(112 days)
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.
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.
The provided document is a 510(k) Premarket Notification for a medical device: "Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential Claim, Tested for use with Chemotherapy Drugs, Fentanyl and Gastric Acid."
The document details the technical characteristics and performance of the device through various tests, often comparing it to predicate devices. It describes the acceptance criteria and study results primarily for the physical and chemical resistance properties of the gloves, as well as biocompatibility testing.
However, it's crucial to note that this document DOES NOT describe a study involving an AI or algorithm-driven device (e.g., for image analysis or disease detection). Therefore, many of the specific questions about human readers, AI assistance, ground truth establishment for AI training, and expert adjudication are not applicable to this type of device and study.
The study described is a non-clinical performance and chemical permeation study of a physical medical device (gloves), not an AI/ML-driven diagnostic or therapeutic system.
Given this, I will describe the acceptance criteria and the study that proves the device meets them based only on the information available in the provided document, acknowledging the non-applicability of AI/ML-specific questions.
Acceptance Criteria and Device Performance for Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential Claim, Tested for use with Chemotherapy Drugs, Fentanyl and Gastric Acid (K233560)
1. Table of Acceptance Criteria and Reported Device Performance
The device performance is assessed against recognized ASTM and ISO standards for medical gloves, primarily focusing on physical properties, freedom from defects, biocompatibility, and resistance to chemical permeation.
| Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Physical Properties | ||
| Freedom from Pinholes (ASTM D5151-19) | AQL 2.5 Inspection Level G-1 | Passes AQL 1.5 Inspection Level: G1 |
| Physical Dimensions (ASTM D6319-19) | Length (min): XXS: Not indicated, XS: 220mm, S: 220mm, M: 230mm, L: 230mm, XL: 230mm, XXL: 230mm Width (± 10mm): XXS: Not indicated, XS: 70mm, S: 80mm, M: 95mm, L: 110mm, XL: 120mm, XXL: 130mm Thickness (min): Palm: 0.05mm, Finger Tip: 0.05mm (ISO 2859-1/S2/AQL 4.0 for dimensions) | Length (min): XXS: 220mm, XS: 220mm, S: 220mm, M: 230mm, L: 230mm, XL: 230mm, XXL: 230mm Width (± 10mm): XXS: 65mm, XS: 70mm, S: 80mm, M: 95mm, L: 110mm, XL: 120mm, XXL: 130mm Thickness (min): Palm: 0.05mm, Finger Tip: 0.05mm (All dimensions met according to ASTM D6319-19 and physical dimensions pass acceptance criteria.) |
| Tensile Strength & Elongation (ASTM D6319-19, D412-16) | Before Ageing: Tensile Strength (MPa) = 14 MPa min, Ultimate Elongation (%) = 500 min After Aging: Tensile Strength (MPa) = 14 MPa min @ 70°C for 168 hrs / 100°C for 22 hrs, Ultimate Elongation (%) = 400 min @ 70°C for 168 hrs / 100°C for 22 hrs | Pass (Meets all specified tensile strength and elongation criteria before and after ageing.) |
| Residual Powder (ASTM D6124-06) | ≤ 2.0 mg/glove | Pass (≤ 2 mg/glove) |
| Biocompatibility (ISO 10993 series) | ||
| Acute Systemic Toxicity (ISO 10993-11) | 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) | 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) | 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. |
| Low Dermatitis Potential claim (Modified Draize 95 Test) | No clinical evidence of the 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. |
| Chemical Permeation (ASTM D6978-05) | Minimum Breakthrough Detection Time (minutes): Generally >240 minutes for most drugs. Specific values for Carmustine (3.3mg/ml) and Thiotepa (10ug/ml) are 22.0 minutes and 34.2 minutes respectively. The maximum testing time is 240 minutes. | Minimum Breakthrough Detection Time (minutes): Achieved >240 minutes for 40 of 42 chemotherapy drugs and all 5 other tested chemicals/acids (Cytovene, Retrovir, Triclosan, Fentanyl Citrate, Simulated Gastric Acid). Carmustine (3.3mg/ml) was 22.0 minutes. Thiotepa (10ug/ml) was 34.2 minutes. |
2. Sample Size Used for the Test Set and Data Provenance
- Physical and Chemical Resistance Tests: The document does not specify the exact sample sizes for each physical or chemical permeation test. However, these tests are generally performed on a sufficient number of glove samples to meet the requirements of the specified ASTM standards (e.g., ASTM D5151 for pinholes usually involves a large number of gloves for AQL testing).
