(77 days)
A patient examination glove is a disposable device intended for medical purpose 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 as per ASTM D6978-05 (2019), Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs: Test Chemotherapy Drugs are as follows: Carmustine 3.3mg/ml, Cisplatin 1 mg/ml, Cyclophosphamide 20 mg/ml, Dacarbazine 10 mg/ml, Doxorubicin, HCl 2 mg/ml, Etoposide 20 mg/ml, Fluorouracil 50 mg/ml, Methotrexate 25 mg/ml, Mitomycin 0.5 mg/ml, Oxaliplatin 5 mg/ml, Paclitaxel 6 mg/ml, Thiotepa 10 mg/ml, Vincristine 1 mg/ml. Test Fentanyl Citrate are as follows: Fentanyl Citrate Injection 100mcg/2ml. Warning: Do not use with Carmustine and Thiotepa. Please note that the following drugs have low permeation times: (1)Carmustine - 14.1 minutes (2)Thiotepa - 57.2 minutes.
Nitrile Powder Free Blue Patient Examination Gloves Non-sterile, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate meets all the requirements of ASTM standards D6319-19, D6978-05 (2019) and FDA 21 CFR 880.6250. Nitrile Powder Free Blue Patient Examination Gloves Non-sterile, Tested For Use With Chemotherapy Drugs are Class I patient examination gloves bear the product code Nitrile - LZA, LZC, OPJ and QDO (21CFR880.6250). The gloves are made from acrylonitrile-butadiene copolymer dispersion. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves without using any lubricant such as powder on the glove surface. These gloves are blue in color and are powder free. The gloves are ambidextrous i.e., can be worn on right hand or left hand, single use disposable devices that come in five sizes (XS, S, M, L and XL). The physical properties of glove, i.e., tensile strength meet ASTM D 6319-19.
The provided document is a 510(k) summary for Nitrile Powder Free Blue Patient Examination Gloves. It details non-clinical testing to demonstrate the device meets acceptance criteria. No information regarding clinical effectiveness studies (such as MRMC studies or standalone algorithm performance for AI devices) is present, as this is not an AI/ML device.
Here's an analysis of the acceptance criteria and the studies that prove the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristic and Parameter | Standard / Test Method | Acceptance Criteria | Proposed Device Performance (Result) | Comparison Analysis (where available) |
|---|---|---|---|---|
| Residual Powder | ASTM D6124-06 (Reapproved 2017) | Less than 2mg / glove | XS: 0.25mg/glove, S: 0.20mg/glove, M: 0.28mg/glove, L: 0.28mg/glove, XL: 0.38mg/glove | Similar |
| Freedom of Holes | ASTM D5151-19 | Inspection level, G-I AQL 2.5 (In accordance with ASTM D6319-19) | Passed G-I, AQL 1.5 | Similar (meets AQL 1.5 which is better than 2.5) |
| Physical Dimensions (ASTM D6319-19) | ||||
| Length | XS: 220mm, min; S: 220mm, min; M: 230mm, min; L: 230mm, min; XL: 230mm, min | XS: 245-251mm; S: 247-255mm; M: 245-255mm; L: 247-255mm; XL: 247-252mm | Similar | |
| Width | XS: 70 ± 10mm; S: 80 ± 10mm; M: 95 ± 10mm; L: 110 ± 10mm; XL: 120 ± 10mm | XS: 76-78mm; S: 82-88mm; M: 95-99mm; L: 111-118mm; XL: 120-127mm | Similar, subject device meets ASTM D6319 requirements | |
| Thickness (Palm) | 0.05mm, min | XS: 0.06-0.06mm; S: 0.06-0.07mm; M: 0.06-0.07mm; L: 0.06-0.06mm; XL: 0.06-0.06mm (average) | Similar (all above min) | |
| Thickness (Finger) | 0.05mm, min | XS: 0.07-0.07mm; S: 0.07-0.08mm; M: 0.07-0.08mm; L: 0.07-0.08mm; XL: 0.07-0.08mm (average) | Similar (all above min) | |
| Physical Properties (ASTM D6319-19) | ||||
| Tensile Strength (Before aging) | 14 MPa, min | XS: 23.97 MPa, S: 26.35 MPa, M: 25.15 MPa, L: 25.11 MPa, XL: 25.85 MPa (average) | Similar (all above min) | |
| Tensile Strength (After accelerated aging) | 14 MPa, min | XS: 27.11 MPa, S: 26.78 MPa, M: 29.22 MPa, L: 25.94 MPa, XL: 26.50 MPa (average) | Similar (all above min) | |
| Ultimate Elongation (Before aging) | 500%, min | XS: 571%, S: 571%, M: 538%, L: 552%, XL: 525% (average) | Similar (all above min) | |
| Ultimate Elongation (After accelerated aging) | 400%, min | XS: 462%, S: 458%, M: 434%, L: 457%, XL: 434% (average) | Similar (all above min) | |
| Chemotherapy Drug Permeation (ASTM D6897-05) | ||||
| Carmustine 3.3mg/ml | >240 minutes (General criteria mentioned in Table 2, but specific values for individual drugs are listed in the Indications for Use and Summary of Technological Characteristics) | 14.1 minutes | Similar; Below 240 minutes permeation times (Warning included) | |
