(90 days)
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs.
The subject device is single use, disposable gloves intended for medical purposes to be worn on the examiner's hands to prevent contamination between patient and examiner. The gloves are powder-free, ambidextrous with beaded cuff, blue colored, nitrile, and tested for use with chemotherapy drugs. The gloves are offered in four sizes: small, medium, large, and extra-large. The subject device is non-sterile.
This document, K212506, is a 510(k) premarket notification for Medical Examination Gloves (Tested for Use with Chemotherapy). It details the acceptance criteria and the study proving the device meets these criteria.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria and device performance are primarily based on the ASTM D6319 standard for medical examination gloves and ASTM D6978 for chemotherapy drug permeation.
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319 | Physical Dimensions Test | Length (mm): S: ≥220; M/L/XL: ≥230 | Length: > 240/Pass (implies all sizes met or exceeded) |
| Width (mm): S: 80±10; M: 95±10; L: 110±10; XL: 120±10 | Width: S: 86-88 /Pass; M: 98-99/ Pass; L: 109-111/ Pass; XL: 115-117/ Pass | ||
| Thickness (mm): Finger: ≥0.05; Palm: ≥0.05 | Finger: 0.11-0.12/Pass; Palm: 0.09-0.10/Pass | ||
| ASTM D5151 | Watertightness Test for Detection of Holes | Meet the requirements of ASTM D5151 AQL 2.5 | 0/125/Pass (0 defects out of 125 samples, meeting AQL 2.5) |
| ASTM D6124 | Powder Content | Meet the requirements of ASTM D6124 < 2.0mg | 0.15mg/Pass |
| ASTM D412 | Physical properties (Tensile Strength & Ultimate Elongation) | Before Aging: Tensile Strength ≥14MPa; Ultimate Elongation ≥500%After Aging: Tensile Strength ≥14MPa; Ultimate Elongation ≥400% | Before Aging: Tensile Strength 14.5-18.9/Pass; Ultimate Elongation 546-778/PassAfter Aging: Tensile Strength 14.4-16.1/Pass; Ultimate Elongation 579-699/Pass |
| ISO 10993-11 | Toxicity (Acute Systemic Toxicity) | Non-acute systemic toxicity | Under conditions of the study, did not show acute systemic toxicity in vivo / Pass |
| ISO 10993-10 | Irritation | Non-irritating | Under the conditions of the study, not an irritant/ Pass |
| ISO 10993-10 | Sensitization | Non-sensitizing | Under conditions of the study, not a sensitizer / Pass |
| ASTM D6978-05 | Chemotherapy Drug Permeation | A set of specific minimum breakthrough detection times for various chemotherapy drugs (see table below). Note: Acceptance criteria for breakthrough times are implied by the provided values; these are the performance targets for the "tested for use with chemotherapy" claim. | |
| Chemotherapy Drug | Concentration | Breakthrough Detection Time in Minutes (Reported Performance) | |
| ------------------------ | ------------------------ | ------------------------------------------------------------- | |
| Carmustine (BCNU) | 3.3 mg/ml (3,300 ppm) | 10.9 Minutes | |
| Cisplatin | 1.0 mg/ml(1,000 ppm) | > 240 Minutes | |
| Cyclophosphamide (Cytoxan) | 20.0 mg/ml(20,000 ppm) | > 240 Minutes | |
| Dacarbazine (DTIC) | 10.0 mg/ml(10,000 ppm) | > 240 Minutes | |
| Doxorubicin HCL (Adriamycin) | 2.0 mg/ml(2,000 ppm) | > 240 Minutes | |
| Etoposide (Toposar) | 20.0 mg/ml(20,000 ppm) | > 240 Minutes | |
| Fluorouracil (Adrucil) | 50.0 mg/ml(50,000 ppm) | > 240 Minutes | |
| Paclitaxel (Taxol) | 6.0 mg/ml(6,000 ppm) | > 240 Minutes | |
| Thio TEPA | 10.0 mg/ml(10,000 ppm) | 15.2 Minutes |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size:
- Watertightness Test (ASTM D5151): 125 samples (0/125/Pass).
