(70 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/black/purple colored, nitrile, and tested for use with chemotherapy drugs. The gloves are offered in six sizes: S, M, L, XL. The subject device is non-sterile.
Here's a breakdown of the acceptance criteria and study information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319 | Physical Dimensions Test | Length(mm): S: ≥220; M/L/XL: ≥230. Width(mm): S: 80±10; M: 95±10; L: 110±10; XL: 120±10. Thickness: Finger: ≥0.05; Palm: ≥0.05 | Length(mm): S: ≥220; M/L/XL: ≥230 (Pass)Width(mm): S: 84-87/Pass; M: 95-98/ Pass; L: 105-109/ Pass; XL:113-117/ PassThickness (mm): Finger: 0.10-0.12/Pass; Palm: 0.07-0.09/Pass |
| ASTM D5151 | Watertightness Test for Detection of Holes | Meet the requirements of ASTM D5151 AQL 2.5 | 0/125/Pass |
| ASTM D6124 | Powder Content | Meet the requirements of ASTM D6124 < 2.0mg | 0.11-0.16mg/Pass |
| ASTM D412 | Physical properties (Before Aging) | Tensile Strength ≥14MPa Ultimate Elongation ≥500% | Tensile Strength: 15.5-35.6MPa/Pass Ultimate Elongation: 513-599%/Pass |
| ASTM D412 | Physical properties (After Aging) | Tensile Strength ≥14MPa Ultimate Elongation ≥400% | Tensile Strength: 14.3-25.3MPa/Pass Ultimate Elongation: 484-576%/Pass |
| ISO 10993-5 | Cytotoxicity | Non- In Vitro Cytotoxicity | Under conditions of the study, device extract is cytotoxic (This seems to be a mismatch, implying it did not meet the criteria based on the wording "is cytotoxic", but the overall conclusion states the device is safe. This requires clarification or closer examination of the original study. For the purpose of this table, I'm listing what is stated in the Results column, even if contradictory at first glance. Further down, in the predicate device comparison, it states the predicate was "not cytotoxic" and for the subject device it states "/"). Update based on review of page 8 Table 1: The predicate device mentions "ISO 10993-5 Under conditions of the study, device extract is cytotoxic" and the subject device has "/". This suggests the subject device might not have been cytotoxic, but the table on page 11 explicitly states "device extract is cytotoxic." This is a significant discrepancy in the document. I will present what is written in the "Results" column on page 11. |
| ISO 10993-11 | Cytotoxicity | Non- acute systemic toxicity | Under conditions of the study, did not show acute systemic toxicity in vivo / Pass |
| ISO 10993-10 | Irritation | Non-irritating | Under conditions of the study, not an irritant. / Pass |
| ISO 10993-10 | Sensitization | Non-sensitizing | Under conditions of the study, not a sensitizer. / Pass |
| ASTM D6978-05 | Chemotherapy Drug Permeation | Individual drug-specific breakthrough detection times (Explicit criteria not stated as a single value, but rather the reported times are the performance data used for acceptance). | Blue Gloves: Carmustine: 26.6 Min Cisplatin: >240 Min Cyclophosphamide: >240 Min Dacarbazine: >240 Min Doxorubicin HCl: >240 Min Etoposide: >240 Min Fluorouracil: >240 Min Methotrexate: >240 Min Mitomycin C: >240 Min Paclitaxel: >240 Min ThioTepa: 58.8 Min Vincristine Sulfate: >240 Min Black Gloves: Carmustine: 27.3 Min Cisplatin: >240 Min Cyclophosphamide: >240 Min Dacarbazine: >240 Min Doxorubicin HCl: >240 Min Etoposide: >240 Min Fluorouracil: >240 Min Methotrexate: >240 Min Mitomycin C: >240 Min Paclitaxel: >240 Min ThioTepa: 77.8 Min Vincristine Sulfate: >240 Min Purple Gloves: Carmustine: 23.5 Min Cisplatin: >240 Min Cyclophosphamide: >240 Min Dacarbazine: >240 Min Doxorubicin HCl: >240 Min Etoposide: >240 Min Fluorouracil: >240 Min Methotrexate: >240 Min Mitomycin C: >240 Min Paclitaxel: >240 Min ThioTepa: 56.1 Min Vincristine Sulfate: >240 Min |
Note on Cytotoxicity: The table on page 11 explicitly states "Under conditions of the study, device extract is cytotoxic." for ISO 10993-5. This appears to contradict the general conclusion that the device is "as safe, as effective." However, the predicate comparison table on page 8 indicates that the predicate device also stated "ISO 10993-5 Under conditions of the study, device extract is cytotoxic," and the subject device has a "/" for this criterion without a definitive pass/fail statement in that specific comparison table. In the non-clinical testing summary, it lists ISO 10993-5 as one of the standards conducted. If the device genuinely exhibited cytotoxicity, it would typically be a concern. Given the overall clearance, there might be further explanation or context not fully detailed in this summary (e.g., the level of cytotoxicity was deemed acceptable, or the "is cytotoxic" statement might be an error in the summary table on page 11, or the nature of the cytotoxicity and its relevance to direct patient contact for a glove was evaluated and deemed non-critical).
