(112 days)
No
The device is a physical examination glove and the summary describes standard testing for physical properties, chemical resistance, and biocompatibility. There is no mention of any computational or analytical functions that would utilize AI/ML.
No
Explanation: The device is an examination glove primarily intended to prevent contamination between the patient and examiner, not to treat or cure a disease or condition.
No
Explanation: The device is an examination glove, worn to prevent contamination. It does not perform any diagnostic function such as detecting, identifying, or monitoring a disease or health condition.
No
The device is a physical examination glove made from nitrile latex, which is a hardware component. The summary describes physical properties, chemical resistance, and biocompatibility testing, all related to the physical material and form of the glove.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is "worn on the examiner's hand or finger to prevent contamination between patient and examiner." This is a barrier function for personal protection and infection control.
- Device Description: The description confirms it's a "patient examination glove."
- Lack of Diagnostic Purpose: An IVD is a device intended for use in vitro for the examination of specimens, including blood, tissues, and urine, from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This glove does not perform any such examination or provide diagnostic information.
- Testing for Chemical Resistance: While the gloves are tested for resistance to chemotherapy drugs, fentanyl, and gastric acid, this testing is related to the protective barrier function of the glove, not for diagnosing or analyzing these substances in a patient specimen.
The testing mentioned is to ensure the glove maintains its integrity and protective properties when exposed to these substances, which is relevant to its use as a barrier in a medical setting. It does not involve analyzing patient samples.
N/A
Intended Use / Indications for Use
Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential Claim, Tested for use with Chemotherapy Drugs, Fentanyl and Gastric Acid is a disposable device intended for medical purposes that are 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, Fentanyl, and Gastric Acid in accordance with ASTM D6978-05 standards Practice for assessment of Medical Glove to Permeation by chemotherapy drugs.
Product codes (comma separated list FDA assigned to the subject device)
LZA, LZC, QDO, OPJ
Device Description
The subject device in this 510(k) Notification is Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential Claim, Tested for use with Chemotherapy Drugs, Fentanyl and Gastric Acid. The subject device is a patient examination glove made from nitrile latex compound, Blue color, powder-free, and non-sterile (Per 21 CFR 880.6250, class I) and come in eight sizes (XXS, XS, S, M, L, XL, and XXL). The device meets all the specifications in ASTM D6319-19, the Standard Specification for Nitrile Examination Gloves and Modified Draize Test. Additionally, the gloves have been tested for biocompatibility and permeability to chemotherapy drugs, fentanyl, and Gastric Acid.
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
Testing was performed in accordance with Modified Draize-95 Test, per FDA's guidance document "Guidance for Industry and FDA Reviewers/Staff: Premarket Notification [510k] Submissions for Testing Skin Sensitization Chemicals in Natural Rubber Products" (1999).
A total of 211 subjects, one hundred and fifty-one subjects were Caucasian (71.6%), thirty subjects were Afro Caribbean (14.0%) and 30 subjects were Asiatic (14.2%) were recruited into the study but six subjects was discontinued due to poor compliance. Hence 205 subjects completed the two stages of the study.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Test Data:
- Freedom from Pin Holes: ASTM D5151 -19 (Re-approved 2011) Standard Test Method for Detection of Holes in Medical Gloves. Acceptance Criteria: AQL 2.5 Inspection Level G-1. Test Result: Pass.
- Physical Dimensions: ASTM D6319 -19 Standard Specification for Nitrile Examination Gloves for Medical Application. Acceptance Criteria: ISO 2859-1/ S2/AQL 4.0. Test Result: Pass.
- Size Length (min) Width (± 10mm): XXS, XS (220mm, 70mm), S (220mm, 80mm), M (230mm, 95mm), L (230mm, 110mm), XL (230mm, 120mm), XXL (230mm, 130mm).
- Thickness: Palm Min 0.05mm, Finger Tip Min 0.05mm.
- Physical Properties: ASTM D6319 -19 Standard Specification for Nitrile Examination Gloves for Medical Application, ASTM D412-16(2021) Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers - Tension.
- Acceptance Criteria: Before Ageing: Tensile Strength (MPa) = 14 MPa, Ultimate Elongation (%) = 500 min. After Aging at 70°C for 168 hrs @ 100°C for 22 hrs: Tensile Strength (MPa) = 14 MPa, Ultimate Elongation (%) = 400 min. Test Result: Pass.
- Powder-free Residue: ASTM D6124-06 (2022) Standard Test Method for Residual Powder on Medical Gloves. Acceptance Criteria: ≤ 2.0 mg/gloves. Test Result: Pass.
- Acute Systemic Toxicity: ISO 10993-11 Biological evaluation on medical device Part 11 – Test for systemic toxicity. Acceptance Criteria: Under the conditions of this study, the test article does not induce acute systemic toxicity. Test Result: Under the conditions of this study, the test article did not induce acute systemic toxicity.
- Dermal Sensitization: ISO 10993-10: 2021 Biological Evaluation on Medical Device - Part 10: Test for Skin Sensitization. Acceptance Criteria: Under the conditions of the study, the device is not a sensitizer. Test Result: Under the conditions of this study, the test article was a non-sensitizer.
