(115 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.
Nitrile Powder Free Blue Examination Gloves, Non-Sterile are Class I patient examination gloves bearing the product code Nitrile – LZA (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 single use disposable devices that come in four sizes (S, M, L and XL).
The provided text describes the acceptance criteria and the results of a study for the "Nitrile Powder Free Blue Examination Gloves, Non-Sterile". Here's the information broken down as requested:
1. A table of acceptance criteria and the reported device performance
| Test Method (Standard) | Purpose | Acceptance Criteria | Reported Device Performance (Result) |
|---|---|---|---|
| ASTM D6124-06 (Reapproved 2017) | To determine the residual powder in the gloves | Less than 2mg / glove | Size S: 0.36mg /gloveSize M: 0.32mg /gloveSize L: 0.36mg /gloveSize XL: 0.38mg /glove |
| ASTM D5151-19 | To determine the holes in the gloves | Inspection level, 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 the gloves | Size S: 220mm, minSize M: 230mm, minSize L: 230mm, minSize XL: 230mm, min | Size S: 254mm, averageSize M: 254mm, averageSize L: 254mm, averageSize XL: 253mm, average |
| ASTM D6319-19 Width | To determine the width of the gloves | Size S: 80 ± 10mmSize M: 95 ± 10mmSize L: 110 ± 10mmSize XL: 120 ± 10mm | Size S: 86mm, averageSize M: 96mm, averageSize L: 107mm, averageSize XL: 118mm, average |
| ASTM D6319-19 Palm Thickness | To determine the thickness of the gloves | Measured in single wall at approximate center of palm area: Palm 0.05mm, min | Size S: 0.06mm, averageSize M: 0.06mm, averageSize L: 0.06mm, averageSize XL: 0.06mm, average |
| ASTM D6319-19 Finger Thickness | To determine the thickness of the gloves | Measured in single wall at 13±3mm from the tip of middle finger: Finger 0.05mm, min | Size S: 0.08mm, averageSize M: 0.08mm, averageSize L: 0.11mm, averageSize XL: 0.10mm, average |
| ASTM D6319-19 Tensile Strength (Before Ageing) | To determine the physical properties - Tensile strength | Before Ageing: Tensile Strength 14 MPa, min for all sizes | Size S: 23 MPa, averageSize M: 22 MPa, averageSize L: 22 MPa, averageSize XL: 22 MPa, average |
| ASTM D6319-19 Tensile Strength (After Ageing) | To determine the physical properties - Tensile strength | After Ageing: Tensile Strength 14 MPa, min for all sizes | Size S: 23 MPa, averageSize M: 23 MPa, averageSize L: 23 MPa, averageSize XL: 22 MPa, average |
| ASTM D6319-19 Ultimate Elongation (Before Ageing) | To determine the physical properties - Ultimate Elongation | Before Ageing: Ultimate Elongation 500%, min for all sizes | Size S: 524%, averageSize M: 522%, averageSize L: 523%, averageSize XL: 536%, average |
| ASTM D6319-19 Ultimate Elongation (After Ageing) | To determine the physical properties - Ultimate Elongation | After Ageing: Ultimate Elongation 400%, min for all sizes | Size S: 538%, averageSize M: 532%, averageSize L: 530%, averageSize XL: 523%, average |
| ISO 10993-10 (Animal Irritation Test) | To determine the potential of the material to produce dermal irritation in Rabbits | Under the condition of study not an irritant. | No observable irreversible alteration on the skin; Primary Irritation Index (PII) was "0"; not corrosive; Primary Irritation Response Category "negligible", meeting the requirement. |
| ISO 10993-10 (Dermal Sensitization Assay Test) | To determine the skin sensitization potential of the material in Guinea pig | Under the condition of the study not a sensitizer. | No sensitization induced by the application of the test material on albino guinea pigs, meeting the requirement. |
| ISO 10993-5 (MEM Elution Assay) | To evaluate the in vitro cytotoxic potential of the test item (both inner and outer surface) | Under the conditions of study non cytotoxic | Under the conditions of the study, cytotoxic. (Note: This is an outlier result compared to the acceptance criteria which states "non cytotoxic". The document then states "Meeting the requirements per ISO 10993-5" in Table 1 for the predicate device, but for the proposed device, it states "Under the conditions of the study, cytotoxic." in Table 2, and "Meeting the requirements per ISO 10993-5" in Table 1 where it compares to "Not done" for the predicate. This seems like a contradiction or an oversight in the provided text.) |
| ISO 10993-11 (Acute Systemic Toxicity) | To provide information on health hazards from a short-term exposure to the extracts of test material by intravenous and intraperitoneal injection in mice | Not induce systemic toxicity | Single dose acute systemic toxicity of extracts using normal saline and sesame oil shown non-toxic effects, meeting the requirement. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the specific sample sizes for each test. Instead, it refers to standards like ASTM and ISO, which would define the required sample sizes for such tests. For instance, for "Freedom of Holes," it refers to "AQL 1.5 with G1," which implies a sampling plan defined by ASTM D5151-19.
