(80 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.
Nitrile Powder Free Black Patient Examination Gloves Non-sterile, Tested For Use With Chemotherapy Drugs meets all the requirements of ASTM standards D6319-19, D6978-05 (2019) and FDA 21 CFR 880.6250. 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 black 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) premarket notification for Nitrile Powder Free Black Patient Examination Gloves, Non-sterile, Tested For Use With Chemotherapy Drugs, and does not pertain to an AI/ML-enabled medical device. Therefore, the information requested about acceptance criteria and studies proving the device meets them in the context of an AI/ML device (e.g., sample size for test sets, data provenance, a number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, training set details) is not applicable to this document.
Instead, the document describes the acceptance criteria and performance of these medical gloves based on non-clinical bench testing to demonstrate substantial equivalence to a predicate device.
Here's the relevant information from the document regarding the glove's performance:
1. A table of acceptance criteria and the reported device performance (for the non-AI device: medical gloves):
| Test Method (Standard) | Purpose | Acceptance Criteria | Reported Device Performance (Result) |
|---|---|---|---|
| ASTM D6124-06 (Residual Powder) | To determine residual powder in gloves | Less than 2mg / glove | XS: 0.23mg/glove, S: 0.20mg/glove, M: 0.25mg/glove, L: 0.25mg/glove, XL: 0.30mg/glove (All below 2mg/glove) |
| ASTM D5151-19 (Detection of Holes) | To determine holes in gloves | G-I, AQL 2.5 (In accordance with ASTM D6319-19) | Passed G-I, AQL 1.5 |
| ASTM D6319-19 (Length) | To determine the length of gloves | XS: ≥220mm, S: ≥220mm, M: ≥230mm, L: ≥230mm, XL: ≥230mm | XS: 244-247mm, S: 243-248mm, M: 243-252mm, L: 243-249mm, XL: 243-249mm (All meet minimums) |
| ASTM D6319-19 (Width) | To determine the width of gloves | XS: 70±10mm, S: 80±10mm, M: 95±10mm, L: 110±10mm, XL: 120±10mm | XS: 76-78mm, S: 81-88mm, M: 95-99mm, L: 102-111mm, XL: 111-119mm (All within specified ranges) |
| ASTM D6319-19 (Palm Thickness) | To determine the thickness of gloves (palm) | Palm: ≥0.05mm | XS, S, M, L, XL: 0.06-0.07mm (All meet minimum) |
| ASTM D6319-19 (Finger Thickness) | To determine the thickness of gloves (finger) | Finger: ≥0.05mm | XS, S, M, L, XL: 0.07-0.08mm (All meet minimum) |
| ASTM D6319-19 (Tensile Strength - Before Aging) | To determine physical properties - Tensile strength (before aging) | ≥14MPa for all sizes | XS: 23.79 MPa, S: 24.89 MPa, M: 25.39 MPa, L: 26.44 MPa, XL: 26.05 MPa (All meet minimum) |
| ASTM D6319-19 (Tensile Strength - After Aging) | To determine physical properties - Tensile strength (after aging) | ≥14MPa for all sizes | XS: 27.52 MPa, S: 26.28 MPa, M: 25.93 MPa, L: 26.21 MPa, XL: 25.98 MPa (All meet minimum) |
| ASTM D6319-19 (Ultimate Elongation - Before Aging) | To determine physical properties - Ultimate Elongation (before aging) | ≥500% for all sizes | XS: 539%, S: 533%, M: 527%, L: 538%, XL: 526% (All meet minimum) |
| ASTM D6319-19 (Ultimate Elongation - After Aging) | To determine physical properties - Ultimate Elongation (after aging) | ≥400% for all sizes | XS: 435%, S: 453%, M: 460%, L: 455%, XL: 470% (All meet minimum) |
| ASTM D6897-05 (Chemotherapy Drug Permeation) | To assess resistance to permeation by chemotherapy drugs | >240 minutes for most drugs specified (Carmustine & Thiotepa are exceptions with lower times) | Carmustine: 32.2 min, Cisplatin: >240 min, Cyclophosphamide: >240 min, Dacarbazine: >240 min, Doxorubicin, HCl: >240 min, Etoposide: >240 min, Fluorouracil: >240 min, Methotrexate: >240 min, Mitomycin: >240 min, Oxaliplatin: >240 min, Paclitaxel: >240 min, Thiotepa: 37.4 min, Vincristine: >240 min. (Meets expectations based on warnings for Carmustine and Thiotepa). |
| ISO 10993-10 (Animal Irritation Test) | To determine potential for dermal irritation | Not an irritant | Passed, Primary Irritation Index (PII) was "0", "negligible" irritation. |
| ISO 10993-10 (Dermal Sensitization Assay) | To determine skin sensitization potential | Not a sensitizer | Passed, no sensitization induced. |
| ISO 10993-11 (Acute Systemic Toxicity) | To provide information on health hazards from short-term exposure | Not induce acute systemic toxicity | Passed, did not demonstrate any adverse toxic reaction. |
2. Sample sizes used for the test set and the data provenance:
- Sample Size for Testing: The document does not specify the exact sample sizes for each non-clinical test (e.g., how many gloves were tested for holes, tensile strength, or chemotherapy permeation for each batch/size). The results are presented as averages or ranges across sizes.
