(272 days)
The Nitrile Examination gloves,is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. In addition these gloves were tested for use with Chemotherapy drugs 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 Nitrile Examination Gloves Sterile with tested for use with Chemotherapy drugs claims. The subject device is a patient examination glove made from nitrile latex compound, white colour, powder free and sterile (Per 21 CFR 880.6250, class I). The device meets all the specifications in ASTM D6319-10, Standard specification for Nitrile Examination Gloves. Additionally, the gloves have been tested for biocompatibility per ISO 10993-5, 10993-10, 10993-11 and permeability to chemotherapy drugs per ASTM D6978-05.
This document describes the acceptance criteria and performance of the Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs Claim, White device (K190725) by Riverstone Resources SDN BHD.
1. Table of Acceptance Criteria and Reported Device Performance
The device was tested against several standards, and the results are summarized below. The "Acceptance Criteria" column refers to the specified requirements in relevant ASTM and ISO standards, while "Reported Device Performance" indicates whether the device met these criteria. "N/A" indicates that specific numerical acceptance criteria were not explicitly stated in the provided text for certain categories, but compliance with the standard itself serves as the acceptance.
| Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| General | ||
| Product Code | LZA and LZC | LZA and LZC |
| Intended Use | A powder-free patient examination glove, disposable, for medical purposes, worn on examiner's hand or finger to prevent contamination between patient and examiner. For over-the-counter use. | A powder-free patient examination glove, disposable, for medical purposes, worn on the examiner's hand or finger to prevent contamination between patient and examiner. For over-the-counter use. |
| Description | Sterile Examination glove made of Nitrile and color White. Tested with chemotherapy Drugs. | Sterile Examination glove made of Nitrile and color White and tested with chemotherapy Drugs. |
| Presentation | Sterile gloves provided in Pouches. | Sterile gloves are provided in Pouches. |
| Ambidextrous | Yes | Yes |
| Material Use | Nitrile Synthetic Latex | Nitrile Synthetic Latex |
| Colour | White | White |
| Sterility | ISO 11737-2:2009, EN ISO 11137-2:2015 | Sterility |
| Single Used | Single used | Single used |
| Non Sterile or Sterile | Sterile | Sterile |
| Dimensions (ASTM D6319-10) | Meets ASTM D6319-10 | |
| Overall Length (mm) | Min 230 mm | N/A (meets standard) |
| Width (± 5mm) | Size S = 85mm, Size M = 95mm, Size L = 105mm, Size XL = 115mm | N/A (meets standard) |
| Thickness at Palm (mm) | Min 0.05 mm | N/A (meets standard) |
| Thickness at Finger Tip (mm) | Min 0.05 mm | N/A (meets standard) |
| Physical Properties (ASTM D6319-10) | Meets ASTM D6319-10 | |
| Tensile Strength (MPa) - Before Ageing | ≥ 14 | N/A (meets standard) |
| Ultimate Elongation (%) - Before Ageing | ≥ 500 | N/A (meets standard) |
| Tensile Strength (MPa) - After Aging (70°C for 168 hrs / 100°C for 22 hrs) | ≥ 14 | N/A (meets standard) |
| Ultimate Elongation (%) - After Aging (70°C for 168 hrs / 100°C for 22 hrs) | ≥ 400 | N/A (meets standard) |
| Freedom from Pin-holes | AQL 2.5, Inspection Level G-1 (ASTM D6319-10) | Meets ASTM D5151-06 (Note: Table listed D6319-10 for Acceptance, but performance reported as D5151-06. Both are relevant for pinholes.) |
| Residual Powder (ASTM D6124-06) | < 2.0 mg/pc | Meets ASTM D6124-06 |
| Biological Evaluation (ISO 10993-10 / ISO 10993-11) | Meets applicable ISO standards | |
| Primary Skin Irritation Test (Rabbit) | Non-irritant | Under the conditions of this study, the test article was a non-irritant. |
| Dermal Sensitization Assay (Guinea pigs) | Non-sensitizer | Under the conditions of this study, the test article was a non-sensitizer. |
| Acute Systemic Toxicity | No adverse biological reaction (ISO 10993-11) | Under the condition of this study, Nitrile Examination glove, sterile shows no adverse biological reaction. |
| Resistance against Chemotherapy Drugs (ASTM D6978-05) | Minimum Breakthrough detection time (specific values for each drug) | Meets ASTM D6978-05 (2013) with the following minimum breakthrough detection times:1) Carmustine (3.3mg/ml): 39 minutes2) Cyclophosphamide (20mg/ml): > 240 minutes3) Cisplatin (1.0mg/ml): > 240 minutes4) Doxorubicin Hydrochloride (2.0mg/ml): > 240 minutes5) Etoposide (20mg/ml):> 240 minutes6) Fluorouracil (50mg/ml): > 240 minutes7) Methotrexate (25mg/ml): > 240 minutes8) Paclitaxel (6mg/ml): > 240 minutes9) Thiotepa (10mg/ml): 97.6 minutes (Note: Breakthrough for Carmustine and Thiotepa listed on page 2 and 4 are the same.) |
Explanation of the Study and Device Performance:
The study conducted to prove the device meets the acceptance criteria is a series of non-clinical tests performed in accordance with recognized international and national standards. The results demonstrate that the subject device (Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs Claim, White) meets all the specified performance requirements for patient examination gloves, including dimensions, physical properties, freedom from holes, residual powder, and biocompatibility.
