(118 days)
A 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.
These gloves were tested for use with Chemotherapy Drugs and Fentanyl Citrate per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Non-Sterile Nitrile Patient Examination Glove is made from synthetic rubber latex. It is single use and powderfree variation of the class I Nitrile Patient Examination Gloves which is coated by on-line polymer with mild on-line chlorination process. These processes modify the surface characteristics and causes it to remain tack-free without the use of any dusting or donning powder. The available sizes are X-Small, Medium, Large and X-Large. The Nitrile Examination Gloves Powder Free (Blue & Black) have been tested for Chemotherapy Drugs and Fentanyl Citrate.
This document describes the testing for Nitrile Examination Gloves, focusing on their resistance to chemotherapy drugs and Fentanyl Citrate. The study assesses the gloves' physical properties, biocompatibility, and chemical permeation alongside the reported device performance.
1. Table of Acceptance Criteria and Reported Device Performance
Chemotherapy and Fentanyl Citrate Permeation (Minimum Breakthrough Detection Time)
| Chemotherapy Drugs | Concentration | Acceptance Criteria (from ASTM D6978-05 implied by claim of use) | Reported Device Performance (Blue Glove) | Reported Device Performance (Black Glove) |
|---|---|---|---|---|
| Carmustine (BCNU) | 3.3 mg/ml | No specific public acceptance criterion provided but tested | 22.6 minutes | 21.8 minutes |
| Cisplatin | 1.0 mg/ml | No specific public acceptance criterion provided but tested | >240 minutes | >240 minutes |
| Cyclophosphamide (Cytoxan) | 20.0 mg/ml | No specific public acceptance criterion provided but tested | >240 minutes | >240 minutes |
| Dacarbazine | 10.0 mg/ml | No specific public acceptance criterion provided but tested | >240 minutes | >240 minutes |
| Doxorubicin HCl | 2.0 mg/ml | No specific public acceptance criterion provided but tested | >240 minutes | >240 minutes |
| Etoposide | 20.0 mg/ml | No specific public acceptance criterion provided but tested | >240 minutes | >240 minutes |
| Fluorouracil | 50.0 mg/ml | No specific public acceptance criterion provided but tested | >240 minutes | >240 minutes |
| Ifosfamide | 50.0 mg/ml | No specific public acceptance criterion provided but tested | >240 minutes | >240 minutes |
| Mitoxantrone | 2 mg/ml | No specific public acceptance criterion provided but tested | >240 minutes | >240 minutes |
| Paclitaxel | 6.0 mg/ml | No specific public acceptance criterion provided but tested | >240 minutes | >240 minutes |
| Thiotepa | 10.0 mg/ml | No specific public acceptance criterion provided but tested | 43.9 minutes | 17.7 minutes |
| Vincristine Sulfate | 1.0 mg/ml | No specific public acceptance criterion provided but tested | >240 minutes | >240 minutes |
| Fentanyl Citrate Injection | 100mcg/2ml | No specific public acceptance criterion provided but tested | >240 minutes | >240 minutes |
| Warning | Advised against use if permeation time is too low | Carmustine, Thiotepa warning | Carmustine, Thiotepa warning |
Physical Properties, Dimensional, and Biocompatibility Testing
| Test | Method | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Freedom From Holes | ASTM D6319-19, D5151-19 | Requirement inspection level G-1, AQL 2.5 | Pass |
| Dimension (Length, Thickness, Width) | ASTM D6319-19 | Length: min. 220mm, 230mm. Thickness: min. 0.05mm. Width: 70-120mm (based on size) | Pass (Meets requirements for various sizes) |
| Physical Properties (Before Aging) | ASTM D6319-19 | Tensile Strength: 14 MPa min. Ultimate Elongation: 500% min. | Pass (Meets 14MPa min, 500% min) |
| Physical Properties (After Aging) | ASTM D6319-19 | Tensile Strength: 14 MPa min. Ultimate Elongation: 400% min. | Pass (Meets 14MPa min, 400% min) |
| Residual Powder Content | ASTM D6319-19, D6124-06 | Not more than 2 mg per glove | Pass |
| Primary Skin Irritation Test | ISO 10993-10 | Not a primary skin irritant | Pass (Did not cause an irritant response) |
| Skin Sensitization Test | ISO 10993-10 | Not a contact sensitizer | Pass (Did not produce a skin sensitization effect) |
| In Vitro Cytotoxicity Test | ISO 10993-5:2009 | No adverse biological reaction | Moderate cytotoxicity at 6.0 cm²/mL; No reactivity at 3.0 cm²/mL |
| Acute Systemic Toxicity | ISO 10993-11 | No adverse biological reaction | Pass (No adverse biological reaction) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size (number of gloves) used for the permeation, physical property, or biocompatibility tests.