- Other physical performance tests (Dimensions, Physical properties, Powder Content): Specific sample sizes are not explicitly stated for all tests but are implied by the results provided (e.g., ranges for width/thickness indicate multiple measurements). These tests are typically performed on a statistically relevant sample size according to the respective ASTM standards.
- Biocompatibility (ISO 10993 series): Sample sizes for the animal studies (toxicity, irritation, sensitization) are not detailed in this summary but would have followed the guidance of the ISO standards.
- Chemotherapy Permeation (ASTM D6978): The permeation results are presented as single breakthrough times for each drug, implying a specific test protocol dictated by the standard, likely involving multiple replicates to ensure reproducibility, though the exact number isn't given.
- Data Provenance: The data is derived from benchtop performance testing and biocompatibility testing. The manufacturer is based in Guangdong, China, which implies the testing was conducted there or by affiliated labs. The document does not specify if the data is retrospective or prospective; however, given it's a 510(k) submission, it's typically data collected specifically for the regulatory submission (i.e., prospective for this purpose).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This submission is for a Class I medical examination glove, which relies on standardized bench testing rather than interpretation of complex medical images or clinical outcomes that would require expert consensus (e.g., radiologists). Therefore, there were no human experts establishing "ground truth" in the diagnostic sense. The "ground truth" for the performance characteristics (e.g., tensile strength, breakthrough time) is defined by the validated test methods and their quantitative results.
4. Adjudication Method for the Test Set
Not applicable. As described above, this involves quantitative bench testing and not subjective expert interpretation requiring adjudication.
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 is typically performed for diagnostic imaging devices where human readers interpret medical images with and without AI assistance. This device is a physical glove, and its performance is evaluated through laboratory bench tests.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
This question is not applicable to this device. This is a physical non-diagnostic medical device. There is no algorithm or AI component involved, hence no "standalone" algorithm performance to evaluate. The device's performance is inherently "standalone" in that it performs its function (e.g., barrier to chemicals, physical strength) intrinsically.
7. The Type of Ground Truth Used
The ground truth used for this device's performance testing is based on:
- Standardized Test Methods (Benchtop Data): Adherence to specific ASTM and ISO standards (e.g., ASTM D6319, ASTM D5151, ASTM D6124, ASTM D412, ASTM D6978, ISO 10993-10, ISO 10993-11). The results obtained from these tests are considered the objective ground truth for the glove's physical and chemical resistance properties.
- Chemical Permeation Data: Direct quantitative measurement of breakthrough times for specific chemotherapy drugs, as determined by ASTM D6978-05.
- Biocompatibility Data: Results from in vivo (for toxicity, irritation, sensitization) studies following ISO 10993 guidelines, which define the biological response to the material.
8. The Sample Size for the Training Set
Not applicable. This device is a physical product, not an AI/ML algorithm. Therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
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November 7, 2021
Guangdong Gymda Medical Technology Co.,ltd Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.1801,No.161 Lujiazui East Rd.,Pudong Shanghai. 200120 China
Re: K212506
Trade/Device Name: Medical Examination Gloves (Tested for Use with Chemotherapy) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-powdered patient examination glove Regulatory Class: Class I, reserved Product Code: LZA, LZC Dated: July 30, 2021 Received: August 9, 2021
Dear Boyle Wang:
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.
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
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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 and Part 809); 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,
For Clarence W. Murray, III, 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) K212506
Device Name
Medical Examination Gloves (Tested for Use with Chemotherapy)
Indications for Use (Describe)
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs.
| Chemotherapy Drug | Concentration | Breakthrough Detection Time in Minutes |
|---|---|---|
| Carmustine (BCNU) | 3.3 mg/ml (3,300 ppm) | 10.9 Minutes |
| Cisplatin | 1.0 mg/ml(1,000 ppm) | > 240 Minutes |
| Cyclophosphamide (Cytoxan) | 20.0 mg/ml(20,000 ppm) | > 240 Minutes |
| Dacarbazine (DTIC) | 10.0 mg/ml(10,000 ppm) | > 240 Minutes |
| Doxorubicin HCL (Adriamycin) | 2.0 mg/ml(2,000 ppm) | > 240 Minutes |
| Etoposide (Toposar) | 20.0 mg/ml(20,000 ppm) | > 240 Minutes |
| Fluorouracil (Adrucil) | 50.0 mg/ml(50,000 ppm) | > 240 Minutes |
| Paclitaxel (Taxol) | 6.0 mg/ml(6,000 ppm) | > 240 Minutes |
| Thio TEPA | 10.0 mg/ml(10,000 ppm) | 15.2 Minutes |
Please note that the following drugs have low permeation times: Carmustine (BCNU) 3.3 mg/ml 10.9 Minutes Thio-Tepa 10.0 mg/ml 15.2 Minutes
Warning: Please do not use with Carmustine (BCNU) and Thiotepa.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary-K212506
This summary of 510(k) is being submitted in accordance with 21 CFR 807.92.