Crucially, the gloves were specifically tested for use with chemotherapy drugs according to ASTM D6978-05: Practice for assessment of medical Glove to Permeation by Chemotherapy Drugs. The results show that for most tested chemotherapy drugs, the gloves provided a breakthrough detection time of greater than 240 minutes (4 hours), indicating good resistance. For Carmustine and Thiotepa, specific breakthrough times of 39 minutes and 97.6 minutes, respectively, were reported. These specific times serve as important cautions for users.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes used for each specific test (e.g., number of gloves tested for dimensions, physical properties, or chemotherapy drug permeation). However, it references established standards such as ASTM D6319-10, ASTM D5151-06, ASTM D6124-06, and ASTM D6978-05, as well as ISO 10993-10 and ISO 10993-11. These standards typically define appropriate sampling plans and methodologies for testing, implying that the sample sizes used conform to these guidelines.
The data provenance is from Malaysia, as Riverstone Resources SDN BHD is located in Malaysia (Lot 55, No 13, Jalan Jasmin 2, Kawasan Perindustrian Bukit Beruntung, 48300, Bukit Beruntung Selangor, Malaysia). The studies were non-clinical, likely laboratory-based, and retrospective in the sense that the test results are reported from completed experiments to demonstrate compliance for premarket notification.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not provided in the document. The "ground truth" for this type of device (a medical glove) is established by adherence to recognized performance standards and laboratory test methods, rather than by expert consensus in a clinical diagnostic sense. The standards themselves (e.g., ASTM, ISO) represent a consensus of expert knowledge in materials science, manufacturing, and medical device testing. The personnel conducting the tests would be qualified laboratory technicians or engineers, but their specific number and qualifications are not detailed.
4. Adjudication Method for the Test Set:
An adjudication method (like 2+1 or 3+1) is typically used in clinical studies involving interpretation of medical images or patient outcomes, especially when there's subjective assessment involved. This document describes non-clinical, laboratory-based performance testing of a physical device against objective criteria defined by standards. Therefore, an adjudication method for determining "ground truth" as described (e.g., by multiple clinical experts) is not applicable to this type of study. The "ground truth" is the objective measurement against the specified standard.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or AI-assisted medical imaging devices where human readers interpret cases, and the AI's impact on their performance is being evaluated. This document is for a medical glove, which is a physical protective barrier, not a diagnostic tool requiring human interpretation of clinical cases.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
No, a standalone (algorithm only) performance study was not done. This concept is applicable to AI or software medical devices. The device in question is a physical medical glove, and its performance is evaluated through laboratory tests, not an algorithm.
7. Type of Ground Truth Used:
The ground truth used for this device's evaluation is primarily based on established performance standards and objective laboratory measurements. This includes:
- Standard Specifications: Adherence to defined physical and chemical properties as outlined in standards like ASTM D6319-10 (dimensions, physical properties), ASTM D5151-06 (freedom from pinholes), ASTM D6124-06 (residual powder).
- Biocompatibility Test Results: Objective scientific assessment of biological responses in accordance with ISO 10993-10 (irritation, sensitization) and ISO 10993-11 (acute systemic toxicity).
- Permeation Resistance Measurements: Objective laboratory determination of breakthrough times for chemotherapy drugs using a standardized method (ASTM D6978-05).
8. Sample Size for the Training Set:
This information is not applicable. The device is a physical medical glove, not an artificial intelligence (AI) or machine learning algorithm. Therefore, there is no "training set" in the context of AI model development.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as there is no training set for this device.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 17, 2019
Riverstone Resources SDN BHD Suresh Kumar QA Manager Lot 56, No 15, Jalan Jasmin 2 Bukit Beruntung, 48300 My
Re: K190725
Trade/Device Name: Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs Claim, White Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC Dated: November 14, 2019 Received: November 18, 2019
Dear Suresh Kumar:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For Elizabeth Claverie, M.S. Assistant Director for THT4B2 DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K190725
Device Name
Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs Claim, White.