The data provenance is not explicitly mentioned (e.g., country of origin, retrospective or prospective). However, the tests were conducted according to international standards (e.g., ASTM, ISO), which implies a standardized, prospective testing approach in a laboratory setting. The applicant is based in Malaysia.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is not a study involving expert readers or ground truth established by medical professionals. The "ground truth" for this device is determined by objective, standardized laboratory measurements (e.g., chemical permeation time, physical properties, biological reactions) as defined by the referenced ASTM and ISO standards.
4. Adjudication Method for the Test Set
Not applicable. There was no human adjudication process involved as the "ground truth" is determined by objective laboratory measurements and adherence to specified test standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of medical images or data. The device in question is examination gloves, and its performance is evaluated through physical, chemical, and biological testing, not by human readers interpreting cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable. This is a medical device (examination gloves), not an AI algorithm. Therefore, the concept of "standalone" performance for an algorithm does not apply. All listed tests are "standalone" in the sense that they assess the intrinsic properties of the glove without human intervention in the measurement process itself, though human technicians conduct and analyze the tests.
7. The Type of Ground Truth Used
The ground truth used for this study is based on:
- Performance Standards: Defined by international standards such as ASTM D6978-05 (for chemotherapy drug permeation), ASTM D6319-19, ASTM D5151-19, ASTM D6124-06 (for physical properties and hole freedom), and ISO 10993-10, ISO 10993-5:2009, ISO 10993-11 (for biocompatibility).
- Objective Laboratory Measurements: Direct measurements of breakthrough time, dimensional properties, tensile strength, elongation, residual powder, and biological response to the glove materials.
8. The Sample Size for the Training Set
Not applicable. There is no training set mentioned or implied in this submission, as the device is not an AI/ML algorithm that requires training data.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this device.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 15, 2023
Careglove Global SDN. BHD. Lim Kwee Shyan Managing Director Lot 17479, Lrg Senawang 3/2, Off JIn Senawang 3 Senawang Ind. Estate Seremban, Negeri Sembilan 70450 Malaysia
Re: K230121
Trade/Device Name: Nitrile Examination Gloves Powder Free Tested For Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC, ODO, OPJ Dated: April 10, 2023 Received: April 13, 2023
Dear Lim Shyan:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
{1}------------------------------------------------
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (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.
Bifeng Qian -S
Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known) K230121
Device Name
NTRILE EXAMINATION GLOVES POWDER FREE TESTED FOR USE WITH CHEMOTHERAPY DRUGS & FENTANYL CITRATE (BLUE)
Indications for Use (Describe)
A 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.
These gloves were tested for use with Chemotherapy Drugs and Fentanyl Citrate per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
| Chemotherapy Drugs | Concentration | Minimum Breakthrough Detection Time (Minutes) |
|---|---|---|
| *Carmustine (BCNU) | 3.3 mg/ml | 22.6 |
| Cisplatin | 1.0 mg/ml | >240 min |
| Cyclophosphamide (Cytoxan) | 20.0 mg/ml | >240 min |
| Dacarbazine | 10.0 mg/ml | >240 min |
| Doxorubicin HCl | 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 |
| Mitoxantrone | 2 mg/ml | >240 min |
| Paclitaxel | 6.0 mg/ml | >240 min |
| *Thiotepa | 10.0 mg/ml | 43.9 |
| Vincristine Sulfate | 1.0 mg/ml | >240 min |
| Fentanyl Citrate Injection | 100mcg/2ml | >240 min |
*Please note that following drugs have extremely low permeation times: Carmustine (BCNU) 3.3mg/ml 22.6 minutes Thiotepa 10.0mg/ml 43.9 minutes
Warning: Do not use these gloves with Carmustine or Thiotepa.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
{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}------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known) K230121
Device Name
NITRILE EXAMINATION GLOVES POWDER FREE TESTED FOR USE WITH CHEMOTHERAPY DRUGS & FENTANYL CITRATE (BLACK)
Indications for Use (Describe)
A 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.
