(83 days)
The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves have been tested for use with chemotherapy drugs using ASTM D6978-05(2019)
Powder Free Polyurethane Examination Gloves, Blue color, tested for use with Chemotherapy Drugs are Patient Examination Gloves, Disposable, single use only and non-sterile. The gloves are made of nitrile rubber materials and are powder free. They are ambidextrous and come in different sizes-XS, S, M, L, XL and XXL. Gloves meet the specification of ASTM D6319-19 and have been tested for resistance to permeation by chemotherapy drugs as per ASTM D6978-05(2019).
The provided text describes the acceptance criteria and performance data for "Powder Free Polyurethane Examination Gloves, Blue color, Tested for use with Chemotherapy Drugs." This is a medical device, and the data pertains to its physical properties, biocompatibility, and resistance to chemotherapy drugs, all tested against established ASTM and ISO standards.
It is important to note that this device is a physical product (gloves) and not an AI/ML powered medical device. Therefore, many of the requested criteria (e.g., sample size for AI test/training sets, data provenance, expert adjudication, MRMC studies) are not applicable in this context. The information provided focuses on material science and medical device performance standards for physical safety and efficacy.
Here's a breakdown of the applicable information based on your request, along with an explanation for why certain criteria are not relevant:
Acceptance Criteria and Device Performance for "Powder Free Polyurethane Examination Gloves"
This device is not an AI/ML powered medical device. The acceptance criteria and performance are established through adherence to recognized international standards for medical examination gloves and specific testing for chemotherapy drug permeation.
1. Table of Acceptance Criteria and Reported Device Performance
| Methodology | Test Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319-19 | Physical Dimensions: Length | Minimum 230mm for all sizes | Pass |
| ASTM D6319-19 | Physical Dimensions: Palm Width | XS: 70±10mm, S: 80±10mm, M: 95±10mm, L:110±10mm, XL: 120±10mm, XXL: 130±10mm | Pass |
| ASTM D6319-19 | Physical Dimensions: Thickness | Finger: 0.05mm (min), Palm: 0.05mm (min) | Pass |
| ASTM D6319-19, ASTM D412-16(2021) | Physical Properties: Tensile Strength and Elongation | Tensile Strength (Min 14 MPa) and Elongation (Before Aging 500% and After Aging 400%) Min | Pass |
| ASTM D6319-19, ASTM D5151-19 | Water leak test | AQL 2.5 | Pass |
| ASTM D6319-19, ASTM D6124-06 (2017) | Powder Residue | Max 2mg/glove | Pass |
| ASTM D6978-05 (2019) | Permeation by Chemotherapy Drugs | See detailed table below. Note: "Do not use with Carmustine or Thiotepa" is a critical warning based on the low breakthrough times measured for these drugs. | Pass (as per specific BDTs) |
| ISO 10993-10 & 23:2021 | Irritation And Skin Sensitization | No Skin sensitization and No Skin irritation | Is non-sensitization and Non-irritation |
| ISO 10993-5:2009 | Cytotoxicity | Not Cytotoxic | showed potential toxicity to L929 cells. (This indicates a finding, but the overall conclusion for biocompatibility still states "not sensitizers, irritants or systemic toxicity," implying this was deemed acceptable within the context of the device's use and other biocompatibility findings). |
| ISO 10993-11:2017 | Acute systemic toxicity study | Subject showed no adverse biological reaction | no evidence of acute systemic toxicity. |
Chemotherapy Drug Permeation Data (from ASTM D6978-05 (2019) testing):
| Chemotherapy Drug | Minimum Breakthrough Detection Time (BDT) in Minutes |
|---|---|
| Carmustine 3.3 mg/ml (3,300 ppm) | 24.0 |
| Cisplatin 1mg/ml (1,000 ppm) | >240 |
| Cyclophosphamide 20mg/ml (20,000 ppm) | >240 |
| Dacarbazine 10 mg/ml (10,000 ppm) | >240 |
| Doxorubicin HCL, 2 mg/ml (2,000 ppm) | >240 |
| Etoposide, 20 mg/ml (20,000 ppm) | >240 |
| Fluorouracil, 50mg/ml (50,000ppm) | >240 |
| Methotrexate, 25mg/ml (25,000ppm) | >240 |
| Paclitaxel, 6mg/ml (6,000ppm) | >240 |
| Thiotepa, 10mg/ml (10,000ppm) | 0.6 |
- Warning: Do not use with Carmustine or Thiotepa due to extremely low permeation times.