| Cisplatin 1 mg/ml | >240 minutes (General criteria) | >240 minutes | Similar | |
| Cyclophosphamide 20 mg/ml | >240 minutes (General criteria) | >240 minutes | Similar | |
| Dacarbazine 10 mg/ml | >240 minutes (General criteria) | >240 minutes | Similar | |
| Doxorubicin, HCl 2 mg/ml | >240 minutes (General criteria) | >240 minutes | Similar | |
| Etoposide 20 mg/ml | >240 minutes (General criteria) | >240 minutes | Similar | |
| Fluorouracil 50 mg/ml | >240 minutes (General criteria) | >240 minutes | Similar | |
| Methotrexate 25 mg/ml | Not specified in predicate, but >240 min in proposed device | >240 minutes | Optional, subject device performs additional Chemo drug test | |
| Mitomycin 0.5 mg/ml | Not specified in predicate, but >240 min in proposed device | >240 minutes | Optional, subject device performs additional Chemo drug test | |
| Oxaliplatin 5 mg/ml | Not specified in predicate, but >240 min in proposed device | >240 minutes | Optional, subject device performs additional Chemo drug test | |
| Paclitaxel 6 mg/ml | >240 minutes (General criteria) | >240 minutes | Similar | |
| Thiotepa 10 mg/ml | >240 minutes (General criteria) | 57.2 minutes | Similar; Below 240 minutes permeation times (Warning included) | |
| Vincristine 1 mg/ml | >240 minutes (General criteria) | >240 minutes | Similar | |
| Fentanyl Citrate Injection 100mcg/2ml | >240 minutes (General criteria) | >240 minutes | Similar | |
| Biocompatibility Testing | ||||
| Animal Irritation Test | ISO 10993-10 | Under the condition of study not an irritant. | No observable irreversible alteration; PII = "0"; not corrosive; negligible primary irritation. Met requirement. | Similar |
| Dermal Sensitization Assay | ISO 10993-10 | Under the condition of the study not a sensitizer. | No sensitization induced. Met requirement. | Similar |
| Acute Systemic Toxicity | ISO 10993-11 | Not induce systemic toxicity | Non-toxic effects of extracts. Met requirement. | Similar |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the exact sample sizes used for each individual test (e.g., number of gloves tested for holes, number of material samples for tensile strength). However, the tests are conducted in accordance with the specified ASTM and ISO standards, which typically include defined sampling plans.
- Data Provenance: The origin of the data is from non-clinical laboratory testing performed by "Mah Sing Healthcare Sdn Bhd" or their contracted laboratories, as part of the 510(k) submission process. The submission is from Malaysia. This is prospective data generated for regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable as the device is a physical medical glove and the testing involves objective measurement against pre-defined physical, chemical, and biological standards, not interpretation by human experts or AI algorithms. Ground truth is established by the test procedures and acceptance criteria defined in the ASTM and ISO standards.
4. Adjudication Method for the Test Set:
This is not applicable. As stated above, the device performance is evaluated against objective standards, not through adjudication of expert interpretations.
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 is not applicable. The device is a physical medical glove. The submission does not involve Artificial Intelligence (AI) or Machine Learning (ML) components, nor does it relate to diagnostic image interpretation where MRMC studies would typically be conducted.
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 medical glove and does not involve an algorithm.
7. The Type of Ground Truth Used:
The ground truth used for these tests is based on defined performance specifications and measurement methodologies established by widely recognized consensus standards such as ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization). For example:
- Physical dimensions: Measured against specified millimeter ranges.
- Tensile strength and elongation: Measured against minimum MPa and percentage values.
- Freedom from holes: Assessed against an Acceptable Quality Limit (AQL) per ASTM D5151-19.
- Chemotherapy drug permeation: Measured as breakthrough detection time in minutes per ASTM D6978-05.
