(137 days)
Not Found
No
The device is a physical barrier (gloves) and the description focuses on material properties and barrier performance, with no mention of computational or analytical functions.
No
The device is a glove intended to prevent contamination, not to treat a condition or disease.
No
This device is a medical glove designed as a barrier to prevent contamination. It does not perform any diagnostic function such as detecting, diagnosing, or monitoring a disease or condition.
No
The device description clearly states it is a physical glove made of Nitrile rubber, a hardware component, and the performance studies focus on physical and chemical properties of the material.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to prevent contamination between patient and examiner by providing a barrier on the hand. While it's tested for use with chemotherapy drugs, this is a safety feature for the user and patient, not a diagnostic function.
- Device Description: The description clearly states it's a disposable Class 1 medical device for barrier protection.
- Lack of Diagnostic Function: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing information about a patient's health status or condition.
- Performance Studies: The performance studies focus on the physical properties, barrier integrity (water tightness), and chemical resistance (permeation by chemotherapy drugs) of the glove. These are not diagnostic performance metrics.
- Key Metrics: The key metrics listed are related to the glove's physical and barrier properties, not diagnostic accuracy (like sensitivity, specificity, etc.).
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This glove does not perform any of these functions.
N/A
Intended Use / Indications for Use
The Powder Free Nitrile Examination Gloves, Blue, Test For Use With Chemotherapy Drugs 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. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs:
| Test Chemotherapy Drug | Concentration | Breakthrough Detection Time in Minutes |
|---|---|---|
| Carmustine (BCNU) | 3.3 mg/ml (3,300 ppm) | 16.9 |
| Cisplatin | 1.0 mg/ml(1,000 ppm) | >240 |
| Cyclophosphamide (Cytoxan) | 20 mg/ml(20,000 ppm) | >240 |
| Dacarbazine | 10 mg/ml(10,000 ppm) | >240 |
| Doxorubicin HCl | 2.0 mg/ml(2,000 ppm) | >240 |
| Eotoside (Toposar) | 20.0 mg/ml(20,000 ppm) | >240 |
| Fluorouracil | 50.0 mg/ml(50,000 ppm) | >240 |
| Mechlorethamine | 1.0 mg/ml(1,000 ppm) | >240 |
| Methotrexate | 25.0 mg/ml(25,000 ppm) | >240 |
| Mitomycin C | 0.5 mg/ml(500 ppm) | >240 |
| Paclitaxel (Taxol) | 6.0 mg/ml(6,000 ppm) | >240 |
| Thio Tepa | 10.0 mg/ml(10,000 ppm) | 22.6 |
| Vincristine Sulfate | 1.0 mg/ml(1,000 ppm) | >240 |
Please note that the following drugs have low permeation times: Carmustine (BCNU) 3.3mg/ml 16.9 Minutes Thio Tepa 10.0 mg/ml 22.6 Minutes.
Warning: Don't to use with either Carmustine or Thio Tepa
Product codes (comma separated list FDA assigned to the subject device)
LZA, LZC
Device Description
The powder free Nitrile Examination glove is a disposable Class 1 medical device made of Nitrile rubber, and is intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. The principal operation of the medical device to provide single use barrier protection for the wearer and the device meets all the requirement specifications for Barrier Protection, tensile properties as defined in ASTM D6319-19, Standard specification for Nitrile Examination Gloves for medical Application.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Examiner's hand or finger
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Examiner (medical purposes)
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)
Non-Clinical Performance Data:
Water tightness Test for Detection of Holes (ASTM D5151):
Purpose: Meet the requirements of ASTM D5151 AQL 2.5
Results: Pass. Total 200 pcs of gloves were tested, 0 pcs rejected.
Physical Dimensions Test (ASTM D6319):
Purpose: Meet specified length, width, and thickness requirements.
Results: Pass. 13 pcs each size, total 65 pcs of gloves were tested, 0 pcs rejected.
Physical properties (ASTM D412):
Purpose: Meet specified Tensile Strength and Ultimate Elongation before and after aging.
Results: Pass. 13 pcs each size, total 65 pcs of gloves were tested, 0 pcs rejected.