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not explicitly state the sample size (number of gloves or test replicates) for each specific test (e.g., physical dimensions, watertightness, chemotherapy permeation). However, testing is performed in accordance with the methodologies described in the cited ASTM and ISO standards, which will specify appropriate sample sizes for validation.
- Data Provenance: The document indicates the manufacturer is "Grand Work Plastic Products Co., Ltd" with a China address (Donggao Industrial Zone, Zanhuang, Hebei, 050000, China). This implies the testing would have been conducted or overseen by the manufacturer, likely at their facilities or accredited contract labs. The data is retrospective, as it was collected as part of the premarket notification (510(k)) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. For a physical device like examination gloves, "ground truth" is established through standardized laboratory testing protocols (e.g., tensile strength, leak tests, chemical permeation) as defined by ASTM and ISO organizations. These tests yield objective, quantitative measurements rather than subjective expert interpretations. Therefore, there are no "experts" in the sense of human readers/annotators establishing ground truth for a test set. The "experts" involved are the scientists and engineers who developed and validated these international testing standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods are relevant for studies where subjective human interpretation or labeling is involved (e.g., medical image analysis, clinical assessments). For physical product testing, the results are typically quantitative and objective, and thus do not require an adjudication process.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This is a physical medical device (gloves), not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Ground Truth: The "ground truth" for this device's performance is established by the objective, quantitative measurements obtained through adherence to the specified ASTM and ISO standard test methods. These standards define the accepted methodologies for determining physical properties, biocompatibility, and chemical resistance. For example:
- Physical properties (length, thickness, tensile strength, elongation): Measured directly using calibrated equipment according to ASTM D6319-19 and ASTM D412-16.
- Watertightness: Determined by the "water leak test" (ASTM D5151-19) which is a pass/fail visual inspection after standardized water filling.
- Powder Residue: Measured gravimetrically according to ASTM D6124-06.
- Chemotherapy Drug Permeation (BDT): Determined by measuring the time it takes for a chemical to permeate the glove material using a detector, as per ASTM D6978-05.
- Biocompatibility (Irritation, Sensitization, Cytotoxicity, Systemic Toxicity): Assessed through laboratory tests (e.g., cell cultures, animal models) conducted according to ISO 10993 standards, yielding specific biological responses.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable. This is not an AI/ML device.
Summary of Study Proving Device Meets Acceptance Criteria:
The study proving the device meets its acceptance criteria is a compilation of non-clinical performance tests conducted in accordance with well-established international standards (ASTM and ISO). These tests systematically evaluate the physical properties, chemical resistance, and biocompatibility of the gloves.
The "Pass" results for each test (as shown in the table under "Non-Clinical Performance Data") demonstrate that the "Powder Free Polyurethane Examination Gloves" meet the pre-defined acceptance criteria for a Class I medical device of this type. The specifics of the testing (e.g., detailed methodology, equipment calibration, environmental controls) would be documented in the full test reports that support the 510(k) submission. The FDA's clearance (K222892) indicates that they have reviewed this data and found it sufficient to demonstrate substantial equivalence to legally marketed predicate devices, confirming the device's safety and effectiveness for its intended use. The critical warning regarding Carmustine and Thiotepa permeation times is a direct outcome of these tests and is vital for safe labeling and use.
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December 15, 2022
Grand Work Plastic Products Co., Ltd % Kathy Liu Project Manager Hongray USA Medical Products Inc. 3973 Schaefer Avenue Chino, California 91710
Re: K222892
Trade/Device Name: Powder Free Polyurethane Examination Gloves, Blue color, Tested for use with Chemotherapy Drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I. reserved Product Code: LZA, LZC, OPJ Dated: August 30, 2022 Received: September 23, 2022
Dear Kathy Liu:
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 (QS) 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 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.
