(115 days)
Not Found
No
The device description and performance studies focus on the physical and material properties of examination gloves, with no mention of AI or ML.
No.
The device is a patient examination glove, intended to prevent contamination between patient and examiner, not to treat or diagnose a disease or condition.
No
Explanation: The device is a patient examination glove, described as a disposable device worn on the hand to prevent contamination. Its intended use is not to diagnose any condition or disease.
No
The device description and performance studies clearly indicate this is a physical medical device (examination gloves) and not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is a "patient examination glove... worn on the examiner's hand or finger to prevent contamination between patient and examiner." This describes a barrier device used during physical examination, not a device used to examine specimens in vitro (outside the body) to diagnose or monitor a medical condition.
- Device Description: The description details the material, manufacturing process, and physical characteristics of a glove. It does not mention any components or functionalities related to analyzing biological samples.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring specific analytes
- Providing diagnostic or monitoring information
- Reagents or assay components
The device is a Class I medical device intended for barrier protection during patient examinations.
N/A
Intended Use / 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
Product codes
LZA
Device Description
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand or finger
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical tests were carried out to demonstrate product performance conformity with standards referenced.
The following bench tests were performed:
- Residual Powder Content
- Physical Properties
- Physical Dimension
- Freedom from Holes
Biocompatibility Testing:
- Animal Irritation Test
- Dermal Sensitization Assay
- Cytotoxicity Test (MEM Elution Assay)
- Acute Systemic Toxicity
Key Results:
- ASTM D6124-06 (Reapproved 2017) Standard Test Method for Residual Powder on Medical Gloves: Resulted in Size S 0.36mg /glove, Size M 0.32mg /glove, Size L 0.36mg /glove, Size XL 0.38mg /glove, meeting the acceptance criteria of Less than 2mg / glove.
- ASTM D5151-19 Standard Test Method for Detection of Holes in Medical Gloves: Resulted in Passed G-I, AQL 1.5, meeting the acceptance criteria of Inspection level, G-I AQL 2.5 (In accordance with ASTM D6319-19).
- ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application (Length): Sizes S, M, L, XL all had an average length of approximately 254mm, meeting the minimum length requirements (S 220mm, M 230mm, L 230mm, XL 230mm).
- ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application (Width): S: 86mm, M: 96mm, L: 107mm, XL: 118mm (all averaged values) meeting the specified ranges for each size.
- ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application (Thickness): Palm average 0.06mm (min 0.05mm), Finger average 0.08mm-0.11mm (min 0.05mm).
- ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application (Tensile Strength): Before and After Ageing, all sizes showed average values around 22-23 MPa, meeting the minimum 14 MPa.
- ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application (Ultimate Elongation): Before Ageing, all sizes showed average values around 522%-536%, meeting the minimum 500%. After Ageing, all sizes showed average values around 523%-538%, meeting the minimum 400%.
- ISO 10993-10 Animal Irritation Test: No observable irreversible alteration, Primary Irritation Index (PII) was "0", "negligible" category met the requirement.
- ISO 10993-10 Dermal Sensitization Assay Test: No sensitization induced, met the requirement.
- ISO 10993-5 Cytotoxicity Test (MEM Elution Assay): Under the conditions of the study, cytotoxic.
- ISO 10993-11 Acute Systemic Toxicity: Shown non-toxic effects, met the requirement.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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)
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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. Bhd |
| Wisma Mah Sing, Penthouse Suite 1, | |
| 163 Jalan Sungai Besi, | |
| Kuala Lumpur | |
| 57100 | |
| MALAYSIA |
Contact Person Details:
Mr. Azlan Hashim
E-mail: azlan.hashim@mshealthcare.com
Tel: +60-3-3396 2288, Extn: 2203
Fax: +60-3-3396 2299 |
| 3.0 Summary
Preparation Date | December 3, 2021 |
| 4.0 Device Name &
Classification | K2212535
Trade Name: Nitrile Powder Free Blue Examination Gloves, Non-sterile
Classification Name: Polymer Patient Examination Glove
Device Classification: I
Regulation Number: 21 CFR 880.6250
Panel: General Hospital
Product Code: LZA |
| 5.0 Identification of
The Legally Marketed
Device | Predicate Device Name: Powder Free Nitrile Examination Gloves
Predicate 510(K) Number: K210369
Manufacture's Name: Pastel Glove Sdn Bhd |
| 6.0 Description of Device | 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). |
| Driving Innovation. Protecting Lives.