- Biocompatibility: Assessed based on observable reactions in animal models according to ISO 10993 series and reported as "Passed" or "Not an irritant/sensitizer/systemic toxin."
8. The Sample Size for the Training Set:
This is not applicable. There is no "training set" as this device is not an AI/ML product. The manufacturing process is controlled and monitored, but there isn't a data-driven training phase for the device itself.
9. How the Ground Truth for the Training Set Was Established:
This is not applicable. As there is no training set for an AI/ML algorithm, there is no ground truth established for one. The "ground truth" for glove manufacturing is established through quality control and adherence to standardized manufacturing practices and raw material specifications.
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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 in blue, with the words "U.S. FOOD & DRUG" on top and "ADMINISTRATION" below.
February 2, 2023 Mah Sing Healthcare Sdn Bhd Ivan Tan Chee Wei Senior QA Manager Wisma Mah Sing, Penthouse Suite 1, 163 Jalan Sungai Besi Kuala Lumpur, Kuala Lumpur 57100 Malaysia
Re: K223415
Trade/Device Name: Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Regulation Number: 21 CFR 880.6250 Regulation Name: Non-powdered patient examination glove Regulatory Class: Class I, reserved Product Code: LZA, LZC, OPJ, QDO
Dear Ivan Tan Chee Wei:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated 01/27/23. Specifically, FDA is updating this SE Letter to correct the contact name to include the two middle names as an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Bifeng Qian, OHT4: Office of Surgical and Infection Control Devices, at: 301-796-2261 or bifeng.gian@fda.hhs.gov.
Sincerely,
Bifeng Qian -S
Bifeng Qian, MD, 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
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Image /page/1/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, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font below.
January 26, 2023
Mah Sing Healthcare Sdn Bhd Ivan Wei Senior QA Manager Wisma Mah Sing, Penthouse Suite 1, 163 Jalan Sungai Besi Kuala Lumpur, Kuala Lumpur 57100 Malaysia
Re: K223415
Trade/Device Name: Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I. reserved Product Code: LZA, LZC, OPJ, QDO Dated: November 1, 2022 Received: November 10, 2022
Dear Ivan Wei:
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 mav, 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.
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
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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 (OS) 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 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
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Indications for Use
510(k) Number (if known) K223415
Device Name
Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate
Indications for Use (Describe)
A patient examination glove is a disposable device intended for medical purpose 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 as per ASTM D6978-05 (2019), Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:
Test Chemotherapy Drugs are as follows:
| Test Chemotherapy Drugs Concentration | Minimum Breakthrough Detection Time in minutes |
|---|---|
| *Carmustine 3.3mg/ml | 14.1 |
| Cisplatin1 mg/ml | >240 |
| Cyclophosphamide 20 mg/ml | >240 |
| Dacarbazine 10 mg/ml | >240 |
| Doxorubicin, HCl2 mg/ml | >240 |
| Etoposide20 mg/ml | >240 |
| Fluorouracil 50 mg/ml | >240 |
| Methotrexate 25 mg/ml | >240 |
| Mitomycin 0.5 mg/ml | >240 |
| Oxaliplatin 5 mg/ml | >240 |
| Paclitaxel 6 mg/ml | >240 |
| *Thiotepa 10 mg/ml | 57.2 |
| Vincristine 1 mg/ml | >240 |
| Test Fentanyl Citrate are as follows: |
Test Chemotherapy Drugs Concentration Fentanyl Citrate Injection 100mcg/2ml
Minimum Breakthrough Detection Time in minutes >240
Warning: Do not use with Carmustine and Thiotepa. Please note that the following drugs have low permeation times: (1)Carmustine - 14.1 minutes (2)Thiotepa - 57.2 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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Image /page/5/Picture/0 description: The image contains the logo for MahSing Healthcare. The word "MahSing" is in a large, bold, red font. Below that, the word "HEALTHCARE" is in a smaller, black, sans-serif font. The logo is simple and clean, with a focus on the company name.
