(97 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 or fingers 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.
This is a 510(k) premarket notification for Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs. This document does not describe the acceptance criteria and study for an AI/ML device. Instead, it focuses on the performance characteristics of medical gloves, particularly their resistance to chemotherapy drugs.
Here’s a breakdown of the information provided, re-interpreting some fields for a non-AI/ML medical device where applicable, and highlighting what is missing in the context of your request for an AI/ML device:
1. A table of acceptance criteria and the reported device performance
The document provides several tables detailing the performance of the gloves.
Permeation by Chemotherapy Drugs (Key Performance Claim):
| Chemotherapy Drug | Concentration | Acceptance Criteria (Implicit, typically > the reported time for predicate or a set standard, often 240 mins) | Reported Device Performance (Breakthrough Detection Time in Minutes) |
|---|---|---|---|
| Carboplatin | 10.0 mg/ml (10,000 ppm) | N/A (Standard would be based on predicate/ASTM D6978) | > 240 Minutes |
| Carmustine (BCNU) | 3.3 mg/ml (3,300 ppm) | N/A (Standard would be based on predicate/ASTM D6978) | 16.4 Minutes |
| Cisplatin | 1.0 mg/ml (1,000 ppm) | N/A (Standard would be based on predicate/ASTM D6978) | > 240 Minutes |
| Cyclophosphamide (Cytoxan) | 20.0 mg/ml (20,000 ppm) | N/A (Standard would be based on predicate/ASTM D6978) | > 240 Minutes |
| Dacarbazine | 10.0 mg/ml (10,000 ppm) | N/A (Standard would be based on predicate/ASTM D6978) | > 240 Minutes |
| Docetaxel | 10.0 mg/ml (10,000 ppm) | N/A (Standard would be based on predicate/ASTM D6978) | > 240 Minutes |
| Doxorubicin HCI | 2.0 mg/ml (2,000 ppm) | N/A (Standard would be based on predicate/ASTM D6978) | > 240 Minutes |
| Epirubicin HCI | 2.0 mg/ml (2,000 ppm) | N/A (Standard would be based on predicate/ASTM D6978) | > 240 Minutes |
| Etoposide | 20.0 mg/ml (20,000 ppm) | N/A (Standard would be based on predicate/ASTM D6978) | > 240 Minutes |
| Fluorouracil | 50.0 mg/ml (50,000 ppm) | N/A (Standard would be based on predicate/ASTM D6978) | > 240 Minutes |
| Gemcitabine | 38.0 mg/ml (38,000 ppm) | N/A (Standard would be based on predicate/ASTM D6978) | > 240 Minutes |
| Ifosfamide | 50.0 mg/ml (50,000 ppm) | N/A (Standard would be based on predicate/ASTM D6978) | > 240 Minutes |
| Irinotecan | 20.0 mg/ml (20,000 ppm) | N/A (Standard would be based on predicate/ASTM D6978) | > 240 Minutes |
| Methotrexate | 25.0 mg/ml (25,000 ppm) | N/A (Standard would be based on predicate/ASTM D6978) | > 240 Minutes |
| Miromycin C | 0.5 mg/ml (500 ppm) | N/A (Standard would be based on predicate/ASTM D6978) | > 240 Minutes |
| Mitoxantrone | 2.0 mg/ml (2,000 ppm) | N/A (Standard would be based on predicate/ASTM D6978) | > 240 Minutes |
| Oxaliplatin | 5.0 mg/ml (5,000 ppm) | N/A (Standard would be based on predicate/ASTM D6978) | > 240 Minutes |
| Paclitaxel | 6.0 mg/ml (6,000 ppm) | N/A (Standard would be based on predicate/ASTM D6978) | > 240 Minutes |
| ThioTepa | 10.0 mg/ml (10,000 ppm) | N/A (Standard would be based on predicate/ASTM D6978) | 98.6 Minutes |
| Vincristine Sulface | 1.0 mg/ml (1,000 ppm) | N/A (Standard would be based on predicate/ASTM D6978) | > 240 Minutes |
Other Non-Clinical Testing Results (from Table 2 and Table 3):
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance / Results |
|---|---|---|---|
| ISO 10993-10:2010 (Irritation) | To determine if device is a skin irritant | The device must be a non-irritant | Pass |
| ISO 10993-10:2010 (Sensitization) | To determine if device is a skin sensitizer | The device must be a non-sensitizer | Pass |
| ISO 10993-5:2009 (Cytotoxicity) | To determine if the device is potential toxicity to L-929 cells | The device must be a non toxicity | Pass |
| ASTM D6124-06 (Residual Powder) | To determine residual powder | ≤ 2 mg/glove | S:0.02, M:0.12, L:0.16, XL:0.14 mg/glove (Pass) |
| ASTM D5151-19 (Freedom from Holes) | To determine water tightness | Meet the requirements of ASTM D5151 AQL 2.5 | S:0/125, M:0/125, L:0/125, XL:0/125 leaks (Pass) |