Residual Powder Content (ASTM D6124):
Purpose: Meet the requirements of ASTM D6124
§ 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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. Food & Drug Administration".
February 18, 2022
Zibo Sinocare Plastic Products Co., Ltd Mila Guo Operation Manager Lot 5, No. 21 Qingtian Road Zibo, Shandong 255414 China
Re: K213306
Trade/Device Name: Powder Free Nitrile Examination Gloves, Blue, Test 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: January 7, 2022 Received: January 27, 2022
Dear Mila Guo:
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,
Clarence W. Murray, III, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K213306
Device Name
Powder Free Nitrile Examination Gloves, Blue, Test For Use With Chemotherapy Drugs
Indications for Use (Describe)
The Powder Free Nitrile Examination Gloves, Blue, Test For Use With Chemotherapy Drugs 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. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs:
| Test Chemotherapy Drug | Concentration | Breakthrough Detection Time in Minutes |
|---|---|---|
| Carmustine (BCNU) | 3.3 mg/ml (3,300 ppm) | 16.9 |
| Cisplatin | 1.0 mg/ml(1,000 ppm) | >240 |
| Cyclophosphamide (Cytoxan) | 20 mg/ml(20,000 ppm) | >240 |
| Dacarbazine | 10 mg/ml(10,000 ppm) | >240 |
| Doxorubicin HCl | 2.0 mg/ml(2,000 ppm) | >240 |
| Eotoside (Toposar) | 20.0 mg/ml(20,000 ppm) | >240 |
| Fluorouracil | 50.0 mg/ml(50,000 ppm) | >240 |
| Mechlorethamine | 1.0 mg/ml(1,000 ppm) | >240 |
| Methotrexate | 25.0 mg/ml(25,000 ppm) | >240 |
| Mitomycin C | 0.5 mg/ml(500 ppm) | >240 |
| Paclitaxel (Taxol) | 6.0 mg/ml(6,000 ppm) | >240 |
| Thio Tepa | 10.0 mg/ml(10,000 ppm) | 22.6 |
| Vincristine Sulfate | 1.0 mg/ml(1,000 ppm) | >240 |
Please note that the following drugs have low permeation times: Carmustine (BCNU) 3.3mg/ml 16.9 Minutes Thio Tepa 10.0 mg/ml 22.6 Minutes.
Warning: Don't to use with either Carmustine or Thio Tepa
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
(K213306)
This summary of K213306 is being submitted in accordance with 21 CFR 807.92
1.0 Submitter's Information
| Submitter Name: | Zibo Sinocare Plastic Products Co., Ltd |
|---|---|
| Registration Number: | 3005060582 |
| Address: | Lot 5, No. 21 Qingtian Road, Zibo, Shandong, China 255414 |
| Contact Person & Title: | Mila Guo, Operation Manager |
| Contact: Tel & Fax : | +86-533-7859433 |
| Email: | sinocare2000@126.com |
Summary Preparation Date: Feb 10, 2022
2.0 Name of the Device
| Proprietary/Trade name: | Powder Free Nitrile Examination Gloves, Blue, Tested For
Use With Chemotherapy Drugs |
|-------------------------|-----------------------------------------------------------------------------------------|
| Common Name: | Patient Examination Gloves, Nitrile, Powder free |
| Classification Name: | Non-Powdered Patient Examination Glove |
| Device Classification: | Class 1 |
| Regulation Number: | 21 CFR 880.6250 |
| Product Code: | LZA, LZC |
3.0 Predicate device
| Primary Device Name: | Nitrile Exam Gloves, Powder Free, Blue (Tested for Use
with Chemotherapy Drugs) |
|----------------------|------------------------------------------------------------------------------------|
| Company name: | Hengchang (Dongying) Medical Technology Co., Ltd. |
| 510(K) Number: | K211714 |
4.0 Device Description:
The powder free Nitrile Examination glove is a disposable Class 1 medical device made of Nitrile rubber, and is intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. The principal operation of the medical device to provide single use barrier protection for the wearer and the device meets
4
all the requirement specifications for Barrier Protection, tensile properties as defined in ASTM D6319-19, Standard specification for Nitrile Examination Gloves for medical Application.