Premarket Notification [510(k)] No: K223415
| 510 (K) SUMMARY | ||
|---|---|---|
| 1.0 Device Name | Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile,Tested For Use With Chemotherapy Drugs and Fentanyl Citrate. | |
| 2.0 Submitter name /Contact details | Mah Sing Healthcare Sdn. BhdWisma Mah Sing, Penthouse Suite 1,163 Jalan Sungai Besi,Kuala Lumpur57100MALAYSIA | |
| Contact Person Details:Ivan Tan Chee Wei (Mr)E-mail: ivan.tan@mshealthcare.comTel: +60-3-3396 2288, Extn: 2213Fax: +60-3-3396 2299 | ||
| 3.0 SummaryPreparation Date | January 18, 2023 | |
| 4.0 Device Name &Classification | Trade Name: Nitrile Powder Free Blue Patient Examination GlovesNon-sterile, Tested for use with Chemotherapy Drugsand Fentanyl Citrate. | |
| Common Name: Nitrile Powder Free Patient Examination Glove | ||
| Classification Name: Patient Examination Gloves SpecialtyPolymer Patient Examination Gloves | ||
| Device Classification: I | ||
| Regulation Number: 21 CFR 880.6250 | ||
| Panel: General Hospital | ||
| Product Code: LZC, LZA, OPJ, QDO | ||
| 5.0 Identification ofThe Legally MarketedDevice | Predicate Device Name: Blue Colored, Powder Free Nitrile ExaminationGloves, Non-sterile, and Tested for UseWith Chemotherapy Drugs and Fentanyl Citrate | |
| Predicate 510(K) Number: K192954 | ||
| Manufacture's Name: Comfort Rubber Gloves Industries Sdn Bhd. | ||
| DrivingInnovation. Protecting Lives. | MAH SING HEALTHCARE SDN BHDLot 6478, Lorong Sungai Puloh / KU6,Kawasan Industri Sungai Puloh,42100 Klang, Selangor.MALAYSIA | T 603 3396 2288F 603 3396 2299mshealthcare.com |
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Image /page/6/Picture/0 description: The image contains the logo for "Mah Sing Healthcare". The word "MahSing" is in red, with the word "Healthcare" in black underneath. The font is sans-serif and bolded.
| 6.0 Description of Device | Nitrile Powder Free Blue Patient Examination Gloves Non-sterile, TestedFor Use With Chemotherapy Drugs and Fentanyl Citrate meets all therequirements of ASTM standards D6319-19, D6978-05 (2019) and FDA21 CFR 880.6250. | |||
|---|---|---|---|---|
| Nitrile Powder Free Blue Patient Examination Gloves Non-sterile, TestedFor Use With Chemotherapy Drugs are Class I patient examination glovesbear the product code Nitrile - LZA, LZC, OPJ and QDO (21CFR880.6250).The gloves are made from acrylonitrile-butadiene copolymer dispersion.Inner surface of gloves undergoes surface treatment process to produce asmooth surface that assists the user in donning the gloves without usingany lubricant such as powder on the glove surface. These gloves are bluein color and are powder free. The gloves are ambidextrous i.e., can be wornon right hand or left hand, single use disposable devices that come in fivesizes (XS, S, M, L and XL). The physical properties of glove, i.e., tensilestrength meet ASTM D 6319-19. | ||||
| 7.0 Indications for Use | A patient examination glove is a disposable device intended for medicalpurpose that is worn on the examiner's hand or finger to preventcontamination between patient and examiner.These gloves were tested for use with Chemotherapy Drugs as perASTM D6978-05 (2019), Standard Practice for Assessment of MedicalGloves to Permeation by Chemotherapy Drugs: | |||
| Test Chemotherapy Drugs are as follows: | ||||
| Test Chemotherapy | Concentration | Minimum Breakthrough | ||
| Drugs | Detection Time in minutes | |||
| *Carmustine | 3.3mg/ml | 14.1 | ||
| Cisplatin | 1 mg/ml | >240 | ||
| Cyclophosphamide | 20 mg/ml | >240 | ||
| Dacarbazine | 10 mg/ml | >240 | ||
| Doxorubicin, HCl | 2 mg/ml | >240 | ||
| Etoposide | 20 mg/ml | >240 | ||
| Fluorouracil | 50 mg/ml | >240 | ||
| Methotrexate | 25 mg/ml | >240 | ||
| Mitomycin | 0.5 mg/ml | >240 | ||
| Oxaliplatin | 5 mg/ml | >240 | ||
| Paclitaxel | 6 mg/ml | >240 | ||
| *Thiotepa | 10 mg/ml | 57.2 | ||
| Vincristine | 1 mg/ml | >240 | ||
| Test Fentanyl Citrate are as follows:Test Chemotherapy Drugs | Concentration | Minimum Breakthrough | ||
| Detection Time in minutes | ||||
| Fentanyl Citrate Injection | 100mcg/2ml | >240 | ||
| Warning: Do not use with Carmustine and Thiotepa. | ||||
| *Note:Please note that the following drugs have low permeation times:(1) Carmustine - 14.1 minutes(2) Thiotepa - 57.2 minutes. | ||||
| ovation. Protecting Lives. | MAH SING HEALTHCARE SDN BHDLot 6478, Lorong Sungai Puloh / KU6,Kawasan Industri Sungai Puloh,42100 Klang, Selangor.MALAYSIA | T 603 3396 2288F 603 3396 2299mshealthcare.com |
DrivingInn
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Image /page/7/Picture/0 description: The image contains the logo for "Mah Sing Healthcare". The words "MahSing" are in a large, bold, red font. Below that, the word "HEALTHCARE" is in a smaller, black, bold font. The logo is simple and professional.