- Primary Skin Irritation: ISO 10993-23:2021 Biological evaluation of medical devices-Part 23: Test for irritation. Acceptance Criteria: Under the conditions of the study, the device is not an irritant. Test Result: Under the conditions of this study, the test article was a non-irritant.
- Resistance against Chemotherapy Drugs, Fentanyl, and Gastric Acid: ASTM D6978-05 Standards Practice for Assessment of resistance of Medical Glove to Permeation by Chemotherapy drugs. See Section 7.0 for detailed results.
Clinical Summary:
- Low Dermatitis Potential claim Modified Draize 95 Test:
- Study type: Modified Draize-95 Test.
- Sample size: 205 subjects completed the study (211 recruited, 6 discontinued).
- Key results: There was no clinical evidence of the presence of residual chemical additives at the level that may induce type IV allergy in the un-sensitized general user population in the test articles.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Key metrics provided are Minimum Breakthrough detection time in minutes for various chemotherapy drugs, fentanyl, and gastric acid.
- Carmustine (BCNU) (3.3mg/ml): 22.0 minutes
- Thiotepa (10ug/ml): 34.2 minutes
- All other listed chemotherapy drugs, Fentanyl, and Gastric Acid: >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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
February 26, 2024
Eco Medi Glove Sdn. Bhd. Suresh Kumar Sivalingam QA Manager Lot 23826, Jalan Tembaga Kuning Kamunting Raya Industrial Estate Taiping, Perak Darul Ridzuan 34600 Malaysia
Re: K233560
Trade/Device Name: Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential Claim, Tested for use with Chemotherapy Drugs, Fentanyl and Gastric Acid Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I. reserved Product Code: LZA, LZC, QDO, OPJ Dated: November 28, 2023 Received: November 28, 2023
Dear Suresh Kumar Sivalingam:
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/cdrb/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,
Image /page/1/Picture/7 description: The image shows the text "Allan Guan-S" in a large, sans-serif font. The text is black and is set against a white background. There is a faint, light blue watermark in the background that is partially obscured by the text.
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
detection time in Minutes
510(k) Number (if known) K233560
Device Name
Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential Claim, Tested for use with Chemotherapy Drugs, Fentanyl and Gastric Acid
Indications for Use (Describe)
Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential Claim, Tested for use with Chemotherapy Drugs, Fentanyl and Gastric Acid is a disposable device intended for medical purposes that are 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, Fentanyl, and Gastric Acid in accordance with ASTM D6978-05 standards Practice for assessment of Medical Glove to Permeation by chemotherapy drugs.
| Chemotherapy Drug and Fentanyl Concentration | Minimum Breakthrough |
|---|---|
| 1. Bendamustine HCl 5mg/ml (5,000ppm) | >240 minutes |
| 2. Bleomycin Sulfate 15mg/ml (15,000ppm) | >240 minutes |
| 3. Busulfan 6mg/ml (6,000 ppm) | >240 minutes |
| 4. Carboplatin 10mg/ml (10,000 ppm) | >240 minutes |
| 5. Carfilzomib 2mg/ml (2,000ppm) | >240 minutes |
| 6. Carmustine 3.3mg/ml (3,300 ppm) | 22.0 minutes |
| 7. Cetuximab 2mg/ml (2,000 ppm) | >240 minutes |
| 8. Cisplatin 1mg/ml (1,000ppm) | >240 minutes |
| 9. Cladribine 1mg/ml (1,000ppm) | >240 minutes |
| 10. Cyclophosphamide, 20 mg/ml (20,000ppm) | >240 minutes |
| 11. Cytarabine (Cytosine), (100,000ppm) | >240 minutes |
| 12. Dacarbazine, 10mg/ml (10,000ppm) | >240 minutes |
| 13. Daunorubicin, HCl, 5mg/ml (5,000 ppm) | >240 minutes |
| 14. Decitabine, 5mg/ml (5,000 ppm) | >240 minutes |
| 15. Docetaxel 10mg/ml (10,000ppm) | >240 minutes |
| 16. Doxorubicin HCl, 2mg/ml (2,000 ppm) | >240 minutes |
| 17. Epirubicin HCl, 2mg/ml (2,000 ppm) | >240 minutes |
| 18. Etoposide, 20mg/ml (20,000 ppm) | >240 minutes |
| 19. Fludarabine Phosphate, 25mg/ml (25,000 ppm) | >240 minutes |
| 20. Fluorouracil, 50 mg/ml (50,000 ppm) | >240 minutes |
| 21. Gemcitabine, HCl, 38mg/ml (38,000 ppm) | >240 minutes |
| 22. Idarubicin HCl, 1mg/ml (1,000ppm) | >240 minutes |
| 23. Ifosfamide, 50mg/ml (50,000 ppm) | >240 minutes |
| 24. Irinotecan, HCl, 20mg/ml (20,000ppm) | >240 minutes |
| 25. Mechlorethamine HCl, 1 mg/ml (1,000 ppm) | >240 minutes |