These gloves were tested for use with Chemotherapy Drugs and Fentanyl Citrate per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
| Chemotherapy Drugs | Concentration | Minimum Breakthrough Detection Time (Minutes) |
|---|---|---|
| *Carmustine (BCNU) | 3.3 mg/ml | 21.8 |
| Cisplatin | 1.0 mg/ml | >240 min |
| Cyclophosphamide (Cytoxan) | 20.0 mg/ml | >240 min |
| Dacarbazine | 10.0 mg/ml | >240 min |
| Doxorubicin HCl | 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 |
| Mitoxantrone | 2 mg/ml | >240 min |
| Paclitaxel | 6.0 mg/ml | >240 min |
| *Thiotepa | 10.0 mg/ml | 17.7 |
| Vincristine Sulfate | 1.0 mg/ml | >240 min |
| Fentanyl Citrate Injection | 100mcg/2ml | >240 min |
- Please note that following drugs have extremely low permeation times: Carmustine (BCNU) 3.3mg/ml 21.8 minutes Thiotepa 10.0mg/ml 17.7 minutes
Warning: Do not use these gloves with Carmustine or Thiotepa.
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.
{5}------------------------------------------------
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."
{6}------------------------------------------------
510(K) SUMMARY
K230121
| Applicant Name | CAREGLOVE GLOBAL SDN BHD | ||
|---|---|---|---|
| Location | Lot 17479, Lorong Senawang 2/3Off Jalan Senawang 3,Senawang Industrial Estate,70450 Seremban,Negeri Sembilan Darul Khusus,Malaysia. | ||
| Phone No: | (60) 6 6782377 | Fax No: | (60) 6 6785377 |
| Contact Person: | Lim Kwee Shyan | ||
| Summary Preparation Date: | 15th May 2023 |
Device Information
| Trade Name: | NITRILE EXAMINATION GLOVES POWDER FREE TESTED FOR USEWITH CHEMOTHERAPY DRUGS & FENTANYL CITRATE (BLUE & BLACK) |
|---|---|
| Common Name: | POWDER FREE NITRILE EXAMINATION GLOVES |
| Classification Name: | Non-Powdered Patient Examination Gloves |
| Product Code: | LZA, LZC, QDO, OPJ |
| Regulation: | 21CFR:880.6250 |
Predicate Device
Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, 510(K) number K213408 product code LZA, LZC, QDO.
Device Description
Non-Sterile Nitrile Patient Examination Glove is made from synthetic rubber latex. It is single use and powderfree variation of the class I Nitrile Patient Examination Gloves which is coated by on-line polymer with mild on-line chlorination process. These processes modify the surface characteristics and causes it to remain tack-free without the use of any dusting or donning powder. The available sizes are X-Small, Medium, Large and X-Large. The Nitrile Examination Gloves Powder Free (Blue & Black) have been tested for Chemotherapy Drugs and Fentanyl Citrate as below:
{7}------------------------------------------------
| Chemotherapy Drugs | Concentration | Minimum Breakthrough Detection Time (minutes) | |
|---|---|---|---|
| Blue | Black | ||
| *Carmustine (BCNU) | 3.3 mg/ml | 22.6 | 21.8 |
| Cisplatin | 1.0 mg/ml | >240 min | >240 min |
| Cyclophosphamide (Cytoxan) | 20.0 mg/ml | >240 min | >240 min |
| Dacarbazine | 10.0 mg/ml | >240 min | >240 min |
| Doxorubicin HCL | 2.0 mg/ml | >240 min | >240 min |
| Etoposide | 20.0 mg/ml | >240 min | >240 min |
| Fluorouracil | 50.0 mg/ml | >240 min | >240 min |
| Ifosfamide | 50.0 mg/ml | >240 min | >240 min |
| Mitoxantrone | 2 mg/ml | >240 min | >240 min |
| Paclitaxel | 6.0 mg/ml | >240 min | >240 min |
| *Thio Tepa | 10.0 mg/ml | 43.9 | 17.7 |
| Vincristine Sulfate | 1.0 mg/ml | >240 min | >240 min |
| Fentanyl Citrate | 100mcg/2ml | >240 min | >240 min |
| *Please note that following drugs have extremely low permeation times: |
-
Carmustine (BCNU)
-
Thio Tepa
Warning: Do not use with Carmustine and Thiotepa
Indications for Use
A 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.