- Data Provenance: The tests were non-clinical bench tests performed by Mah Sing Healthcare Sdn. Bhd. (Malaysia), as indicated by the sender and manufacturer information. There is no mention of country of origin of data in the sense of patient data, as this device does not use patient data for its function. All tests are by standard methods (ASTM, ISO). The studies are inherently "prospective" in the sense that they are conducted specifically for this submission against defined standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. Ground truth for these physical and chemical tests is established by the specified ASTM and ISO standard test methods, which are objective, reproducible procedures. No human experts are involved in establishing "ground truth" for the physical properties of a glove in the way they would for medical image interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. As these are objective bench tests, there is no need for human adjudication of results. The results are quantitative measurements or direct observations according to specified protocols.
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:
- Not applicable. This is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/ML device. The "standalone" performance here refers to the glove's physical and chemical properties and its resistance to chemotherapy drugs, which are measured directly.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For this device, the "ground truth" is defined by the measurement outcomes according to internationally recognized standard test methods (ASTM and ISO) for physical properties (e.g., dimensions, tensile strength, freedom from holes, powder residue) and chemical resistance (chemotherapy drug permeation). For biocompatibility, it's defined by the in vivo animal study results according to ISO standards.
8. The sample size for the training set:
- Not applicable. There is no training set for a non-AI/ML device.
9. How the ground truth for the training set was established:
- Not applicable. There is no training set for a non-AI/ML device.
In summary, this document demonstrates the safety and effectiveness of medical gloves through adherence to established material and performance standards, not through AI/ML model validation studies.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
March 24, 2023
Mah Sing Healthcare Sdn Bhd Ivan Tan Chee Wei Senior QA Manager Lot 6478, Lorong Sungai Puloh/KU6, Kawasan Industri Sungai Puloh, Klang. Selangor 42100 Malaysia
Re: K230002
Trade/Device Name: Nitrile Powder Free Black Patient Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC, OPJ Dated: January 3, 2023 Received: January 3, 2023
Dear Ivan Tan Chee 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 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 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.
Allan Gl
For 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) K230002
Device Name
Nitrile Powder Free Black Patient Examination Gloves, Non-Sterile, Tested For Use With Chemotherapy Drugs
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 | 32.2 |
| Cisplatin 1mg/ml | >240 |
| Cyclophosphamide 20mg/ml | >240 |
| Dacarbazine 10mg/ml | >240 |
| Doxorubicin, HCl 2mg/ml | >240 |
| Etoposide 20mg/ml | >240 |
| Fluorouracil 50mg/ml | >240 |
| Methotrexate 25mg/ml | >240 |
| Mitomycin 0.5mg/ml | >240 |
| Oxaliplatin 5mg/ml | >240 |
| Paclitaxel 6mg/ml | >240 |
| *Thiotepa 10mg/ml | 37.4 |
| Vincristine 1mg/ml | >240 |
Warning: Do not use with Carmustine and Thiotepa. Please note that the following drugs have low permeation times: (1)Carmustine - 32.2 minutes (2)Thiotepa - 37.4 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.
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.
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image contains the logo for Mah Sing Healthcare. The words "MahSing" are in red, with the "M" being the largest letter. Below that, the word "HEALTHCARE" is in black. The logo is simple and professional.
