pass |
| ASTM D5151-19 | Water-leak test | AQL 1.5 (ISO 2859-1) | Pass |
| ASTM D6124-06(2017) | Residual powder test | <2mg/glove | Pass |
| ISO 10993-10:2010(2016) | Dermal Irritation | Under conditions of this study,the subject device is non-irritating | Pass |
| ISO 10993-10:2010(2016) | Skin Sensitization | Under conditions of this study,the subject device is non-sensitizing | Pass |
Non-clinical performance testing method full Titles:
- ASTM D412 Test Methods for Vulcanized Rubber and Thermoplastic Elastomers— Tension O
- O ASTM D573 Test Method for Rubber—Deterioration in an Air Oven x ASTM D3578 Specificationfor Rubber Examination Gloves
- ASTM D6319 Standard Specification for Nitrile Examination Gloves for Medical Application O
- ASTM D5151 Test Method for Detection of Holes in Medical Gloves O
- O ASTM D6124 Test Method for Residual Powder on Medical Gloves
- O ISO 2859 Sampling Procedures and Tables for Inspection by Attributes Test results show that under the conditions of the testing, there is no difference in physical attributes between the proposed device and the predicate device.
- O ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs
Biocompatibility Testing was performed utilizing: ISO 10993 Biological Evaluation of Medical Devices
- ISO 10993 Part 10: Tests for Irritation and Sensitization. Both Skin Irritation and Dermal O Magnuson/Kligman Sensitization performed.
- ISO 10993 Part 11: Tests for assessment of Systemic Toxicity O
No human clinical or animal performance testing was performed.
Conclusion: The conclusions drawn from comparing 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 device.
§ 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.