(152 days)
No
The 510(k) summary describes a standard examination glove and its testing for chemical resistance and physical properties. There is no mention of AI or ML technology in the intended use, device description, or performance studies.
No
The device is described as an "examination glove" intended to "prevent contamination between patient and examiner," which is a barrier function, not a therapeutic one.
No
This device is a medical glove, a barrier device worn to prevent contamination. It does not perform any diagnostic function.
No
The device is a physical examination glove made of nitrile rubber, clearly described as a hardware device intended to be worn on the hand or finger.
Based on the provided text, 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 purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner." This describes a barrier device for protection, not a device used to examine specimens derived from the human body for diagnostic purposes.
- Device Description: The description reinforces that it's a "patient examination glove made from nitrile rubber compound."
- Lack of IVD Characteristics: The text does not mention any analysis of biological samples, diagnostic testing, or any other activities typically associated with in vitro diagnostics. The testing performed is related to the glove's physical properties, biocompatibility, and barrier function against chemicals.
Therefore, this device falls under the category of a medical device, specifically a patient examination glove, but not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Cornflower Blue Powder Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate 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. It is for over-the-counter use.
In addition, these gloves were tested for use with Chemotherapy Drugs and Fentanyl Citrate in accordance with ASTM D6978-05, Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Product codes
LZA, LZC, OPJ, QDO
Device Description
The subject device in this 510(k) Notification is a Cornflower Blue Powder Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate. The subject device is a patient examination glove made from nitrile rubber compound, Cornflower Blue color, powder-free, and non-sterile (Per 21 CFR 880.6250, class I). The device meets all the specifications in ASTM D6319-19, the Standard Specification for Nitrile Examination Gloves. Additionally, the gloves have been tested for biocompatibility and permeability to chemotherapy drugs and fentanyl citrate.
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 / over-the-counter use.
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)
The device underwent non-clinical testing for:
- Freedom from Pin holes according to ASTM D5151 -19 (Re-approved 2011), meeting AQL 2.5 and Inspection Level G-1.
- Dimensions according to ASTM D6319 -19, meeting specified lengths and widths, and ISO 2859-1 / S2/AQL 4.0 for width and thickness at palm and fingertip.
- Physical properties according to ASTM D6319 -19 and ASTM D412-16(2021) for before ageing and ASTM D6319 -19 and ASTM D412-06(2021) for after ageing, meeting specified Tensile Strength and Ultimate Elongation.
- Powder-free residue according to ASTM D6124-06(2022), meeting the criteria of less than or equal to 2.0 mg/pc.
- Irritation according to ISO 10993-23:2021, showing the test article was a non-irritant.
- Sensitization according to ISO 10993-10:2021, showing the test article was a non-sensitizer.
- Acute Systemic Toxicity according to ISO 10993-11:2017, showing the test article did not induce acute systemic toxicity.
- Resistance against Chemotherapy Drugs and Fentanyl Citrate according to ASTM D6978-05(2019), showing specific minimum breakthrough detection times for various drugs, with warnings for Carmustine and ThioTepa.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Pin-hole Level: AQL 2.5 Inspection Level G-1
- Tensile Strength (MPa): 14min (Before Ageing and After Ageing)
- Ultimate Elongation (%): 500min (Before Ageing), 400min (After Ageing)
- Residual Powder: 240 minutes
- Breakthrough detection time for Cytarabine (100mg/ml): >240 minutes
- Breakthrough detection time for Doxorubicin Hydrochloride (2.0mg/ml): >240 minutes
- Breakthrough detection time for Etoposide (20mg/ml): >240 minutes
- Breakthrough detection time for Flourouracil (50mg/ml): >240 minutes
- Breakthrough detection time for Methorexate (25mg/ml): >240 minutes
- Breakthrough detection time for Paclitaxel (6mg/ml): >240 minutes
- Breakthrough detection time for Thiotepa (10mg/ml): 56.2 minutes
- Breakthrough detection time for Fentanyl Citrate Injection (100mg/2ml): >240 minutes
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 7, 2024
ECO Medi Glove Sdn. Bhd Suresh Kumar QA Manager Lot 23826, Jalan Tembaga Kuning, Kamunting Raya Industrial Estate Taiping, Perak Darul Ridzuan 34600 Malaysia
Re: K232764
Trade/Device Name: Cornflower Blue Powder Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I. reserved Product Code: LZA, LZC, OPJ, QDO Dated: December 13, 2023 Received: December 18, 2023
Dear Suresh Kumar:
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 (the 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 available 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
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Allan G
For Bifeng Qian, M.D., Ph.D. Assistant Director
2
DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K232764
Device Name
Cornflower Blue Powder Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentany1 Citrate
Indications for Use (Describe)
Cornflower Blue Powder Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentany1 Citrate 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. It is for over-the- counter use.