Indications for Use (Describe)
The Nitrile Examination gloves,is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. In addition these gloves were tested for use with Chemotherapy drugs in accordance with ASTM D6978-05 standards : Practice for assessment of medical Glove to Permeation by Chemotherapy Drugs.
Chemotherapy Drug and Concentration
Minimum Breakthrough detection time in Minutes
-
- Carmustine (BCNU)(3.3mg/ml) 39 minutes 2) Cyclophosphamide (20mg/ml) > 240 minutes 3) Cisplatin (1.0mg/ml) > 240 minutes 4) Doxorubicin Hydrochloride (2.0mg/ml) > 240 minutes > 240 minutes 5) Etoposide (20mg/ml) 6) Fluorouracil (50mg/ml) > 240 minutes 7) Methorexate (25mg/ml) > 240 minutes > 240 minutes 8) Paclitaxel (6mg/ml) 9) Thiotepa (10mg/ml) 97.6 minutes
Caution:
Thiotepa (10mg/ml),Breakthrough Detected at 97.6 Minutes Carmustine (3.3mg/ml),Breakthrough Detected at 39 Minutes
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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Lot 55, No 13, Jalan Jasmin 2, Kawasan Perindustrian Bukit Beruntung,
48300 Bukit Beruntung. Selangor
510k No:K190725
510(K) Summary Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs claim,White
1.0 Submitter :
| Company Name | : RIVERSTONE RESOURCES SDN BHD |
|---|---|
| Company Address | : Lot 55, No 13, Jalan Jasmin 2,Kawasan Perindustrian Bukit Beruntung48300,Bukit Beruntung SelangorMalaysia. |
| Contact Person | : Mr Suresh Kumar |
| Telephone No | : 603-60283033 |
| : qa1@riverstone.com.my |
2.0 Preparation Date : 11th December 2019
3.0 Name of the Device
Trade Name / Proprietary Name: Nitrile Examination Glove Sterile tested for use with Chemotherapy Drugs claims,White
Device Name: Nitrile Patient Examination gloves.
Device Classification Name: Patient Examination gloves (21 CFR 880.6250).
Device Class: Class I.
Product Code: LZA and LZC.
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Lot 55, No 13, Jalan Jasmin 2, Kawasan Perindustrian Bukit Beruntung, 48300 Bukit Beruntung. Selangor
510k No:K190725
4.0) Identification of The Legally Marketed Device:
K180452, White Nitrile Examination Glove, Sterile with Chemotherapy Drugs Claim
5.0 Device Description
The subject device in this 510(k) Notification is Nitrile Examination Gloves Sterile with tested for use with Chemotherapy drugs claims. The subject device is a patient examination glove made from nitrile latex compound, white colour, powder free and sterile (Per 21 CFR 880.6250, class I). The device meets all the specifications in ASTM D6319-10, Standard specification for Nitrile Examination Gloves. Additionally, the gloves have been tested for biocompatibility per ISO 10993-5, 10993-10, 10993-11 and permeability to chemotherapy drugs per ASTM D6978-05.
6.0 Indications for Use
The Nitrile Examination gloves, is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. In addition these gloves were tested for use with Chemotherapy drugs in accordance with ASTM D6978-05 standards: Practice for assessment of medical Glove to Permeation by Chemotherapy Drugs.
