(52 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:
Chemotherapy Drugs Permeation
The following chemicals have been tested with these gloves.
Test Chemotherapy Drugs Concentration Breakthrough Detection Time in minutes *Carmustine 3.3mg/ml 24.8 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 C 0.5 mg/ml >240 Oxaliplatin 5 mg/ml >240 Paclitaxel 6 mg/ml >240 *Thiotepa 10 mg/ml 38.4 Vincristine 1 mg/ml >240
Warning- Not for use with Carmustine and Thiotepa.
Nitrile Powder Free Blue 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.
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 (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 four sizes (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 Blue Patient Examination Gloves Non-Sterile, Tested For Use With Chemotherapy Drugs". This document outlines the acceptance criteria and performance data for a medical device that is a physical commodity, not an AI/ML powered device. As such, information regarding AI/ML specific criteria like human-in-the-loop performance, effect size of human readers with AI assistance, standalone algorithm performance, number of experts for ground truth, or training set details are not applicable and not present in the document.
The acceptance criteria and reported device performance are based on recognized ASTM and ISO standards for medical gloves.
Here's the information extracted from the provided text, structured according to your request where applicable for a non-AI/ML device:
1. A table of acceptance criteria and the reported device performance
| Characteristics and Parameters | Standard | Acceptance Criteria | Reported Device Performance and Results |
|---|---|---|---|
| Chemotherapy Drugs Permeation Test (ASTM D6978-05 (2019)) | ASTM D6978-05 | Minimum Breakthrough Detection Time (min) | |
| Carmustine | - | 24.8 | 24.8 min |
| Cisplatin | - | >240 | >240 min |
| Cyclophosphamide | - | >240 | >240 min |
| Dacarbazine | - | >240 | >240 min |
| Doxorubicin, HCl | - | >240 | >240 min |
| Etoposide | - | >240 | >240 min |
| Fluorouracil | - | >240 | >240 min |
| Methotrexate | - | >240 | >240 min |
| Mitomycin C | - | >240 | >240 min |
| Oxaliplatin | - | >240 | >240 min |
| Paclitaxel | - | >240 | >240 min |
| Thiotepa | - | 38.4 | 38.4 min |
| Vincristine | - | >240 | >240 min |
| Residual Powder Content | ASTM D6124-06 (Reapproved 2017) | Less than 2mg / glove | Size S 0.32mg /glove, Size M 0.28mg /glove, Size L 0.32mg /glove, Size XL 0.30mg /glove |
| Freedom from Holes | ASTM D5151-19 | Inspection level, G-I AQL 2.5 (In accordance with ASTM D6319-19) | Passed G-I, AQL 1.5 |
| Physical Dimensions - Length | ASTM D6319-19 | Size S 220mm, min; Size M 230mm, min; Size L 230mm, min; Size XL 230mm, min | Size S 250 - 255mm, Size M 250 - 255mm, Size L 245 - 252mm, Size XL 245 - 252mm |
| Physical Dimensions - Width | ASTM D6319-19 | Size S 80 ± 10mm; Size M 95 ± 10mm; Size L 110 ± 10mm; Size XL 120 ± 10mm | Size S 83 - 85mm, Size M 93 - 96mm, Size L 105 - 109mm, Size XL 116 - 118mm |
| Physical Dimensions - Thickness (Cuff) | ASTM D6319-19 | Measured in single wall at cuff edge area Cuff 0.05mm, min | Size S 0.05 - 0.06mm, Size M 0.05 - 0.06mm, Size L 0.05 - 0.06mm, Size XL 0.05 - 0.06mm |
| Physical Dimensions - Thickness (Palm) | ASTM D6319-19 | Measured in single wall at approximate center of palm area Palm 0.05mm, min | Size S 0.06 - 0.07mm, Size M 0.06 - 0.06mm, Size L 0.06 - 0.07mm, Size XL 0.06 - 0.07mm |
| Physical Dimensions - Thickness (Finger) | ASTM D6319-19 | Measured in single wall at 13±3mm from the tip of middle finger Finger 0.05mm, min | Size S 0.08 - 0.09mm, Size M 0.09 - 0.10mm, Size L 0.10 - 0.11mm, Size XL 0.10 - 0.11mm |
| Tensile Strength (Before aging) | ASTM D6319-19 | 14MPa, min for all sizes | Size S 21.94 MPa, average; Size M 22.08 MPa, average; Size L 21.76 MPa, average; Size XL 22.05 MPa, average |
| Tensile Strength (After accelerated aging) | ASTM D6319-19 | 14MPa, min for all sizes | Size S 29.53 MPa, average; Size M 29.12 MPa, average; Size L 24.90 MPa, average; Size XL 29.63 MPa, average |
| Ultimate Elongation (Before aging) | ASTM D6319-19 | 500%, min for all sizes | Size S 537%, average; Size M 550%, average; Size L 526%, average; Size XL 536%, average |