In addition, these gloves were tested for use with Chemotherapy Citrate in accordance with ASTM D6978-05, Standards Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
| Drug Concentration | Minimum Breakthrough detection time in Minutes |
|---|---|
| Carmustine (3.3mg/ml or 3000ppm) | 15.4 minutes |
| Cyclophosphamide (20mg/ml or 20,000ppm) | >240 minutes |
| Cytarabine (100mg/ml) | >240 minutes |
| Doxorubicin Hydrochloride (2.0mg/ml or 2000ppm) | >240 minutes |
| Etoposide (20mg/ml or 20,000ppm) | >240 minutes |
| Flourouracil (50mg/ml or 50,000) | >240 minutes |
| Methorexate (25mg/ml or 25,000ppm) | >240 minutes |
| Paclitaxel (6mg/ml or 6,000ppm) | >240 minutes |
| Thiotepa (10mg/ml or 10,000ppm) | 56.2 minutes |
| Fentanyl Citrate Injection (100mg/2ml) | >240 minutes |
The maximum testing time is 240 minutes.
Please note that the following drugs have extremely low permeation time.
- Carmustine (BCNU) (3.3mg/ml)- Minimum Breakthrough detection time 15.4 minutes.
- Thiotepa (10ug/ml) Minimum Breakthrough detection time 56.2 minutes.
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)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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4
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FORM FDA 3881 (6/20)
Page 1 of 1
EF PSC Publishing Services (301) 443-6740
5
ECO Medi Glove Sdn. Bhd. (815262-D)
Plant 1: Lot 32586, No. 118, Jalan Logam 7, Kamunting Raya Industrial Estate, 34600 Taiping. Perak Darul Ridzuan. MALAYSIA
Plant 2: Lot 23826, Jalan Tembaga Kuning, Kamunting Raya Industrial Estate, 34600 Taiping. Perak Darul Ridzuan. MALAYSIA
s@ecomediglove.com.my Website: www.ecomediglove.com.
06 2216
FAX: +60 5 895 3660
TEL +60-3-806 2326
SST NO.: A11-1808-21015730
FAX +60-5-895 7668
K232764 510(K) Summary
Cornflower Blue Powder Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
1.0 Submitter:
| Company Name | : | ECO Medi Glove Sdn. Bhd. |
|---|---|---|
| Company Address | : | Lot 23826, Jalan Tembaga Kuning, |
| Kamunting Raya Industrial Estate, | ||
| 34600 Taiping, Perak Darul Ridzuan, | ||
| Malaysia. | ||
| Contact Person | : | Mr. Suresh Kumar |
| Telephone | : | +605-806 2316 |
| Fax | : | +605-806 2315 |
| : | qa1@riverstone.com.my |
- 2.0 7th February 2024 Preparation Date :
3.0 Name of the Device
Trade Name / Proprietary Name: Cornflower Blue Powder Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Device Name: Nitrile Patient Examination gloves.
Device Classification Name: Patient Examination gloves (21 CFR 880.6250).
Device Class: Class I.
Product Code: LZA, LZC, OPJ and QDO
6
Plant 1: Lot 32586, No. 118, Jalan Logam 7, Kamunting Raya Industrial Estate, 34600 Taiping. Perak Darul Ridzuan. MALAYSIA
Plant 2: Lot 23826, Jalan Tembaga Kuning, Kamunting Raya Industrial Estate, 34600 Taiping. Perak Darul Ridzuan. MALAYSIA
E-mail : sales@ecomediglove.com.my Website: www.ecomediglove.com.r
TEL +60-5-806 2316 FAX +60-5-895 7668
SST NO.: A11-1808-21015730
4.0 Identification of The Legally Marketed Device:
Predicate Device: K103249, Cornflower Blue Powder-Free Exam Gloves with Tested for Use with Chemotherapy Drug Labeling Claim
Reference Device: K220375, Intercept Free, Nitrile Two Toned White/Green, Powder- Free, Textured Fingertips, Non-sterile, Ambidextrous, Beaded Cuff, Medical Examination Gloves, Tested for Use with the Opioids Fentanyl Citrate, Heroin, and both Opioids in simulated Gastric Acid (Vomit)
5.0 Device Description
The subject device in this 510(k) Notification is a Cornflower Blue Powder Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate. The subject device is a patient examination glove made from nitrile rubber compound, Cornflower Blue color, powder-free, and non-sterile (Per 21 CFR 880.6250, class I). The device meets all the specifications in ASTM D6319-19, the Standard Specification for Nitrile Examination Gloves. Additionally, the gloves have been tested for biocompatibility and permeability to chemotherapy drugs and fentanyl citrate.