The data provenance is from Mah Sing Healthcare Sdn Bhd, located in Kuala Lumpur, Malaysia. The tests are non-clinical bench tests and biocompatibility tests conducted to support a premarket notification (510(k)). These are typically prospective tests performed specifically for the submission.
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)
This information is not applicable. The device is a medical glove, and the tests relate to its physical properties, chemical properties (residual powder), and biocompatibility, as measured by standard laboratory methods. There is no mention of human expert assessment or ground truth establishment in the context of medical image analysis or similar diagnostic tasks.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods are typically relevant in clinical studies or studies involving human interpretation of data where disagreements need to be resolved. The tests performed are laboratory-based and follow standardized testing 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
This information is not applicable. MRMC studies and AI assistance effectiveness are relevant for AI/ML-enabled diagnostic devices. The device in question is a medical glove, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a medical glove and does not involve any algorithms or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the tests performed is based on:
- Standardized measurement techniques and physical limits defined by international standards (ASTM D6124-06, ASTM D5151-19, ASTM D6319-19).
- Biological and chemical assays for biocompatibility (ISO 10993-10, ISO 10993-5, ISO 10993-11) where the "truth" is whether the material elicits a specific biological response (e.g., irritation, sensitization, cytotoxicity, systemic toxicity) above a defined threshold.
8. The sample size for the training set
This information is not applicable. There is no training set as the device is a physical product (medical glove) and not an AI/ML system.
9. How the ground truth for the training set was established
This information is not applicable, as there is no training set.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services-USA seal. To the right of the seal is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
December 4, 2021
Mah Sing Healthcare Sdn Bhd Azlan Hashim Head, QA/RA Wisma Mah Sing, Penthouse Suite 1, 163 Jalan Sungai Besi Kuala Lumpur, Kuala Lumpur 57100 Malaysia
Re: K212535
Trade/Device Name: Nitrile Powder Free Blue Examination Gloves, Non-Sterile Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: October 23, 2021 Received: November 1, 2021
Dear Azlan Hashim:
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.
For Clarence W. Murray, III, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K212535
Device Name
Nitrile Powder Free Blue Examination Gloves, Non-Sterile
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
| 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.
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 "Mah Sing" are in large, red, bold letters. Underneath that, the word "HEALTHCARE" is in smaller, black, bold letters.