| Ultimate Elongation (After accelerated aging) | ASTM D6319-19 | 400%, min for all sizes | Size S 452%, average; Size M 450%, average; Size L 436%, average; Size XL 458%, average |
| Animal Irritation Test (ISO 10993-10) | ISO 10993-10 | 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 is "negligible". |
| Dermal Sensitization Assay Test (ISO 10993-10) | ISO 10993-10 | Under the condition of the study not a sensitizer. | No sensitization induced by the application of the test material on albino guinea pigs. |
| Acute Systemic Toxicity (ISO 10993-11) | ISO 10993-11 | Not induce systemic toxicity | The single dose acute systemic toxicity of extracts from test material using both normal saline and sesame oil, shown non-toxic effects. |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the specific sample sizes used for each test (e.g., number of gloves tested for each characteristic) or the detailed data provenance beyond adherence to international standards like ASTM and ISO. Given the nature of product testing for medical gloves, it is implied that appropriate sample sizes were used as prescribed by the respective ASTM and ISO standards. The tests are non-clinical (bench tests and biocompatibility tests). There is no explicit mention of data provenance in terms of country of origin or retrospective/prospective data collection for these non-clinical tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as the "ground truth" for physical properties and chemical permeation of medical gloves is established by the specified ASTM and ISO standards and their defined methodologies, not by expert consensus on specific samples in the same way an AI model's output would be adjudicated. The tests are objective measurements against defined criteria.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The tests are objective measurements according to established standards. There is no human adjudication process described for these types of tests.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
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.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" is defined by the technical specifications and methodologies outlined in the referenced ASTM standards (e.g., ASTM D6319-19 for physical properties, ASTM D6978-05 (2019) for chemotherapy drug permeation, ASTM D6124-06 for residual powder, ASTM D5151-19 for freedom from holes) and ISO standards (e.g., ISO 10993-10 and ISO 10993-11 for biocompatibility). These standards provide objective measurement criteria and test protocols.
8. The sample size for the training set
Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
February 19, 2022
Mah Sing Healthcare Sdn Bhd Sazalinda Musa Senior RA Executive Wisma Mah Sing, Penthouse Suite 1, 163 Jalan Sungai Besi Kuala Lumpur, Kuala Lumpur 57100 Malaysia
Re: K214110
Trade/Device Name: Nitrile Powder Free Blue 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 Dated: December 17, 2021 Received: December 29, 2021
Dear Sazalinda Musa:
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.
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
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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Clarence W. Murray, III, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K214110
Device Name
Nitrile Powder Free Blue 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:
Chemotherapy Drugs Permeation The following chemicals have been tested with these gloves.
Test Chemotherapy Drugs Concentration Breakthrough Detection Time in minutes *Carmustine 3.3mg/ml 24.8 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 C 0.5 mg/ml >240 Oxaliplatin 5 mg/ml >240 Paclitaxel 6 mg/ml >240 *Thiotepa 10 mg/ml 38.4 Vincristine 1 mg/ml >240
Warning- Not for use with Carmustine and Thiotepa.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
× Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image contains the logo for Mah Sing Healthcare. The words "MahSing" are in a bold, red font on the top line. Below that, the word "HEALTHCARE" is in a smaller, black font.
