(152 days)
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.
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.
This document is a 510(k) Premarket Notification from ECO Medi Glove Sdn. Bhd. for their Cornflower Blue Powder Free Nitrile Examination Glove, which has been tested for use with chemotherapy drugs and Fentanyl Citrate. The document summarizes the device's characteristics, its intended use, and the performance criteria it meets based on non-clinical testing.
Here's the breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Chemotherapy & Fentanyl Permeation (ASTM D6978-05) | ||
| Carmustine (3.3mg/ml) | Minimum Breakthrough detection time: Not specified as a strict acceptance criteria, but predicate's performance was 7.28 minutes for comparison. The subject device should demonstrate comparable or better performance for substantial equivalence. | 15.4 minutes (Note: A warning is issued not for use with Carmustine due to low permeation time) |
| Cyclophosphamide (20mg/ml) | Minimum Breakthrough detection time: Not specified, but predicate's performance was >240 minutes. | >240 minutes |
| Cytarabine (100mg/ml) | Minimum Breakthrough detection time: Not specified, but predicate's performance was >240 minutes. | >240 minutes |
| Doxorubicin HCl (2.0mg/ml) | Minimum Breakthrough detection time: Not specified, but predicate's performance was >240 minutes. | >240 minutes |
| Etoposide (20mg/ml) | Minimum Breakthrough detection time: Not specified, but predicate's performance was >240 minutes. | >240 minutes |
| Fluorouracil (50mg/ml) | Minimum Breakthrough detection time: Not specified, but predicate's performance was >240 minutes. | >240 minutes |
| Methotrexate (25mg/ml) | Minimum Breakthrough detection time: Not specified, but predicate's performance was >240 minutes. | >240 minutes |
| Paclitaxel (6mg/ml) | Minimum Breakthrough detection time: Not specified, but predicate's performance was >240 minutes. | >240 minutes |
| Thiotepa (10mg/ml) | Minimum Breakthrough detection time: Not specified as a strict acceptance criteria, but predicate's performance was 2.67 minutes for comparison. The subject device should demonstrate comparable or better performance for substantial equivalence. | 56.2 minutes (Note: A warning is issued not for use with ThioTepa due to low permeation time) |
| Fentanyl Citrate Injection (100mg/2ml) | Minimum Breakthrough detection time: Not specified, but reference device's performance was No breakthrough time at 240 minutes. | >240 minutes |
| Physical (ASTM D6319-19) | ||
| Overall Length (mm) | XS, S: Min 220mm; M, L, XL, XXL: Min 230mm | Meets ASTM D6319-19 |
| Width (±10mm) | XXS = 65mm; XS = 70mm; S = 80mm; M = 95mm; L = 110mm; XL = 120mm; XXL = 130mm | ISO 2859-1 / S2/AQL 4.0 |
| Thickness at Palm (mm) | Min: 0.05 mm | ISO 2859-1 / S2/AQL 4.0 |
| Thickness at Finger Tip (mm) | Min: 0.05 mm | Meets ASTM D6319-19 |
| Tensile Strength (MPa) - Before Aging | 14min | Meets ASTM D6319-19 |
| Ultimate Elongation (%) - Before Aging | 500min | Meets ASTM D6319-19 |
| Tensile Strength (MPa) - After Aging (70°C for 168 hrs @ 100°C for 22 hrs) | 14min | Meets ASTM D6319-19 |
| Ultimate Elongation (%) - After Aging | 400min | Meets ASTM D6319-19 |
| Freedom from Pinholes (ASTM D5151-19) | AQL 2.5, Inspection Level G-1 | Meets ASTM D5151-19 |
| Powder-free Residue (ASTM D6124-06(2022)) | ≤2.0 mg/pc | Meets ASTM D6124-06(2022) |
| Biocompatibility | ||
| Irritation (ISO 10993-23:2021) | Not an irritant | Pass (test article was a non-irritant) |
| Sensitization (ISO 10993-10:2021) | Not a sensitizer | Pass (test article was a non-sensitizer) |
| Acute Systemic Toxicity (ISO 10993-11:2017) | Not induce acute systemic toxicity | Pass (did not induce any acute systemic toxicity) |
Study Proving Device Meets Acceptance Criteria:
The document indicates that the device meets the acceptance criteria through non-clinical testing. These tests were conducted according to established international and national standards.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: The document does not explicitly state the specific sample sizes used for each individual test (e.g., number of gloves tested for permeation, number of samples for physical properties, number of animals for biocompatibility). It references the standards used, which typically define the required sample sizes for such tests. For example, for "Freedom from Pinholes," it mentions "AQL 2.5, Inspection Level G-1" which implies a sampling plan based on the number of units in a lot. For "Width" and "Thickness" it references "ISO 2859-1 / S2/AQL 4.0," also indicating a sampling scheme.