| ASTM D5250-19 / ASTM D6319-19 (Dimensions - Length) | To determine physical dimensions | S: ≥220 mm; M/L/XL: ≥230 mm | >230 mm (Pass) |
| ASTM D5250-19 / ASTM D6319-19 (Dimensions - Width) | To determine physical dimensions | S: 80±10mm; M: 95±10mm; L: 110±10mm; XL: 120±10mm | S: 88, M: 98-99, L: 110-112, XL: 115-117 mm (Pass) |
| ASTM D5250-19 / ASTM D6319-19 (Dimensions - Thickness) | To determine physical dimensions | Finger: ≥0.05mm; Palm: ≥0.05mm | Finger: 0.101-0.128 mm; Palm: 0.067-0.078 mm (Pass) |
| ASTM D412-06a-2013 (Tensile Strength - Before Aging) | To determine physical properties | Before Aging: Tensile Strength ≥14MPa | 25.4 ~36.3 MPa (Pass) |
| ASTM D412-06a-2013 (Elongation - Before Aging) | To determine physical properties | Before Aging: Ultimate Elongation ≥500% | 508%~563% (Pass) |
| ASTM D412-06a-2013 (Tensile Strength - After Aging) | To determine physical properties | After Aging: Tensile Strength ≥14MPa | 25.8~35.6 MPa (Pass) |
| ASTM D412-06a-2013 (Elongation - After Aging) | To determine physical properties | After Aging: Ultimate Elongation ≥400% | 483%~525% (Pass) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Chemo Permeation: Not explicitly stated as a single number. The testing is done "in accordance with ASTM D6978-05" which specifies test methods. While not clearly itemized in the summary, typical ASTM D6978 testing involves multiple specimens per drug.
- Sample Size for Biocompatibility: Not explicitly stated, but standard ISO 10993 tests involve specific numbers of samples/animals or cell cultures as per the standard.
- Sample Size for Physical Tests (e.g., Holes, Dimensions, Tensile Strength): For "Freedom from Holes," the results show "S:0/125 leaks", "M:0/125 leaks", "L:0/125 leaks", "XL:0/125 leaks," implying a sample size of 125 gloves per size for this test. Other physical tests (dimensions, tensile strength) are usually performed on a representative sample set as per the ASTM standards.
- Data Provenance: Not specified whether the tests were conducted in China (where the manufacturer is located) or another country. The testing methods used are international ASTM and ISO standards. It's a prospective series of tests conducted on the manufactured device.
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 section is Not Applicable to this type of device (medical gloves). The "ground truth" for medical gloves is established through objective physical and chemical testing against recognized national and international standards (ASTM, ISO), not through expert clinical consensus or interpretation of medical images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is Not Applicable. Adjudication methods like 2+1 or 3+1 are used in clinical trials or studies involving human readers/interpreters to resolve discrepancies, typically for AI/ML diagnostic tools. For physical devices like gloves, performance is measured objectively against predefined criteria.
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 is Not Applicable. An MRMC study is relevant for AI/ML diagnostic or assistive technologies where human readers are involved in interpretation. This document describes physical, non-AI/ML device performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is Not Applicable. This device is not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device is established by:
- Objective physical measurements: e.g., length, width, thickness, tensile strength, elongation, powder content.
- Objective chemical permeation testing: measuring breakthrough time of chemotherapy drugs using analytical methods as specified in ASTM D6978-05.
- Biocompatibility assays: in-vitro (cytotoxicity) and in-vivo (irritation, sensitization) tests as per ISO 10993 standards.
These are validated laboratory test methods, not expert consensus or clinical outcomes data in the usual sense for diagnostic devices.
8. The sample size for the training set
This is Not Applicable. This device is not an AI/ML algorithm that requires a training set. The descriptions pertain to physical performance testing of a manufactured product.
9. How the ground truth for the training set was established
This is Not Applicable. As it's not an AI/ML device, there is no training set or corresponding ground truth establishment process in the context of your request.