Bifeng Qian -S
Bifeng Oian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K22892
Device Name
Powder Free Polyurethane Examination Gloves, Blue color, Tested for use with Chemotherapy Drugs
Indications for Use (Describe)
The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves have been tested for use with chemotherapy drugs using ASTM D6978-05(2019)
| Chemotherapy Drug | Minimum Breakthrough Detection Time (BDT) in Minutes |
|---|---|
| Carmustine 3.3 mg/ml (3,300 ppm) | 24.0 |
| Cisplatin 1mg/ml (1,000 ppm) | >240 |
| Cyclophosphamide 20mg/ml (20,000 ppm) | >240 |
| Dacarbazine 10 mg/ml (10,000 ppm) | >240 |
| Doxorubicin HCL, 2 mg/ml (2,000 ppm) | >240 |
| Etoposide, 20 mg/ml (20,000 ppm) | >240 |
| Fluorouracil, 50mg/ml (50,000ppm) | >240 |
| Methotrexate, 25mg/ml (25,000ppm) | >240 |
| Paclitaxel, 6mg/ml (6,000ppm) | >240 |
| Thiotepa, 10mg/ml (10,000ppm) | 0.6 |
- Please note that the following drugs have extremely low permeation times: Carmustine: 24.0 minutes, Thiotepa: 0.6 minutes
Warning: Do not use with Carmustine or Thiotepa.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CER 801 Subpart D) | X Over-The-Counter Use (21 CER 801 Subpart C) |
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Donggao Industrial Zone, Zanhuang, Hebei, 050000, China
Product: Powder Free Polyurethane Examination Gloves, Blue color, Tested for use with Chemotherapy Drugs
510(K) SUMMARY
This summary of 510(K) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR §807.92.
The assigned 510(K) number is: K222892 Date Prepared: November 20, 2022
1. Owner's Identification:
Mrs. Wu Yuli Grand Work Plastic Products Co., Ltd. Donggao Industrial Zone, Zanhuang, Hebei, 050000, China Tel: 86-311-66179668
Contact: Ms. Kathy Liu, Project Manager Address: 3973 Schaefer Ave., Chino, CA 91710 Tel: 909-590-1611 Email: kathyliu@hongrayusa.com or fdareg(@)hongray.com.cn
2. Name of the Device:
Trade Name: Powder Free Polyurethane Examination Gloves, Blue color, Tested for use with Chemotherapy Drugs Common Name: Exam Gloves Classification Name: Patient Examination Glove Specialtv Classification Regulation: 21 CFR 880.6250 Classification Panel: 880 General Hospital and Personal Use Product Code: LZA, LZC, OPJ Device Class: Class I
3. Predicate Device Information:
Central Medicare Sdn Bhd. Non Sterile Powder Free Polyurethane Examination Gloves (Blue and Black colors)- (K203036)
Reference device:
Inner Mongolia Cureguard Medical Technology Co.,Ltd. Disposable Nitrile Examination Glove (Tested for use with Chemotherapy Drug) (K222642)
4. Device Description:
Powder Free Polyurethane Examination Gloves, Blue color, tested for use with Chemotherapy Drugs are Patient Examination Gloves, Disposable, single use only and non-sterile. The gloves are made of nitrile rubber materials and are powder free. They are ambidextrous and come in different sizes-XS, S, M, L, XL and XXL. Gloves meet the specification of ASTM D6319-19
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Donggao Industrial Zone, Zanhuang, Hebei, 050000, China
and have been tested for resistance to permeation by chemotherapy drugs as per ASTM D6978-05(2019).
5. Intended Use/Indication for Use
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves have been tested for use with chemotherapy drugs using ASTM D6978-05(2019)
| Chemotherapy Drug | Minimum Breakthrough Detection Time(BDT) in Minutes |
|---|---|
| Carmustine 3.3 mg/ml (3,300 ppm) | 24.0 |
| Cisplatin 1mg/ml (1,000 ppm) | >240 |
| Cyclophosphamide 20mg/ml (20,000 ppm) | >240 |
| Dacarbazine 10 mg/ml (10,000 ppm) | >240 |
| Doxorubicin HCL, 2 mg/ml (2,000 ppm) | >240 |
| Etoposide, 20 mg/ml (20,000 ppm) | >240 |
| Fluorouracil, 50mg/ml (50,000ppm) | >240 |
| Methotrexate, 25mg/ml (25,000ppm) | >240 |
| Paclitaxel, 6mg/ml (6,000ppm) | >240 |
| Thiotepa, 10mg/ml (10,000ppm) | 0.6 |
- Please note that the following drugs have extremely low permeation times:
Carmustine: 24.0 minutes, Thiotepa: 0.6 minutes
Warning: Do not use with Carmustine and Thiotepa.
6.Comparison of Subject Device and Predicate Device:
The proposed and predicate device share the same technological characteristics and design by both meeting the standard specification ASTM D6319-19.
Biocompatibility study was performed on the proposed device. Under the conditions of the studies, the proposed devices are not sensitizers, irritants or systemic toxicity.
The proposed and predicate device are made from Polyurethane synthetic latex. The technological characteristics and design for the proposed device have been confirmed and the standard requirements that are appropriate for powder free polyurethane examinations gloves (ASTMD6319-19) have been met.