Premarket Notification [510(k)] No: K214110
| 510 (K) SUMMARY | |
|---|---|
| 1.0 Device Name | Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile,Tested For Use With Chemotherapy Drugs. |
| 2.0 Submitter name /Contact details | Mah Sing Healthcare Sdn. BhdWisma Mah Sing, Penthouse Suite 1,163 Jalan Sungai Besi,Kuala Lumpur57100MALAYSIAContact Person Details:Sazalinda Musa (Ms)E-mail: sazalinda.m@mshealthcare.comTel: +60-3-3396 2288, Extn: 2282Fax: +60-3-3396 2299 |
| 3.0 SummaryPreparation Date | December 17, 2021 |
| 4.0 Device Name &Classification | Trade Name: Nitrile Powder Free Blue Patient Examination Gloves,Non-sterile, Tested For Use With Chemotherapy Drugs.Common Name: Nitrile Powder Free Patient Examination GloveClassification Name: Patient Examination Gloves Specialty (code LZC),Polymer Patient Examination Gloves (code LZA).Device Classification: IRegulation Number: 21 CFR 880.6250Panel: General HospitalProduct Code: LZC, LZA |
| 5.0 Identification ofThe Legally MarketedDevice | Predicate Device Name: Dermagrip Powder Free Blue Nitrile PatientExamination Gloves, Non-sterile, Tested For UseWith Chemotherapy DrugsPredicate 510(K) Number: K161422Manufacture's Name: WRP Asia Pacific 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
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Image /page/4/Picture/1 description: The image shows 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 professional, and the colors are eye-catching.
6.0 Description of Device
Nitrile Powder Free Blue 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.
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 (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 four sizes (S, M, L and XL). The physical properties of glove, i.e., tensile strength meet ASTM D 6319-19.
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.
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:
Chemotherapy Drugs Permeation
The following chemicals have been tested with these gloves.
| Test Chemotherapy Drugs | Concentration | Breakthrough Detection Time in minutes |
|---|---|---|
| *Carmustine | 3.3mg/ml | 24.8 |
| 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 C | 0.5 mg/ml | >240 |
| Oxaliplatin | 5 mg/ml | >240 |
| Paclitaxel | 6 mg/ml | >240 |
| *Thiotepa | 10 mg/ml | 38.4 |
| Vincristine | 1 mg/ml | >240 |
*Note:
Please note that the following drugs have low permeation times:
(1) Carmustine – 24.8 minutes
(2) Thiotepa – 38.4 minutes.
HOW DOES HEALTHCARE SPENDING COMPARE?
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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Image /page/5/Picture/1 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, with all letters being the same size. The logo is simple and modern.
8.0 Summary of the Nitrile Powder Free Blue Patient Examination Gloves Non-sterile, Tested For Use With Chemotherapy Drugs meets all the requirements of ASTM Technological Characteristic of standards D6319-19, D6978-05 (2019) and FDA 21 CFR 880.6250. the Device
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 (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 four sizes (S, M, L and XL). The physical properties of glove, i.e., tensile strength meet ASTM D 6319-19.
| Characteristics andParameters | Standard | Proposed Device | Predicate device | ComparisonAnalysis |
|---|---|---|---|---|
| 510(k) Number | - | - | K161422 | - |
| Name of device | - | Nitrile Powder Free BluePatient ExaminationGloves, Non-Sterile | Powder Free NitrileExamination GlovesNon- Sterile | 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 | Similar |
| Product Code | - | LZA, LZC | LZA, LZC | Similar |
| 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, Color andSurface Appearance | - | 1. Ambidextrous2. Blue3. Powder Free4. Finger Textured | 1. Ambidextrous2. Blue3. Powder Free4. Finger Textured | Same ambidextrousDesign, same color,same features andSame texturedarea |
Table 1
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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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 and slightly larger than the other letters. Below "MahSing" is the word "HEALTHCARE" in black, with all letters capitalized.