Premarket Notification [510(k)] No: K230002
| 510 (K) SUMMARY | |
|---|---|
| 1.0 Device Name | Nitrile Powder Free Black Patient Examination Gloves, Non-Sterile, Tested For Use With Chemotherapy Drugs. |
| 2.0 Submitter name /Contact details | Mah Sing Healthcare Sdn. BhdLot 6478, Lorong Sungai Puloh/KU6,Kawasan Industri Sungai Puloh,Klang, Selangor 42100MALAYSIA |
| 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 | February 20, 2023 |
| 4.0 Device Name &Classification | Trade Name: Nitrile Powder Free Black Patient Examination GlovesNon-sterile, Tested for use with Chemotherapy Drugs |
| 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: LZA, LZC, OPJ | |
| 5.0 Identification ofThe Legally MarketedDevice | Predicate Device Name: Nitrile Powder Free Blue Patient ExaminationGloves, Non-Sterile, Tested For Use WithChemotherapy Drugs |
| Predicate 510(K) Number: K214110 | |
| Manufacture's Name: Mah Sing Healthcare Sdn. Bhd |
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
DrivingInnovation. Protecting Lives.
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image contains the logo for Mah Sing Healthcare. The word "MahSing" is in red, with the first letter of each word capitalized. Below that, the word "HEALTHCARE" is in black, with all letters capitalized. The logo is simple and modern, with a focus on the company's name and industry.
| 6.0 Description of Device | Nitrile Powder Free Black Patient Examination Gloves Non-sterile,Tested For Use With Chemotherapy Drugs meets all the requirements ofASTM standards D6319-19, D6978-05 (2019) and FDA 21 CFR880.6250. | ||||
|---|---|---|---|---|---|
| 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 blackin 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 inminutes | ||||
| *Carmustine | 3.3mg/ml | 32.2 | |||
| 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 | 37.4 | |||
| Vincristine | 1 mg/ml | >240 |
*Warning: Do not use with Carmustine and Thiotepa
Note:
Please note that the following drugs have low permeation times:
- (1) Carmustine 32.2 minutes
(2) Thiotepa - 37.4 minutes.
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
DrivingInnovation. Protecting Lives.
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image contains the logo for "MahSing Healthcare". The word "MahSing" is in red, bold, and large font. Below it, the word "HEALTHCARE" is in black, bold, and a smaller font.
8.0 Summary of the Technological Characteristic of The Device
Nitrile Powder Free Black Patient Examination Gloves Non-sterile, Tested For Use with Chemotherapy Drugs meets all the requirements of ASTM standards D6319-19, D6978-05 (2019) and FDA 21 CFR 880.6250
| Table | 1 |
|---|---|
| Characteristics andParameters | Standard | Proposed Device | Predicate device | ComparisonAnalysis |
|---|---|---|---|---|
| 510(k) Number | - | K230002 | K214110 | - |
| Manufacturer | - | Mah Sing Healthcare Sdn.Bhd. | Mah Sing Healthcare Sdn.Bhd. | Same |
| Name of device | - | Nitrile Powder FreeBlack PatientExamination Gloves,Non-Sterile, Tested foruse with chemotherapydrugs and | Nitrile Powder FreeBlue PatientExamination Gloves,Non-Sterile, Tested foruse with chemotherapydrugs | 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 | LZA, LZC | Same |
| Classification | - | Class 1 | Class 1 | Same |
| Raw Rubber Material | ASTM D 6319-19 | Nitrile | Nitrile | Same |
| Color | - | Black | Blue | Different |
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
{6}------------------------------------------------
Image /page/6/Picture/0 description: The image contains the logo for Mah Sing Healthcare. The word "MahSing" is in red, with the "M" and "S" capitalized. Below that, the word "HEALTHCARE" is in black, with all letters capitalized. The logo is simple and clean, with a focus on the company name.