Premarket Notification [510(k)] No: K212535
| 510 (K) SUMMARY | |
|---|---|
| 1.0 Device Name | Nitrile Powder Free Blue Examination Gloves, Non-Sterile |
| 2.0 Submitter name /Contact details | Mah Sing Healthcare Sdn. BhdWisma Mah Sing, Penthouse Suite 1,163 Jalan Sungai Besi,Kuala Lumpur57100MALAYSIAContact Person Details:Mr. Azlan HashimE-mail: azlan.hashim@mshealthcare.comTel: +60-3-3396 2288, Extn: 2203Fax: +60-3-3396 2299 |
| 3.0 SummaryPreparation Date | December 3, 2021 |
| 4.0 Device Name &Classification | K2212535Trade Name: Nitrile Powder Free Blue Examination Gloves, Non-sterileClassification Name: Polymer Patient Examination GloveDevice Classification: IRegulation Number: 21 CFR 880.6250Panel: General HospitalProduct Code: LZA |
| 5.0 Identification ofThe Legally MarketedDevice | Predicate Device Name: Powder Free Nitrile Examination GlovesPredicate 510(K) Number: K210369Manufacture's Name: Pastel Glove Sdn Bhd |
| 6.0 Description of Device | Nitrile Powder Free Blue Examination Gloves, Non-Sterile are Class Ipatient examination gloves bearing the product code Nitrile – LZA(21CFR880.6250). The gloves are made from acrylonitrile-butadienecopolymer dispersion. Inner surface of gloves undergoes surfacetreatment process to produce a smooth surface that assists the user indonning the gloves without using any lubricant such as powder on theglove surface. These gloves are blue in color and are powder free. Thegloves are ambidextrous single use disposable devices that come infour sizes (S, M, L and XL). |
| Driving Innovation. Protecting Lives.MAH SING HEALTHCARE SDN BHDLot 6478, Lorong Sungai Puloh / KU6,Kawasan Industri Sungai Puloh,42100 Klang, Selangor.T 603 3396 2288F 603 3396 2299mshealthcare.com | |
| 7.0 Indications for Use | 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. |
| 8.0 Summary of the Technological Characteristic of the Device | Nitrile Powder Free Blue Examination Gloves, Non-sterile possesses the following technological characteristics (as compared to ASTM's or equivalent standards. Summary of substantial equivalence is shown in Table 1 of this "510(k) Summary". Non-clinical performance testing was performed to support a determination of substantial equivalence (refer to performance testing in Table 2) of this “510(k)” summary. The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use and performs in accordance with |
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image contains the logo for Mah Sing Healthcare. The word "MahSing" is in red, with the "M", "S", and "g" being larger than the other letters. Below "MahSing" is the word "HEALTHCARE" in black, block letters. The logo is simple and clean, with a focus on the company name.
standards referenced.
.
| Characteristics andParameters | Standard | Proposed Device | Predicate device | ComparisonAnalysis |
|---|---|---|---|---|
| 510(k) Number | - | K212535 | K210369 | - |
| Name of device | - | Nitrile Powder Free BlueExamination Gloves,Non-Sterile | Powder Free NitrileExamination Gloves Non-Sterile | - |
| Product Code | - | LZA | LZA | Same productcode |
| Intended Use | - | A patient examinationglove is a disposabledevice intended formedical purpose that isworn on the examiner'shand or finger to preventcontamination betweenpatient and examiner. | A patient examinationglove is a disposabledevice intended formedical purpose that isworn on the examiner'shand or finger to preventcontamination betweenpatient and examiner. | Same intendeduse |
| Classification | - | Class 1 | Class 1 | Same Class |
| Raw Rubber Material | ASTM D 6319-19 | Nitrile (Acrylonitrile-butadiene) | Nitrile (Acrylonitrile-butadiene) | Same syntheticrubber material |
| Design, Colour andSurface Appearance | - | 1. Ambidextrous2. Blue3. Powder free4. Finger Textured | 1. Ambidextrous2. Blue3. Powder free4. Finger Textured | Sameambidextrousdesign, samecolour, somefeatures, and sametextured area |
| Characteristics andParameters | Standard | Proposed Device | Predicate device | ComparisonAnalysis |