| Characteristics andParameters | Standard | Proposed Device | Predicate device | ComparisonAnalysis |
|---|---|---|---|---|
| Chemotherapy DrugPermeation Test | ASTM D6897-05 | |||
| Test ChemotherapyDrugs | Concentration | Minimum Breakthrough Detection Time (min) | ||
| Fluorouracil | 50 mg/ml | >240 | >240 | Similar |
| Etoposide | 20 mg/ml | >240 | >240 | Similar |
| Cyclophosphamide | 20 mg/ml | >240 | >240 | Similar |
| Fluorouracil | 50 mg/ml | >240 | >240 | Similar |
| *Carmustine | 3.3mg/ml | 24.8 | 15.0 | SimilarBelow 240 minutespermeation time,similar withpredicate device |
| *Thiotepa | 10 mg/ml | 38.4 | 2.0 | SimilarBelow 240 minutespermeation time,similar withpredicate device |
| Paclitaxel | 6 mg/ml | >240 | >240 | Similar |
| Doxorubicin, HCl | 2 mg/ml | >240 | >240 | Similar |
| Dacarbazine | 10 mg/ml | >240 | >240 | Similar |
| Cisplatin | 1 mg/ml | >240 | >240 | Similar |
| Ifosfamide | 50 mg/ml | Not tested | >240 | Optional, Predicatedevice performadditionalChemotherapy drugtest |
| Mitoxantrone | 2.0 mg/ml | Not tested | >240 | Optional, Predicatedevice performadditionalChemotherapy drugtest |
| Vincristine | 1 mg/ml | >240 | >240 | Similar |
| Methotrexate | 25 mg/ml | >240 | >240 | Similar |
| Mitomycin C | 0.5 mg/ml | >240 | >240 | Similar |
| Oxaliplatin | 5 mg/ml | >240 | Not tested | Optional, Subjectdevice performadditionalChemotherapy drugtest |
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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Image /page/7/Picture/0 description: The image shows the logo for Mah Sing Healthcare. The words "Mah Sing" are in a large, bold, red font. Below that, the word "HEALTHCARE" is in a smaller, black, sans-serif font. The logo is simple and professional.
| Characteristics andParameters | Standard | Proposed Device | Predicate device | ComparisonAnalysis |
|---|---|---|---|---|
| Overall Length (Minimum230mm) | ASTM D 6319-19 | 245 - 255 mm | Min. 240 mm | Similar |
| WidthS: 75mm - 95mmM: 85mm - 105mmL: 100mm – 120mmXL:110mm - 130mm | ASTM D 6319-19 | S: 83 - 85mmM: 93 - 96mmL: 105 - 109mmXL: 116 - 118mm | Not stated by predicatedevice | Similar, subjectdevice meetrequirementsof ASTMD6319 |
| Cuff Thickness(Minimum 0.05mm) | ASTM D 6319-19 | 0.05 - 0.06mm | 0.06 - 0.08mm | Similar |
| Palm Thickness(Minimum 0.05mm) | ASTM D 6319-19 | 0.06 - 0.07mm | 0.07 - 0.10mm | Similar |
| Finger Thickness(Minimum 0.05mm) | ASTM D 6319-19 | 0.08 - 0.11mm | 0.07 - 0.09mm | Similar |
| Tensile Strength(Before aging) Minimum14 MPa | ASTM D 6319-19 | Average: 21.96MPa | Meets | Similar |
| Tensile Strength(After accelerated aging)Minimum 14 MPa | ASTM D 6319-19 | Average: 28.30MPa | Meets | Similar |
| Ultimate Elongation(before aging) Minimum500% | ASTM D 6319-19 | Average: 537% | 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.S: 0.32 mg /gloveM: 0.28 mg /gloveL: 0.32 mg /gloveXL: 0.30 mg/glove | Average powder residueMeets | Similar |
| Animal Irritation Test | ISO 10993-10Biological evaluationof medical devices -Part 10: Tests forirritation and skinsensitization | Passed.Under the conditions ofstudy, not an irritant | PassedNot a primary skin irritantunder the conditions of thestudy | Similar |
| Dermal Sensitization | ISO 10993-10Biological evaluationof medical devices -Part 10: Tests forirritation and skinsensitization | Passed.Under the conditions ofstudy, not a sensitizer | PassedNot a contact sensitizerunder the conditions of thestudy | Similar |
| Acute Systemic Toxicity | ISO 10993-11Biological evaluationof medical devices -Part 11: Tests forsystemic toxicity | Not induce systemictoxicity | Predicate device has notperformed test. | Subject devicesmeet requirementsof ISO 10993-11 |