| Chemotherapy Drug and concentration | Minimum Breakthrough detection time |
|---|---|
| in Minutes | |
| 1)Carmustine (BCNU) (3.3mg/ml) | 39 minutes |
| 2)Cyclophosphamide (20mg/ml) | > 240 minutes |
| 3)Cytarabine (10mg/ml) | > 240 minutes |
| 4)Doxorubicin Hydrochloride (2 mg/ml) | > 240 minutes |
| 5)Etoposide (20mg/ml) | > 240 minutes |
| 6)Fluorouracil (50mg/ml) | > 240 minutes |
| 7)Methorexate (25mg/ml) | > 240 minutes |
| 8) Paclitaxel (6mg/ml) | > 240 minutes |
| 9) Thiotepa (10mg/ml) | 97.6 minutes |
Caution:
Thiotepa (10mg/ml), Breakthrough Detected at 97.6 Minutes Carmustine (3.3mg/ml), Breakthrough Detected at 39 Minutes
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Lot 55, No 13, Jalan Jasmin 2, Kawasan Perindustrian Bukit Beruntung,
48300 Bukit Beruntung. Selangor
510k No:K190725
7.0 Specification for Nitrile gloves: 7.1 Dimension and Thickness of Gloves
| Dimension | Size S | Size M | Size L | Size XL |
|---|---|---|---|---|
| Overall Length (mm) (Minimum) | 230 | 230 | 230 | 230 |
| Width (± 5mm) | 85 | 95 | 105 | 115 |
| Thickness at Palm (mm) (Minimum) | 0.05 | 0.05 | 0.05 | 0.05 |
| Thickness at Finger Tip (mm)(Minimum) | 0.05 | 0.05 | 0.05 | 0.05 |
7.2 Gloves Physical Properties and Holes
| Measurement | Before Ageing | After Aging at 70°C for168 hrs @ 100°C for 22 hrs |
|---|---|---|
| Tensile Strength (MPa) | 14min | 14 Min |
| Ultimate Elongation (%) | 500min | 400min |
| Pin-hole Level | AQL 2.5Inspection Level G-1 | AQL 2.5Inspection Level G-1 |
Gloves meet all the specification listed in ASTM D 6319-10
7.3 Summary of the Technological Characteristics of the Device compared to the Predicate Device
| Characteristics | AcceptanceCriteria | Nitrile ExaminationGlove Sterile testedfor use withchemotherapydrugs claim, WhiteK190725 | White NitrileExaminationGloves SterileTested For UsedWithChemotherapyDrugs Claim,K180452 | Comparison |
|---|---|---|---|---|
| LZA and LZC | LZA and LZC | LZA and LZC | Same | |
| 510k No:K190725 | ||||
| Intended use | A powder freepatientexaminationglove is adisposable deviceintended formedical purposesthat is worn onthe examiner'shand or finger topreventcontaminationbetween patientand examiner.The device is forover-the-counteruse. | A powder freepatient examinationglove is a disposabledevice intended formedical purposesthat is worn on theexaminer's hand orfinger to preventcontaminationbetween patient andexaminer. Thedevice is for over-the-counter use. | A powder freepatientexaminationglove is adisposable deviceintended formedical purposesthat is worn onthe examiner'shand or finger topreventcontaminationbetween patientand examiner.The device is forover-the-counteruse. | Same |
| Description | Sterile Examinationglove made ofNitrile and colorWhite and testedwith chemotherapyDrugs | SterileExaminationglove made ofNitrile and colorWhite | Same | |
| Presentation | Sterile gloves areprovided in Pouches | Sterile gloves areprovided inPouches | Same | |
| Ambidextrous | Yes | Yes | Same | |
| Material use | Nitrile SyntheticLatex | Nitrile SyntheticLatex | Nitrile SyntheticLatex | Same |
| Colour | White | White | Same | |
| Sterility | SterilityISO 11737-2:2009EN ISO 11137-2:2015 | Sterility | Sterility | Same |
| Single used | Single used | Single used | Same | |
| Non Sterile orSterile | Sterile | Sterile | Same | |
| 510k No:K190725 | ||||
| Dimensions | Overall Length(mm)Min 230 mmWidth (± 5mm)Size S = 85mmSize M = 95mmSize L = 105mmSize XL = 115mmThickness at Palm (mm)Min; 0.05 mmThickness at Finger Tip (mm)Min 0.05 mm | Meets ASTMD6319-10 | Meets ASTMD6319-10 | Same |
| Physicalproperties | Before AgeingTensile Strength (MPa)= 14minUltimateElongation (%)= 500minAfter Aging at70°C for168 hrs @ 100°Cfor 22 hrsTensile Strength (MPa)= 14minUltimateElongation (%)= 400min | Meets ASTMD6319-10 | Meets ASTMD6319-10 | Same |
| Freedom frompinholes | AQL 2.5Inspection LevelG-1ASTM D6319-10 | Meets ASTMD5151-06 | Meets ASTMD5151-06 | Same |
| ResidualPowder | < 2.0 mg/pcASTM D6124-06 | Meets ASTMD6124-06 | Meets ASTMD6124-06 | Same |
| BiologicalEvaluation onMedical Device-Primary SkinIrritation Test | Non irritant-Primary SkinIrritation inRabbit | Under the conditionsof this study, the testarticle was a non-irritant. | Under theconditions of thisstudy, the testarticle was a non-irritant. | Same |
