(57 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 document provided describes the acceptance criteria and the study that proves the device, Edma Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs), meets these criteria.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Edma Nitrile Examination Gloves are primarily based on established ASTM standards for medical examination gloves and specifically for resistance to chemotherapy drugs. The device performance is evaluated against these standards.
| Acceptance Criterion (Standard) | Requirement | Reported Device Performance | Study that Proves |
|---|---|---|---|
| General Glove Specifications | |||
| ASTM D6319-19 (Standard Specification for Nitrile Examination Gloves for Medical Application) | General physical properties (e.g., tensile strength, elongation, dimensions) | The subject device meets the requirements of ASTM D6319-19. Length, width, and thickness values fall within the ranges specified by ASTM D6319-19 for various sizes, despite some differences from the predicate device. | Performance Testing (Bench) conducted according to ASTM D6319-19. This is a non-clinical, benchtop study. |
| ASTM D5151-19 (Standard Test Method for Detection of Holes in Medical Gloves) | Be free from holes, AQL=2.5 | The device is free from holes when tested in accordance with ASTMD5151 AQL=2.5. | Performance Testing (Bench) conducted according to ASTM D5151-19. This is a non-clinical, benchtop study. |
| ASTM D6124-06 (Reapproved 2017) (Standard Test Method for Residual Powder on Medical Gloves) | Powder content: 2mg per glove (maximum, generally for powdered gloves; for powder-free, a very low limit applies) | The device reports 0.07 mg per glove, meeting the requirements of ASTM D6124. | Performance Testing (Bench) conducted according to ASTM D6124-06. This is a non-clinical, benchtop study. |
| Chemotherapy Permeation Resistance | |||
| ASTM D6978-05 (Reapproved 2019) (Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs) | Minimum breakthrough detection time for various chemotherapy drugs. The standard itself specifies the test method, and the "acceptance" would be the demonstrated breakthrough times. | Carmustine (BCNU) 3.3 mg/ml: 22.8 Minutes | Permeation testing (Bench) conducted according to ASTM D6978-05. This is a non-clinical, benchtop study. |
| Cisplatin 1.0 mg/ml: > 240 Minutes | (Same as above) | ||
| Cyclophosphamide (Cytoxan) 20.0 mg/ml: > 240 Minutes | (Same as above) | ||
| Dacarbazine (DTIC) 10.0 mg/ml: > 240 Minutes | (Same as above) | ||
| Doxorubicin HCl 2.0 mg/ml: > 240 Minutes | (Same as above) | ||
| Etoposide 20.0 mg/ml: > 240 Minutes | (Same as above) | ||
| Fluorouracil 50.0 mg/ml: > 240 Minutes | (Same as above) | ||
| Paclitaxel 6.0 mg/ml: > 240 Minutes | (Same as above) | ||
| Thio Tepa 10.0 mg/ml: 26.1 Minutes | (Same as above) | ||
| Biocompatibility | |||
| ISO 10993-10:2010 (Biological Evaluation of Medical Devices - Part 10: Tests for Irritation And Skin Sensitization) | Not an irritant, not a sensitizer | Irritation: Under the conditions of the study, not an irritant. Sensitization: Under conditions of the study, not a sensitizer. This complies with ISO10993-10. | Biocompatibility testing conducted according to ISO 10993-10:2010. This is a non-clinical study. |
| ISO 10993-5:2009 (Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity) | Not cytotoxic | Under conditions of the study, the device extract is not cytotoxic. This complies with ISO10993-5. | Biocompatibility testing conducted according to ISO 10993-5:2009. This is a non-clinical study. |
Note: The acceptance criteria for the chemotherapy drug permeation are the demonstrated breakthrough times as determined by the ASTM D6978-05 standard. The warning for Carmustine and Thiotepa indicates that while tested, their low permeation times mean they are not recommended for use with these gloves.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state a 'test set' sample size in the context of typical AI algorithm evaluation (e.g., number of images or cases). The studies mentioned are primarily benchtop performance tests on the physical gloves themselves and biocompatibility tests. Therefore, the 'sample size' would pertain to the number of gloves or material samples tested per batch, according to the respective ASTM and ISO standards. The specific number of physical units tested for each standard is not detailed in this summary, but these standards have their own sampling plans inherent to their methodologies.
The provenance of the data is not specified in terms of country of origin for the testing, nor is it explicitly stated whether the tests were retrospective or prospective. However, given they are benchtop performance and biocompatibility studies, they are inherently prospective in nature, as the tests are conducted on manufactured samples of the device to assess its performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable to this device. Ground truth established by human experts (e.g., radiologists) is relevant for diagnostic AI/CADe devices. The Edma Nitrile Examination Gloves are a Class I medical device (non-powdered patient examination glove) that undergoes physical, chemical, and biological performance testing against industrial standards, not interpretation by medical experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable to this device. Adjudication methods are used in studies where human expert interpretation is involved in establishing ground truth for AI algorithms. For the Edma Nitrile Examination Gloves, the performance is assessed through objective, standardized laboratory tests.