- Biocompatibility / Modified Draize-95 Test (Low Dermatitis Potential Claim):
- Sample Size: 211 subjects initially recruited, with 205 subjects completing the two stages of the study (6 subjects discontinued due to poor compliance).
- Data Provenance: Not explicitly stated (e.g., country of origin), but the study was performed to support a 510(k) submission to the FDA for sale in the US market. Given the manufacturer is based in Malaysia (Eco Medi Glove Sdn. Bhd.), it is plausible the study was conducted there or in a region with compatible regulatory standards.
- Retrospective or Prospective: This was a prospective clinical study (Modified Draize-95 Test) specifically conducted to evaluate the low dermatitis potential of the device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- For physical and chemical resistance tests: Ground truth is established by objective, standardized laboratory measurements based on ASTM and ISO methods. No human "experts" in the sense of adjudicating medical images or clinical outcomes are involved in establishing ground truth for these types of tests.
- For the Modified Draize-95 Test: The ground truth for skin sensitization (type IV allergy) or irritation is based on the clinical observation of the subjects' skin reactions by qualified personnel (e.g., dermatologists or trained clinical researchers) following the specified protocol (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) which pertains to the Modified Draize-95 Test). The document does not specify the number or specific qualifications of these observers, but it is implied they are clinical professionals capable of evaluating skin reactions.
4. Adjudication Method for the Test Set
- For physical and chemical resistance tests: No adjudication is typically needed as tests are objective measurements against defined thresholds.
- For the Modified Draize-95 Test: The nature of the Modified Draize test involves direct clinical observation for skin reactions. While not explicitly stated as "adjudication," the interpretation of skin reactions by the clinical team would constitute the "ground truth." There is no indication of multiple independent readers or complex adjudication schemes like 2+1 or 3+1 as would be seen for subjective image interpretation.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done
- No, an MRMC comparative effectiveness study was NOT done. This type of study (comparing human readers with and without AI assistance on medical cases) is relevant for AI-powered diagnostic devices, not for physical medical devices like examination gloves.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. There is no algorithm or AI component to this device. The performance is the intrinsic material performance of the glove itself.
7. The Type of Ground Truth Used
- For physical properties: Measurement against engineering specifications and industry standards (e.g., freedom from pinholes, dimensions, tensile strength).
- For chemical permeation: Objective measurement of breakthrough time using standardized chemical testing methods (ASTM D6978-05).
- For biocompatibility (dermal irritation/sensitization): Clinical observation of human subjects for skin reactions following a standardized protocol (Modified Draize-95 Test) and in-vitro/in-vivo biological evaluations per ISO 10993. The "ground truth" is the observed biological response or lack thereof.
8. The Sample Size for the Training Set
- Not applicable. This device is a physical product and does not involve AI/ML models that require a "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no AI/ML component, there is no training set or ground truth establishment for a training set.
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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.
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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
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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
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 |
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| 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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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
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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.