5.0 Indication for use:
The Powder Free Nitrile Examination Gloves, Blue, Tested For Use With Chemotherapy Drugs 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.
In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs:
| No. | Test Chemotherapy Drugs | Concentration | Minimum Breakthrough
Detection Time in Minutes |
|-----|-------------------------|------------------------|---------------------------------------------------|
| 1 | Carmustine (BCNU) | 3.3 mg/ml (3,300 ppm) | 16.9 |
| 2 | Cisplatin | 1.0 mg/ml(1,000 ppm) | >240 |
| 3 | Cyclophosphamide | 20 mg/ml(20,000 ppm) | >240 |
| 4 | Dacarbazine | 10 mg/ml(10,000 ppm) | >240 |
| 5 | Doxorubicin HCI | 2.0 mg/ml(2,000 ppm) | >240 |
| 6 | Eotoside (Toposar) | 20.0 mg/ml(20,000 ppm) | >240 |
| 7 | Fluorouracil | 50.0 mg/ml(50,000 ppm) | >240 |
| 8 | Mechlorethamine | 1.0 mg/ml(1,000 ppm) | >240 |
| 9 | Methotrexate | 25.0 mg/ml(25,000 ppm) | >240 |
| 10 | Mitomycin C | 0.5 mg/ml(500 ppm) | >240 |
| 11 | Paclitaxel (Taxol) | 6.0 mg/ml(6,000 ppm) | >240 |
| 12 | Thio Tepa | 10.0 mg/ml(10,000 ppm) | 22.6 |
| 13 | Vincristine Sulfate | 1.0 mg/ml(1,000 ppm) | >240 |
Please note that the following drugs have low permeation times:
Carmustine (BCNU) 3.3 mg/ml 16.9 Minutes;
Thio Tepa 10.0 mg/ml 22.6 Minutes.
Warning: Do not use with either Carmustine or Thio Tepa
5
6.0 Technological Characteristics Comparison Table
Shown below is a technological comparison of the subject device (K213306) with the
| Items | Predicate Device: K211714 | Subject Device: K213306 | Comparison | |
|---|---|---|---|---|
| Product Code | LZA, LZC | LZA, LZC | Same | |
| Device Class | Class I | Class I | Same | |
| Indication for use | ||||
| (IFU) | A patient examination glove is | |||
| a disposable device intended | ||||
| for medical purposes that is | ||||
| worn on the examiner's hands | ||||
| to prevent contamination | ||||
| between patient and examiner. | ||||
| These gloves were tested for | ||||
| use with chemotherapy drugs, | ||||
| per ASTM D6978-05 Standard | ||||
| Practice for Assessment of | ||||
| Resistance of Medical Gloves | ||||
| to Permeation by | ||||
| Chemotherapy Drugs. | The Powder Free Nitrile | |||
| Examination Gloves, Blue, | ||||
| Tested For Use With | ||||
| Chemotherapy Drugs 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. In addition, | ||||
| these gloves were tested for use | ||||
| with chemotherapy drugs in | ||||
| accordance with ASTM | ||||
| D6978-05 (2019) Standard | ||||
| Practice for Assessment of | ||||
| Medical gloves to Permeation by | ||||
| Chemotherapy Drugs. | Similar | |||
| Regulation No | 21 CFR 880.6250 | 21 CFR 880.6250 | Same | |
| Powder free | yes | yes | Same | |
| Design Feature | Ambidextrous | Ambidextrous | Same | |
| Sterility | Non-Sterile | Non-Sterile | Same | |
| Material | Nitrile | Nitrile | Same |
predicate device (K211714) .Table 1- General Comparison:
6
| Former Release
| Chemical | Calcium Stearate Dispersion | Calcium Stearate Dispersion | Same |
|---|---|---|---|
| Device | |||
| Description and | |||
| Specifications | Comply with ASTM D6319-19 | Comply with ASTM D6319-19 | Similar |
| Label and | |||