These gloves were tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
| Chemotherapy Drugs | Concentration | Minimum Breakthrough Detection Time (minutes) | |
|---|---|---|---|
| Blue | Black | ||
| *Carmustine (BCNU) | 3.3 mg/ml | 22.6 | 21.8 |
| Cisplatin | 1.0 mg/ml | >240 min | >240 min |
| Cyclophosphamide (Cytoxan) | 20.0 mg/ml | >240 min | >240 min |
| Dacarbazine | 10.0 mg/ml | >240 min | >240 min |
| Doxorubicin HCL | 2.0 mg/ml | >240 min | >240 min |
| Etoposide | 20.0 mg/ml | >240 min | >240 min |
| Fluorouracil | 50.0 mg/ml | >240 min | >240 min |
| Ifosfamide | 50.0 mg/ml | >240 min | >240 min |
| Mitoxantrone | 2 mg/ml | >240 min | >240 min |
| Paclitaxel | 6.0 mg/ml | >240 min | >240 min |
| *Thio Tepa | 10.0 mg/ml | 43.9 | 17.7 |
| Vincristine Sulfate | 1.0 mg/ml | >240 min | >240 min |
| Fentanyl Citrate | 100mcg/2ml | >240 min | >240 min |
| *Please note that following drugs have extremely low permeation times: |
rugs have extremely low permeation times: owing ul
-
Carmustine (BCNU)
-
Thio Tepa
Warning: Do not use with Carmustine and Thiotepa
{8}------------------------------------------------
Summary of The Technological Characteristic
The Nitrile Examination Gloves Powder Free – Blue & Black, are summarized with the following technological characteristic compared to ASTM D6319 or equivalent standards.
| Characteristic | Standard | Subject DeviceK230121 | Predicate DeviceK213408 | Remarks |
|---|---|---|---|---|
| Product Code | - | LZA, LZC, QDO, OPJ | LZA, LZC, QDO | Same |
| Intended Use | - | Intended for medicalpurposes that is worn on theexaminer's hand to preventcontamination betweenpatient and examiner | Intended for medicalpurposes that is worn on theexaminer's hand to preventcontamination betweenpatient and examiner | Same |
| Design | - | Powder Free, Non-Sterile,Ambidextrous, Beaded Cuff | Powder Free, Non-Sterile,Ambidextrous, Beaded Cuff | Same |
| Indications forUse | - | A patient examination gloveis a disposable deviceintended for medicalpurposes that is worn on theexaminer's hand to preventcontamination betweenpatient and examiner.These gloves were tested foruse with ChemotherapyDrugs and Fentanyl Citrateas per ASTM D6978-05Standard Practice forAssessment of MedicalGloves to Permeation byChemotherapy Drugs. | A patient examination gloveis a disposable deviceintended for medicalpurposes that is worn on theexaminer's hand to preventcontamination betweenpatient and examiner.These gloves were tested foruse with ChemotherapyDrugs and Fentanyl Citrateas per ASTM D6978-05Standard Practice forAssessment of MedicalGloves to Permeation byChemotherapy Drugs. | Same |
| Construction | - | Ambidextrous, PolymerCoated or Chlorinated,Powder Free Nitrile | Ambidextrous, PolymerCoated or Chlorinated,Powder Free Nitrile | Same |
| Color Description | - | Blue & Black | Blue | Different |
| Material | - | Nitrile | Nitrile | Similar |
| Single Use | - | Yes | Yes | Same |
| Packaging | - | Packed in Dispenser Boxes | Packed in Dispenser Boxes | Same |
| Chemo DrugsClaim | - | Chemo Drugs & FentanylCitrate claim | Chemo Drugs & FentanylCitrate claim | Same |
| Sterility | - | Non-Sterile | Non-Sterile | Same |
| Dimension | ||||