| 26. Melphalan HCl, 5mg/ml (5,000 ppm) | >240 minutes |
| 27. Methotrexate, 25mg/ml (25,000 ppm) | >240 minutes |
| 28. Mitomycin C, 0.5mg/ml (500 ppm) | >240 minutes |
| 29. Mitoxantrone HCl, 2mg/ml (2,000 ppm) | >240 minutes |
| 30. Oxaliplatin, 5mg/ml (5,000ppm) | >240 minutes |
| 31. Paclitaxel, 6mg/ml (6,000ppm) | >240 minutes |
| 32. Paraplatin, 10mg/ml (10,000 ppm) | >240 minutes |
| 33. Pemetrexed, 25mg/ml (25,000 ppm) | >240 minutes |
4
| 34. Raltitrexed, 0.5mg/ml (500 ppm) | >240 minutes |
|---|---|
| 35. Thiotepa, 10mg/ml (10,000 ppm) | 34.2 minutes |
| 36. Topotecan, 1mg/ml (1,000 ppm) | >240 minutes |
| 37. Trisenox (Arsenic Trioxide), 1mg/ml (1,000ppm) | >240 minutes |
| 38. Velcade (Bortezomib), 1mg/ml (1,000ppm) | >240 minutes |
| 39. Vidaza (Azacytidine) 25mg/ml (25,000 ppm) | >240 minutes |
| 40. Vinblastine Sulfate, 1mg/ml (1,000 ppm) | >240 minutes |
| 41. Vincristine Sulfate 1mg/ml (1,000 ppm) | >240 minutes |
| 42. Zoledronic Acid, 0.8mg/ml (800 ppm) | >240 minutes |
| Other Drugs, Fentanyl and Gastric Acid Concentration Minimum Breakthrough detection time in Minutes | |
| 1. Cytovene (Ganciclovir), (10,000ppm) | >240 minutes |
| 2. Retrovir 10mg/ml (10,000 ppm) | >240 minutes |
| 3. Triclosan, 3mg/ml (3,000 ppm) | >240 minutes |
| 4. Fentanyl Citrate Injection 100mcg/2ml | >240 minutes |
| 5. Simulated Gastric Acid | >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 22.0 minutes.
Thiotepa (10ug/ml) – Minimum Breakthrough detection time 34.2 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) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ----------------------------------------------------------------------- | --------------------------------------------------------------------------------- |
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5
ECO Medi Glove Sdn. Bhd. (815262-D)
Darul Ridzijan, MALAYSIA ak 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
510(K) Summary K233560
Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential Claim, Tested for use with Chemotherapy Drugs, Fentanyl and Gastric Acid
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 Sivalingam |
| Telephone | : | +605-806 2316 |
| Fax | : | +605-806 2315 |
| : | qa1@riverstone.com.my | |
| Preparation Date | : | 26th February 2024 |
Name of the Device 3.0
2.0
Trade Name / Proprietary Name: Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential Claim, Tested for use with Chemotherapy Drugs, Fentanyl and Gastric Acid
Device Name: Low Dermatitis Nitrile Patient Examination gloves.
Device Classification Name: Non-Powdered Patient Examination Glove
Device Regulation Number: 21 CFR 880.6250
Device Class: Class I.
Product Code: LZA, LZC, QDO and OPJ
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.my
TEL +60-5-806 2316
FAX +60-5-895 7668
4.0 Identification of The Legally Marketed Device:
Predicate Device: K181066, Powder Free Examination Glove (Blue) with Low Dermatitis Claim and with tested for use with Chemotherapy Drugs Claims.
Predicate Device Manufacturer: ECO Medi Glove Sdn. Bhd.
Reference Predicate: K202622, Halyard Lavender, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Reference Device Manufacturer: O & M Halyard, Inc.
This reference predicate is being used to support additional chemotherapy and other drugs that were not tested in the predicate.
Device Description 5.0
The subject device in this 510(k) Notification is Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential Claim, Tested for use with Chemotherapy Drugs, Fentanyl and Gastric Acid. The subject device is a patient examination glove made from nitrile latex compound, Blue color, powder-free, and non-sterile (Per 21 CFR 880.6250, class I) and come in eight sizes (XXS, XS, S, M, L, XL, and XXL). The device meets all the specifications in ASTM D6319-19, the Standard Specification for Nitrile Examination Gloves and Modified Draize Test. Additionally, the gloves have been tested for biocompatibility and permeability to chemotherapy drugs, fentanyl, and Gastric Acid.
6.0 Indications for Use
Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential Claim, Tested for use with Chemotherapy Drugs, Fentanyl and Gastric Acid is a disposable device intended for medical purposes that are 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, Fentanyl, and gastric acid in accordance with ASTM D6978-05 standards Practice for assessment of Medical Glove to Permeation by chemotherapy drugs.