1.0 Submitter's Information
GUANGDONG GYMDA MEDICAL TECHNOLOGY CO.,LTD Name: Address: No.13, Quan'an Third Road, Phase 2 of High-tech Zone, Nanxiong City, Shaoguan City, Guangdong Province, 512400, China Contact: Olivia Chen Date of Preparation: Jul 30, 2021
Designated Submission Correspondent
Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 1801, No. 161 Lujiazui East Rd., Pudong Shanghai, 200120 China Tel: +86-21-50313932 Email: Info@truthful.com.cn
2.0 Device Information
Trade name: Medical Examination Gloves (Tested for Use with Chemotherapy) Common name: Patient Examination Gloves Classification name: Non-powdered patient examination glove S, M, L, XL Model(s):
3.0 Classification
Production code: LZA.LZC Regulation number: 21CFR880.6250 Classification: Class I Panel: General Hospital
4.0 Predicate Device Information
Ever Growth (Vietnam) Co., Ltd. Manufacturer:
Device: Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, Orange Color
510(k) number: K190860
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5.0 Device Description
The subject device is single use, disposable gloves intended for medical purposes to be worn on the examiner's hands to prevent contamination between patient and examiner. The gloves are powder-free, ambidextrous with beaded cuff, blue colored, nitrile, and tested for use with chemotherapy drugs. The gloves are offered in four sizes: small, medium, large, and extra-large. The subject device is non-sterile.
6.0 Indication for Use
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs
| Chemotherapy Drug | Concentration | Breakthrough DetectionTime in Minutes |
|---|---|---|
| Carmustine (BCNU) | 3.3 mg/ml (3,300 ppm) | 10.9 |
| Cisplatin | 1.0 mg/ml(1,000 ppm) | > 240 |
| Cyclophosphamide(Cytoxan) | 20.0 mg/ml(20,000 ppm) | > 240 |
| Dacarbazine (DTIC) | 10.0 mg/ml(10,000 ppm) | > 240 |
| Doxorubicin HCl | 2.0 mg/ml(2,000 ppm) | > 240 |
| Etoposide | 20.0 mg/ml(20,000 ppm) | > 240 |
| Fluorouracil | 50.0 mg/ml(50,000 ppm) | > 240 |
| Paclitaxel | 6.0 mg/ml(6,000 ppm) | > 240 |
| Thio Tepa | 10.0 mg/ml(10,000 ppm) | 15.2 |
Please note that the following drugs have low permeation times: Carmustine (BCNU) 3.3 mg/ml 10.9 Minutes; Thio Tepa 10.0 mg/ml 15.2 Minutes.
Warning: Please do not use with Carmustine (BCNU) and Thiotepa.