| LengthXS, S,M, L, XL | ASTM D6319-19 | Meet 220mm minMeet 230mm min | Minimum 240mm | Similar |
| Thickness (palm),Thickness (finger), | Meet 0.05mm minMeet 0.05mm min | 0.06 - 0.09mm0.07 - 0.10mm | Similar | |
| Width | XS: Meet $70 \pm 10$ mmS: Meet $80 \pm 10$ mmM: Meet $95 \pm 10$ mmL: Meet $110 \pm 10$ mmXL: Meet $120 \pm 10$ mm | 70 - 75 mm80 - 86 mm93 - 97 mm102 - 106 mm114 - 116 mm | Similar | |
| Characteristic | Standard | Subject DeviceK230121 | Predicate DeviceK213408 | Remarks |
| Physical Properties | ||||
| (Before Ageing)i) Tensile Strength(MPa)ii) UltimateElongation (%) | ASTM D6319-19 | Meet 14MPa min.Meet 500% min | Meet 14MPa min.Meet 500% min | Similar |
| (After Aging)i) Tensile Strength(MPa)ii) UltimateElongation (%)Water Leak Test,1000 ml | ASTM D6319-19 | Meets 14MPa minMeet 400% min. | Meets 14MPa minMeet 400% min. | Similar |
| Before Aging, AQL | ASTM D6319-19ASTM D5151-19 | Passes at AQL 1.5 | Passes at AQL 1.5 | Similar |
| Powder FreeResidue | ASTM D6319-19ASTM D6124-06 | Meet 2mg/glove max. | Meet 2mg/glove max | Similar |
| Powder FreeResidue, mg/glove | ||||
| BiocompatibilityTest | ||||
| i) Primary SkinIrritation Test | ISO 10993-10 | PassesConclusion: Under theconditions of this study thetest material did not cause anirritant response | Passes (Not a primary skinirritant)There was no erythema oroedema noted on test siteafter (1±0.1), (24±2), (48±2)and (72±2) hours. The primaryIrritation Index (PII) was "0".Also, no mortality after 72hours. The gloves areconsidered negligible. | Similar |
| ii)Skin SensitizationTest | ISO 10993-10 | PassesConclusion: Under theconditions of this study, thetest material did not produce askin sensitization effect | Passes (Not a contactsensitizer)There was no positive allergicreaction observed during thechallenge phase (at 0, 24hours and 48 hours) inanimals treated with the testmaterial and negative control.Conclusion: Under theconditions of this study, thetest material did not produce askin sensitization effect. | Similar |
| iii) In VitroCytotoxicity Test | ISO 10993-5:2009 | Conclusion: Under conditionof this study, test materialexhibited moderatecytotoxicity reactivity at 6.0cm²/mL extract concentrationsand no cytotoxicity reactivityat the 3.0 cm²/mL extractconcentrations of the test. | Exhibit severe cytotoxicityreactivity at 100%, 50%, and25% extract concentration. Nocytotoxicity reactivity at12.5%, 6.25% and 3.125%extract concentrations. | Similar |
| iv) Acute SystemicToxicity | ISO 10993-11 | Conclusion: Under condition.of this study, the test materialshowed no adverse biologicalreaction after administration ofthe sample's extract on the | Passes (no adverse biologicalreaction) No mortality wasobserved (72±2) hours. | Similar |
| Characteristic | Standard | Subject DeviceK230121 | Predicate DeviceK213408 | Remarks |
| rats during the period of thestudy. |
{9}------------------------------------------------
{10}------------------------------------------------
Summary of Non-Clinical Testing
Following is a table showing the actual measured parameters of the gloves (e.g length, thickness, physical properties, etc.) as compared to ASTM, EN and ISO. All data meets the standard reference requirement.