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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 Breakthroughdetection 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 Breakthroughdetection 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 Breakthroughdetection 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 Injection100mcg/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 DevicePowder Free NitrileExamination Glove Bluewith Low DermatitisPotential Claim, Tested foruse with ChemotherapyDrugs, Fentanyl andGastric Acid | Predicate DevicePowder Free ExaminationGloves (Blue) with LowDermatitis Claim and withTested for use withChemotherapy DrugsClaimsK181066 | ComparisonAnalysis |
|---|---|---|---|---|
| Product Code | LZA, LZC, QDO and OPJ | LZA, LZC, QDO and OPJ | LZA, LZC | The subject deviceand predicate devicehave differenceswith the addition ofQDO & OPJ for thesubject device. |
| RegulationNumber | 880.6250 | 880.6250 | 880.6250 | Same |
| DeviceClassification | Class 1 | Class 1 | Class 1 | Same |
| Intended use | A powder-free patientexamination glove is adisposable device intended formedical purposes that is wornon the examiner's hand orfinger to preventcontamination between patientand examiner. The device isfor over-the-counter use. | A powder-free patientexamination glove is adisposable device intendedfor medical purposes that isworn on the examiner's handor finger to preventcontamination betweenpatient and examiner. Thedevice is for over-the-counter use. | A powder-free patientexamination glove is adisposable device intendedfor medical purposes that isworn on the examiner's handor finger to preventcontamination betweenpatient and examiner. Thedevice is for over-the-counteruse. | 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 DevicePowder Free NitrileExamination Glove Bluewith Low DermatitisPotential Claim, Testedfor use withChemotherapy Drugs,Fentanyl and GastricAcid | Predicate DevicePowder Free ExaminationGloves (Blue) with LowDermatitis Claim and withTested for use withChemotherapyDrugs ClaimsK181066 | ComparisonAnalysis | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Dimensions | |||||||||||
| Reference StandardASTN D6319-19 | SizeLength(min)Width(±10mm) | SizeLength(min)Width(±10mm) | SizeLength(min)Width(±10mm) | Different:Additional sizesXXS, XS, and XXLwere added to thesubject device.The XXS and XSare applicable forsmaller hand sizesusers.The XXL isapplicable forlarger hand sizesusers. | |||||||
| XXSXSSMLXLXXL | Not indicated220mm220mm230mm230mm230mm230mm | Not indicated70mm80mm95mm110mm120mm130mm | XXSXSSMLXLXXL | 220mm220mm220mm230mm230mm230mm230mm | 65mm70mm80mm95mm110mm120mm130mm | SMLXL | 220mm230mm230mm230mm | 85mm95mm105mm115mm | |||
| ThicknessPalmFinger Tip | Min 0.05mmMin 0.05mm | ThicknessPalmFinger Tip | Min 0.05mmMin 0.05mm | ThicknessPalmFinger Tip | Min 0.05mmMin 0.05mm | ||||||
| Same | |||||||||||
| BeforeAgeingAfterAging at70°C for168 hrs@ 100°Cfor 22 hrs | BeforeAgeingAfterAging at70°C for168 hrs@ 100°Cfor 22 hrs | BeforeAgeingAfterAging at70°C for168 hrs@ 100°Cfor 22 hrs | |||||||||
| TensileStrength(MPa)UltimateElongation | 14min500min | 14min400min | TensileStrength(MPa)UltimateElongation | 14min500min | 14min400min | TensileStrength(MPa)UltimateElongation | 14min500min | 14min400min |
{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 | AcceptanceCriteria | Subject DevicePowder Free NitrileExamination Glove Bluewith Low DermatitisPotential Claim, Tested foruse with ChemotherapyDrugs, Fentanyl andGastric Acid | Predicate DevicePowder Free ExaminationGloves (Blue) with LowDermatitis Claim andwith Tested for use withChemotherapy DrugsClaimsK181066 | ComparisonAnalysis |
|---|---|---|---|---|
| Freedom from PinholesASTM D5151-19 | AQL 2.5 InspectionLevel G-1 | Passes AQL 1.5 InspectionLevel: G1 | Passes AQL 1.5 InspectionLevel: G1 | Same |
| Residual PowderASTM D6124-06 | ≤2.0 mg/glove | ≤2 mg/glove | ≤2 mg/glove | Same |
| Dermal IrritationISO 10993-23:2021 | Under the conditionsof the study, thedevice is not anirritant. | Under the conditions of thisstudy, the test article was a non-irritant. | Under the conditions of thisstudy, the test article was anon-irritant. | Same |
| Dermal SensitizationISO 10993-10: 2021 | Under the conditionsof the study, thedevice is not asensitizer. | Under the conditions of thisstudy, the test article was a non-sensitizer. | Under the conditions of thisstudy, the test article was anon-sensitizer. | Same |