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
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
| No. | Chemotherapy Drug Concentration | Minimum Breakthrough
detection time in Minutes |
|-----|------------------------------------------------------|---------------------------------------------------|
| 1 | Bendamustine HCl 5mg/ml (5,000ppm) | >240 minutes |
| 2 | Bleomycin Sulfate 15mg/ml (15,000ppm) | >240 minutes |
| 3 | Busulfan 6mg/ml (6,000 ppm) | >240 minutes |
| 4 | Carboplatin 10mg/ml (10,000 ppm) | >240 minutes |
| 5 | Carfilzomib 2mg/ml (2,000ppm) | >240 minutes |
| 6 | Carmustine 3.3mg/ml (3,300 ppm) | 22.0 minutes |
| 7 | Cetuximab 2mg/ml (2,000 ppm) | >240 minutes |
| 8 | Cisplatin 1mg/ml (1,000ppm) | >240 minutes |
| 9 | Cladribine 1mg/ml (1,000ppm) | >240 minutes |
| 10 | Cyclophosphamide, 20 mg/ml (20,000ppm) | >240 minutes |
| 11 | Cytarabine (Cytosine), (100,000ppm) | >240 minutes |
| 12 | Dacarbazine, 10mg/ml (10,000ppm) | >240 minutes |
| 13 | Daunorubicin, HCI, 5mg/ml (5,000 ppm) | >240 minutes |
| 14 | Decitabine, 5mg/ml (5,000 ppm) | >240 minutes |
| 15 | Docetaxel 10mg/ml (10,000ppm) | >240 minutes |
| 16 | Doxorubicin HCI, 2mg/ml (2,000 ppm) | >240 minutes |
| 17 | Epirubicin HCl, 2mg/ml (2,000 ppm) | >240 minutes |
| 18 | Etoposide, 20mg/ml (20,000 ppm) | >240 minutes |
| 19 | Fludarabine Phosphate, 25mg/ml (25,000 ppm) | >240 minutes |
| 20 | Fluorouracil, 50 mg/ml (50,000 ppm) | >240 minutes |
| 21 | Gemcitabine, HCI, 38mg/ml (38,000 ppm) | >240 minutes |
| 22 | Idarubicin HCI, 1mg/ml (1,000ppm) | >240 minutes |
| 23 | Ifosfamide, 50mg/ml (50,000 ppm) | >240 minutes |
| 24 | Irinotecan, HCI, 20mg/ml (20,000ppm) | >240 minutes |
| 25 | Mechlorethamine HCl, 1 mg/ml (1,000 ppm) | >240 minutes |
| 26 | Melphalan HCI, 5mg/ml (5,000 ppm) | >240 minutes |
| 27 | Methotrexate, 25mg/ml (25,000 ppm) | >240 minutes |
| 28 | Mitomycin C, 0.5mg/ml (500 ppm) | >240 minutes |
| 29 | Mitoxantrone HCI, 2mg/ml (2,000 ppm) | >240 minutes |
| 30 | Oxaliplatin, 5mg/ml (5,000ppm) | >240 minutes |
| 31 | Paclitaxel, 6mg/ml (6,000ppm) | >240 minutes |
| 32 | Paraplatin, 10mg/ml (10,000 ppm) | >240 minutes |
| 33 | Pemetrexed, 25mg/ml (25,000 ppm) | >240 minutes |
| 34 | Raltitrexed, 0.5mg/ml (500 ppm) | >240 minutes |
| 35 | Thiotepa, 10mg/ml (10,000 ppm) | 34.2 minutes |
| 36 | Topotecan, 1mg/ml (1,000 ppm) | >240 minutes |
| No. | Chemotherapy Drug Concentration | Minimum Breakthrough
detection time in Minutes |
| 38 | Velcade (Bortezomib), 1mg/ml (1,000ppm) | >240 minutes |
| 39 | Vidaza (Azacytidine) 25mg/ml (25,000 ppm) | >240 minutes |
| 40 | Vinblastine Sulfate, 1mg/ml (1,000 ppm) | >240 minutes |
| 41 | Vincristine Sulfate 1mg/ml (1,000 ppm) | >240 minutes |
| 42 | Zoledronic Acid, 0.8mg/ml (800 ppm) | >240 minutes |
| No. | Other Drugs, Fentanyl and Gastric Acid Concentration | Minimum Breakthrough
detection time in Minutes |
| 1 | Cytovene (Ganciclovir), 10,000ppm) | >240 minutes |
| 2 | Retrovir 10mg/ml (10,000 ppm) | >240 minutes |
| 3 | Triclosan, 3mg/ml (3,000 ppm) | >240 minutes |
| 4 | Fentanyl Citrate Injection
100mcg/2ml | >240 minutes |
| 5 | Simulated Gastric Acid | >240 minutes |
8
g. Perak Darul Ridzuan. MALAYSIA
00 Taiping. Perak Darul Ridzuan. MALAYSIA
E-mail : sales@ecomediglove.com.my Website: www.ecomediglove.com.my
SST NO.: A11-1808-21015730
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 22.0 minutes. Thiotepa (10ug/ml) - Minimum Breakthrough detection time 34.2 minutes.