| Test | Method | Acceptance Criteria | Result | ||||
|---|---|---|---|---|---|---|---|
| Freedom FromHoles | ASTMD6319-19ASTMD5151-19 | Meet requirement inspection level G-1, AQL 2.5 | Pass | ||||
| Dimension | ASTMD6319-19 | Size | Pass | ||||
| XSmall | |||||||
| Small | |||||||
| Medium | |||||||
| Large | |||||||
| XLarge | |||||||
| Length, min. mm | 220 | ||||||
| 230 | |||||||
| Thickness, min. mm | 0.05 | ||||||
| Width, ± 10 mm | 70 | ||||||
| 80 | |||||||
| 95 | |||||||
| 110 | |||||||
| 120 | |||||||
| Physicalproperties | ASTMD6319-19 | Pass | |||||
| Before Aging | |||||||
| After Accelerated Aging | |||||||
| TensileStrength | |||||||
| UltimateElongation | |||||||
| TensileStrength | |||||||
| UltimateElongation | |||||||
| 14 MPa min. | 500% min. | ||||||
| 14 MPa min. | 400 % min. | ||||||
| ResidualPowder Content | ASTMD6319-19ASTMD6124-06 | Not more than 2 mg per glove | Pass | ||||
| Biocompatibility | |||||||
| i) Primary SkinIrritation | ISO 10993-10 | Not a primary skin irritant | Pass | ||||
| ii) SkinSensitization | ISO 10993-10 | Not a contact sensitizer | Pass | ||||
| iii) In VitroCytotoxicity | ISO 10993-5:2009 | No adverse biological reaction | Moderate cytotoxicityreactivity at 6.0 cm²/mLand no reactivity at 3.0cm²/mL extractconcentrations | ||||
| iv) AcuteSystemicToxicity | ISO 10993-11 | No adverse biological reaction | Pass | ||||
| ChemotherapyDrug | Concentration | Minimum Breakthrough Detection Time(minutes) | Remark |
{11}------------------------------------------------
| Proposed Device | Predicate Device | ||||
|---|---|---|---|---|---|
| Blue | Black | Blue | |||
| *Carmustine (BCNU) | 3.3 mg/ml | 22.6 | 21.8 | 22.5 | Different |
| Cisplatin | 1.0 mg/ml | >240 min | >240 min | >240 min | Same |
| Cyclophosphamide(Cytoxan) | 20.0 mg/ml | >240 min | >240 min | >240 min | Same |
| Dacarbazine | 10.0 mg/ml | >240 min | >240 min | >240 min | Same |
| Doxorubicin HCL | 2.0 mg/ml | >240 min | >240 min | >240 min | Same |
| Etoposide | 20.0 mg/ml | >240 min | >240 min | >240 min | Same |
| Fluorouracil | 50.0 mg/ml | >240 min | >240 min | >240 min | Same |
| Ifosfamide | 50.0 mg/ml | >240 min | >240 min | >240 min | Same |
| Mitoxantrone | 2 mg/ml | >240 min | >240 min | >240 min | Same |
| Paclitaxel | 6.0 mg/ml | >240 min | >240 min | >240 min | Same |
| *Thio Tepa | 10.0 mg/ml | 43.9 | 17.7 | 36.1 | Different |
| Vincristine Sulfate | 1.0 mg/ml | >240 min | >240 min | >240 min | Same |
| Fentanyl Citrate | 100mcg/2ml | >240 min | >240 min | >240 min | Same |
| Warning | Please note that following drugs have extremely low permeation times:1. Carmustine (BCNU) (3.3 mg/ml) 2. Thio Tepa (10 mg/ml) | *Please note that following drugs have extremely low permeation times:1. Carmustine (BCNU) (3.3 mg/ml)2. Thio Tepa (10 mg/ml) | Similar |
Summary of Clinical Testing
Not applicable.
CONCLUSIONS
The conclusions drawn from the non-clinical tests demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device, K213408, Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate.
§ 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.