| Characteristics andParameters | Standard | Proposed Device | Predicate device | ComparisonAnalysis |
| Expiration Date | ASTM D 7160-16Standard Practice forDetermination ofExpiration Dating forMedical Gloves | 3 years from date ofmanufactured | Predicate device has notstated. | - |
| Manufacturer | - | Mah Sing Healthcare Sdn.Bhd. | WRP Asia Pacific 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
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Image /page/8/Picture/0 description: The image contains the logo for Mah Sing Healthcare. The word "MahSing" is 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.
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 0.32mg /gloveSize M 0.28mg /gloveSize L 0.32mg /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 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 250 - 255mmSize M 250 - 255mmSize L 245 - 252mmSize XL 245 - 252mm |
| ASTM D6319-19Standard Specification forNitrile Examination Glovesfor Medical Application. | To determine thewidth of the gloves | Size S 80 ± 10mmSize M 95 ± 10mmSize L 110 ± 10mmSize XL 120 ± 10mm | Size S S: 83 - 85mmSize M M: 93 - 96mmSize L L: 105 - 109mmSize XL XL: 116 - 118mm |
| 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 cuff edge areaCuff 0.05mm, min | Size S 0.05 - 0.06mmSize M 0.05 - 0.06mmSize L 0.05 - 0.06mmSize XL 0.05 - 0.06mm |
| Measured in single wall at approximate center of palm areaPalm 0.05mm, min | Size S 0.06 - 0.07mmSize M 0.06 - 0.06mmSize L 0.06 - 0.07mmSize XL 0.06 - 0.07mm | ||
| Measured in single wall at 13±3mm from the tip of middle fingerFinger 0.05mm, min | Size S 0.08 - 0.09mmSize M 0.09 - 0.10mmSize L 0.10 - 0.11mmSize XL 0.10 - 0.11mm | ||
| ASTM D6319-19Standard Specificationfor Nitrile ExaminationGloves for MedicalApplication. | To determine thephysical properties-Tensile strength | Before AgeingTensile Strength14Mpa, min for all sizes | Size S 21.94 MPa, averageSize M 22.08 MPa, averageSize L 21.76 MPa, averageSize XL 22.05 MPa, average |
| After AgeingTensile Strength14Mpa, min for all sizes | Size S 29.53 MPa, averageSize M 29.12 MPa, averageSize L 24.90 MPa, averageSize XL 29.63 MPa, average | ||
| To determine thephysical properties-Ultimate Elongation | Before AgeingUltimate Elongation500%, min for all sizes | Size S 537%, averageSize M 550%, averageSize L 526%, averageSize XL 536%, average | |
| After AgeingUltimate Elongation 400%,min for all sizes | Size S 452%, averageSize M 450%, averageSize L 436%, averageSize XL 458%, average |
MAH SING HEALTHCARE SDN BHD Lot 6478, Lorong Sungai Puloh / KU6, Kawasan Industri Sungai Puloh, 42100 Klang, Selangor. MALAYSIA
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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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| 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 10993-11Biological 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 non-toxic 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
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 met the acceptance criteria defined in standards referenced.
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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| 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 is as safe, as effective, and performs as well as or betterthan the legally marketed predicate device K161422. |
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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.