- Data Provenance: The document does not explicitly state the country of origin of the data. However, given that the manufacturer is ECO Medi Glove Sdn. Bhd. located in Taiping, Perak Darul Ridzuan, Malaysia, it is highly probable that the testing was conducted in Malaysia or contracted to a testing facility recognized in the region. The data is retrospective, as it's a summary of tests already performed for the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not applicable in this context. The "ground truth" here is defined by objective physical and chemical measurements according to standardized test methods (ASTM, ISO). There is no "expert consensus" or "clinical ground truth" involved in evaluating the performance of examination gloves against these specific criteria. The standards themselves, developed by expert committees, define the acceptable levels.
4. Adjudication Method for the Test Set:
This information is not applicable. Since the evaluation involves objective measurements against predefined criteria in recognized standards, there is no need for an adjudication method by human readers or experts in the way it would be for a diagnostic medical device reading images or interpreting clinical data.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This information is not applicable. This device is a medical glove, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to human readers and AI assistance is entirely irrelevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not applicable. As stated above, this device is a medical glove and does not involve any algorithms or AI for standalone performance evaluation.
7. The Type of Ground Truth Used:
The "ground truth" in this context is established by:
- Standardized Test Methods: Adherence to widely accepted national and international standards such as ASTM D6978-05 (for chemotherapy drug permeation), ASTM D6319-19 (for physical properties and dimensions), ASTM D5151-19 (for pinholes), ASTM D6124-06(2022) (for powder-free residue), and ISO 10993 series (for biocompatibility).
- Objective Measurement Data: The results of the tests conducted in accordance with these standards provide the "ground truth" for whether the glove meets the defined performance characteristics. For breakthrough times, it's the measured time; for physical properties, it's the quantitative values compared to minimum/maximum thresholds; for biocompatibility, it's the qualitative assessment (Pass/Fail) based on biological response.
8. The Sample Size for the Training Set:
This information is not applicable. There is no "training set" in the context of physical product testing for a medical glove. The testing performed is to verify the manufactured product meets defined specifications.
9. How the Ground Truth for the Training Set was Established:
This information is not applicable for the same reason as in point 8.
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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
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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
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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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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 CitrateConcentration | Minimum Breakthroughdetection 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 | SizeXXS | Size XS | Size S | Size M | Size L | Size XL | SizeXXL |
|---|---|---|---|---|---|---|---|
| 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 for168 hrs @ 100°C for 22 hrs |
|---|---|---|
| Tensile Strength (MPa) | 14min | 14 Min |
| Ultimate Elongation (%) | 500min | 400min |
| Pin-hole Level | AQL 2.5Inspection Level G-1 | AQL 2.5Inspection 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 BluePowder Free NitrileExamination GloveTested for Use withChemotherapyDrugs and FentanylCitrate(subject device) | Predicate DeviceCornflower BluePowder-Free ExamGloves with Testedfor Use withChemotherapy DrugLabeling ClaimK103249 | Reference DeviceIntercept Free, NitrileTwo TonedWhite/Green, Powder-Free, TexturedFingertips, Non-sterile,Ambidextrous, BeadedCuff, MedicalExamination Gloves,Tested for Use with theOpioids FentanylCitrate, Heroin, andboth Opioids insimulated Gastric Acid(Vomit)K220375 | AssessmentSimilarities andDifferences |
|---|---|---|---|---|---|
| Product Code | LZA, LZC, OPJ andQDO | LZA, LZC | LZA, LZC, QDO | Same | |
