Nitrile Powder Free Blue Patient Examination Gloves Non-Sterile, Tested For Use With Chemotherapy Drugs

Q: Who is the manufacturer of Nitrile Powder Free Blue Patient Examination Gloves Non-Sterile, Tested For Use With Chemotherapy Drugs?

Mah Sing Healthcare Sdn. Bhd. filed the 510(k) submission for Nitrile Powder Free Blue Patient Examination Gloves Non-Sterile, Tested For Use With Chemotherapy Drugs (K214110).

Q: What is the FDA product code for Nitrile Powder Free Blue Patient Examination Gloves Non-Sterile, Tested For Use With Chemotherapy Drugs?

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

Q: What is the regulatory pathway for Nitrile Powder Free Blue Patient Examination Gloves Non-Sterile, Tested For Use With Chemotherapy Drugs?

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

Q: Who can help prepare an FDA 510(k) submission like Nitrile Powder Free Blue Patient Examination Gloves Non-Sterile, Tested For Use With Chemotherapy Drugs?

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.

K214110 · Mah Sing Healthcare Sdn. Bhd. · LZA · Feb 19, 2022 · General Hospital

Device Facts

Record ID	K214110
Device Name	Nitrile Powder Free Blue Patient Examination Gloves Non-Sterile, Tested For Use With Chemotherapy Drugs
Applicant	Mah Sing Healthcare Sdn. Bhd.
Product Code	LZA · General Hospital
Decision Date	Feb 19, 2022
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

Disposable, non-sterile, ambidextrous nitrile (acrylonitrile-butadiene) patient examination glove; blue color; powder-free. Used by healthcare professionals in clinical settings to prevent cross-contamination. Tested for permeation resistance against specific chemotherapy drugs per ASTM D6978-05 (2019). Provides a physical barrier; protects both patient and examiner. Not for use with Carmustine or Thiotepa.

Clinical Evidence

No clinical data. Bench testing only, including physical properties (tensile strength, elongation), dimensions, freedom from holes (ASTM D5151-19), residual powder (ASTM D6124-06), and chemotherapy drug permeation (ASTM D6978-05). Biocompatibility testing performed per ISO 10993-10 and ISO 10993-11.

Technological Characteristics

Material: Acrylonitrile-butadiene copolymer. Form: Ambidextrous, powder-free, blue, finger-textured. Sizes: S, M, L, XL. Standards: ASTM D6319-19 (physical properties/dimensions), ASTM D6978-05 (chemotherapy permeation), ASTM D5151-19 (holes), ASTM D6124-06 (powder). Biocompatibility: ISO 10993-10 (irritation/sensitization), ISO 10993-11 (systemic toxicity).

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hand or finger to prevent cross-contamination between patient and examiner. Tested for use with chemotherapy drugs per ASTM D6978-05 (2019).

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

Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-sterile, Tested For Use With Chemotherapy Drugs (K161422)

Related Devices

K212532 — Disposable Powder Free Nitrile Exam Gloves (Tested For Use With Chemotherapy Drugs) · Crdlight Optoelectronic Technology Co., Ltd. · Nov 11, 2021
K181066 — Powder Free Nitrile Examination Glove (Blue) with Low Dermatitis claim and with tested for Use with Chemotherapy Drugs Claims · Eco Medi Glove Sdn. Bhd. · Sep 26, 2018
K212827 — Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs · Jr Engineering & Medical Technologies (M) Sdn. Bhd. · Dec 6, 2021
K161422 — DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS · Wrp Asia Pacific Sdn. Bhd. · Oct 20, 2016
K233405 — Blue Powder Free Nitrile Examination Glove with Chemotherapy Drugs and Fentanyl Test Claim · Eco Medi Glove Sdn. Bhd. · Dec 28, 2023