The following table of the device properties is a summary to show the technological characteristics of the proposed devices in relation to the predicate device:
| Proposed DeviceK222892 | Predicate DeviceK203036 | Reference DeviceK222642 | Comparison | |
|---|---|---|---|---|
| Trade Name | Powder FreePolyurethaneExamination Gloves,Blue color, Tested for | Non Sterile PowderFree PolyurethaneExamination Gloves(Blue and Black colors) | Disposable NitrileExamination Glove(Tested for use withChemotherapy Drug) | Similar |
| use with ChemotherapyDrugs | ||||
| ProductCode | LZA, LZC, OPJ | LZA | LZA, LZC | Same asK222642 |
| RegulationNumber | 21 CFR 880.6250 | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Class | I | I | I | Same |
| Indicationsfor Use | Powder FreePolyurethaneExamination Gloves,Blue color, Tested foruse with ChemotherapyDrugs is a disposabledevice intended formedical purposes thatis worn on theexaminer's hand toprevent contaminationbetween patient andexaminer. Gloves havebeen tested for use withchemotherapy drugsusing ASTM D6978 | Non Sterile PowderFree PolyurethaneExamination Gloves(Blue and Black colors)is a patient medicalexam glove which is adisposable deviceintended for medicalpurpose that is worn onthe examiner's hand orfinger to preventcontamination betweenexaminer and patient. | A patient ExaminationGlove is a disposabledevice intended formedical purposes thatis worn on theexaminer's hand toprevent contaminationbetween patient andexaminer. These gloveswere tested for use withchemotherapy drugs | Same |
| Material | Polyurethane | Polyurethane | Nitrile | Same asK203036 |
| Powder orPowder Free | Powder Free | Powder Free | Powder Free | Same |
| Color | Blue | Blue and Black | Blue | Similar |
| Single use | Single use | Single use | Single use | Same |
| Design Feature | Ambidextrous | Ambidextrous | Ambidextrous | Same |
| LabelingInformation | Single-use indication,powder free, devicename, glove size,quantity, PolyurethaneExamination Gloves,Non Sterile, tested foruse with Chemo-drugs | Single-use indication,powder free, devicename, glove size,quantity, PolyurethaneExamination Gloves,Non Sterile | Single-use indication,powder free, devicecolor, device name,glove size and quantity,Non-Sterile, astatement of standardASTM D6978-05compliance and asummary of the testingresults | Similar |
| TechnologicalCharacteristics | ProposedDeviceK222892 | PredicateDeviceK203036 | ReferenceDeviceK222642 | Comparison |
| Length | Minimum230mm | Minimum230mm | Minimum 230mm | Same |
| Palm Width (size) (mm) | ||||
| XS | 70±10 | 70±10 | 70±10 | Same |
| S | 80±10 | 80±10 | 80±10 | Same |
| M | 95±10 | 95±10 | 95±10 | Same |
| L | 110±10 | 110±10 | 110±10 | Same |
| XL | 120±10 | 120±10 | 120±10 | Same |
| XXL | 130±10 | N/A | N/A | Different |
| Thickness(mm) | ||||
| Finger | Minimum 0.05 | Minimum 0.05 | Minimum 0.05 | Same |
| Palm | Minimum 0.05 | Minimum 0.05 | Minimum 0.05 | Same |
| Tensile Strength,Before Aging | 14MPa, min | 14MPa, min | 14MPa, min | Same |
| UltimateElongation,Before Aging | 500%, min | 500%, min | 500%, min | Same |
| Tensile Strength,After AcceleratedAging | 14MPa, min | 14MPa, min | 14MPa, min | Same |
| UltimateElongation, AfterAccelerated Aging | 400%, min | 400%, min | 400%, min | Same |
| Watertight (1000ml) | 21 CFR 800.20 ASTMD5151 AQL 2.5 | 21 CFR 800.20ASTM D5151 | 21 CFR 800.20ASTM D5151 | Same |
| Powder-Content | ≤ 2 mg per glove | ≤ 2 mg per glove | ≤ 2 mg per glove | Same |
| ISO 10993-10&23Skin Irritation andSensitization Study | Under the conditionsof the study, not anirritant, not asensitizer | Under the conditionsof the study, thesubject device is non-irritating and non-sensitization | Under the conditionsof the study, not anirritant, not asensitizer | Same |
| ISO 10993-5Cytotoxicity Test | showed potentialtoxicity to L929 cells | N/A | Under conditions ofthe study, deviceextract is cytotoxic. | Similar |