| Labeling | 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 ofthe | |||
| testing results. | Single-use indication, powder | ||
| free, device color, device name, | |||
| glove size and quantity, | |||
| Non-Sterile, a statement of | |||
| standard ASTM D6978-05 | |||
| (2019) compliance and a | |||
| summary of the testing results. | Same |
1) Table 2- Device Dimension and Performance Comparison
| Items | Predicate Device: K211714 | Subject Device: K213306 | Comparison |
|---|---|---|---|
| Color | White, Blue | Blue | Similar, Note 1 |
| Length | |||
| mm | Complies with ASTM D6319-19: | ||
| S: $\u2265$ 220 mm; M/L/XL: $\u2265$ 230 mm. | Minimum 230 mm | Similar | |
| Palm | Complies with ASTM D6319-19 | ||
| Palm: $\u2265$ 0.05mm | 0.08+/-0.03 mm | ||
| Cuff | 0.08+/-0.03 mm | Similar, Note 2 | |
| Finger | Complies with ASTM D6319-19 | ||
| Finger: $\u2265$ 0.05mm | 0.08+/-0.03mm | ||
| Before aging | Complies with ASTM D6319-19: | ||
| $\u2265$ 500% | 500% min | Same | |
| After aging | $\u2265$ 400% min | 400% min | Same |
| Before aging | Complies with ASTM D6319-19 | ||
| $\u2265$ 14MPa | 15MPa min | Similar | |
| After aging | $\u2265$ 14MPa | 14MPa min | Same |
| Palm width | |||
| (mm) | Complies with ASTMD6319-19: | X-Small: 70+/- 10mm | Same |
| S:80±10mm; | Small:80 +/- 10mm | ||
| M:95±10mm; | Medium: 95+/- 10mm | ||
| L: 110±10mm; | Large:110 +/- 10mm | ||
| XL: 120±10mm; | X-large: 120 +/- 10mm | ||
| Freedom from | |||
| pinholes | Complies with ASTM D6319-19 | ||
| and ASTM D5151-19 G-1, AQL | |||
| 2.5 | Be free from holes when tested | ||
| in accordance with ASTM | |||
| D5151, and meet the standard | |||
| ASTM D6319 | Same | ||
| Residual powder | Complies with ASTM D6319-19, | ||
| 240 mins | Cisplatin, 1.0mg/ml, >240 mins | Same | |
| Cyclophosphamide, 20 mg/ml , |
240 mins | Cyclophosphamide (Cytoxan),
20.0 mg/ml, >240 mins | Same |
| | Dacarbazine (DTIC), 10.0 mg/ml,
240 min | Dacarbazine (DTIC),
10.0 mg/ml, >240 mins | Same |
| | Doxorubicin Hydrochloride, 2.0
mg/ml, >240 min | Doxorubicin Hydrochloride,
2.0 mg/ml, >240 mins | Same |
| | Etoposide (Toposar), 20.0 mg/ml,
240 min | Eotoposide (Toposar),
20.0 mg/ml, >240 mins | Same |
| | Fluorouracil, 50.0 mg/ml, > 240
min | Fluorouracil, 50.0mg/ml,
240 mins | Same |
| | / | Mechlorethamine, 1.0 mg/ml,
240 mins | Meet ASTM
D6978 |
| | Methotrexate 25 mg/ml,
240
min | Methotrexate, 25.0 mg/ml,
240 mins | Same |
| | Mitomycin C 0.5 mg/ml,
240
min | Mitomycin C, 0.5 mg/ml,
240 min | Same |
| | Paclitaxel, 6.0 mg/ml, >240 min | Paclitaxel (Taxol), 6.0 mg/ml,
240 mins | Same |
| Thiotepa, 10.0 mg/ml 57.4mins ,
Vincristine Sulfate 1.0 mg/ml, >240 min | Thiotepa, 10.0 mg/ml, 22.6 mins
Vincristine Sulfate, 1.0 mg/ml,
240 mins | Similar note 3
Same | |
7
8
Notes:
-
The color of the subject device is different with that of the predicate. The subject device was evaluated according to ISO 10993-1 standards.
-
The physical properties are a little different with that of the predicate, but they all meet the requirements of ASTM D6319-19.
-
Breakthrough detection times of Carmustine (BCNU) and Thio Tepa are different. The IFU Statement has clearly defined on the labeling.