| Overall Length(Minimum 230mm) | ASTM D 6319-19 | Average: 254 mm | Average: 242 mm | Similar |
| WidthS: 75mm - 95mmM: 85mm - 105mmL: 100mm – 120mmXL:110mm -- 130mm | ASTM D 6319-19 | Average value:S: 86mmM: 96mmL: 107mmXL: 118mm | S: 84mmM: 94mmL: 103mm | Similar |
| Palm Thickness(Minimum 0.05mm) | ASTM D 6319-19 | Average: 0.06mm | Average: 0.06mm | Similar |
| Finger Thickness(Minimum 0.05mm) | ASTM D 6319-19 | Average: 0.09mm | Average: 0.08mm | Similar |
| Tensile Strength(Before aging)Minimum 14 MPa | ASTM D 6319-19 | Average: 22.3MPa | Average: 17.75MPa | Similar |
| Tensile Strength(After accelerated aging)Minimum 14 MPa | ASTM D 6319-19 | Average: 22.8MPa | Average: 16.07MPa | Similar |
| Ultimate Elongation(before aging)Minimum 500% | ASTM D 6319-19 | Average: 526% | Average: 560% | Similar |
| Ultimate Elongation(after accelerated aging)Minimum 400% | ASTM D 6319-19 | Average 531% | Average: 510% | Similar |
| Freedom of HolesMeet AQL 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.S: 0.36 mg /gloveM: 0.32 mg /gloveL: 0.36 mg /gloveXL: 0.38 mg/glove | Average powder residuefor each size.S: 0.45 mg /gloveM: 0.43 mg /gloveL: 0.27 mg /glove | Similar |
| Animal Irritation Test | ISO 10993-10Biological evaluationof medical devices -Part 10: Tests forirritation and skinsensitization | Under the conditions ofstudy, not an irritant | Under the conditions ofstudy, not an irritant | Similar |
| Dermal Sensitization | ISO 10993-10Biological evaluationof medical devices -Part 10: Tests forirritation and skinsensitization | Under the conditions ofstudy, not a sensitizer | Under the conditions ofstudy, not a sensitizer. | Similar |
| Cytotoxicity Test(MEM Elution Assay) | ISO 10993-5Biological evaluationof medical devices -Part 5: Tests for invitro cytotoxicity | Under the conditions ofthe study, cytotoxic. | Not done | Meeting therequirements perISO 10993-5 |
| Characteristics andParameters | Standard | Proposed Device | Predicate device | ComparisonAnalysis |
| Acute Systemic Toxicity | ISO 10993-11Biological evaluationof medical devices –Part 11: Tests forsystemic toxicity | Not induce systemictoxicity | Not induce systemictoxicity | Similar |
| Expiration Date | ASTM D 7160-16Standard Practice forDetermination ofExpiration Dating forMedical Gloves | 3 years from date ofmanufactured | Not stated | - |
| Manufacturer | - | Mah Sing HealthcareSdn Bhd | Pastel Glove Sdn Bhd | - |
Table 1
MAH SING HEALTHCARE SDN BHD
DrivingInnovation. Protecting Lives.
Lot 6478, Lorong Sungai Puloh / KU6, Kawasan Industri Sungai Puloh, 42100 Klang, Selangor. MALAYSIA
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image shows the logo for Mah Sing Healthcare. The words "Mah Sing" are in red, with "Mah Sing" stacked on top of "Healthcare". The word "Healthcare" is in black. The logo is simple and modern.
MAH SING HEALTHCARE SDN BHD
Driving Innovation. Protecting Lives.
Lot 6478, Lorong Sungai Puloh / KU6, Kawasan Industri Sungai Puloh, 42100 Klang, Selangor. MALAYSIA
{6}------------------------------------------------
Image /page/6/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.
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 S 0.36mg /gloveSize M 0.32mg /gloveSize L 0.36mg /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 S 220mm, minSize M 230mm, minSize L 230mm, minSize XL 230mm, min | Size S 254mm, averageSize M 254mm, averageSize L 254mm, averageSize XL 253mm, average |
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.
{7}------------------------------------------------
Image /page/7/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.
| ASTM D6319-19 | To determine the | Size S | $80 \pm 10mm$ | Size S | 86mm, average |
|---|---|---|---|---|---|
| Standard Specification | width of the gloves | Size M | $95 \pm 10mm$ | Size M | 96mm, average |
| for Nitrile Examination | Size L | $110 \pm 10mm$ | Size L | 107mm, average | |
| Gloves for Medical | Size XL | $120 \pm 10mm$ | Size XL | 118mm, average | |
| Application. |
Driving Innovation. Protecting Lives.