| Acute Systemic ToxicityISO 10993-11 | Under the conditionsof this study, the testarticle does not inducesystemic toxicity. | Under the conditions of thisstudy, the test article did notinduce any systemic toxicity. | Under the conditions of thisstudy, the test article did notinduce any systemic toxicity. | Same |
| Low Dermatitis PotentialclaimModified Draize 95 Test | No clinical evidencepresence of residualchemical additivesthat may induce typeIV allergy in humansubject. | There was no clinical evidenceof the presence of residualchemical additives at the levelthat may induce type IV allergyin the un-sensitized general userpopulation in the test articles. | There was no clinical evidenceof the presence of residualchemical additives at the levelthat may induce type IVallergy in the un-sensitizedgeneral user population in thetest 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 | AcceptanceCriteria | Subject DevicePowder Free NitrileExamination GloveBlue with LowDermatitisPotential Claim,Tested for use withChemotherapyDrugs, Fentanyland Gastric Acid | Reference PredicateHalyard Lavender,Powder-FreeExam GlovesTested for UsewithChemotherapyDrugs andFentanyl CitrateK202622 | Predicate DevicePowder FreeExaminationGloves (Blue) withLow DermatitisClaim and withTested for use withChemotherapyDrugs ClaimsK181066 | ComparisonAnalysis |
|---|---|---|---|---|---|---|
| Chemotherapy Drug Permeation | Minimum Breakthrough detection time in Minutes | |||||
| Test | ||||||
| No. | ChemotherapyDrug/Concentration | |||||
| 1 | Bendamustine HCl5mg/ml (5,000ppm) | >240 minutes | >240 minutes | / | Same | |
| 2 | Bleomycin Sulfate15mg/ml (15,000ppm) | >240 minutes | >240 minutes | / | Same | |
| 3 | Busulfan6mg/ml (6,000 ppm) | >240 minutes | >240 minutes | / | Same | |
| 4 | Carboplatin10mg/ml (10,000 ppm) | >240 minutes | >240 minutes | / | Same | |
| 5 | Carfilzomib2mg/ml (2,000ppm) | >240 minutes | >240 minutes | / | Same | |
| 6 | Carmustine3.3mg/ml (3,300 ppm) | 22.0 minutes | 0.3 minutes | 12.9 minutes | Similar | |
| 7 | Cetuximab2mg/ml (2,000 ppm) | StandardsPractice forAssessment of | >240 minutes | >240 minutes | / | Same |
| 8 | Cisplatin1mg/ml (1,000ppm) | resistance ofMedical Gloveto Permeation | >240 minutes | >240 minutes | >240 minutes | Same |
| 9 | Cladribine1mg/ml (1,000ppm) | byChemotherapy | >240 minutes | >240 minutes | / | Same |
| 10 | Cyclophosphamide20 mg/ml (20,000ppm) | drugsASM D6978-05 | >240 minutes | >240 minutes | >240 minutes | Same |
| 11 | Cytarabine (Cytosine)(100,000ppm) | >240 minutes | >240 minutes | / | Same | |
| 12 | Dacarbazine10mg/ml (10,000ppm) | >240 minutes | >240 minutes | / | Same | |
| 13 | Daunorubicin HCI5mg/ml (5,000 ppm) | >240 minutes | >240 minutes | / | Same | |
| 14 | Decitabine5mg/ml (5,000 ppm) | >240 minutes | >240 minutes | / | Same | |
| 15 | Docetaxel10mg/ml (10,000ppm) | >240 minutes | >240 minutes | / | Same | |
| 16 | Doxorubicin HCI2mg/ml (2,000 ppm) | >240 minutes | >240 minutes | >240 minutes | Same | |
| 17 | Epirubicin HCl2mg/ml (2,000 ppm) | >240 minutes | >240 minutes | / | Same | |
| 18 | Etoposide20mg/ml (20,000 ppm) | >240 minutes | >240 minutes | >240 minutes | Same | |
| 19 | Fludarabine Phosphate25mg/ml (25,000 ppm) | >240 minutes | >240 minutes | / | Same | |
| 20 | Fluorouracil50 mg/ml (50,000 ppm) | >240 minutes | >240 minutes | >240 minutes | Same | |
| 21 | Gemcitabine, HCI38mg/ml (38,000 ppm) | >240 minutes | >240 minutes | / | Same | |
| 22 | Idarubicin HCI1mg/ml (1,000ppm) | >240 minutes | >240 minutes | / | Same | |
| Characteristics | AcceptanceCriteria | Subject DevicePowder FreeNitrileExamination GloveBlue with LowDermatitisPotential Claim,Tested for use withChemotherapyDrugs, Fentanyland Gastric Acid | ReferencePredicateHalyard Lavender,Powder-FreeExam GlovesTested for UsewithChemotherapyDrugs andFentanyl CitrateK202622 | Predicate DevicePowder FreeExaminationGloves (Blue)with LowDermatitisClaim and withTested for usewithChemotherapyDrugs ClaimsK181066 | ComparisonAnalysis | |
| No. | Chemotherapy Drug Permeation TestChemotherapy | Minimum Breakthrough detection time in Minutes | ||||
| Drug/Concentration | ||||||
| 23 | Ifosfamide50mg/ml (50,000 ppm) | >240 minutes | >240 minutes | / | Same | |
| 24 | IrinotecanHCI, 20mg/ml (20,000ppm) | >240 minutes | >240 minutes | / | Same | |