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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 a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 5, 2021
Jiangsu Yanfang Medical Technology Co., Ltd. % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.1801,No.161 East Lujiazui Rd.,Pudong Shanghai. 200120 China
Re: K212036
Trade/Device Name: Nitrile Powder Free 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: August 25, 2021 Received: August 31, 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.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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.
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 Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K212036
Device Name
Nitrile Powder Free 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 |
|---|---|---|
| Carboplatin | 10.0 mg/ml(10,000 ppm) | > 240 Minutes |
| Carmustine (BCNU) | 3.3 mg/ml (3,300 ppm) | 16.4 Minutes |
| Cisplatin | 1.0 mg/ml(1,000 ppm) | > 240 Minutes |
| Cyclophosphamide (Cytoxan) | 20.0 mg/ml(20,000 ppm) | > 240 Minutes |
| Dacarbazine | 10.0 mg/ml(10,000 ppm) | > 240 Minutes |
| Docetaxel | 10.0 mg/ml(10,000 ppm) | > 240 Minutes |
| Doxorubicin HCI | 2.0 mg/ml(2,000 ppm) | > 240 Minutes |
| Epirubicin HCI | 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 |
| Gemcitabine | 38.0 mg/ml(38,000 ppm) | > 240 Minutes |
| Ifosfamide | 50.0 mg/ml(50,000 ppm) | > 240 Minutes |
| Irinotecan | 20.0 mg/ml(20,000 ppm) | > 240 Minutes |
| Methotrexate | 25.0 mg/ml(25,000 ppm) | > 240 Minutes |
| Miromycin C | 0.5 mg/ml(500 ppm) | > 240 Minutes |
| Mitoxantrone | 2.0 mg/ml(2,000 ppm) | > 240 Minutes |
| Oxaliplatin | 5.0 mg/ml(5,000 ppm) | > 240 Minutes |
| Paclitaxel | 6.0 mg/ml(6,000 ppm) | > 240 Minutes |
| ThioTepa | 10.0 mg/ml(10,000 ppm) | 98.6 Minutes |
| Vincristine Sulface | 1.0 mg/ml(1,000 ppm) | > 240 Minutes |
The maximum testing time is 240 minutes. Please note that the following drug has an extremely low permeation time: Carmustine (BCNU) 3.3 mg/ml 16.4 Minutes Thio Tepa 10.0 mg/ml 98.6 Minutes
Thio Tepa 10.0 mg/ml 98.0 Minutes
VIII in Plasma at -19C
Warning: Please do not use with Carmustine (BCNU).
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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510(k) Summary (K212036)
This summary of 510(k) is being submitted in accordance with 21 CFR 807.92.
1.0 Submitter's Information
Jiangsu Yanfang Medical Technology Co., Ltd. Name: Address: No.16, Kaiyuan Road, Changjing Town, Jiangyin, Wuxi, Jiangsu, China 214411. Contact: Kaijian Wei Date of Preparation: Oct.05,2021
Designated Submission Correspondent
Mr. Boyle Wang 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
Nitrile Powder Free Examination Gloves, Trade name: 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, Blue Color, Tested For Use With Chemotherapy Drugs 510(k) number: K190736
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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 or fingers 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 |
|---|---|---|
| Carboplatin | 10.0 mg/ml(10,000 ppm) | > 240 |
| Carmustine (BCNU) | 3.3 mg/ml (3,300 ppm) | 16.4 |
| Cisplatin | 1.0 mg/ml(1,000 ppm) | > 240 |
| Cyclophosphamide(Cytoxan) | 20.0 mg/ml(20,000 ppm) | > 240 |
| Dacarbazine | 10.0 mg/ml(10,000 ppm) | > 240 |
| Docetaxel | 10.0 mg/ml(10,000 ppm) | > 240 |
| Doxorubicin HCI | 2.0 mg/ml(2,000 ppm) | > 240 |
| Epirubicin HCI | 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 |
| Gemcitabine | 38.0 mg/ml(38,000 ppm) | > 240 |
| Ifosfamide | 50.0 mg/ml(50,000 ppm) | > 240 |
| Irinotecan | 20.0 mg/ml(20,000 ppm) | > 240 |
| Methotrexate | 25.0 mg/ml(25,000 ppm) | > 240 |
| Miromycin C | 0.5 mg/ml(500 ppm) | > 240 |
| Mitoxantrone | 2.0 mg/ml(2,000 ppm) | > 240 |
| Oxaliplatin | 5.0 mg/ml(5,000 ppm) | > 240 |
| Paclitaxel | 6.0 mg/ml(6,000 ppm) | > 240 |
| ThioTepa | 10.0 mg/ml(10,000 ppm) | 98.6 |
| Vincristine Sulface | 1.0 mg/ml(1,000 ppm) | > 240 |
The maximum testing time is 240 minutes. Please note that the following drug has an extremely low permeation time:
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Carmustine (BCNU) 3.3 mg/ml 16.4 Minutes Thio Tepa 10.0 mg/ml 98.6 Minutes Warning: Please do not use with Carmustine (BCNU).
