(52 days)
Not Found
No
The device description and performance studies focus on the physical and chemical properties of the glove material and its barrier function, with no mention of AI or ML technology.
No
The device is a patient examination glove, intended to prevent contamination, not to treat a disease or condition.
No
The document describes patient examination gloves, which are used to prevent contamination between patient and examiner. They are listed as a Class I disposable device and their function is protective, not diagnostic.
No
The device is a physical examination glove, which is a hardware medical device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device 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." This describes a barrier device for personal protection and infection control.
- IVD Definition: An In Vitro Diagnostic device is defined as a medical device that is intended for use in vitro for the examination of specimens, including blood, tissues, and body excretions, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the safety and compatibility of any tissue or organ for transplantation.
- Lack of Diagnostic Function: This device does not perform any tests on patient specimens to provide diagnostic information. Its function is purely protective.
- Testing for Chemotherapy Drugs: While the gloves are tested for permeation by chemotherapy drugs, this testing is to ensure the glove's barrier function and safety for the user when handling these substances. It is not a diagnostic test performed on a patient sample.
- Device Description: The description focuses on the physical properties and materials of the glove, consistent with a protective barrier device.
- Performance Studies: The performance studies listed are related to the physical integrity, barrier properties (freedom from holes, chemotherapy drug permeation), and biocompatibility of the glove, not diagnostic accuracy.
- Key Metrics: The key metrics are related to the physical characteristics and barrier performance of the glove, not diagnostic performance metrics like sensitivity or specificity.
In summary, the primary function and intended use of this device are for protection and contamination prevention, not for performing diagnostic tests on patient samples. Therefore, it does not fit the definition of an In Vitro Diagnostic device.
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.
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.
Product codes
LZA, LZC
Device Description
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.
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, medical purpose
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:
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Residual Powder Content:
- Size S 0.32mg /glove
- Size M 0.28mg /glove
- Size L 0.32mg /glove
- Size XL 0.30mg /glove
Freedom of Holes: Passed G-I, AQL 1.5
Length:
- Size S 250 - 255mm
- Size M 250 - 255mm
- Size L 245 - 252mm
- Size XL 245 - 252mm
Width:
- Size S S: 83 - 85mm
- Size M M: 93 - 96mm
- Size L L: 105 - 109mm
- Size XL XL: 116 - 118mm
Thickness:
Cuff
- Size S 0.05 - 0.06mm
- Size M 0.05 - 0.06mm
- Size L 0.05 - 0.06mm
- Size XL 0.05 - 0.06mm
Palm - Size S 0.06 - 0.07mm
- Size M 0.06 - 0.06mm
- Size L 0.06 - 0.07mm
- Size XL 0.06 - 0.07mm
Finger - Size S 0.08 - 0.09mm
- Size M 0.09 - 0.10mm
- Size L 0.10 - 0.11mm
- Size XL 0.10 - 0.11mm
Tensile Strength (Before Ageing):
- Size S 21.94 MPa, average
- Size M 22.08 MPa, average
- Size L 21.76 MPa, average
- Size XL 22.05 MPa, average
Tensile Strength (After Ageing):
- Size S 29.53 MPa, average
- Size M 29.12 MPa, average
- Size L 24.90 MPa, average
- Size XL 29.63 MPa, average
Ultimate Elongation (Before Ageing):
- Size S 537%, average
- Size M 550%, average
- Size L 526%, average
- Size XL 536%, average
Ultimate Elongation (After Ageing):
- Size S 452%, average
- Size M 450%, average
- Size L 436%, average
- Size XL 458%, average
Animal Irritation Test: 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.
Dermal Sensitization Assay Test: 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.
Acute 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.
Chemotherapy Drugs Permeation Breakthrough Detection Time in minutes:
- Carmustine: 24.8
- Cisplatin: >240
- Cyclophosphamide: >240
- Dacarbazine: >240
- Doxorubicin, HCl: >240
- Etoposide: >240
- Fluorouracil: >240
- Methotrexate: >240
- Mitomycin C: >240
- Oxaliplatin: >240
- Paclitaxel: >240
- Thiotepa: 38.4
- Vincristine: >240
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). 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)
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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