MAH SING HEALTHCARE SDN BHD Lot 6478, Lorong Sungai Puloh / KU6, Kawasan Industri Sungai Puloh, 42100 Klang, Selangor. MALAYSIA
{8}------------------------------------------------
Image /page/8/Picture/0 description: The image contains the logo for Mah Sing Healthcare. The words "MahSing" are in red, and the word "Healthcare" is in black. The words are stacked on top of each other, with "MahSing" on top and "Healthcare" on the bottom.
| 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 S 0.06mm, averageSize M 0.06mm, averageSize L 0.06mm, averageSize XL 0.06mm, average |
| Measured in single wall at 13±3mm from the tip of middle fingerFinger0.05mm, min | Size S 0.08mm, averageSize M 0.08mm, averageSize L 0.11mm, averageSize XL 0.10mm, average | ||
| ASTM D6319-19Standard Specificationfor Nitrile ExaminationGloves for MedicalApplication. | To determine thephysical properties-Tensile strength | Before AgeingTensile Strength14 MPa, min for all sizes | Size S 23 MPa, averageSize M 22 MPa, averageSize L 22 MPa, averageSize XL 22 MPa, average |
| After AgeingTensile Strength14 MPa, min for all sizes | Size S 23 MPa, averageSize M 23 MPa, averageSize L 23 MPa, averageSize XL 22 MPa, average | ||
| To determine thephysical properties-Ultimate Elongation | Before AgeingUltimate Elongation500%, min for all sizes | Size S 524%, averageSize M 522%, averageSize L 523%, averageSize XL 536%, average | |
| After AgeingUltimate Elongation 400%,min for all sizes | Size S 538%, averageSize M 532%, averageSize L 530%, averageSize XL 523%, average |
MAH SING HEALTHCARE SDN BHD Lot 6478, Lorong Sungai Puloh / KU6, T 603 3396 2288 F 603 3396 2299 mshealthcare.com
Driving Innovation. Protecting Lives.
Kawasan Industri Sungai Puloh, 42100 Klang, Selangor. MALAYSIA
{9}------------------------------------------------
Image /page/9/Picture/0 description: The image contains 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 font is bold and sans-serif.
| 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 testto produce 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 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 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 10993-5Biological evaluation ofmedical devices - Part 5:Tests for in vitrocytotoxicity(MEM Elution Assay) | To evaluate the invitro cytotoxicpotential of the testitem (both innerand outer surface) | Under the conditionsof study noncytotoxic | Under the conditions of the study,cytotoxic. |
| ISO 10993-11Biological evaluation ofmedical devices - Part 11:Tests for systemic toxicity(Acute Systemic Toxicity) | To provideinformation onhealth hazardslikely to arise froma short-termexposure to theextracts of testmaterial byintravenous andintraperitonealinjection in mice | Not induce systemictoxicity | Under the condition of this study, thesingle dose acute systemic toxicity ofextracts from test material using bothnormal saline and sesame oil, shown nontoxic effects, thereof met the requirement. |
Non-clinical tests were carried out to demonstrate product performance conformity with standards referenced.
The following bench tests were performed:
Non-clinical tests
- Residual Powder Content
- Physical Properties
- Physical Dimension
- Freedom from Holes
MAH SING HEALTHCARE SDN BHD
DrivingInnovation. Protecting Lives.
Lot 6478, Lorong Sungai Puloh / KU6, Kawasan Industri Sungai Puloh, 42100 Klang, Selangor. MALAYSIA
{10}------------------------------------------------
Image /page/10/Picture/0 description: The image contains the logo for Mah Sing Healthcare. The word "MahSing" is in red, with the "M" and "S" being larger than the other letters. Below "MahSing" is the word "HEALTHCARE" in black, block letters. The logo is simple and modern.
Biocompatibility Testing
- Animal Irritation Test
- Dermal Sensitization Assay
- Cytotoxicity Test (MEM Elution Assay)
- Acute Systemic Toxicity
The results from these performance evaluations demonstrated that the Nitrile Powder Free Blue Examination Gloves, Non-Sterile 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 demonstrate that thesubject device in 510(K) submission, Nitrile Powder Free BlueExamination Gloves, Non-Sterile is as safe, as effective, and performsas well as or better than the legally marketed predicate device K210369. |
Driving Innovation. Protecting Lives.
MAH SING HEALTHCARE SDN BHD Lot 6478, Lorong Sungai Puloh / KU6, Kawasan Industri Sungai Puloh, 42100 Klang, Selangor. MALAYSIA
§ 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.