| Intended use | A powder-free patientexamination glove is adisposable deviceintended for medicalpurposes that is wornon the examiner's handor finger to preventcontamination betweenpatient and examiner.The device is for over-the-counter use. | A powder-free patientexamination glove is adisposable deviceintended for medicalpurposes that is wornon the examiner'shand or finger toprevent contaminationbetween patient andexaminer. The deviceis for over-the-counteruse. | A Nitrile powder freemedical examinationglove is a disposabledevice, worn on the handor finger to preventcontamination betweenexaminer and patient orvictim. This specialtyglove has also beentested for use with theOpioid drugs fentanylcitrate, Heroin, and bothOpioid in simulatedGastric Acid. | Similar Except thereference deviceglove intended usestatement wasextended toaddress the opioiddrug Heroin andgastric acid | |
| Material use | Nitrile compound | Nitrile compound | Nitrile compound | Nitrile compound | Same |
| Color | Cornflower Blue | Cornflower Blue | WhiteOutside/LimeGreen 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 |
| CuffingBeading | 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 220mmM, L, XL, XXL:Min 230mmWidth (±10mm) | Overall Length (mm)Min 230mmWidth (± 10mm) | Meets sizesspecified in ASTMD6319. | Meets sizes specifiedin ASTM D6319. | Different: Subjectdevice sizes meetASTM D6319-19 withaddition of XXS. |
|---|---|---|---|---|---|
| Sizes :Extra Extra Small(XXS) = 65mmExtra Small (XS) =70mmSmall (S) = 80mmMedium (M) = 95mmLarge (L) = 110mmExtra Large (XL)= 120mmDouble Extra Large(XXL) = 130mm | Sizes:Extra Extra Small(XXS) = 65mmExtra Small (XS)=70mmSmall (S) = 80mmMedium = 95mmLarge (L) = 110mmExtra Large (XL) =120mmDouble Extra Large(XXL) = 130mm | ||||
| Thickness atPalm (mm) Min;0.05 mm Thicknessat Finger Tip (mm)Min 0.05 mm | Thickness atPalm (mm) Min;0.05 mmThickness atFinger 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
| Physicalproperties | Before AgeingTensile Strength(MPa)= 14minUltimateElongation (%)= 500minAfter Aging at70°C for168 hrs @ 100°Cfor 22 hrsTensile Strength(MPa)= 14minUltimateElongation (%)= 400min | Meets ASTM D6319-19 | Meets ASTM D6319-19 | Meets ASTM D6319-19 | Same |
|---|---|---|---|---|---|
| Freedom frompinholes | AQL 2.5Inspection LevelG-1 | MeetsASTM D5151-19 | MeetsASTM D5151-19 | MeetsASTM D5151-19 | Same |
| Residual Powder | ≤2.0 mg/pc | MeetsASTM D6124-06(2022) | MeetsASTM D6124-06(2022) | MeetsASTM D6124-06(2022) | Same |
| Biocompatibility | ISO 10993-23:2021Biologicalevaluation ofmedical devices-Part 23: Test forirritation | Under the conditions ofthis study, the testarticle was a non-irritant. | Under the conditionsof this study, the testarticle was a non-irritant. | Under the conditions ofthis study, the test articlewas a non-irritant. | Same |
| ISO 10993-10:2021 BiologicalEvaluation onMedical Device –Part 10:Test for SkinSensitization | Under the conditions ofthis study, the testarticle was a non-sensitizer. | Under the conditionsof this study, the testarticle was a non-sensitizer. | Under the conditions ofthis study, the test articlewas a non-sensitizer. | Same | |
| ISO 10993-11Biologicalevaluation onmedical device Part11 – Test forsystemic toxicity | Not induce any acutesystemic toxicity | Not induce anyacute systemictoxicity | Not induce any acutesystemic toxicity | Same |
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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
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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 fromPin holes | ASTM D5151 -19(Re-approved 2011) | AQL 2.5Inspection Level G-1 | MeetsASTM D5151-19 |
| Dimensions | ASTM D6319 -19 | LengthXS, X: Min 220mmM, L, XL, XXL: Min 230mm | MeetsASTM D6319-19 |
| ASTM D6319 -19 | WidthSize XXS = 65mm±10(InternalRequirement)Size XS = 70mm±10Size S = 80mm±10Size M = 95mm±10Size L = 110mm±10Size XL = 120mm±10Size 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 | |||
| Physicalproperties | ASTM D6319 -19ASTM D412-16(2021) | Before AgeingTensile Strength (MPa)= 14minUltimate Elongation (%)= 500min | Meets ASTMD6319-19 |
| ASTM D6319 -19 andASTM D412-06(2021) | After Aging at 70°C for168 hrs @ 100°C for 22 hrsTensile Strength (MPa)= 14minUltimate Elongation (%)= 400min | ||
| Powder-freeresidue | ASTM D6124-06(2022) | ≤2.0 mg/pc | MeetsASTM D6124-06(2022) |
| Irritation | ISO 10993-23:2021 | Not an irritant | Pass |
| Sensitization | ISO 10993-10:2021 | Not a sensitizer | Pass |
| Acute SystemicToxicity | ISO 10993-11:2017 | Not induce acute systemictoxicity | Pass |
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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.
§ 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.