(57 days)
Not Found
No
The 510(k) summary describes a standard medical examination glove and its performance testing against established standards. There is no mention of AI or ML technology in the intended use, device description, or performance studies.
No.
The device, an examination glove, is intended to prevent contamination between patient and examiner, not to treat a disease or health condition.
No
Explanation: The device is a medical glove, a physical barrier intended to prevent contamination between patient and examiner. It is not designed to diagnose any condition or disease.
No
The device description clearly states it is a physical product (gloves) and does not mention any software components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a "disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner." This describes a barrier device used externally.
- Device Description: The description reinforces this, detailing a physical barrier (gloves) for preventing contamination.
- Lack of IVD Characteristics: IVD devices are typically used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of biological specimens.
- Testing: While the gloves are tested for chemotherapy drug permeation, this is a performance characteristic of the barrier, not an in vitro diagnostic test.
In summary, the device is a medical glove, which is a Class I or Class II medical device depending on its intended use and claims, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications 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.
Product codes (comma separated list FDA assigned to the subject device)
LZA, LZC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hands or fingers
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner / medical purpose
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
Results:
Irritation: Under the conditions of the study, not an irritant.
Sensitization: Under conditions of the study, not a sensitizer.
Cytotoxicity: Under conditions of the study, the device extract is not cytotoxic.
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.
Tests conducted:
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
| 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 |
Warning: Please do not use with Carmustine (BCNU) and Thiotepa.
Physical Properties:
Before Aging: Tensile Strength 14MPa, min; Ultimate Elongation 500% min
After Aging: Tensile Strength 14MPa, min; Ultimate Elongation 400%min
Comply with ASTM D6319
Freedom from Holes: Be free from holes when tested in accordance with ASTMD5151 AQL=2.5
Powder Content: 0.07 mg per glove, Meet the requirements of ASTM D6124
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
1
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
2
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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3
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
4
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 Detection
Time 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
5
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 | Same |
|---|---|---|---|
| Class | I | I | Same |
| Intended 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. | 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. | Same | ||
| Powdered or | |||
| Powered 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 and | |||
| quantity,Non-Sterile, | |||
| a statement of standard | |||
| ASTM | |||
| D6978-05 | |||
| compliance and a | |||
| summary of the testing | |||
| results. | Single-use indication, powder | ||
| free, device color, device | |||
| name, glove size and | |||
| quantity, Non-Sterile, a | |||
| statement of standard | |||
| ASTM | |||
| D6978-05 | |||
| compliance and a summary | |||
| of the testing results. | Similar |
Table2 Device Dimensions Comparison
| Designation | Size | ||||||
|---|---|---|---|---|---|---|---|
| XS | S | M | L | XL | Tolerance | ||
| Predicate | |||||||
| Device(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 | |||||
| Subject | |||||||
| Device(K211547) | Designation | XS | S | M | L | XL | Tolerance |
| Length, mm | NA | 220 | 230 | 230 | 230 | min |
6
| 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 | | |
| Physical
Properties | Before
Aging | Tensile
Strength | 14MPa, min | 14MPa, min | Same |
| | | Ultimate
Elongation | 500% min | 500% min | Same |
| | After
Aging | Tensile
Strength | 14MPa, min | 14MPa, min | Same |
| | | Ultimate
Elongation | 400%min | 400%min | Same |
| | | Comply with ASTM D6319 | | Comply with ASTM
D6319 | Same |
| Freedom from Holes | | Be free from holes when tested
in accordance with
ASTMD5151 AQL=2.5 | | Be free from holes when tested
in accordance with
ASTMD5151 AQL=2.5 | Same |
| Powder Content | | 0.07 mg per glove, Meet the
requirements of ASTM D6124 | | Meet the requirements
of 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) 10.0
mg/ml:> 240 Minutes | | Dacarbazine (DTIC)
10.0 mg/ml:
240 Minutes | Same |
| | | Doxorubicin HCl 2.0 mg/ml: >
240 Minutes | | Doxorubicin
Hydrochloride 2.0 | Same |
Table3 Performance Comparison
7
| mg/ml: >240 Minutes | |||
|---|---|---|---|
| Chemotherapy Drugs | |||
| Tested with Minimum | |||
| Breakthrough | |||
| Detection Time as | |||
| Tested per ASTM D | |||
| 6978 | Etoposide 20.0 mg/ml: > 240 | ||
| Minutes | Etoposide (Toposar) 20.0 | ||
| mg/ml: >240 Minutes | Same | ||
| Fluorouracil 50.0 mg/ml: >240 | |||
| Minutes | Fluorouracil 50.0 | ||
| mg/ml: >240 | |||
| Minutes | Same | ||
| Paclitaxel 6.0 mg/ml: > 240 | |||
| Minutes | Paclitaxel (Taxol) 6.0 | ||
| mg/ml: |
240 Minutes | Same |
| | Thio Tepa 10.0 mg/ml: 26.1
Minutes | 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 (ISO | |||
| 10993-10:2010 | ||||
| Biological | ||||
| Evaluation of | ||||
| Medical Devices - | ||||
| Part 10: Tests For | ||||
| Irritation And Skin | ||||
| Sensitization) | Under the | |||
| conditions of | ||||
| the study, not | ||||
| an irritant | ||||
| Sensitization (ISO | ||||
| 10993-10:2010 | ||||
| Biological | ||||
| Evaluation of | ||||
| Medical Devices - | ||||
| Part 10: Tests For | ||||
| Irritation And Skin | ||||
| Sensitization) | Under | |||
| conditions of | ||||
| the study, not a | ||||
| sensitizer. | Comply with | |||
| ISO10993-10 | Same | |||
| Cytotoxicity (ISO | ||||
| 10993-5:2009 | ||||
| Biological | ||||
| Evaluation of | ||||
| Medical Devices - | Under | |||
| conditions of | ||||
| the study, the | ||||
| device extract | ||||
| is not cytotoxic | Under | |||
| conditions of | ||||
| the study, the | ||||
| device extract | ||||
| is not cytotoxic | Same |
8
| | Part 5: Tests For In
Vitro 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.
9
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.