| Characteristics andParameters | Standard | Proposed Device(K230002) | Predicate device(K214110) | ComparisonAnalysis |
|---|---|---|---|---|
| Chemotherapy DrugPermeation Test | ASTM D6897-05 | |||
| Test ChemotherapyDrugs | Concentration | Minimum Breakthrough Detection Time (min) | ||
| *Carmustine | 3.3mg/ml | 32.2 | 24.8 | 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 | 37.4 | 38.4 | SimilarBelow 240 minutespermeation times |
| Vincristine | 1 mg/ml | >240 | >240 | Similar |
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
{7}------------------------------------------------
Image /page/7/Picture/0 description: The image contains the logo for Mah Sing Healthcare. The word "MahSing" is in a large, red, bold font. Below that, the word "HEALTHCARE" is in a smaller, black, bold font.
| Characteristics andParameters | Standard | Proposed Device(K230002) | Predicate device(K214110) | ComparisonAnalysis |
|---|---|---|---|---|
| LengthXS: Min.220mmS: Min.220mmM: Min.230mmL: Min.230mmXL: Min. 230mm | ASTM D 6319-19 | XS: 244 - 247mmS: 243 - 248mmM: 243 - 252mmL: 243 - 249mmXL: 243 - 249mm | 245 - 255mm | Similar |
| WidthXS:60mm - 80mmS: 70mm – 90mmM: 85mm - 105mmL: 100mm – 120mmXL:110mm - 130mm | ASTM D 6319-19 | XS: 76 - 78mmS: 81 - 88mmM: 95 - 99mmL: 102 - 111mmXL: 111 - 119mm | S: 83 - 85mmM: 93 - 96mmL: 105 - 109mmXL: 116 - 118mm | Similar |
| Palm Thickness(Minimum 0.05mm) | ASTM D 6319-19 | 0.06 - 0.07mm | 0.06 - 0.07mm | Similar |
| Finger Thickness(Minimum 0.05mm) | ASTM D 6319-19 | 0.07 - 0.08mm | 0.08 - 0.11mm | Similar |
| Tensile Strength(Before aging) Minimum14 MPa | ASTM D 6319-19 | Average: 25.31MPa | Average: 21.96MPa | Similar |
| Tensile Strength(After accelerated aging)Minimum 14 MPa | ASTM D 6319-19 | Average: 26.38MPa | Average: 28.30MPa | Similar |
| Ultimate Elongation(before aging) Minimum500% | ASTM D 6319-19 | Average: 533% | Average: 537% | Similar |
| Ultimate Elongation(after accelerated aging)Minimum 400% | ASTM D 6319-19 | Average: 455% | Average: 449% | Similar |
| Freedom of Holes MeetAQL 2.5 at G1 | ASTM D 5151-19 | Meet AQL 1.5 with G1 | Meet AQL 1.5 with G1 | Same |
| Residual powder test(Less than 2mg/glove) | ASTM D 6124-06 | Average powder residuefor each size.XS: 0.23mg/gloveS: 0.20mg/gloveM: 0.25mg/gloveL: 0.25mg/gloveXL: 0.30mg/glove | Average powder residuefor each size:S: 0.32mg/gloveM: 0.28mg/gloveL: 0.32mg/gloveXL: 0.30mg/glove | Similar |
| Animal Irritation Test | ISO 10993-10Biological evaluationof medical devices -Part 10: Tests forirritation and skinSensitization | Passed.Under the conditions ofstudy, not an irritant | Passed.Under the conditions ofstudy, not an irritant | Same |
| Dermal Sensitization | ISO 10993-10Biological evaluationof medical devices -Part 10: Tests forirritation and skinsensitization | Passed.Under the conditions ofstudy, not a sensitizer | Passed.Under the conditions ofstudy, not a sensitizer | Same |
| Acute Systemic Toxicity | ISO 10993-11Biological evaluationof medical devices -Part 11: Tests forsystemic toxicity | Not induce acute systemictoxicity | Not induce acute systemictoxicity | Same |
| Characteristics andParameters | Standard | Proposed Device(K230002) | Predicate device(K214110) | ComparisonAnalysis |
| Indication for use | - | Nitrile Powder Free BlackPatient ExaminationGloves, Non-Sterile,Tested for Use withChemotherapy Drugs 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. | Nitrile Powder Free BluePatient ExaminationGloves, Non-Sterile,Tested for Use withChemotherapy Drugs 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. | Same |
MAH SING HEALTHCARE SDN BHD Lot 6478, Lorong Sungai Puloh / KU6,
DrivingInnovation. Protecting Lives.