| Biological Evaluation on Medical Device- Dermal Sensitization Assay | Non -sensitizer- Skin sensitization in Giunea pigsISO 10993-10 | 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.510k No:K190725 | Same |
| Acute Systemic Toxicity | ISO 10993-11 | Under the condition of this study, Nitrile Examination glove, sterile shows no adverse biological reaction | Under the condition of this study, Nitrile Examination glove, sterile shows no adverse biological reaction | same |
| Resistance against Chemotherapy Drugs | Standards Practice for Assessment of resistance of Medical Glove to Permeation by Chemotherapy drugsASTM D6978-05(2013) | 1) Carmustine (3.3mg/ml or 3000ppm), Minimum Breakthrough detection time : 39 µg/cm²/minute2) Cyclophosphamide (20mg/ml or 20,000ppm), Minimum Breakthrough detection time: >240 µg/cm²/minute3) Cisplatin (1.0mg/ml or 1,000ppm), Minimum Breakthrough detection time: >240 µg/cm²/minute4)Doxorubicin Hydrochloride (2.0mg/l), Minimum Breakthrough detection time: >240 µg/cm²/minute5) Etoposide | 1) Carmustine (3.3mg/ml or 3000ppm), Minimum Breakthrough detection time : 17.1 µg/cm²/minute2) Cyclophosphamide (20mg/ml or 20,000ppm), Minimum Breakthrough detection time: >240 µg/cm²/minute3) Cisplatin (1.0mg/ml or 1,000ppm), Minimum Breakthrough detection time: >240 µg/cm²/minute4)Doxorubicin Hydrochloride (2.0mg/ml or 2000ppm), Minimum | Similar |
| (20mg/ml or20,000ppm),MinimumBreakthroughdetection time: >240µg/cm²/minute6) Flourouracil(50mg/ml or50,000), MinimumBreakthroughdetection time: >240µg/cm²/minute7) Paclitaxel(6mg/ml or6,000ppm),MinimumBreakthroughdetection time: >240µg/cm²/minute8) Thiotepa(10mg/ml or10,000ppm),MinimumBreakthroughdetection time: 97.6µg/cm²/minute9) Methotrexate (25mg/ml ),MinimumBreakthroughdetection time: >240µg/cm²/minute | Breakthroughdetection time:>240µg/cm²/minute5) Etoposide(20mg/ml or20,000ppm),MinimumBreakthroughdetection time:>240µg/cm²/minute6) Flourouracil(50mg/ml or50,000),MinimumBreakthroughdetection time:>240µg/cm²/minute7) Paclitaxel(6mg/ml or6,000ppm),MinimumBreakthroughdetection time:>240µg/cm²/minute8) Thiotepa(10mg/ml or10,000ppm),MinimumBreakthroughdetection time:56.9µg/cm²/minute9) Dacarbazine(1.0 mg/ml ),MinimumBreakthroughdetection time:>240µg/cm²/minute |
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Lot 55, No 13, Jalan Jasmin 2, Kawasan Perindustrian Bukit Beruntung,
48300 Bukit Beruntung. Selangor
510k No:K190725
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Lot 55, No 13, Jalan Jasmin 2, Kawasan Perindustrian Bukit Beruntung,
48300 Bukit Beruntung. Selangor
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Lot 55, No 13, Jalan Jasmin 2, Kawasan Perindustrian Bukit Beruntung,
48300 Bukit Beruntung. Selangor
510k No:K190725
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Lot 55, No 13, Jalan Jasmin 2, Kawasan Perindustrian Bukit Beruntung,
48300 Bukit Beruntung. Selangor
510k No:K190725
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Lot 55, No 13, Jalan Jasmin 2, Kawasan Perindustrian Bukit Beruntung,
48300 Bukit Beruntung. Selangor
510k No:K190725
8.0 Summary of Non-Clinical Testing.
Non-clinical testing was performed to verify that the subject device will meet the acceptance criteria of the performance test shown below:
| Technological Characteristics | Standard/Test/FDA Guidance | Result Summary |
|---|---|---|
| Dimensions | ASTM D6319-10 | Meets |
| Physical properties | ASTM D6319-10 | Meets |
| Freedom from pinholes | ASTM D6319-10 | Meets |
| Residual Powder | ASTM D5151-06 | Meets |
| Biological Evaluation onMedical Device-Primary Skin Irritation Test | ISO 10993-10 | Meets |
| Biological Evaluation onMedical Device-Dermal Sensitization Assay | ISO 10993-10 | Meets |
| Acute Systemic Toxicity | ISO 10993-11 | Meets |
The subject device meets the applicable requirements for patients gloves with regards to dimension and sizes, physical properties, freedom from holes and powder Residuals as found in the following standards: ASTM D6139, ASTM D5151, ASTM D6124.The subject device passes biological reactivity testing for dermal sensitization, irritation and acute systemic toxicity with accordance ISO10993-10 AND ISO 10993-11
9.0 Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed device.
§ 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.