6.0 Indications for Use
Cornflower Blue Powder Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate 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. It is for over-thecounter use.
In addition, these gloves were tested for use with Chemotherapy Drugs and Fentanyl Citrate in accordance with ASTM D6978-05, Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
| Chemotherapy Drug and Fentanyl Citrate
Concentration | Minimum Breakthrough
detection time in Minutes |
|---------------------------------------------------------|---------------------------------------------------|
| Carmustine (3.3mg/ml or 3000ppm), | 15.4 minutes |
| Cyclophosphamide (20mg/ml or 20,000ppm), | >240 minutes |
| Cytarabine (100mg/ml) | >240 minutes |
| Doxorubicin Hydrochloride (2.0mg/ml or 2000ppm), | >240 minutes |
| Etoposide (20mg/ml or 20,000ppm), | >240 minutes |
| Flourouracil (50mg/ml or 50,000), | >240 minutes |
7
Plant 1: Lot 32586, No. 118, Jalan Logam 7, Kamunting Raya Industrial Estate, 34600 Taiping. Perak Darul Ridzuan. MALAYSIA
Plant 2: Lot 23826, Jalan Tembaga Kuning, Kamunting Raya Industrial Estate, 34600 Taiping. Perak Darul Ridzuan. MALAYSIA
| Methorexate (25mg/ml or 25,000ppm), | >240 minutes |
|---|---|
| Paclitaxel (6mg/ml or 6,000ppm), | >240 minutes |
| Thiotepa (10mg/ml or 10,000ppm), | 56.2 minutes |
| Fentanyl Citrate Injection 100mg/2ml | >240 minutes |
The maximum testing time is 240 minutes. Please note that the following drugs have extremely low permeation time.
Carmustine (BCNU) (3.3mg/ml)- Minimum Breakthrough detection time 15.4 minutes. Thiotepa (10ug/ml) - Minimum Breakthrough detection time 56.2 minutes.
WARNING: Not for use with Carmustine and ThioTepa
7.0 Specification for Nitrile exam gloves (ASTM D6319-19):
Dimension and Thickness of Gloves 7.1
| Dimension | Size
XXS | Size XS | Size S | Size M | Size L | Size XL | Size
XXL |
|---------------------------------|-------------|---------|---------|---------|---------|---------|-------------|
| Overall Length (mm) | N/A | 220min | 220min | 230min | 230min | 230min | 230min |
| Width (± 10mm) | N/A | 70 | 80 | 95 | 110 | 120 | 130 |
| Thickness at Palm (mm) | N/A | 0.05min | 0.05min | 0.05min | 0.05min | 0.05min | 0.05min |
| Thickness at Finger Tip
(mm) | N/A | 0.05min | 0.05min | 0.05min | 0.05min | 0.05min | 0.05min |
7.2 Gloves Physical Properties and Holes
| Measurement | Before Ageing | After Aging at 70°C for
168 hrs @ 100°C for 22 hrs |
|-------------------------|---------------------------------|-------------------------------------------------------|
| Tensile Strength (MPa) | 14min | 14 Min |
| Ultimate Elongation (%) | 500min | 400min |
| Pin-hole Level | AQL 2.5
Inspection Level G-1 | AQL 2.5
Inspection Level G-1 |
Gloves meet all the specifications listed in ASTM D 6319-19
8
ECO Medi Glove Sd
Plant 1 : Lot 32586, No. 118, Jalan Logam 7, Kamunting Raya Industrial Estate, 34600 Taiping, Perak Darul Ridzuan. MALAYSIA
Plant 2 : Lot 23826, Jalan Tembaga Kuning Raya Industrial Estate, 34600 Taiping. Perak Darul Ridzuan. MALAYSIA
E-mail : sales@ecomediglove.com.my Website: www.ecomediglove.com.my
TEL +60-5-806 2316 FAX +60-5-895 7668
SST NO. : A11-1808-21015730
Comparison of Proposed and Predicate Device
| Characteristics | Acceptance Criteria | Cornflower Blue
Powder Free Nitrile
Examination Glove
Tested for Use with
Chemotherapy
Drugs and Fentanyl
Citrate
(subject device) | Predicate Device
Cornflower Blue
Powder-Free Exam
Gloves with Tested
for Use with
Chemotherapy Drug
Labeling Claim
K103249 | Reference Device
Intercept Free, Nitrile
Two Toned
White/Green, Powder-
Free, Textured
Fingertips, Non-sterile,
Ambidextrous, Beaded
Cuff, Medical
Examination Gloves,
Tested for Use with the
Opioids Fentanyl
Citrate, Heroin, and
both Opioids in
simulated Gastric Acid
(Vomit)
K220375 | Assessment
Similarities and
Differences |
|--------------------|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | | | |
| Product Code | | LZA, LZC, OPJ and
QDO | LZA, LZC | LZA, LZC, QDO | Same |
| Intended use | | A powder-free 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.