MAH SING HEALTHCARE SDN BHD
Lot 6478, Lorong Sungai Puloh / KU6,
Kawasan Industri Sungai Puloh,
42100 Klang, Selangor.
T 603 3396 2288
F 603 3396 2299
mshealthcare.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 and
Parameters | Standard | Proposed Device | Predicate device | Comparison
Analysis |
|-------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| 510(k) Number | - | K212535 | K210369 | - |
| Name of device | - | Nitrile Powder Free Blue
Examination Gloves,
Non-Sterile | Powder Free Nitrile
Examination Gloves Non-
Sterile | - |
| Product Code | - | LZA | LZA | Same product
code |
| Intended 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. | 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. | Same intended
use |
| Classification | - | Class 1 | Class 1 | Same Class |
| Raw Rubber Material | ASTM D 6319-19 | Nitrile (Acrylonitrile-
butadiene) | Nitrile (Acrylonitrile-
butadiene) | Same synthetic
rubber material |
| Design, Colour and
Surface Appearance | - | 1. Ambidextrous
2. Blue
3. Powder free
4. Finger Textured | 1. Ambidextrous
2. Blue
3. Powder free
4. Finger Textured | Same
ambidextrous
design, same
colour, some
features, and same
textured area |
| Characteristics and
Parameters | Standard | Proposed Device | Predicate device | Comparison
Analysis |
| Overall Length
(Minimum 230mm) | ASTM D 6319-19 | Average: 254 mm | Average: 242 mm | Similar |
| Width
S: 75mm - 95mm
M: 85mm - 105mm
L: 100mm – 120mm
XL:110mm -- 130mm | ASTM D 6319-19 | Average value:
S: 86mm
M: 96mm
L: 107mm
XL: 118mm | S: 84mm
M: 94mm
L: 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 Holes
Meet 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 residue
for each size.
S: 0.36 mg /glove
M: 0.32 mg /glove
L: 0.36 mg /glove
XL: 0.38 mg/glove | Average powder residue
for each size.
S: 0.45 mg /glove
M: 0.43 mg /glove
L: 0.27 mg /glove | Similar |
| Animal Irritation Test | ISO 10993-10
Biological evaluation
of medical devices -
Part 10: Tests for
irritation and skin
sensitization | Under the conditions of
study, not an irritant | Under the conditions of
study, not an irritant | Similar |
| Dermal Sensitization | ISO 10993-10
Biological evaluation
of medical devices -
Part 10: Tests for
irritation and skin
sensitization | Under the conditions of
study, not a sensitizer | Under the conditions of
study, not a sensitizer. | Similar |
| Cytotoxicity Test
(MEM Elution Assay) | ISO 10993-5
Biological evaluation
of medical devices -
Part 5: Tests for in
vitro cytotoxicity | Under the conditions of
the study, cytotoxic. | Not done | Meeting the
requirements per
ISO 10993-5 |
| Characteristics and
Parameters | Standard | Proposed Device | Predicate device | Comparison
Analysis |
| Acute Systemic Toxicity | ISO 10993-11
Biological evaluation
of medical devices –
Part 11: Tests for
systemic toxicity | Not induce systemic
toxicity | Not induce systemic
toxicity | Similar |
| Expiration Date | ASTM D 7160-16
Standard Practice for
Determination of
Expiration Dating for
Medical Gloves | 3 years from date of
manufactured | Not stated | - |
| Manufacturer | - | Mah Sing Healthcare
Sdn 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 for | |||
| Residual Powder on Medical | |||
| Gloves. | To determine the | ||
| residual powder in | |||
| the gloves | Less than 2mg / glove | Size S 0.36mg /glove | |
| Size M 0.32mg /glove | |||
| Size L 0.36mg /glove | |||
| Size XL 0.38mg /glove | |||
| ASTM D5151-19 | |||
| Standard Test Method for | |||
| Detection of Holes in | |||
| Medical Gloves. | 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 | |||
| Standard Specification | |||
| for Nitrile Examination | |||
| Gloves for Medical | |||
| Application. | To determine the | ||
| length of the gloves | Size S 220mm, min | ||
| Size M 230mm, min | |||
| Size L 230mm, min | |||
| Size XL 230mm, min | Size S 254mm, average | ||
| Size M 254mm, average | |||
| Size L 254mm, average | |||
| Size 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 D6319-19 | |||