T 603 3396 2288 F 603 3396 2299 mshealthcare.com
Kawasan Industri Sungai Puloh,
42100 Klang, Selangor.
MALAYSIA
{8}------------------------------------------------
Image /page/8/Picture/1 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.
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 0.23mg/gloveSize S 0.20mg/gloveSize M 0.25mg/gloveSize L 0.25mg/gloveSize XL 0.30mg/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 withASTM D6319-19) | 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 244 - 247mmSize S 243 - 248mmSize M 243 - 252mmSize L 243 - 249mmSize XL 243 - 249mm |
| 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 81 - 88mmSize M 95 - 99mmSize L 102 - 111mmSize XL 111 - 119mm |
| Non-Clinical Testing (Cont'd) | |||
| Test Method | Purpose | Acceptance Criteria | Result |
| ASTM D6319-19Standard Specificationfor Nitrile ExaminationGloves for MedicalApplication. | To determine thethickness of thegloves | Measured in single wall at approximate center of palm areaPalm0.05mm, min | Size XS0.06 – 0.07mmSize S0.06 – 0.07mmSize M0.06 – 0.07mmSize L0.06 – 0.07mmSize XL0.06 – 0.07mm |
| Measured in single wall at 13±3mm from the tip of middlefingerFinger0.05mm, min | Size XS0.07 – 0.08mmSize S0.07 – 0.08mmSize M0.07 – 0.08mmSize L0.07 – 0.08mmSize XL0.07 – 0.08mm | ||
| ASTM D6319-19Standard Specificationfor Nitrile ExaminationGloves for MedicalApplication. | To determine thephysical properties-Tensile strength | Before AgeingTensile Strength14MPa, min for all sizes | Size XS23.79 MPa, averageSize S24.89 MPa, averageSize M25.39 MPa, averageSize L26.44 MPa, averageSize XL26.05 MPa, average |
| After AgeingTensile Strength14MPa, min for all sizes | Size XS27.52 MPa, averageSize S26.28 MPa, averageSize M25.93 MPa, averageSize L26.21 MPa, averageSize XL25.98 MPa, average | ||
| To determine thephysical properties-Ultimate Elongation | Before AgeingUltimate Elongation500%, min for all sizes | Size XS539%, averageSize S533%, averageSize M527%, averageSize L538%, averageSize XL526%, average | |
| After AgeingUltimate Elongation 400%,min for all sizes | Size XS435%, averageSize S453%, averageSize M460%, averageSize L455%, averageSize XL470%, 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 = 32.2Cisplatin 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 = 37.4Vincristine 1 mg/ml = >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
{9}------------------------------------------------
Image /page/9/Picture/0 description: The image shows the logo for Mah Sing Healthcare. The words "Mah Sing" are in red, with "Mah" stacked on top of "Sing". Below that, the word "HEALTHCARE" is in black. The logo is simple and modern.
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
{10}------------------------------------------------
Image /page/10/Picture/1 description: The image contains the logo for Mah Sing Healthcare. The word "MahSing" is in red, and the word "Healthcare" is in black. The word "Healthcare" is directly below the word "MahSing".
| Biocompatibility Testing | |||||
|---|---|---|---|---|---|
| Test Method | Purpose | Acceptance Criteria | Result | ||
| ISO 10993-10Biological evaluation ofmedical devices - Part10: Tests for irritationand skin sensitization(Animal IrritationTest) | To determine thepotential of thematerial under test toproduce dermalirritation in Rabbits | Under the conditionof study 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 irritant 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 theskin sensitizationpotential of thematerial both interms of inductionand elicitation inGuinea pig | Under the conditionof the 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 provideinformation onhealth hazards likelyto arise from a short-term exposure to theextracts of testmaterial byintravenous andintraperitonealinjection in mice | Not induce acutesystemic toxicity | Under the condition of this study, thesingle dose acute systemic toxicity ofextracts from test material using bothnormal saline and sesame oil, did notdemonstrate any adverse toxic reaction,thereof met the requirement. |
Non-clinical tests were carried out to demonstrate product performance conformity with the 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
{11}------------------------------------------------
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 Black Patient Examination Gloves, Non-Sterile, Tested for Use With Chemotherapy Drugs 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 device. |
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.