7.0 Technological Characteristic Comparison Table
Table1-General Comparison
| Item | Subject Device(K212506) | Predicate Device(K190860) | Remark |
|---|---|---|---|
| Product Code | LZA,LZC | LZA,LZC | Same |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 | Same |
| Class | I | I | Same |
| Intended Use | A patient examinationgloves is a disposabledevice intended for medicalpurpose that is worn on theexaminer's hand orfingers to preventcontamination betweenpatient and examiner. Inaddition, these gloves weretested for use withchemotherapy drugs inaccordance with ASTMD6978-05 StandardPractice for Assessment ofMedical gloves toPermeation byChemotherapy Drugs. | A patient examinationgloves is a disposabledevice intended for medicalpurpose that is worn on theexaminer's hand orfingers to preventcontamination betweenpatient and examiner. Inaddition, these gloves weretested for use withchemotherapy drugs inaccordance with ASTMD6978-05 StandardPractice for Assessment ofMedical gloves toPermeation byChemotherapy Drugs. | Same |
| Powdered or Poweredfree | Powdered free | Powdered free | Same |
| Design Feature | Ambidextrous | Ambidextrous | Same |
| Sterility | Non-Sterile | Non-Sterile | Same |
| Labeling Information | Single-use indication,powder free, device color,device name, glove size andquantity,Non-Sterile,a statement of standardASTM D6978-05compliance and asummary of the testingresults. | Single-use indication,powder free, device color,device name, glove sizeand quantity, Non-Sterile, astatement of standardASTM D6978-05compliance and asummary of the testingresults. | Same |
| Dimensions(mm) | Length:S:≥220;M/L/XL: ≥230;Width:S: 80±10;M: 95±10;L: 110±10;XL: 120±10 | Length:XS/S/M/L/XL: ≥230;Width:XS:70±10;S: 80±10;M: 95±10;L: 110±10;XL: 120±10 | SimilarAnalysis1 |
| Thickness(mm) | Finger: ≥0.05;Palm: ≥0.05 | Finger: ≥0.05;Palm: ≥0.05 | Same |
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| Analysis2 | ||||||
|---|---|---|---|---|---|---|
| PhysicalProperties | TensileStrength | 14MPa, min | TensileStrength | 14MPa, min | Same | |
| BeforeAging | UltimateElongation | 500% min | UltimateElongation | 500% min | Same | |
| AfterAging | TensileStrength | 14MPa, min | TensileStrength | 14MPa, min | Same | |
| UltimateElongation | 400%min | UltimateElongation | 400%min | Same | ||
| Freedom from Holes | Be free from holes when tested in accordance withASTMD5151 AQL=2.5 | Be free from holes when tested in accordance withASTMD5151 AQL=2.5 | Same | |||
| Powder Content | 0.15 mg per glove, Meet the requirements ofASTM D6124 | Meet the requirements ofASTM D6124 | SimilarAnalysis3 | |||
| Biocompatibility | ISO 10993-10;Under the conditions of the study, not an irritantor a sensitizerISO 10993-5Under conditions of thestudy, device extract iscytotoxicISO 10993-11;Under thecondition of acutesystemic toxicity test,the test article did notshow acute systemictoxicity in vivo. | ISO 10993-10;Under the conditions of the study, not an irritantor a sensitizerISO 10993-5Under conditions of thestudy, device extract isnot cytotoxicN.A. | Same// | |||
| Carmustine (BCNU) 3.3mg/ml: 10.9 Minutes | Carmustine (BCNU) 3.3mg/ml:White:11.8 Minutes;Orange:31.6Minutes | SimilarAnalysis 4 | ||||
| Cisplatin 1.0 mg/ml: > 240Minutes | Cisplatin 1.0 mg/ml: > 240Minutes | Same |
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| Chemotherapy DrugsTested with MinimumBreakthroughDetection Time asTested per ASTM D6978 | Cyclophosphamide(Cytoxan) 20.0 mg/ml: >240 Minutes | Cyclophosphamide(Cytoxan)20.0 mg/ml: > 240 Minutes | Same |
|---|---|---|---|
| Dacarbazine (DTIC) 10.0mg/ml: > 240 Minutes | Dacarbazine (DTIC) 10.0mg/ml:>240 Minutes | Same | |
| Doxorubicin HCl 2.0 mg/ml:> 240 Minutes | Doxorubicin Hydrochloride2.0mg/ml: >240 Minutes | Same | |
| Etoposide 20.0 mg/ml: >240 Minutes | Etoposide (Toposar) 20.0mg/ml: >240 Minutes | Same | |
| Fluorouracil 50.0 mg/ml: >240 Minutes | Fluorouracil 50.0 mg/ml: >240 Minutes | Same | |
| Paclitaxel 6.0 mg/ml: >240Minutes | Paclitaxel (Taxol) 6.0mg/ml:>240 Minutes | Same | |
| Thio Tepa 10.0 mg/ml: 15.2Minutes | Thio-Tepa 10.0 mg/ml:White:16.9 Minutes;Orange: 72.5 Minutes | SimilarAnalysis 5 |
Analysis 1:
The physical dimensions are different with that of the predicate, but they all meet the requirements of ASTM D6319-19, so the differences do not raise any new safety or performance questions.