WARNING: Not for use with Carmustine and ThioTepa
9
aiping. Perak Darul Ridzuan. MALAYSIA
4600 Taiping. Perak Darul Ridzuan. MALAYSIA
ecomedialove.com.my
TEL +60-5-806 2316
SST NO. : A11-1808-21015730
FAX +60-5-895 7668
7.0 Summary of the Technological Characteristics
Comparison of Proposed and Predicate Devices
| Characteristics | Acceptance Criteria | Subject Device
Powder Free Nitrile
Examination Glove Blue
with Low Dermatitis
Potential Claim, Tested for
use with Chemotherapy
Drugs, Fentanyl and
Gastric Acid | Predicate Device
Powder Free Examination
Gloves (Blue) with Low
Dermatitis Claim and with
Tested for use with
Chemotherapy Drugs
Claims
K181066 | Comparison
Analysis |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| Product Code | LZA, LZC, QDO and OPJ | LZA, LZC, QDO and OPJ | LZA, LZC | The subject device
and predicate device
have differences
with the addition of
QDO & OPJ for the
subject device. |
| Regulation
Number | 880.6250 | 880.6250 | 880.6250 | Same |
| Device
Classification | Class 1 | Class 1 | Class 1 | 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 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. | Same |
| Material use | Nitrile compound | Nitrile compound | Nitrile compound | Same |
| Color | Blue | Blue | Blue | Same |
| Sterility | Non sterile | Non sterile | Non sterile | Same |
| Single use | Single use | Single use | Single use | Same |
| Surface | Finger Textured | Finger Textured | Finger Textured | Same |
| Cuffing Beading | Rolled Beading | Rolled Beading | Rolled Beading | Same |
| Design | Ambidextrous | Ambidextrous | Ambidextrous | Same |
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, Kamunting 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
| Characteristics | Acceptance Criteria | Subject Device
Powder Free Nitrile
Examination Glove Blue
with Low Dermatitis
Potential Claim, Tested
for use with
Chemotherapy Drugs,
Fentanyl and Gastric
Acid | Predicate Device
Powder Free Examination
Gloves (Blue) with Low
Dermatitis Claim and with
Tested for use with
Chemotherapy
Drugs Claims
K181066 | Comparison
Analysis | | | | | | | |
|-------------------------------------|--------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|-------------------------------------------------------------|---------------------------------------------------------|-------------------|----------------------------------|--------------------------------|------|
| Dimensions | | | | | | | | | | | |
| Reference Standard
ASTN D6319-19 | Size
Length
(min)
Width
(±10mm) | Size
Length
(min)
Width
(±10mm) | Size
Length
(min)
Width
(±10mm) | Different:
Additional sizes
XXS, XS, and XXL
were added to the
subject device.
The XXS and XS
are applicable for
smaller hand sizes
users.
The XXL is
applicable for
larger hand sizes
users. | | | | | | | |
| | XXS
XS
S
M
L
XL
XXL | Not indicated
220mm
220mm
230mm
230mm
230mm
230mm | Not indicated
70mm
80mm
95mm
110mm
120mm
130mm | | XXS
XS
S
M
L
XL
XXL | 220mm
220mm
220mm
230mm
230mm
230mm
230mm | 65mm
70mm
80mm
95mm
110mm
120mm
130mm | S
M
L
XL | 220mm
230mm
230mm
230mm | 85mm
95mm
105mm
115mm | |
| | Thickness
Palm
Finger Tip | Min 0.05mm
Min 0.05mm | Thickness
Palm
Finger Tip | Min 0.05mm
Min 0.05mm | Thickness
Palm
Finger Tip | Min 0.05mm
Min 0.05mm | | | | | |
| | | | | | | | | | | | Same |
| | | | | | | | | | | | |
| | | | Before
Ageing
After
Aging at
70°C for
168 hrs
@ 100°C
for 22 hrs | Before
Ageing
After
Aging at
70°C for
168 hrs
@ 100°C
for 22 hrs | Before
Ageing
After
Aging at
70°C for
168 hrs
@ 100°C
for 22 hrs | | | | | | |
| | Tensile
Strength
(MPa)
Ultimate
Elongation | 14min
500min | 14min
400min | Tensile
Strength
(MPa)
Ultimate
Elongation | 14min
500min | 14min
400min | Tensile
Strength
(MPa)
Ultimate
Elongation | 14min
500min | 14min
400min | | |
11
· (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
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
| Characteristics | Acceptance
Criteria | Subject Device
Powder Free Nitrile
Examination Glove Blue
with Low Dermatitis
Potential Claim, Tested for
use with Chemotherapy
Drugs, Fentanyl and
Gastric Acid | Predicate Device
Powder Free Examination
Gloves (Blue) with Low
Dermatitis Claim and
with Tested for use with
Chemotherapy Drugs
Claims
K181066 | Comparison
Analysis |
|--------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Freedom from Pinholes
ASTM D5151-19 | AQL 2.5 Inspection