7.0 Technological Characteristic Comparison Table
| Item | Subject Device | Predicate Device | Remark |
|---|---|---|---|
| Product Code | LZA,LZC | LZA,LZC | Same |
| 510(k) Reference | K212036 | K190736 | Same |
| 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 |
| Sterile vs Non-Sterile | Non-Sterile | Non-Sterile | Same |
| Color | Blue | Blue | 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 |
| Dimensions - Length | Complies with ASTM | Complies with ASTM D6319- | Similar |
| D6319-19: | 19: ≥230 mm. | ||
| S: ≥220 mm;M/L/XL: ≥230 mm. | ≥230 mm. | ||
| Dimensions - Width | Complies with ASTM D6319-19:S:80±10mm;M:95±10mm;L: 110±10mm;XL: 120±10mm; | Complies with ASTM D6319-19:XS: 70±10mm;S:80±10mm;M:95±10mm;L: 110±10mm;XL: 120±10mm; | Similar |
| Dimensions - Thickness | Complies with ASTM D6319-19Palm:≥0.05mmFinger: ≥0.05mm | Complies with ASTM D6319-19Palm:≥0.05mmFinger: ≥0.05mm | Same |
| Physical Properties - Tensile Strength | Complies with ASTM D6319-19:Before Aging: ≥14MPaAfter Aging: ≥500% | Complies with ASTM D6319-19:Before Aging: ≥14MPaAfter Aging: ≥500% | Same |
| Physical Properties - Elongation | Complies with ASTM D6319-19:Before Aging: ≥14MPaAfter Aging: ≥400% | Complies with ASTM D6319-19:Before Aging: ≥14MPaAfter Aging: ≥400% | Same |
| Freedom from Holes | Complies with ASTM D6319-19and ASTM D5151-19G-1, AQL 2.5 | Complies with ASTM D6319-19and ASTM D5151-19G-1, AQL 2.5 | Same |
| Powder Content | Complies with ASTM D6319-19,< 2 mg per glove | Complies with ASTM D6319-19,< 2 mg per glove | Same |
| Biocompatibility | Complies with ISO10993-5 (2009)* Under the conditions of thestudy, the device is notcytotoxic.Complies with ISO10993-10 (2010)* Under the conditions of thestudy, the device is a non-irritant and a non-sensitizer. | Comply with ISO10993-10(2010) and ISO10993-5 (2009) | Same |
| Chemotherapy drugs tested | Breakthrough Detection Time in Minutes | / | |
| Subject Device | Predicate Device | ||
| Bleomycin Sulfate 15.0 mg/ml | Not tested | > 240 | Different |
| Busulfan 6.0 mg/ml | Not tested | > 240 | Different |
| Carboplatin 10.0 mg/ml | > 240 | > 240 | Same |
| Carmustine (BCNU), 3.3 mg/ml | 16.4 | 59.4 | Same |
| Chloroquine 50.0 mg/ml | Not tested | > 240 | Different |
| Cisplatin 1 mg/ml | > 240 | > 240 | Same |
| Cyclophosphamide 20 mg/ml | > 240 | > 240 | Same |
| Cyclosporin A 100.0 mg/ml | Not tested | > 240 | Different |
| Cytarabine 100.0 mg/ml | Not tested | > 240 | Different |
| Dacarbazine (DTIC), 10.0 mg/ml | > 240 | > 240 | Same |
| Daunorubicin 5.0 mg/ml | Not tested | > 240 | Different |
| Docetaxel 10.0 mg/ml | > 240 | > 240 | Same |
| Doxorubicin Hydrochloride, 2.0 mg/ml | > 240 | > 240 | Same |
| Epirubicin 2.0 mg/ml | > 240 | > 240 | Same |
| Etoposide (Toposar), 20.0 mg/ml | > 240 | > 240 | Same |
| Fludarabine 25.0 mg/ml | Not tested | > 240 | Different |
| Fluorouracil, 50.0 mg/ml | > 240 | > 240 | Same |
| Gemcitabine 38.0 mg/ml | > 240 | > 240 | Same |
| Idaribicin 1.0 mg/ml | Not tested | > 240 | Different |
| Ifosfamide 50.0 mg/ml | > 240 | > 240 | Same |
| Irinotecan 20.0 mg/ml | > 240 | > 240 | Same |
| Mechlorethamine HCl 1.0 mg/ml | Not tested | > 240 | Different |
| Melphalan 5 mg/ml | Not tested | > 240 | Different |
| Methotrexate 25 mg/ml | > 240 | > 240 | Same |
| Mitomycin C 0.5 mg/ml | > 240 | > 240 | Same |
| Mitoxantrone 2.0 mg/ml | > 240 | > 240 | Same |