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
This information is not applicable to this device. MRMC studies are relevant for diagnostic AI/CADe devices that involve human readers. The Edma Nitrile Examination Gloves are a physical barrier device, and their performance is not assessed in a clinical setting with human readers interpreting results.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable to this device. "Standalone" performance refers to AI algorithm performance without human intervention. The Edma Nitrile Examination Gloves do not incorporate an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the Edma Nitrile Examination Gloves is established by objective measurements and results from standardized laboratory tests according to recognized industry standards (ASTM and ISO). For example:
- Physical Properties: Direct measurements of tensile strength, elongation, dimensions against specified ranges in ASTM D6319-19.
- Freedom from Holes: Outcome of a water leak test or similar method specified in ASTM D5151-19.
- Powder Content: Direct measurement of residual powder according to ASTM D6124-06.
- Chemotherapy Permeation: Direct measurement of breakthrough time using the established methodology in ASTM D6978-05.
- Biocompatibility: Laboratory results showing the absence of irritation, sensitization, or cytotoxicity based on ISO 10993-10:2010 and ISO 10993-5:2009.
8. The sample size for the training set
This information is not applicable to this device. Training sets are used for machine learning algorithms. The Edma Nitrile Examination Gloves do not involve AI or machine learning.
9. How the ground truth for the training set was established
This information is not applicable to this device, as there is no training set for an AI algorithm.
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Image /page/0/Picture/0 description: The image shows 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.
July 15, 2021
Edma Group, LLC % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.1801, No.161 Lujiazui East Rd., Pudong Shanghai. 200120 China
Re: K211547
Trade/Device Name: Edma Nitrile Examination Gloves (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 Dated: May 12, 2021 Received: May 19, 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); 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 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,
Ryan Ortega, PhD Acting 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) K211547
Device Name
Edma Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)
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) | 22.8 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 | 2.0 mg/ml(2,000 ppm) | > 240 Minutes |
| Etoposide | 20.0 mg/ml(20,000 ppm) | > 240 Minutes |
| Fluorouracil | 50.0 mg/ml(50,000 ppm) | >240 Minutes |
| Paclitaxel | 6.0 mg/ml(6,000 ppm) | >240 Minutes |
| Thio Tepa | 10.0 mg/ml(10,000 ppm) | 26.1 Minutes |
Please note that the following drugs have low permeation times: Carmustine (BCNU) 3.3 mg/ml 22.8 Minutes Thio-Tepa 10.0 mg/ml 26.1 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 (K211547)
This summary of 510(k) is being submitted in accordance with 21 CFR 807.92.
1.0 Submitter's Information
Name: Edma Group, LLC. Address: 3634 E Piccadilly Rd, Phoenix, AZ 85018. Contact: Mr. Vio Cretu Date of Preparation: Jul.13,2021
Designated Submission Correspondent
Mr. Boyle Wanq Shanghai Truthful Information Technology Co., Ltd. Room 1801, No. 161 East Lujiazui Rd., Pudong Shanghai, 200120 China Tel: +86-21-50313932 Email: Info@truthful.com.cn
2.0 Device Information
Trade name: Edma Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) Common name: Patient Examination Gloves Classification name: Non-powdered patient examination glove Model(s): S, M, L, XL
3.0 Classification
Production code: LZA.LZC Regulation number: 21CFR880.6250 Classification: Class I Panel: General Hospital
4.0 Predicate Device Information
Manufacturer: Ever Growth (Vietnam) Co., Ltd.
- 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
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510(k) number: K190860
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.
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) | 22.8 |
| 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) | 26.1 |
Please note that the following drugs have low permeation times: Carmustine (BCNU) 3.3 mg/ml 22.8 Minutes; Thio Tepa 10.0 mg/ml 26.1 Minutes.
Warning: Please do not use with Carmustine (BCNU) and Thiotepa.