Level G-1 | Passes AQL 1.5 Inspection
Level: G1 | Passes AQL 1.5 Inspection
Level: G1 | Same |
| Residual Powder
ASTM D6124-06 | ≤2.0 mg/glove | ≤2 mg/glove | ≤2 mg/glove | Same |
| Dermal Irritation
ISO 10993-23:2021 | Under the conditions
of the study, the
device is not an
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 |
| Dermal Sensitization
ISO 10993-10: 2021 | Under the conditions
of the study, the
device is not a
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 |
| Acute Systemic Toxicity
ISO 10993-11 | Under the conditions
of this study, the test
article does not induce
systemic toxicity. | Under the conditions of this
study, the test article did not
induce any systemic toxicity. | Under the conditions of this
study, the test article did not
induce any systemic toxicity. | Same |
| Low Dermatitis Potential
claim
Modified Draize 95 Test | No clinical evidence
presence of residual
chemical additives
that may induce type
IV allergy in human
subject. | There was no clinical evidence
of the presence of residual
chemical additives at the level
that may induce type IV allergy
in the un-sensitized general user
population in the test articles. | There was no clinical evidence
of the presence of residual
chemical additives at the level
that may induce type IV
allergy in the un-sensitized
general user population in the
test articles. | Same |
12
(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
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 |
|---|
| No. | Characteristics | Acceptance
Criteria | Subject Device
Powder Free Nitrile
Examination Glove
Blue with Low
Dermatitis
Potential Claim,
Tested for use with
Chemotherapy
Drugs, Fentanyl
and Gastric Acid | Reference Predicate
Halyard Lavender,
Powder-Free
Exam Gloves
Tested for Use
with
Chemotherapy
Drugs and
Fentanyl Citrate
K202622 | Predicate Device
Powder Free
Examination
Gloves (Blue) with
Low Dermatitis
Claim and with
Tested for use with
Chemotherapy
Drugs Claims
K181066 | Comparison
Analysis |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| | Chemotherapy Drug Permeation | | | Minimum Breakthrough detection time in Minutes | | |
| Test | | | | | | |
| No. | Chemotherapy
Drug/Concentration | | | | | |
| 1 | Bendamustine HCl
5mg/ml (5,000ppm) | | >240 minutes | >240 minutes | / | Same |
| 2 | Bleomycin Sulfate
15mg/ml (15,000ppm) | | >240 minutes | >240 minutes | / | Same |
| 3 | Busulfan
6mg/ml (6,000 ppm) | | >240 minutes | >240 minutes | / | Same |
| 4 | Carboplatin
10mg/ml (10,000 ppm) | | >240 minutes | >240 minutes | / | Same |
| 5 | Carfilzomib
2mg/ml (2,000ppm) | | >240 minutes | >240 minutes | / | Same |
| 6 | Carmustine
3.3mg/ml (3,300 ppm) | | 22.0 minutes | 0.3 minutes | 12.9 minutes | Similar |
| 7 | Cetuximab
2mg/ml (2,000 ppm) | Standards
Practice for
Assessment of | >240 minutes | >240 minutes | / | Same |
| 8 | Cisplatin
1mg/ml (1,000ppm) | resistance of
Medical Glove
to Permeation | >240 minutes | >240 minutes | >240 minutes | Same |
| 9 | Cladribine
1mg/ml (1,000ppm) | by
Chemotherapy | >240 minutes | >240 minutes | / | Same |
| 10 | Cyclophosphamide
20 mg/ml (20,000ppm) | drugs
ASM D6978-
05 | >240 minutes | >240 minutes | >240 minutes | Same |
| 11 | Cytarabine (Cytosine)
(100,000ppm) | | >240 minutes | >240 minutes | / | Same |
| 12 | Dacarbazine
10mg/ml (10,000ppm) | | >240 minutes | >240 minutes | / | Same |
| 13 | Daunorubicin HCI
5mg/ml (5,000 ppm) | | >240 minutes | >240 minutes | / | Same |
| 14 | Decitabine
5mg/ml (5,000 ppm) | | >240 minutes | >240 minutes | / | Same |
| 15 | Docetaxel
10mg/ml (10,000ppm) | | >240 minutes | >240 minutes | / | Same |
| 16 | Doxorubicin HCI
2mg/ml (2,000 ppm) | | >240 minutes | >240 minutes | >240 minutes | Same |
| 17 | Epirubicin HCl
2mg/ml (2,000 ppm) | | >240 minutes | >240 minutes | / | Same |
| 18 | Etoposide
20mg/ml (20,000 ppm) | | >240 minutes | >240 minutes | >240 minutes | Same |
| 19 | Fludarabine Phosphate
25mg/ml (25,000 ppm) | | >240 minutes | >240 minutes | / | Same |
| 20 | Fluorouracil
50 mg/ml (50,000 ppm) | | >240 minutes | >240 minutes | >240 minutes | Same |
| 21 | Gemcitabine, HCI
38mg/ml (38,000 ppm) | | >240 minutes | >240 minutes | / | Same |
| 22 | Idarubicin HCI
1mg/ml (1,000ppm) | | >240 minutes | >240 minutes | / | Same |
| Characteristics | | Acceptance
Criteria | Subject Device
Powder Free
Nitrile
Examination Glove
Blue with Low
Dermatitis
Potential Claim,
Tested for use with
Chemotherapy