| Oxaliplatin 2.0 mg/ml | > 240 | > 240 | Same |
| Paclitaxel (Taxol), 6.0 mg/ml | > 240 | > 240 | Same |
| Paraplatin 10 mg/ml | Not tested | > 240 | Different |
| Retrovir 10 mg/ml | Not tested | > 240 | Different |
| Rituximab 10 mg/ml | Not tested | > 240 | Different |
| Thiotepa, 10.0 mg/ml | 98.6 | 118.5 | Different |
| Topotecan HCl 1 mg/ml | Not tested | > 240 | Different |
| Trisonex 1 mg/ml | Not tested | > 240 | Different |
| Velcade (Bortezomib) 1 mg/ml | Not tested | > 240 | Different |
| Vincristine 1.0 mg/ml | > 240 | > 240 | Same |
Table1-Comparison of Subject and Predicate Devices
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8.0 Summary of Non-Clinical Testing
Biocompatibility Testing
The biocompatibility evaluation for Nitrile Powder Free Examination Gloves,Tested For Use With Chemotherapy Drugs was conducted in accordance with the following standards:
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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
| Test Method | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ISO 10993-10:2010Tests For Irritation AndSkin Sensitization | To determine if deviceis a skin irritant | The device must be anon-irritant | Pass |
| ISO 10993-10:2010Tests For Irritation AndSkin Sensitization | To determine if deviceis a skin sensitizer | The device must be anon- sensitizer | Pass |
| ISO 10993-5:2009Tests For In VitroCytotoxicity | To determine if thedevice is potentialtoxicity to L-929cells. | The device must be anon toxicity. | Pass |
| Test Method | Purpose | Acceptance Criteria | Results(2 mg/glove) |
| ASTM D6124-06(Reapproved 2017)Standard Test Methodfor Residual Powder onMedical Gloves | To determine residualpowder | ≤ 2 mg/glove | S:0.02M:0.12L:0.16XL:0.14Pass |
| ASTMD5151-19Standard Test Methodfor Detection of Holesin Medical Gloves | To determine watertightness | Meet the requirementsof ASTM D5151 AQL2.5 | S:0/125 leaks |
| M: 0/125 leaks | |||
| L: 0/125 leaks | |||
| XL: 0/125 leaks | |||
| Pass | |||
| ASTM D5250-19Standard Specificationfor Poly (vinyl chloride)Gloves for MedicalApplication | To determine physicaldimensions | Length(mm):S:≥220. | Length(mm):>230 |
| M/L/XL: ≥230 | Width(mm): | ||
| Width(mm): | S: 88 | ||
| S: 80±10; | M: 98-99 | ||
| M: 95±10; | L: 110-112 | ||
| L: 110±10; | XL: 115-117 | ||
| XL: 120±10; | Pass | ||
| Thickness (mm): | Finger: 0.101-0.128 | ||
| Finger: ≥0.05 | Palm: 0.067-0.78 | ||
| Palm: ≥0.05 | Pass | ||
| ASTM D412-06a-2013Standard Test Methodsfor Vulcanized Rubberand ThermoplasticElastomers-Tension | To determine physicalproperties | Before Aging:TensileStrength≥14MPaUltimateElongation≥500% | Before Aging:Tensile Strength:25.4 ~36.3 MPaUltimate Elongation:508%~563% |
| After Aging:TensileStrength≥14MPaUltimateElongation≥400% | After Aging:Tensile Strength:25.8~35.6 MPaUltimate Elongation:483%~525%Pass | ||
Table 2 Biocompatibility Testing
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 3 Non-Clinical Testing
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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, Nitrile Powder Free Examination Gloves,Tested For Use With
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Chemotherapy Drugs is as safe, as effective, and performs as well as or better than the legally marketed predicated device under K190736.
§ 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.