8.0 Summary of the Technological Characteristic of the Device
Nitrile Powder Free Blue Patient Examination Gloves Non-sterile, Tested For Use with Chemotherapy Drugs and Fentanyl Citrate meets all the requirements of ASTM standards D6319-19, D6978-05 (2019) and FDA 21 CFR 880.6250.
| 1able | 1 |
|---|---|
| ----------- | --- |
| Characteristics andParameters | Standard | Proposed Device | Predicate device | ComparisonAnalysis |
|---|---|---|---|---|
| 510(k) Number | - | K223415 | K192954 | Different |
| Manufacturer | - | Mah Sing Healthcare Sdn.Bhd. | Comfort Rubber GlovesIndustries Sdn Bhd | Different |
| Name of device | - | Nitrile Powder Free BluePatient ExaminationGloves, Non-Sterile,Tested for use withchemotherapy drugs andfentanyl citrate | Blue Colored, PowderFree Nitrile ExaminationGloves, Non-Sterile, andTested for use withchemotherapy drugs andfentanyl citrate | Similar |
| Device ClassificationName/Regulation Number | Patient ExaminationGlove,21 CFR Part 880.6250 | Patient ExaminationGlove,21 CFR Part 880.6250 | Patient ExaminationGlove,21 CFR Part 880.6250 | Same |
| Product Code | - | LZA, LZC, OPJ, QDO | LZA, LZC, QDO | Same |
| Classification | - | Class 1 | Class 1 | Same |
| Raw Rubber Material | ASTM D 6319-19 | Nitrile | Nitrile | Same |
| Color | - | Blue | Blue | Same |
| Characteristics andParameters | Standard | Proposed Device | Predicate device | ComparisonAnalysis |
| Chemotherapy DrugPermeation Test | ASTM D6897-05 | |||
| Test ChemotherapyDrugs | Concentration | Minimum Breakthrough Detection Time (min) | ||
| *Carmustine | 3.3mg/ml | 14.1 | 18.2 | SimilarBelow 240 minutespermeation times |
| Cisplatin | 1 mg/ml | >240 | >240 | Similar |
| Cyclophosphamide | 20 mg/ml | >240 | >240 | Similar |
| Dacarbazine | 10 mg/ml | >240 | >240 | Similar |
| Doxorubicin, HCl | 2 mg/ml | >240 | >240 | Similar |
| Etoposide | 20 mg/ml | >240 | >240 | Similar |
| Fluorouracil | 50 mg/ml | >240 | >240 | Similar |
| Methotrexate | 25 mg/ml | >240 | Not tested | Optional, Subjectdevice performadditionalChemotherapy drugtest |
| Mitomycin | 0.5 mg/ml | >240 | Not tested | Optional, Subjectdevice performadditionalChemotherapy drugtest |
| Oxaliplatin | 5 mg/ml | >240 | Not tested | Optional, Subjectdevice performadditionalChemotherapy drugtest |
| Paclitaxel | 6 mg/ml | >240 | >240 | Similar |
| *Thiotepa | 10 mg/ml | 57.2 | 57.3 | SimilarBelow 240 minutespermeation times |
| Vincristine | 1 mg/ml | >240 | >240 | Similar |
| Fentanyl Citrate Injection | 100 mcg/2ml | >240 | >240 | Similar |
| Characteristics andParameters | Standard | Proposed Device | Predicate device | ComparisonAnalysis |
| LengthXS: Min. 220mmS: Min.220mmM: Min.230mmL: Min.230mmXL: Min.230mm | ASTM D 6319-19 | XS: 245 -251mmS: 247 - 255mmM: 245 - 255mmL: 247 - 255mmXL: 247- 252mm | Min. 240 mm | Similar |
| WidthXS:60mm - 80mmS: 70mm – 90mmM: 85mm - 105mmL: 100mm - 120mmXL:110mm - 130mm | ASTM D 6319-19 | XS: 76 - 78mmS: 82 - 88mmM: 95 - 99mmL: 111 - 118mmXL: 120 - 127mm | Not stated by predicatedevice | Similar, subjectdevice meetrequirementsof ASTMD6319 |
| Palm Thickness(Minimum 0.05mm) | ASTM D 6319-19 | Average: 0.06mm | Min 0.05 | Similar |
| Finger Thickness(Minimum 0.05mm) | ASTM D 6319-19 | Average: 0.07mm | Min 0.05 | Similar |
| Tensile Strength(Before aging) Minimum14 MPa | ASTM D 6319-19 | Average: 25.29MPa | Meets | Similar |