2) Table 3- Biocompatibility Testing
| Bio-compatibility | Items | Predicate Device: K211714 | Subject Device: K213306 | Remark |
|---|---|---|---|---|
| Irritation (ISO | ||||
| 10993-10:2010 | ||||
| Biological | ||||
| Evaluation of | ||||
| Medical Devices | ||||
| -Part 10: Tests For | ||||
| Irritation And Skin | ||||
| Sensitization) | Complies with ISO 10993-10 | |||
| (2010) | ||||
| *Under the conditions of the | ||||
| study, the device is a | ||||
| nonirritant and a | ||||
| non-sensitizer. | The test result showed that | |||
| the response of the test | ||||
| article extract was | ||||
| categorized as negligible | ||||
| under the test condition. | Same | |||
| Sensitization (ISO | ||||
| 10993-10:2010 | ||||
| Biological | ||||
| Evaluation of | ||||
| Medical Devices - | ||||
| Part 10: Tests For | ||||
| Irritation And Skin | ||||
| Sensitization) | Under the conditions of this | |||
| study, the test article extract | ||||
| showed no significant | ||||
| evidence of causing skin | ||||
| sensitization in the guinea | ||||
| pig. The positive rate of | ||||
| sensitization was 0%. No | ||||
| evidence of skin sensitization | ||||
| in guinea pigs was found. | Same | |||
| Cytotoxicity (ISO | ||||
| 10993-5:2009 | ||||
| Biological | ||||
| Evaluation of | ||||
| Medical Devices | ||||
| -Part 5: Tests For In | ||||
| Vitro Cytotoxicity) | Complies with ISO 10993-5 | |||
| (2009) |
- Under the conditions of the
study, the device is not
cytotoxic. | Under the conditions of this
study, the test article extract
did not show potential toxicity
to L929 cells. | Same |
9
| 7.0 Summary of Non-Clinical Performance Data: | |
|---|---|
| ----------------------------------------------- | -- |
| Test Method | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ASTM D5151 | Water tightness | ||
| Test for Detection | |||
| of Holes | Meet the requirements of ASTM | ||
| D5151 AQL 2.5 | Pass | ||
| Total 200 pcs of gloves were | |||
| tested, 0 pcs rejected | |||
| ASTM D6319 | Physical | ||
| Dimensions Test | Length(mm): | ||
| S: ≥220 mm; | |||
| M/L/XL: ≥230 mm. | |||
| Width(mm): | |||
| S:80±10mm; | |||
| M:95±10mm; | |||
| L: 110±10mm; | |||
| XL: 120±10mm. | |||
| Thickness (mm): | |||
| Finger: ≥0.05 | |||
| Palm: ≥0.05 | Pass | ||
| 13 pcs each size,total 65 | |||
| pcs of gloves were tested, 0 | |||
| pcs rejected. | |||
| ASTM D412 | Physical properties | Before Aging | |
| Tensile Strength ≥14MPa | |||
| Ultimate Elongation ≥500% | |||
| After Aging | |||
| Tensile Strength ≥14MPa | |||
| Ultimate Elongation≥500% | Pass | ||
| 13 pcs each size, total 65 | |||
| pcs of gloves were tested, 0 | |||
| pcs rejected. | |||
| ASTM D6124 | Residual Powder | ||
| Content | Meet the requirements of ASTM | ||
| D6124 Pass | |||
| Under the conditions of this | |||
| study, the test article extract | |||
| did not show potential | |||
| toxicity to L929 cells. |
10
Biocompatibility Testing
The biocompatibility evaluation for Nitrile Exam Gloves, Powder Free, Blue, 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 Subject Device were evaluated per ASTM D6319-19, 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 Subject 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 device met the acceptance criteria in the relevant test methods cited below:
11
-
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.
8.0 Summary of Clinical Test:
Clinical data was not needed for this device.
9.0 Conclusion:
Based on the nonclinical tests data, it can be concluded that the Disposable Powder Free Nitrile Examination Glove, Blue, Tested For Use With Chemotherapy Drugs is as safe, as effective, and performs as well as or better than the legally marketed predicated device under K211714.