Drugs, Fentanyl
and Gastric Acid | Reference
Predicate
Halyard Lavender,
Powder-Free
Exam Gloves
Tested for Use
with
Chemotherapy
Drugs and
Fentanyl Citrate
K202622 | Predicate Device
Powder Free
Examination
Gloves (Blue)
with Low
Dermatitis
Claim and with
Tested for use
with
Chemotherapy
Drugs Claims
K181066 | Comparison
Analysis |
| No. | Chemotherapy Drug Permeation Test
Chemotherapy | | | Minimum Breakthrough detection time in Minutes | | |
| | Drug/Concentration | | | | | |
| 23 | Ifosfamide
50mg/ml (50,000 ppm) | | >240 minutes | >240 minutes | / | Same |
| 24 | Irinotecan
HCI, 20mg/ml (20,000ppm) | | >240 minutes | >240 minutes | / | Same |
| 25 | Mechlorethamine HCl
1 mg/ml (1,000 ppm) | | >240 minutes | >240 minutes | / | Same |
| 26 | Melphalan HCI
5mg/ml (5,000 ppm) | Standards
Practice for | >240 minutes | >240 minutes | / | Same |
| 27 | Methotrexate
25mg/ml (25,000 ppm) | | >240 minutes | >240 minutes | >240 minutes | Same |
| 28 | Mitomycin C
0.5mg/ml (500 ppm) | | >240 minutes | >240 minutes | / | Same |
| 29 | Mitoxantrone HCI
2mg/ml (2,000 ppm) | | >240 minutes | >240 minutes | / | Same |
| 30 | Oxaliplatin
5mg/ml (5,000ppm) | Assessment of
resistance of | >240 minutes | >240 minutes | / | Same |
| 31 | Paclitaxel
6mg/ml (6,000ppm) | Medical Glove to
Permeation by | >240 minutes | >240 minutes | >240 minutes | Same |
| 32 | Paraplatin
10mg/ml (10,000 ppm) | Chemotherapy
drugs | >240 minutes | >240 minutes | / | Same |
| 33 | Pemetrexed
25mg/ml (25,000 ppm) | ASM D6978-05 | >240 minutes | >240 minutes | / | Same |
| 34 | Raltitrexed
0.5mg/ml (500 ppm) | | >240 minutes | >240 minutes | / | Same |
| 35 | Thiotepa
10mg/ml (10,000 ppm) | | 34.2 minutes | 30.9 minutes | 27.7 minutes | Similar |
| 36 | Topotecan
1mg/ml (1,000 ppm) | | >240 minutes | >240 minutes | / | Same |
| 37 | Trisenox (Arsenic Trioxide)
1mg/ml (1,000ppm) | | >240 minutes | >240 minutes | / | Same |
| 38 | Velcade (Bortezomib)
1mg/ml (1,000ppm) | | >240 minutes | / | / | *Different |
| 39 | Vidaza (Azacytidine)
25mg/ml (25,000 ppm) | | >240 minutes | / | / | *Different |
| 40 | Vinblastine Sulfate
1mg/ml (1,000 ppm) | | >240 minutes | >240 minutes | / | Same |
| 41 | Vincristine Sulfate
1mg/ml (1,000 ppm) | | >240 minutes | >240 minutes | / | Same |
| 42 | Zoledronic Acid
0.8mg/ml (800 ppm) | | >240 minutes | >240 minutes | / | Same |
| Characteristics | Acceptance
Criteria | Subject Device
Powder Free Nitrile
Examination Glove
Blue with Low
Dermatitis Potential
Claim, Tested for use
with Chemotherapy
Drugs, Fentanyl and
Gastric Acid | Reference Predicate
Halyard Lavender,
Powder-Free
Exam Gloves
Tested for Use
with
Chemotherapy
Drugs and
Fentanyl Citrate
K202622 | Predicate Device
Powder Free
Examination
Gloves (Blue) with
Low Dermatitis
Claim and with
Tested for use with
Chemotherapy
Drugs Claims
K181066 | Comparison
Analysis | |
| Drug/Chemical Permeation Test | | Standards
Practice for
Assessment of
resistance of
Medical Glove
to Permeation
by
Chemotherapy
drugs
ASM D6978-
05 | Minimum Breakthrough detection time in Minutes | | | |
| No. | Drug, Chemical
/Concentration | | | | | |
| 1 | Cytovene (Ganciclovir)
10,000ppm) | >240 minutes | >240 minutes | / | Same | |
| 2 | Retrovir
10mg/ml (10,000 ppm) | >240 minutes | >240 minutes | / | Same | |
| 3 | Triclosan
3mg/ml (3,000 ppm) | >240 minutes | >240 minutes | / | Same | |
| 4 | Fentanyl Citrate Injection
100mcg/2ml | >240 minutes | >240 minutes | / | Same | |
| 5 | Simulated Gastric Acid | >240 minutes | / | / | *Different | |
| *Subject glove has been tested with additional chemotherapy drugs and simulated gastric acid to meet current user demand and to meet competitive market demand. | | | | | | |
| Carmustine (BCNU) (3.3mg/ml)- Minimum Breakthrough detection time 22.0 minutes. Thiotepa (10ug/ml) - Minimum Breakthrough detection time 34.2 minutes. | | | | | | |
13
(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
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
14
ogam 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
FAX +60-5-895 7668
E-mail : sales@ecomediglove.com.my Website: www.ecomediglove.com.my
TEL +60-5-806 2316
SST NO. : A11-1808-21015730
WARNING: Not for use with Carmustine and ThioTepa
Summary of Non-Clinical Performance Test Data 8.0
| Test Methodology | Test Standard | Acceptance Criteria | Test Result | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Freedom | |||||||||||||||||||||||||||||||||