The device is for over-
the-counter use. | A powder-free 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. The device
is for over-the-counter
use. | A Nitrile powder free
medical examination
glove is a disposable
device, worn on the hand
or finger to prevent
contamination between
examiner and patient or
victim. This specialty
glove has also been
tested for use with the
Opioid drugs fentanyl
citrate, Heroin, and both
Opioid in simulated
Gastric Acid. | Similar Except the
reference device
glove intended use
statement was
extended to
address the opioid
drug Heroin and
gastric acid |
| Material use | Nitrile compound | Nitrile compound | Nitrile compound | Nitrile compound | Same |
| Color | | Cornflower Blue | Cornflower Blue | White
Outside/Lime
Green inside | Same |
| Sterility | Non sterile | Non sterile | Non sterile | Non sterile | Same |
| Single use | Single use | Single use | Single use | Single use | Same |
| Sterility | Non-Sterile | Non-Sterile | Non-Sterile | Non-Sterile | Same |
| Surface | Finger Textured | Finger Textured | Finger Textured | Finger Textured | Same |
| Cuffing
Beading | Rolled Beading | Rolled Beading | Rolled Beading | Rolled Beading | Same |
| Design | Ambidextrous | Ambidextrous | Ambidextrous | Ambidextrous | Same |
9
ECO Medi Glove Sdn. Bhd. (815262-D)
Plant 1 : Lot 32586, No. 118, Jalan Logam 7, Kamunting Raya Industrial Estate, 34600 Taiping. Perak Darul Ridzuan. MALAYSIA
Plant 2 : Lot 23826, Jalan Tembaga Kuning Raya Industrial Estate, 34600 Taiping. Perak Darul Ridzuan. MALAYSIA
E-mail : sales@ecomediglove.com.my Website: www.ecomediglove.com.my
TEL +60-5-806 2316
FAX +60-5-895 7668
| SST NO. : A11-1808-21015730 | |
|---|---|
| Dimensions | Overall Length (mm)
XS, S: Min 220mm
M, L, XL, XXL:
Min 230mm
Width (±10mm) | Overall Length (mm)
Min 230mm
Width (± 10mm) | Meets sizes
specified in ASTM
D6319. | Meets sizes specified
in ASTM D6319. | Different: Subject
device sizes meet
ASTM D6319-19 with
addition of XXS. |
|------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|-----------------------------------------|-----------------------------------------------------------------------------------|
| | Sizes :
Extra Extra Small
(XXS) = 65mm
Extra Small (XS) =
70mm
Small (S) = 80mm
Medium (M) = 95mm
Large (L) = 110mm
Extra Large (XL)
= 120mm
Double Extra Large
(XXL) = 130mm | Sizes:
Extra Extra Small
(XXS) = 65mm
Extra Small (XS)=
70mm
Small (S) = 80mm
Medium = 95mm
Large (L) = 110mm
Extra Large (XL) =
120mm
Double Extra Large
(XXL) = 130mm | | | |
| | Thickness at
Palm (mm) Min;
0.05 mm Thickness
at Finger Tip (mm)
Min 0.05 mm | Thickness at
Palm (mm) Min;
0.05 mm
Thickness at
Finger Tip (mm)
Min 0.05 mm | | | |
10
ECO Medi Glove Sdn. Bhd. (815262-D)
Plant 1 : Lot 32586, No. 118, Jalan Logam 7, Kamunting Raya Industrial Estate, 34600 Taiping. Perak Darul Ridzuan. MALAYSIA
Plant 2 : Lot 23826, Jalan Tembaga Kuning Raya Industrial Estate, 34600 Taiping. Perak Darul Ridzuan. MALAYSIA
E-mail : sales@ecomediglove.com.my Website: www.ecomediglove.com.my
TEL +60-5-806 2316