| Tensile Strength(After accelerated aging)Minimum 14 MPa | ASTM D 6319-19 | Average: 27.11MPa | Meets | Similar |
| Ultimate Elongation(before aging) Minimum500% | ASTM D 6319-19 | Average: 551% | Meets | Similar |
| Ultimate Elongation(after accelerated aging)Minimum 400% | ASTM D 6319-19 | Average: 449% | Meets | Similar |
| Freedom of Holes MeetAQL 2.5 at G1 | ASTM D 5151-19 | Meet AQL 1.5 with G1 | Passes | Similar |
| Residual powder test(Less than 2mg/glove) | ASTM D 6124-06 | Average powder residuefor each size.XS: 0.25mg/gloveS: 0.20mg/gloveM: 0.28mg/gloveL: 0.28mg/gloveXL: 0.38mg/glove | Meets | Similar |
| Animal Irritation Test | ISO 10993-10Biological evaluationof medical devices -Part 10: Tests forirritation and skinsensitization | Passed.Under the conditions ofstudy, not an irritant | PassesUnder the conditions ofthe study, the subjectdevice is non-irritating | Similar |
| Dermal Sensitization | ISO 10993-10Biological evaluationof medical devices -Part 10: Tests forirritation and skinsensitization | Passed.Under the conditions ofstudy, not a sensitizer | PassesUnder the conditions ofthe study, the subjectdevice is non-sensitization | Similar |
| Acute Systemic Toxicity | ISO 10993-11Biological evaluationof medical devices -Part 11: Tests forsystemic toxicity | Not induce acute systemictoxicity | PassesUnder the conditions ofthe study, the subjectshowed no adversebiological reaction | Similar |
| Characteristics andParameters | Standard | Proposed Device | Predicate device | ComparisonAnalysis |
| Indication for use | - | Nitrile Powder Free BluePatient ExaminationGloves, Non-Sterile,Tested for Use withChemotherapy Drugs andFentanyl Citrate is apatient examination gloveis a disposable deviceintended for medicalpurpose that is worn onthe examiner's hand orfinger to preventcontamination betweenpatient and examiner.These gloves were testedfor use withChemotherapy Drugs asper ASTM D6978-05(2019), Standard Practicefor Assessment ofMedical Gloves toPermeation byChemotherapy Drugs. | Blue Colored, PowderFree Nitrile ExaminationGloves, Non-sterile, andTested for Use withChemotherapy Drugs andFentanyl Citrate is aspecialty medical glovewhich is a disposabledevice intended formedical purpose that isworn on the examiner'shand or finger to preventcontamination betweenexaminer and patient. Theglove was tested for usewith Chemotherapy Drugsand Fentanyl Citrate as perASTM D6978-05Standard Practice forAssessment of MedicalGloves to Permeation byChemotherapy Drugs. | Same intendeduse |
Driving Innovation. Protecting Lives.
mah sing healthcare sdn bhd Lot 6478, Lorong Sungai Puloh / KU6, Kawasan Industri Sungai Puloh, 42100 Klang, Selangor. MALAYSIA
T 603 3396 2288 F 603 3396 2299 mshealthcare.com
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DrivingInnovation. Protecting Lives.
MAH SING HEALTHCARE SDN BHD Lot 6478, Lorong Sungai Puloh / KU6, Kawasan Industri Sungai Puloh, 42100 Klang, Selangor. MALAYSIA
T 603 3396 2288 F 603 3396 2299 mshealthcare.com
{9}------------------------------------------------
Image /page/9/Picture/0 description: The image contains the logo for "MahSing Healthcare". The word "MahSing" is in a large, bold, red font. Below that, the word "HEALTHCARE" is in a smaller, bold, black font. The logo is simple and professional.
Lot 6478, Lorong Sungai Puloh / KU6,
Kawasan Industri Sungai Puloh,
42100 Klang, Selangor.
MALAYSIA
F 603 3396 2299 mshealthcare.com
Driving Innovation. Protecting Lives.