| ISO 10993-11Acutesystemic toxicity | no evidence of acutesystemic toxicity | N/A | Under conditions ofthe study, deviceextract is non-toxic. | Same |
| Tested Chemotherapy Drug andConcentration | Minimum BDT (Minutes) | Comparison | ||
| Proposed DeviceK222892 | Reference DeviceK222642 | |||
| Carmustine 3.3 mg/ml (3,300 ppm) | 24.0 | 22.0 | Similar | |
| Cisplatin 1mg/ml (1,000 ppm) | >240 | >240 | Same | |
| Cyclophosphamide 20mg/ml (20,000 ppm) | >240 | >240 | Same | |
| Dacarbazine 10 mg/ml (10,000 ppm) | >240 | >240 | Same | |
| Doxorubicin HCL, 2 mg/ml (2,000 ppm) | >240 | >240 | Same | |
| Etoposide, 20 mg/ml (20,000 ppm) | >240 | >240 | Same | |
| Fluorouracil, 50mg/ml (50,000ppm) | >240 | >240 | Same | |
| Methotrexate, 25mg/ml (25,000ppm) | >240 | N/A | Different | |
| Mitomycin C (0.5 mg/ml) | N/A | >240 | Different | |
| Vincristine sulfate (1.0 mg/ml) | N/A | >240 | Different | |
| Paclitaxel, 6mg/ml (6,000ppm) | >240 | >240 | Same | |
| Thiotepa, 10mg/ml (10,000ppm) | 0.6 | 59.2 | Similar |
General Comparison Table:
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Donggao Industrial Zone, Zhanhuang, Hebei, 050000, China
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Donggao Industrial Zone, Zanhuang, Hebei, 050000, China
Technological Characteristic Comparison Table:
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Donggao Industrial Zone, Zanhuang, Hebei, 050000, China
Chemotherapy Permeation Comparison Claim:
7. Non-Clinical Performance Data
Non-clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device met the performance criteria with the following standards:
| Methodology | Test Performed | Acceptance Criteria | Results |
|---|---|---|---|
| ASTM D6319- 19 | Physical DimensionsLength | Minimum 230mm for all sizes | Pass |
| ASTM D6319- 19 | Physical DimensionsPalm Width | XS: 70±10mmS: 80±10mmM: 95±10mmL:110±10mmXL: 120±10mmXXL: 130±10mm | Pass |
| ASTM D6319- 19 | Physical DimensionsThickness | Finger: 0.05mm (min)Palm: 0.05mm (min) | Pass |
| ASTM D6319- 19ASTM D412-16(2021) | Physical Properties | Tensile Strength (Min14 Mpa) and Elongation(Before Aging 500% and after aging 400%) Min | Pass |
| ASTM D6319- 19ASTM D5151-19 | Water leak test | AQL 2.5 | Pass |
| ASTM D6319- 19ASTM D6124-06 (2017 | Powder Residue | Max 2mg/glove | Pass |
| ASTM D6978-05 (2019) | Permeation byChemotherapy Drugs | Refer the above table | Pass |
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Donggao Industrial Zone, Zanhuang, Hebei, 050000, China
| ISO 10993-10&23:2021 | Irritation And SkinSensitization | No Skin sensitization andNo Skin irritation | Is non-sensitizationand Non-irritation |
|---|---|---|---|
| ISO 10993-5:2009 | Cytotoxicity | Not Cytotoxic | showed potentialtoxicity to L929cells. |
| ISO 10993-11:2017 | Acute systemic toxicitystudy | Subject showed no adversebiological reaction | no evidence of acutesystemic toxicity. |
- ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical ● Application.
- . ASTM D5151-19, Standard Test Method for Detection of Holes in Medical Gloves.
- ASTM D6124-06 (Reapproved 2017), Standard Test Method for Residual Powder on ● Medical Gloves
- . ASTM D412-16 (2021) Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers-Tension
- ASTM D6978-05 (Reapproved 2019), Assessment of Reissuance of Medical Gloves to Permeation by Chemotherapy Drugs.
- ISO 10993-10:2021 Biological Evaluation of Medical Devices Part 10: Tests For . Skin Sensitization.
- ISO 10993-23:2021 Biological Evaluation of Medical Devices Part 10: Tests For ● Skin Irritation.
- ISO 10993-5:2009 Biological Evaluation of Medical Devices Part 5: Tests For In . Vitro Cytotoxicity
- . ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
8. Clinical Performance Data
N/A
9. Conclusion:
The conclusions drawn from the nonclinical tests demonstrate that the 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.