7.0 Technological Characteristic Comparison Table
| Item | Subject Device(K211547) | Predicate Device(K190860) | Remark |
|---|---|---|---|
| Product Code | LZA,LZC | LZA,LZC | Same |
Table1-General Comparison
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| Regulation No. | 21CFR880.6250 | 21CFR880.6250 | Same |
|---|---|---|---|
| Class | I | I | Same |
| Intended Use | A patient examination glovesis a disposable deviceintended for medical purposethat is worn on theexaminer's hand orfingers to preventcontamination betweenpatient and examiner. Inaddition, these gloves weretested for use withchemotherapy drugs inaccordance with ASTMD6978-05 Standard Practicefor Assessment of Medicalgloves toPermeationbyChemotherapy Drugs. | A patient examination glovesis a disposable deviceintended for medical purposethat is worn on theexaminer's hand orfingers to preventcontamination betweenpatient and examiner. Inaddition, these gloves weretested for use withchemotherapy drugs inaccordance with ASTMD6978-05 Standard Practicefor Assessment of Medicalgloves toPermeationbyChemotherapy Drugs. | Same |
| Powdered orPowered free | 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 standardASTMD6978-05compliance and asummary of the testingresults. | Single-use indication, powderfree, device color, devicename, glove size andquantity, Non-Sterile, astatement of standardASTMD6978-05compliance and a summaryof the testing results. | Similar |
Table2 Device Dimensions Comparison
| Designation | Size | ||||||
|---|---|---|---|---|---|---|---|
| XS | S | M | L | XL | Tolerance | ||
| PredicateDevice(K190860) | Length, mm | 230 | 230 | 230 | 230 | 230 | min |
| Width, mm | 70 | 80 | 95 | 110 | 120 | ±10 | |
| Thickness, mm: | |||||||
| Finger | 0.05 | min | |||||
| Palm | 0.05 | min | |||||
| SubjectDevice(K211547) | Designation | XS | S | M | L | XL | Tolerance |
| Length, mm | NA | 220 | 230 | 230 | 230 | min |
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| Width, mm | NA | 80 | 95 | 110 | 120 | ±10 | |
|---|---|---|---|---|---|---|---|
| Thickness, mm: | |||||||
| Finger | 0.08 | min | |||||
| Palm | 0.08 | min | |||||
| Remark | Different |
Analysis: 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.
| Item | Subject device(K211547) | Predicate device(K190860) | Remark | ||
|---|---|---|---|---|---|
| Colorant | Blue | White, Orange | Different | ||
| PhysicalProperties | BeforeAging | TensileStrength | 14MPa, min | 14MPa, min | Same |
| UltimateElongation | 500% min | 500% min | Same | ||
| AfterAging | TensileStrength | 14MPa, min | 14MPa, min | Same | |
| UltimateElongation | 400%min | 400%min | Same | ||
| Comply with ASTM D6319 | Comply with ASTMD6319 | Same | |||
| Freedom from Holes | Be free from holes when testedin accordance withASTMD5151 AQL=2.5 | Be free from holes when testedin accordance withASTMD5151 AQL=2.5 | Same | ||
| Powder Content | 0.07 mg per glove, Meet therequirements of ASTM D6124 | Meet the requirementsof ASTM D6124 | Same | ||
| Carmustine (BCNU) 3.3 mg/ml:22.8 Minutes | Carmustine (BCNU)3.3 mg/ml:White:11.8 Minutes;Orange:31.6Minutes | Similar | |||
| Cisplatin 1.0 mg/ml: >240 Minutes | Cisplatin 1.0 mg/ml:>240 Minutes | Same | |||
| 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)10.0 mg/ml:>240 Minutes | Same | |||
| Doxorubicin HCl 2.0 mg/ml: >240 Minutes | DoxorubicinHydrochloride 2.0 | Same |
Table3 Performance Comparison
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| mg/ml: >240 Minutes | |||
|---|---|---|---|
| Chemotherapy DrugsTested with MinimumBreakthroughDetection Time asTested per ASTM D6978 | Etoposide 20.0 mg/ml: > 240Minutes | Etoposide (Toposar) 20.0mg/ml: >240 Minutes | Same |
| Fluorouracil 50.0 mg/ml: >240Minutes | Fluorouracil 50.0mg/ml: >240Minutes | Same | |
| Paclitaxel 6.0 mg/ml: > 240Minutes | Paclitaxel (Taxol) 6.0mg/ml:>240 Minutes | Same | |
| Thio Tepa 10.0 mg/ml: 26.1Minutes | Thio-Tepa 10.0 mg/ml:White:16.9 Minutes;Orange: 72.5 Minutes | Similar |
Analysis: The color of the subject device is different of that of the predicate. Biocompatibility testing was successfully completed for the subject device, demonstrating that any color differences do not affect the safety of the proposed device.
| Table4 Safety Comparison | ||||
|---|---|---|---|---|
| Item | Subject device(K211547) | Predicated device(K190860) | Remark | |
| Material | Nitrile | Nitrile | Same | |
| Biocompatibility | Irritation (ISO10993-10:2010BiologicalEvaluation ofMedical Devices -Part 10: Tests ForIrritation And SkinSensitization) | Under theconditions ofthe study, notan irritant | ||
| Sensitization (ISO10993-10:2010BiologicalEvaluation ofMedical Devices -Part 10: Tests ForIrritation And SkinSensitization) | Underconditions ofthe study, not asensitizer. | Comply withISO10993-10 | Same | |
| Cytotoxicity (ISO10993-5:2009BiologicalEvaluation ofMedical Devices - | Underconditions ofthe study, thedevice extractis not cytotoxic | Underconditions ofthe study, thedevice extractis not cytotoxic | Same |
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| Part 5: Tests For InVitro Cytotoxicity) | |||||
|---|---|---|---|---|---|
| -- | --------------------------------------------- | -- | -- | -- | -- |
8.0 Summary of Non-Clinical Testing
Biocompatibility Testing
The biocompatibility evaluation for Edma Nitrile 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 10993-5:2009 Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity
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.
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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, Edma Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs), K211547,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.