{10}------------------------------------------------
Image /page/10/Picture/1 description: The image shows the logo for Mah Sing Healthcare. The word "MahSing" is in large, red, bold letters. Below that, the word "HEALTHCARE" is in smaller, black, bold letters.
9.0 Summary of Non-Clinical Testing
Table 2 -Performance Testing
| Non-Clinical Testing | |||
|---|---|---|---|
| Test Method | Purpose | Acceptance Criteria | Result |
| ASTM D6124-06(Reapproved 2017)Standard Test Method forResidual Powder on MedicalGloves. | To determine theresidual powder inthe gloves | Less than 2mg / glove | Size XS 0.25mg /gloveSize S 0.20mg /gloveSize M 0.28mg /gloveSize L 0.28mg /gloveSize XL 0.38mg /glove |
| ASTM D5151-19Standard Test Method forDetection of Holes inMedical Gloves. | To determine theholes in the gloves | Inspection level, G-IAQL 2.5(In accordance with ASTMD6319-19) | Passed G-I, AQL 1.5 |
| ASTM D6319-19Standard Specificationfor Nitrile ExaminationGloves for MedicalApplication. | To determine thelength of the gloves | Size XS 220mm, minSize S 220mm, minSize M 230mm, minSize L 230mm, minSize XL 230mm, min | Size XS 245 - 251mmSize S 247 - 255mmSize M 245 - 255mmSize L 247 - 255mmSize XL 247 - 252mm |
| ASTM D6319-19Standard Specification forNitrile Examination Glovesfor Medical Application. | To determine thewidth of the gloves | Size XS 70 ± 10mmSize S 80 ± 10mmSize M 95 ± 10mmSize L 110 ± 10mmSize XL 120 ± 10mm | Size XS 76 - 78mmSize S 82 - 88mmSize M 95 - 99mmSize L 111 - 118mmSize XL 120 - 127mm |
| Non-Clinical Testing (Cont'd) | |||
| Test Method | Purpose | Acceptance Criteria | Result |
| ASTM D6319-19Standard Specificationfor Nitrile ExaminationGloves for MedicalApplication. | To determine thethickness of thegloves | Palm0.05mm, min | Measured in single wall at approximate center of palm areaSize XS 0.06 - 0.06mmSize S 0.06 - 0.07mmSize M 0.06 - 0.07mmSize L 0.06 - 0.06mmSize XL 0.06 - 0.06mm |
| Finger0.05mm, min | Measured in single wall at 13±3mm from the tip of middle fingerSize XS 0.07 — 0.07mmSize S 0.07 - 0.08mmSize M 0.07 - 0.08mmSize L 0.07 - 0.08mmSize XL 0.07 - 0.08mm | ||
| ASTM D6319-19Standard Specificationfor Nitrile ExaminationGloves for MedicalApplication. | To determine thephysical properties-Tensile strength | Before AgeingTensile Strength14Mpa, min for all sizes | Size XS 23.97 MPa, averageSize S 26.35 MPa, averageSize M 25.15 MPa, averageSize L 25.11 MPa, averageSize XL 25.85 MPa, average |
| After AgeingTensile Strength14Mpa, min for all sizes | Size XS 27.11 MPa, averageSize S 26.78 MPa, averageSize M 29.22 MPa, averageSize L 25.94 MPa, averageSize XL 26.50 MPa, average | ||
| To determine thephysical properties-Ultimate Elongation | Before AgeingUltimate Elongation500%, min for all sizes | Size XS 571%, averageSize S 571%, averageSize M 538%, averageSize L 552%, averageSize XL 525%, average | |
| After AgeingUltimate Elongation 400%,min for all sizes | Size XS 462%, averageSize S 458%, averageSize M 434%, averageSize L 457%, averageSize XL 434%, average | ||
| Non-Clinical Testing (Cont'd) | |||
| Test Method | Purpose | AcceptanceCriteria | Result |
| ASTM D6897-05Standard Practice forAssessment of Resistanceof Medical Gloves toPermeation byChemotherapy Drugs | To provide a uniformprocedure for assessing theresistance of medical glovematerials to permeation bychemotherapy drugs, andto establish a consistentreporting of the test data. | >240minutes | *Carmustine 3.3mg/ml = 4.1Cisplatin 1 mg/ml = >240Cyclophosphamide 20 mg/ml = >240Dacarbazine 10 mg/ml = >240Doxorubicin, HCl 2 mg/ml = >240Etoposide 20 mg/ml = >240Fluorouracil 50 mg/ml = >240Methotrexate 25 mg/ml = >240Mitomycin 0.5 mg/ml = >240Oxaliplatin 5 mg/ml = >240Paclitaxel 6 mg/ml = >240*Thiotepa 10 mg/ml = 57.2Vincristine 1 mg/ml = >240Fentanyl Citrate Injection 100mcg/2ml = >240 |
MAH SING HEALTHCARE SDN BHD
DrivingInnovation. Protecting Lives.