| 25 | Mechlorethamine HCl1 mg/ml (1,000 ppm) | >240 minutes | >240 minutes | / | Same | |
| 26 | Melphalan HCI5mg/ml (5,000 ppm) | StandardsPractice for | >240 minutes | >240 minutes | / | Same |
| 27 | Methotrexate25mg/ml (25,000 ppm) | >240 minutes | >240 minutes | >240 minutes | Same | |
| 28 | Mitomycin C0.5mg/ml (500 ppm) | >240 minutes | >240 minutes | / | Same | |
| 29 | Mitoxantrone HCI2mg/ml (2,000 ppm) | >240 minutes | >240 minutes | / | Same | |
| 30 | Oxaliplatin5mg/ml (5,000ppm) | Assessment ofresistance of | >240 minutes | >240 minutes | / | Same |
| 31 | Paclitaxel6mg/ml (6,000ppm) | Medical Glove toPermeation by | >240 minutes | >240 minutes | >240 minutes | Same |
| 32 | Paraplatin10mg/ml (10,000 ppm) | Chemotherapydrugs | >240 minutes | >240 minutes | / | Same |
| 33 | Pemetrexed25mg/ml (25,000 ppm) | ASM D6978-05 | >240 minutes | >240 minutes | / | Same |
| 34 | Raltitrexed0.5mg/ml (500 ppm) | >240 minutes | >240 minutes | / | Same | |
| 35 | Thiotepa10mg/ml (10,000 ppm) | 34.2 minutes | 30.9 minutes | 27.7 minutes | Similar | |
| 36 | Topotecan1mg/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 Sulfate1mg/ml (1,000 ppm) | >240 minutes | >240 minutes | / | Same | |
| 41 | Vincristine Sulfate1mg/ml (1,000 ppm) | >240 minutes | >240 minutes | / | Same | |
| 42 | Zoledronic Acid0.8mg/ml (800 ppm) | >240 minutes | >240 minutes | / | Same | |
| Characteristics | AcceptanceCriteria | Subject DevicePowder Free NitrileExamination GloveBlue with LowDermatitis PotentialClaim, Tested for usewith ChemotherapyDrugs, Fentanyl andGastric Acid | Reference PredicateHalyard Lavender,Powder-FreeExam GlovesTested for UsewithChemotherapyDrugs andFentanyl CitrateK202622 | Predicate DevicePowder FreeExaminationGloves (Blue) withLow DermatitisClaim and withTested for use withChemotherapyDrugs ClaimsK181066 | ComparisonAnalysis | |
| Drug/Chemical Permeation Test | StandardsPractice forAssessment ofresistance ofMedical Gloveto PermeationbyChemotherapydrugsASM D6978-05 | Minimum Breakthrough detection time in Minutes | ||||
| No. | Drug, Chemical/Concentration | |||||
| 1 | Cytovene (Ganciclovir)10,000ppm) | >240 minutes | >240 minutes | / | Same | |
| 2 | Retrovir10mg/ml (10,000 ppm) | >240 minutes | >240 minutes | / | Same | |
| 3 | Triclosan3mg/ml (3,000 ppm) | >240 minutes | >240 minutes | / | Same | |
| 4 | Fentanyl Citrate Injection100mcg/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 | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Freedomfrom Pin Holes | ASTM D5151 -19(Re-approved 2011)Standard Test Methodfor Detection of Holesin Medical Gloves | AQL 2.5Inspection Level G-1 | Pass | ||||||||||||||||||||||||||||||
| PhysicalDimensions | ASTM D6319 -19Standard Specificationfor Nitrile ExaminationGloves for MedicalApplication | 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 StandardSpecification for NitrileExamination Gloves forMedical ApplicationASTM D412-16(2021)Standard Test Methods forVulcanized Rubber andThermoplastic Elastomers -Tension | Before AgeingTensile Strength (MPa) = 14 MPaUltimate Elongation (%) = 500 minAfter Aging at 70°C for168 hrs @ 100°C for 22hrs Tensile Strength(MPa) = 14 MPaUltimate Elongation (%) =400 min | Pass |
| Powder-freeResidue | ASTM D6124-06(2022)Standard Test Method forResidual Powder on MedicalGloves | ≤ 2.0 mg/gloves | Pass |
| Acute SystemicToxicity | ISO 10993-11 Biologicalevaluation on medical devicePart 11 – Test for systemictoxicity | Under the conditions of thisstudy, the test article does notinduce acute systemictoxicity | Under the conditionsof this study, the testarticle did not induceacute systemictoxicity |
| DermalSensitization | ISO 10993-10: 2021Biological Evaluation onMedical Device - Part 10:Test for Skin Sensitization | Under the conditions of thestudy, the device is not asensitizer | Under the conditionsof this study, the testarticle was a non-sensitizer. |
| Primary SkinIrritation | ISO 10993-23:2021Biological evaluation ofmedical devices-Part 23: Testfor irritation | Under the conditions of thestudy, the device is not anirritant | Under the conditionsof this study, the testarticle was a non-irritant. |
| Resistance againstChemotherapyDrugs, Fentanyl,and Gastric Acid | ASTM D6978-05Standards Practice forAssessment of resistance ofMedical Glove to Permeationby 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.
§ 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.