FAX +60-5-895 7668
SST NO. : A11-1808-21015730
| Physical
properties | Before Ageing
Tensile Strength
(MPa)
= 14min
Ultimate
Elongation (%)
= 500min
After Aging at
70°C for
168 hrs @ 100°C
for 22 hrs
Tensile Strength
(MPa)
= 14min
Ultimate
Elongation (%)
= 400min | Meets ASTM D6319-19 | Meets ASTM D6319-19 | Meets ASTM D6319-19 | Same |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|------|
| Freedom from
pinholes | AQL 2.5
Inspection Level
G-1 | Meets
ASTM D5151-19 | Meets
ASTM D5151-19 | Meets
ASTM D5151-19 | Same |
| Residual Powder | ≤2.0 mg/pc | Meets
ASTM D6124-
06(2022) | Meets
ASTM D6124-
06(2022) | Meets
ASTM D6124-06(2022) | Same |
| Biocompatibility | ISO 10993-23:
2021
Biological
evaluation of
medical devices-
Part 23: Test for
irritation | Under the conditions of
this study, the test
article was a non-
irritant. | Under the conditions
of this study, the test
article was a non-
irritant. | Under the conditions of
this study, the test article
was a non-irritant. | Same |
| | ISO 10993-10:
2021 Biological
Evaluation on
Medical Device –
Part 10:
Test for Skin
Sensitization | Under the conditions of
this study, the test
article was a non-
sensitizer. | Under the conditions
of this study, the test
article was a non-
sensitizer. | Under the conditions of
this study, the test article
was a non-sensitizer. | Same |
| | ISO 10993-11
Biological
evaluation on
medical device Part
11 – Test for
systemic toxicity | Not induce any acute
systemic toxicity | Not induce any
acute systemic
toxicity | Not induce any acute
systemic toxicity | Same |
11
O Medi Glove Sdn. Bhd.
600 Taiping. Perak Darul Ridzuan, MALAYSIA
amunting Raya Industrial Estate, 34600 Taiping. Perak Darul Ridzuan. MALAYSIA + 73876 lalan Temna
les@ecomedielove.com site: www.ecomedialove.com.my
60-5-806 2316
Resistance
Drugs and
against
5
FAX +60-5-895 7668
| . | ST NO. : A11-1808-21015730 |
|---|---|
| 10 m . " . " . " . " . " . " . " . " . " . " . " . " . " . " . " . " . " . " . " . " . " . " . " . " . " . " . " . " . " . " . " . " . " . " . " . " . " . " . " . " . " . " . |
Standards Practice 1) Carmustine 1) Carmustine Tested with: Fentanyl Similar: Subject for Assessment of (BCNU) 3.3mg/ml (BCNU) 3.3mg/ml citrate (Injectable): Device was tested Chemotherany resistance of 15.4 minutes 7.28 minutes 100mg/2mil: No with the same Medical Glove to 2) Cyclophosphamide 2) Cisplatin breakthrough time at 240 chemicals as the (Cytoxan) 1.0mg/mL, >240 Fentanyl Citrate Permeation by minutes predicate except Chemotherapy (20mg/ml) minutes with the addition of drugs ASTM >240 minutes 3) Cyclophosphamide Heroin saturated in fentanyl citrate D6978-05(2019) 3) Cytarabine HCI (Cytoxan) injectable Fentanyl No (reference device). (100mg/ml) (20mg/ml) breakthrough time at >240 minutes >240 minutes 240 minutes 4) Doxorubicin HCI 4) Doxorubicin HCI (2.0mg/ml) (2.0mg/ml) And both opioid drugs >240 minutes >240 minutes Fentanyl and Heroin 5) Etoposide 5) Etoposide mixed with simulated (20.0mg/ml (20.0mg/ml gastric acid: represents >240 minutes >240 minutes opioid-contaminated 6) Fluorouracil 6) 5-Fluorouracil vomit from overdose (50.0mg/ml) (50.0mg/ml) victims. >240 minutes >240 minutes No breakthrough time at 7) 7) Methotrexate 240 minutes (25mg/ml) (25mg/ml) >240 minutes >240 minutes 8) Paclitaxel 8) Paclitaxel (6.0mg/ml) (6.0mg/ml) >240 minutes >240 minutes 9) ThioTepa 9) ThioTepa (10.0mg/ml) (10.0mg/ml) 56.2 minutes 2.67 minutes Tested with: Fentanyl Warning : Not for use Citrate (Injection), with Carmustine or 100mg/2ml: no Thio Tepa breakthrough time at 240 minutes 240 minutes
Warning: Not for use with Carmustine or
Thio Tepa
12
ECO Medi Glove Sdn. Bh
Plant 1 : Lot 32586, No. 118, Jalan Logam 7, Kamunting Raya Industrial Estate, 34600 Taiping, Perak Darul Ridzuan. MALAYSIA Plant 2 : Lot 23826, Jalan Tembaga Kuning Raya Industrial Estate, 34600 Taiping. Perak Darul Ridzuan. MALAYSIA
E-mail : sales@ecomediglove.com.my Website: www.ecomediglove.com.my
TEL +60-5-806 2316 SST NO. : A11-1808-21015730 FAX +60-5-895 7668
8.0 Summary of Non-Clinical Testing
| Characteristics | Test Standard | Acceptance Criteria | Test Result |
|---|---|---|---|
| Freedom from | |||
| Pin holes | ASTM D5151 -19 | ||
| (Re-approved 2011) | AQL 2.5 | ||
| Inspection Level G-1 | Meets | ||
| ASTM D5151-19 | |||
| Dimensions | ASTM D6319 -19 | Length | |
| XS, X: Min 220mm | |||
| M, L, XL, XXL: Min 230mm | Meets | ||
| ASTM D6319-19 | |||
| ASTM D6319 -19 | Width | ||
| Size XXS = 65mm±10 | |||
| (Internal | |||
| Requirement) | |||
| Size XS = 70mm±10 | |||
| Size S = 80mm±10 | |||
| Size M = 95mm±10 | |||
| Size L = 110mm±10 | |||
| Size XL = 120mm±10 | |||
| Size XXL =130mm±10 | ISO 2859-1 / | ||
| S2/AQL 4.0 | |||
| ASTM D6319 -19 | Thickness at Palm (mm) | ||
| Min: 0.05 mm | ISO 2859-1 / | ||
| S2/AQL 4.0 | |||
| Thickness at Finger Tip | |||
| (mm) Min: 0.05 mm | |||
| Physical | |||
| properties | ASTM D6319 -19 | ||
| ASTM D412-16(2021) | Before Ageing | ||
| Tensile Strength (MPa) | |||
| = 14min | |||
| Ultimate Elongation (%) | |||
| = 500min | Meets ASTM | ||
| D6319-19 | |||
| ASTM D6319 -19 and | |||
| ASTM D412-06(2021) | After Aging at 70°C for | ||
| 168 hrs @ 100°C for 22 hrs | |||
| Tensile Strength (MPa) | |||
| = 14min | |||
| Ultimate Elongation (%) | |||
| = 400min | |||
| Powder-free | |||
| residue | ASTM D6124-06(2022) | ≤2.0 mg/pc | Meets |
| ASTM D6124-06 | |||
| (2022) | |||
| Irritation | ISO 10993-23:2021 | Not an irritant | Pass |
| Sensitization | ISO 10993-10:2021 | Not a sensitizer | Pass |
| Acute Systemic | |||
| Toxicity | ISO 10993-11:2017 | Not induce acute systemic | |
| toxicity | Pass |
13
aiping. Perak Darul Ridzuan. MALAYSIA
iping. Perak Darul Ridzuan. MALAYSIA
NO. : A11-1808-210157
8.0 Summary of Clinical Testing
N/A.
9.0 Conclusion
The Conclusions drawn from the non-clinical tests demonstrate that the subject device, Cornflower Blue Powder Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, is as safe, as effective, and performs as well as or better than the legally marketed Predicate device cleared under K103249.