Lot 6478, Lorong Sungai Puloh / KU6, Kawasan Industri Sungai Puloh, 42100 Klang, Selangor. MALAYSIA
T 603 3396 2288 F 603 3396 2299 mshealthcare.com
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DrivingInnovation. Protecting Lives.
MAH SING HEALTHCARE SDN BHD Lot 6478, Lorong Sungai Puloh / KU6, Kawasan Industri Sungai Puloh, 42100 Klang, Selangor. MALAYSIA
T 603 3396 2288 F 603 3396 2299 mshealthcare.com
{12}------------------------------------------------
Image /page/12/Picture/1 description: The image contains the logo for Mah Sing Healthcare. The words "MahSing" are in a large, red, stylized font. Below that, the word "HEALTHCARE" is in a smaller, black, sans-serif font. The logo is simple and professional.
| Biocompatibility Testing | |||
|---|---|---|---|
| Test Method | Purpose | AcceptanceCriteria | Result |
| ISO 10993-10Biological evaluation ofmedical devices - Part10: Tests for irritationand skin sensitization(Animal IrritationTest) | To determine the potentialof the material under testto produce dermalirritation in Rabbits | Under thecondition ofstudy not anirritant. | There was no observable irreversiblealteration on the skin at the sites of contactwith the test material. The PrimaryIrritation Index (PII) was "0". The testmaterial was not corrosive, and thePrimary Irritation Response Category istherefore "negligible", thereof met therequirement. |
| ISO 10993-10Biological evaluation ofmedical devices -Part 10: Tests forirritation and skinsensitization(Dermal SensitizationAssay Test) | To determine the skinsensitization potential ofthe material both interms of induction andelicitation in Guinea pig | Under thecondition ofthe study not asensitizer. | There was no sensitization induced by theapplication of the test material on thealbino guinea pigs under the condition ofthis test, thereof met the requirement. |
| ISO 10993-11Biological evaluation ofmedical devices - Part 11:Tests for systemic toxicity(Acute Systemic Toxicity) | To provide informationon health hazards likely toarise from a short-termexposure to the extracts oftest material byintravenous andintraperitoneal injectionin mice | Not inducesystemictoxicity | Under the condition of this study, thesingle dose acute systemic toxicity ofextracts from test material using bothnormal saline and sesame oil, shown non-toxic effects, thereof met the requirement. |
Non-clinical tests were carried out to demonstrate product performance conformity with standards referenced.
DrivingInnovation. Protecting Lives.
mah sing healthcare sdn bhd Lot 6478, Lorong Sungai Puloh / KU6, Kawasan Industri Sungai Puloh, 42100 Klang, Selangor. MALAYSIA
T 603 3396 2288 F 603 3396 2299 mshealthcare.com
{13}------------------------------------------------
Image /page/13/Picture/0 description: The image contains the logo for Mah Sing Healthcare. The words "Mah Sing" are in a large, red, stylized font. Below that, the word "HEALTHCARE" is in a smaller, black, sans-serif font. The logo is simple and professional.
Attachment 1 Additional Information Page 9 of 9
The following bench tests were performed:
Non-clinical tests
- Residual Powder Content
- Physical Properties
- Physical Dimension
- Freedom from Holes
- Chemotherapy Drug Permeation Test
Biocompatibility Testing
- Animal Irritation Test
- Dermal Sensitization Assay
- Acute Systemic Toxicity
The results from these performance evaluations demonstrated that the Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile, Tested for Use With Chemotherapy Drugs and Fentanyl Citrate met the acceptance criteria defined in standards referenced.
| 10.0 Summary of Clinical Testing | Clinical Testing is not needed for this device. |
|---|---|
| 11.0 Conclusion | The conclusion drawn from the non-clinical test demonstratethat the subject device is as safe, as effective, and performs aswell as or better than the legally marketed predicate deviceK192954. |
DrivingInnovation. Protecting Lives.
MAH SING HEALTHCARE SDN BHD Lot 6478, Lorong Sungai Puloh / KU6, Kawasan Industri Sungai Puloh, 42100 Klang, Selangor. MALAYSIA
T 603 3396 2288 F 603 3396 2299 mshealthcare.com
§ 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.