Who is the manufacturer of Nitrile Powder Free Blue Examination Gloves, Non-Sterile?

Mah Sing Healthcare Sdn. Bhd. filed the 510(k) submission for Nitrile Powder Free Blue Examination Gloves, Non-Sterile (K212535).

What is the FDA product code for Nitrile Powder Free Blue Examination Gloves, Non-Sterile?

LZA. It is classified under 21 CFR 880.6250 as a Class 1 device in the General Hospital panel.

What is the regulatory pathway for Nitrile Powder Free Blue Examination Gloves, Non-Sterile?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Nitrile Powder Free Blue Examination Gloves, Non-Sterile?

Powder Free Nitrile Examination Gloves (K210369).

Who can help prepare an FDA 510(k) submission like Nitrile Powder Free Blue Examination Gloves, Non-Sterile?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Nitrile Powder Free Blue Examination Gloves, Non-Sterile

K212535 · Mah Sing Healthcare Sdn. Bhd. · LZA · Dec 4, 2021 · General Hospital

Device Facts

Record ID	K212535
Device Name	Nitrile Powder Free Blue Examination Gloves, Non-Sterile
Applicant	Mah Sing Healthcare Sdn. Bhd.
Product Code	LZA · General Hospital
Decision Date	Dec 4, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.6250
Device Class	Class 1

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.

Device Story

Nitrile powder-free blue examination gloves; disposable; ambidextrous; non-sterile. Manufactured from acrylonitrile-butadiene copolymer dispersion. Inner surface treated for smooth donning without lubricants. Available in sizes S, M, L, XL. Used in clinical settings by healthcare professionals to provide a barrier against contamination between examiner and patient. Device acts as a physical barrier; no active components or software.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing including residual powder content (ASTM D6124-06), freedom from holes (ASTM D5151-19), physical dimensions and properties (ASTM D6319-19), and biocompatibility (ISO 10993-5, ISO 10993-10, ISO 10993-11).

Technological Characteristics

Material: Acrylonitrile-butadiene copolymer (nitrile). Design: Ambidextrous, blue, powder-free, finger-textured. Standards: ASTM D6319-19 (dimensions, physical properties), ASTM D5151-19 (holes), ASTM D6124-06 (residual powder), ISO 10993 (biocompatibility). Non-sterile. Single-use.

Indications for Use

Indicated for use as a disposable medical device worn on the examiner's hand or finger to prevent cross-contamination between patient and examiner.

Regulatory Classification

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.

Predicate Devices

Powder Free Nitrile Examination Gloves (K210369)

Related Devices

K211319 — Purism Non-Sterile Powder Free Nitrile Examination Gloves · Dezhou Purism Medical Technology Co., Ltd. · Aug 19, 2021
K223004 — Disposable Nitrile Examination Gloves · Jiangxi Handspro Products Solutions Co., Ltd. · Dec 4, 2022
K223281 — Disposable Nitrile Examination Glove · Anhui Kindguard Medical Supplies Technology Co., Ltd. · Dec 7, 2022
K211434 — Nitrile Patient Examination Gloves · Zhangjiagang Huayuan Protective Equipment Co., Ltd. · Aug 5, 2021
K212722 — Nitrile Examination Gloves · Wuhan Huirui Technology Co., Ltd. · Nov 26, 2021

Submission Summary (Full Text)

{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. 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

Nitrile Powder Free Blue Examination Gloves, Non-Sterile

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Related Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

Nitrile Powder Free Blue Examination Gloves, Non-Sterile

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Related Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

Create Alert

Search Filters

Agent Token

Welcome

Check your email

Welcome!