| Standard Specification | |||
| for Nitrile Examination | |||
| Gloves for Medical | |||
| Application. | 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, average | ||
| Size M 0.06mm, average | |||
| Size L 0.06mm, average | |||
| Size XL 0.06mm, average | |||
| Measured in single wall at 13±3mm from the tip of middle finger | |||
| Finger | |||
| 0.05mm, min | Size S 0.08mm, average | ||
| Size M 0.08mm, average | |||
| Size L 0.11mm, average | |||
| Size XL 0.10mm, average | |||
| ASTM D6319-19 | |||
| Standard Specification | |||
| for Nitrile Examination | |||
| Gloves for Medical | |||
| Application. | To determine the | ||
| physical properties- | |||
| Tensile strength | Before Ageing | ||
| Tensile Strength | |||
| 14 MPa, min for all sizes | Size S 23 MPa, average | ||
| Size M 22 MPa, average | |||
| Size L 22 MPa, average | |||
| Size XL 22 MPa, average | |||
| After Ageing | |||
| Tensile Strength | |||
| 14 MPa, min for all sizes | Size S 23 MPa, average | ||
| Size M 23 MPa, average | |||
| Size L 23 MPa, average | |||
| Size XL 22 MPa, average | |||
| To determine the | |||
| physical properties- | |||
| Ultimate Elongation | Before Ageing | ||
| Ultimate Elongation | |||
| 500%, min for all sizes | Size S 524%, average | ||
| Size M 522%, average | |||
| Size L 523%, average | |||
| Size XL 536%, average | |||
| After Ageing | |||
| Ultimate Elongation 400%, | |||
| min for all sizes | Size S 538%, average | ||
| Size M 532%, average | |||
| Size L 530%, average | |||
| Size 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 10993-10 | |||
| Biological evaluation of | |||
| medical devices - Part | |||
| 10: Tests for irritation | |||
| and skin sensitization | |||
| (Animal Irritation | |||
| Test) | To determine the | ||
| potential of the | |||
| material under test | |||
| to produce dermal | |||
| irritation in Rabbits | Under the condition | ||
| of study not an | |||
| irritant. | There was no observable irreversible | ||
| alteration on the skin at the sites of contact | |||
| with the test material. The Primary | |||
| Irritation Index (PII) was "0". The test | |||
| material was not corrosive, and the | |||
| Primary Irritation Response Category is | |||
| therefore "negligible", thereof met the | |||
| requirement. | |||
| ISO 10993-10 | |||
| Biological evaluation of | |||
| medical devices - | |||
| Part 10: Tests for | |||
| irritation and skin | |||
| sensitization | |||
| (Dermal Sensitization | |||
| Assay Test) | To determine the | ||
| skin sensitization | |||
| potential of the | |||
| material both in | |||
| terms of induction | |||
| and elicitation in | |||
| Guinea pig | Under the condition | ||
| of the study not a | |||
| sensitizer. | There was no sensitization induced by the | ||
| application of the test material on the | |||
| albino guinea pigs under the condition of | |||
| this test, thereof met the requirement. | |||
| ISO 10993-5 | |||
| Biological evaluation of | |||
| medical devices - Part 5: | |||
| Tests for in vitro | |||
| cytotoxicity | |||
| (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. | |||
| ISO 10993-11 | |||
| Biological evaluation of | |||
| medical devices - Part 11: | |||
| Tests for systemic toxicity | |||
| (Acute Systemic Toxicity) | To provide | ||
| information on | |||
| health hazards | |||
| likely to arise from | |||
| a short-term | |||
| exposure to the | |||
| extracts of test | |||
| material by | |||
| intravenous and | |||
| intraperitoneal | |||
| injection in mice | Not induce systemic | ||
| toxicity | Under the condition of this study, the | ||
| single dose acute systemic toxicity of | |||
| extracts from test material using both | |||
| normal 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
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 the |
| subject device in 510(K) submission, Nitrile Powder Free Blue | |
| Examination Gloves, Non-Sterile is as safe, as effective, and performs | |
| as 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