| from Pin Holes | ASTM D5151 -19 | ||||||||||||||||||||||||||||||||
| (Re-approved 2011) | |||||||||||||||||||||||||||||||||
| Standard Test Method | |||||||||||||||||||||||||||||||||
| for Detection of Holes | |||||||||||||||||||||||||||||||||
| in Medical Gloves | AQL 2.5 | ||||||||||||||||||||||||||||||||
| Inspection Level G-1 | Pass | ||||||||||||||||||||||||||||||||
| Physical | |||||||||||||||||||||||||||||||||
| Dimensions | ASTM D6319 -19 | ||||||||||||||||||||||||||||||||
| Standard Specification | |||||||||||||||||||||||||||||||||
| for Nitrile Examination | |||||||||||||||||||||||||||||||||
| Gloves for Medical | |||||||||||||||||||||||||||||||||
| Application | ISO 2859-1/ S2/AQL 4.0 | Pass | |||||||||||||||||||||||||||||||
| Size Length (min) Width (± 10mm) XXS Not indicated Not indicated XS 220mm 70mm S 220mm 80mm M 230mm 95mm L 230mm 110mm XL 230mm 120mm XXL 230mm 130mm Thickness Palm Min 0.05mm Finger Tip Min 0.05mm |
15
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
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
| Test Methodology | Test Standard | Acceptance Criteria | Test Result |
|---|---|---|---|
| Physical Properties | ASTM D6319 -19 Standard | ||
| Specification for Nitrile | |||
| Examination Gloves for | |||
| Medical Application |
ASTM D412-16(2021)
Standard Test Methods for
Vulcanized Rubber and
Thermoplastic Elastomers -
Tension | Before Ageing
Tensile Strength (MPa) = 14 MPa
Ultimate Elongation (%) = 500 min
After Aging at 70°C for
168 hrs @ 100°C for 22
hrs Tensile Strength
(MPa) = 14 MPa
Ultimate Elongation (%) =
400 min | Pass |
| Powder-free
Residue | ASTM D6124-06
(2022)
Standard Test Method for
Residual Powder on Medical
Gloves | ≤ 2.0 mg/gloves | Pass |
| Acute Systemic
Toxicity | ISO 10993-11 Biological
evaluation on medical device
Part 11 – Test for systemic
toxicity | Under the conditions of this
study, the test article does not
induce acute systemic
toxicity | Under the conditions
of this study, the test
article did not induce
acute systemic
toxicity |
| Dermal
Sensitization | ISO 10993-10: 2021
Biological Evaluation on
Medical Device - Part 10:
Test for Skin Sensitization | Under the conditions of the
study, the device is not a
sensitizer | Under the conditions
of this study, the test
article was a non-
sensitizer. |
| Primary Skin
Irritation | ISO 10993-23:2021
Biological evaluation of
medical devices-Part 23: Test
for irritation | Under the conditions of the
study, the device is not an
irritant | Under the conditions
of this study, the test
article was a non-
irritant. |
| Resistance against
Chemotherapy
Drugs, Fentanyl,
and Gastric Acid | ASTM D6978-05
Standards Practice for
Assessment of resistance of
Medical Glove to Permeation
by Chemotherapy drugs | See Section 7.0 | See Section 7.0 |
16
arul Ridzuan, MALAYSIA
ediglove.com.my Website: www.ecomediglove.com.my
TEL +60-5-806 2316
SST NO.: A11-1808-21015730
FAX +60-5-895 7668
9.0 Clinical Summary
Testing was performed in accordance with Modified Draize-95 Test, per FDA's guidance document "Guidance for Industry and FDA Reviewers/Staff: Premarket Notification [510k] Submissions for Testing Skin Sensitization Chemicals in Natural Rubber Products" (1999).
The age of the subjects ranged from 18 to 65 years who reasonably reflect the general user population in the US, gave all negative results. A total of 211 subjects, one hundred and fifty-one subjects were Caucasian (71.6%), thirty subjects were Afro Caribbean (14.0%) and 30 subjects were Asiatic (14.2%) were recruited into the study but six subjects was discontinued due to poor compliance. Hence 205 subjects completed the two stages of the study. Age range of the study subjects were between 18 - 60 years (mean 29.37 ± 11.37 years). One hundred and ninety subjects were female (58.0%) and eighty-six subjects were male (42.0%).
There was no clinical evidence of the presence of residual chemical additives at the level that may induce type IV allergy in the un-sensitized general user population in the test articles.
10.0 Conclusion
The Conclusions drawn from the non-clinical tests demonstrate that the subject device, Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential Claim, Tested for use with Chemotherapy Drugs. Fentanyl and Gastric Acid is as safe, as effective, and performs as well as or better than the legally marketed Predicate device cleared under K181066.