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). 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ ### 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) CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number. {3}------------------------------------------------ Image /page/3/Picture/0 description: The image contains the logo for Mah Sing Healthcare. The words "MahSing" are in 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. Bhd Wisma Mah Sing, Penthouse Suite 1, 163 Jalan Sungai Besi, Kuala Lumpur 57100 MALAYSIA Contact Person Details: Sazalinda Musa (Ms) E-mail: sazalinda.m@mshealthcare.com Tel: +60-3-3396 2288, Extn: 2282 Fax: +60-3-3396 2299 | | 3.0 Summary Preparation 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 Glove Classification Name: Patient Examination Gloves Specialty (code LZC), Polymer Patient Examination Gloves (code LZA). Device Classification: I Regulation Number: 21 CFR 880.6250 Panel: General Hospital Product Code: LZC, LZA | | 5.0 Identification of The Legally Marketed Device | Predicate Device Name: Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-sterile, Tested For Use With Chemotherapy Drugs Predicate 510(K) Number: K161422 Manufacture'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 {4}------------------------------------------------ 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 {5}------------------------------------------------ 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 and Parameters | Standard | Proposed Device | Predicate device | Comparison Analysis | |-------------------------------------------------|-------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------| | 510(k) Number | - | - | K161422 | - | | Name of device | - | Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile | Powder Free Nitrile Examination Gloves Non- Sterile | Similar | | Device Classification Name/Regulation Number | Patient Examination Glove, 21 CFR Part 880.6250 | Patient Examination Glove, 21 CFR Part 880.6250 | Patient Examination Glove, 21 CFR Part 880.6250 | Similar | | Product Code | - | LZA, LZC | LZA, LZC | Similar | | 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, Color 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 color, same features and Same textured area | ### 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 {6}------------------------------------------------ Image /page/6/Picture/0 description: The image contains the logo for Mah Sing Healthcare. The word "MahSing" is in red, with the "M" and "S" capitalized and slightly larger than the other letters. Below "MahSing" is the word "HEALTHCARE" in black, with all letters capitalized. | Characteristics and Parameters | Standard | Proposed Device | Predicate device | Comparison Analysis | |--------------------------------------|---------------|-------------------------------------------|------------------|--------------------------------------------------------------------------------------| | Chemotherapy Drug Permeation Test | ASTM D6897-05 | | | | | Test Chemotherapy Drugs | 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 | Similar Below 240 minutes permeation time, similar with predicate device | | *Thiotepa | 10 mg/ml | 38.4 | 2.0 | Similar Below 240 minutes permeation time, similar with predicate 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, Predicate device perform additional Chemotherapy drug test | | Mitoxantrone | 2.0 mg/ml | Not tested | >240 | Optional, Predicate device perform additional Chemotherapy drug test | | 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, Subject device perform additional Chemotherapy drug test | #### 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 {7}------------------------------------------------ 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 and Parameters | Standard | Proposed Device | Predicate device | Comparison Analysis | |------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|---------------------------------------------------------------------| | Overall Length (Minimum 230mm) | ASTM D 6319-19 | 245 - 255 mm | Min. 240 mm | Similar | | Width S: 75mm - 95mm M: 85mm - 105mm L: 100mm – 120mm XL:110mm - 130mm | ASTM D 6319-19 | S: 83 - 85mm M: 93 - 96mm L: 105 - 109mm XL: 116 - 118mm | Not stated by predicate device | Similar, subject device meet requirements of ASTM D6319 | | 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) Minimum 14 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) Minimum 500% | 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 Meet AQL 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 residue for each size. S: 0.32 mg /glove M: 0.28 mg /glove L: 0.32 mg /glove XL: 0.30 mg/glove | Average powder residue Meets | Similar | | Animal Irritation Test | ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization | Passed. Under the conditions of study, not an irritant | Passed Not a primary skin irritant under the conditions of the study | Similar | | Dermal Sensitization | ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization | Passed. Under the conditions of study, not a sensitizer | Passed Not a contact sensitizer under the conditions of the study | Similar | | Acute Systemic Toxicity | ISO 10993-11 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity | Not induce systemic toxicity | Predicate device has not performed test. | Subject devices meet requirements of ISO 10993-11 | | Characteristics and Parameters | Standard | Proposed Device | Predicate device | Comparison Analysis | | Expiration Date | ASTM D 7160-16 Standard Practice for Determination of Expiration Dating for Medical Gloves | 3 years from date of manufactured | Predicate device has not stated. | - | | 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 {8}------------------------------------------------ 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 for Residual Powder on Medical Gloves. | To determine the residual powder in the gloves | Less than 2mg / glove | Size S 0.32mg /glove Size M 0.28mg /glove Size L 0.32mg /glove Size XL 0.30mg /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 250 - 255mm Size M 250 - 255mm Size L 245 - 252mm Size XL 245 - 252mm | | ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application. | To determine the width of the gloves | Size S 80 ± 10mm Size M 95 ± 10mm Size L 110 ± 10mm Size XL 120 ± 10mm | Size S S: 83 - 85mm Size M M: 93 - 96mm Size L L: 105 - 109mm Size XL XL: 116 - 118mm | | 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 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 | | | | 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 | | | | 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 | | ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application. | To determine the physical properties- Tensile strength | Before Ageing Tensile Strength 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 | | | | After Ageing Tensile Strength 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 | | | To determine the physical properties- Ultimate Elongation | Before Ageing Ultimate Elongation 500%, min for all sizes | Size S 537%, average Size M 550%, average Size L 526%, average Size XL 536%, average | | | | After Ageing Ultimate Elongation 400%, min for all sizes | Size S 452%, average Size M 450%, average Size L 436%, average Size XL 458%, 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 {9}------------------------------------------------ Image /page/9/Picture/0 description: The image contains the logo for Mah Sing Healthcare. The words "MahSing" are in red, with the word "Healthcare" in black underneath. The font is sans-serif and bolded. MAH SING HEALTHCARE SDN BHD Lot 6478, Lorong Sungai Puloh / KU6, Kawasan Industri Sungai Puloh, 42100 Klang, Selangor. MALAYSIA T 603 3396 2288 F 603 3396 2299 mshealthcare.com {10}------------------------------------------------ Image /page/10/Picture/0 description: The image contains the logo for Mah Sing Healthcare. The words "Mah Sing" are in red, and the word "Healthcare" is in black. The word "Healthcare" is directly below "Mah Sing". | 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 10993-11 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 ### 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 {11}------------------------------------------------ | 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 is as safe, as effective, and performs as well as or better than the legally marketed predicate device K161422. | DrivingInnovation. Protecting Lives. MAH SING HEALTHCARE SDN BHD Lot 6478, Lorong Sungai Puloh / KU6, Kawasan Industri Sungai Puloh, 42100 Klang, Selangor. MALAYSIA T 603 3396 2288 F 603 3396 2299 mshealthcare.com

Nitrile Powder Free Blue Patient Examination Gloves Non-Sterile, Tested For Use With Chemotherapy Drugs

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 Patient Examination Gloves Non-Sterile, Tested For Use With Chemotherapy Drugs

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

Welcome

Check your email

Welcome!