Analysis 2:
The color of the subject device is different with that of the predicate. The subject device was evaluated according to ISO 10993-1 standards, and there were no risks identified.
Analysis 3:
Powder Content of subject device is similar with that of the predicate, because the predicate did not publish the exact results of the powder content. But they all meet the requirements of ASTM D6319-19, so the differences do not raise any new safety or performance questions.
Analysis 4:
And Breakthrough detection times of Carmustine (BCNU) and Thio Tepa of subject device are different with those of the predicate. The Chemotherapy Labeling Claims has clearly defined on the labeling. So it does not raise any new safety or performance questions.
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8.0 Summary of Non-Clinical Testing
Biocompatibility Testing
The biocompatibility evaluation for Medical Examination Gloves (Tested for Use with Chemotherapy) was conducted in accordance with the following standards:
ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests for Irritation And Skin Sensitization.
ISO 10993-11 Third edition 2017-09, Biological evaluation of medical devices -Part 11: Tests for systemic toxicity
Performance Testing (Bench)
Physical performance qualities of the proposed device were evaluated per ASTM D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application.
Permeation testing was conducted to support the addition of the labeling claim: Tested for use with chemotherapy drugs. In addition, the proposed device was tested according to ASTM D6978-05 (Reapproved 2019), Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs, in which minimum breakthrough times were determined for a wide range of chemotherapy drugs.
In summary, the performance testing of the subject device was conducted to adequately demonstrate the effectiveness of the device in accordance with the relevant test methods cited below:
- ASTM D6124-06 (Reapproved 2017), Standard Test Method for -Residual Powder on Medical Gloves
- -ASTM D5151-19, Standard Test Method for Detection of Holes in Medical Gloves.
- ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application.
- ASTM D 6978-05 (Reapproved 2019) ,Standard Practice for -Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
Table 2 - Summary of non-clinical performance testing
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| TestMethod | Purpose | Acceptance Criteria | Results | |
|---|---|---|---|---|
| ASTMD6319 | PhysicalDimensionsTest | Length(mm):S:≥220;M/L/XL:≥230; | Length:> 240/Pass; | |
| Width(mm):S: 80±10; | Width:S: 86-88 /Pass | |||
| M: 95±10; | M: 98-99/ Pass | |||
| L: 110±10; | L: 109-111/ Pass | |||
| XL: 120±10 | XL:115-117/ Pass | |||
| Thickness (mm):Finger: ≥0.05Palm: ≥0.05 | Finger: 0.11-0.12/Pass | |||
| Palm: 0.09-0.10/Pass | ||||
| ASTMD5151 | WatertightnessTest forDetection ofHoles | Meet the requirements of ASTM D5151AQL 2.5 | 0/125/Pass | |
| ASTMD6124 | PowderContent | Meet the requirements of ASTM D6124 <2.0mg | 0.15mg/Pass; | |
| ASTMD412 | Physicalproperties | BeforeAging | TensileStrength≥14MPa | 14.5-18.9/Pass; |
| UltimateElongation≥500% | 546-778/Pass; | |||
| AfterAging | TensileStrength≥14MPa | 14.4-16.1/Pass; | ||
| UltimateElongation≥400% | 579-699/Pass; | |||
| ISO10993-11 | Toxicity | Non- acute systemictoxicity | Under conditions ofthe study, did notshow acute systemictoxicity in vivo / Pass | |
| ISO10993-10 | Irritation | Non-irritating | Under the conditionsof the study, not anirritant/ Pass | |
| ISO10993-10 | Sensitization | Non-sensitizing | Under conditions ofthe study, not asensitizer / Pass |
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9.0 _Summary of Clinical Testing
Clinical testing is not needed for this device.
10.0 Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the subject device, Medical Examination Gloves (Tested for Use with Chemotherapy) is as safe, as effective, and performs as well as or better than the legally marketed predicated device under K190860.
§ 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.