2. Sample size used for the test set and the data provenance:
- Physical Dimensions (ASTM D6319): Not explicitly stated, but the results show ranges across sizes (S, M, L, XL).
- Watertightness Test (ASTM D5151): The results specify "0/125/Pass," indicating a sample size of 125 items (gloves) were tested, all passing (0 failures).
- Powder Content (ASTM D6124): Not explicitly stated.
- Physical Properties (ASTM D412): Not explicitly stated.
- Biocompatibility (ISO 10993-5, -10, -11): Not explicitly stated.
- Chemotherapy Drug Permeation (ASTM D6978-05): Not explicitly stated, however, the standard ASTM D6978 mandates three specimens be tested for each drug exposure for each material tested (so, 3 specimens per drug per color of glove). There are 12 drugs tested for 3 colors, so at least 3 x 12 x 3 = 108 specimens would have been tested as a minimum requirement for this standard.
The data provenance is from non-clinical bench testing conducted to relevant ASTM and ISO standards, indicating laboratory testing. The country of origin of the test data is not explicitly stated, but given the manufacturer is Jiangsu Bytech Medical Supplies Co.,Ltd. in China, it is likely the testing was performed either in China or by a certified lab contracted by the manufacturer. The data is reported retrospectively as part of the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This device is a physical product (gloves) and the tests conducted are bench-top performance tests and biocompatibility tests. Therefore, human experts are typically not used to establish a "ground truth" in the way they would for an AI diagnostic device (e.g., radiologists reviewing images). The ground truth is established by the methods and specifications defined in the referenced industry standards (ASTM, ISO). Laboratory technicians and chemists, qualified to perform these specific tests, would have conducted the studies.
4. Adjudication method for the test set:
Not applicable, as this involves objective laboratory measurements against established standards, not human interpretation requiring adjudication.
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:
Not applicable. This device is a medical glove, not an AI diagnostic or assistance tool. The evaluation focuses on its physical and chemical properties.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI algorithm.
7. The type of ground truth used:
The ground truth is based on:
- Standardized Test Methods: Specifications and methodologies outlined in ASTM (e.g., D6319, D5151, D6124, D412, D6978) and ISO standards (e.g., 10993-5, 10993-10, 10993-11).
- Objective Measurements: These standards define how properties like dimensions, watertightness, powder content, tensile strength, elongation, and drug permeation breakthrough times are measured objectively.
- Pre-defined Acceptance Criteria: The pass/fail criteria for these measurements are often specified within the standards or derived from regulatory guidance for the device type.
8. The sample size for the training set:
Not applicable. This is a physical device, not a machine learning model, so there is no training set in this context.
9. How the ground truth for the training set was established:
Not applicable. There is no training set.
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April 21, 2022
Jiangsu Bytech Medical Supplies Co.,Ltd. % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.1801,No.161 Lujiazui East Rd.,Pudong Shanghai. 200120 China
Re: K220382
Trade/Device Name: Disposable Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) - Blue/Black/Purple Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC Dated: January 28, 2022 Received: February 10, 2022
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 mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
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
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Indications for Use
510(k) Number (if known) K220382
Device Name
Disposable Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)- Blue/Black/Purple
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.
- The following is the resistance to permeation by chemotherapy drugs for the blue gloves.
| Chemotherapy Drug | Concentration | Breakthrough Detection Time in Minutes |
|---|---|---|
| Carmustine | 3.3 mg/ml | 26.6 Minutes |
| Cisplatin | 1.0 mg/ml | > 240 Minutes |
| Cyclophosphamide | 20.0 mg/ml | > 240 Minutes |
| Dacarbazine | 10.0 mg/ml | > 240 Minutes |
| Doxorubicin HCI | 2.0 mg/ml | > 240 Minutes |
| Etoposide | 20.0 mg/ml | > 240 Minutes |
| Fluorouracil | 50.0 mg/ml | > 240 Minutes |
| Methotrexate | 25.0 mg/ml | > 240 Minutes |
| Mitomycin C | 0.5 mg/ml | > 240 Minutes |
| Paclitaxel | 6.0 mg/ml | > 240 Minutes |
| ThioTepa | 10.0 mg/ml | 58.8 Minutes |
| Vincristine Sulfate | 1.0 mg/ml | > 240 Minutes |
Please note that the following drugs have low permeation times: Carmustine 3.3 mg/ml 26.6 Minutes ThioTepa 10.0 mg/ml 58.8 Minutes Warning: Please do not use with Carmustine and ThioTepa.
- The following is the resistance to permeation by chemotherapy drugs for the black gloves.
| Chemotherapy Drug | Concentration | Breakthrough Detection Time in Minutes |
|---|---|---|
| Carmustine | 3.3 mg/ml | 27.3 Minutes |
| Cisplatin | 1.0 mg/ml | > 240 Minutes |
| Cyclophosphamide | 20.0 mg/ml | > 240 Minutes |
| Dacarbazine | 10.0 mg/ml | > 240 Minutes |
| Doxorubicin HCI | 2.0 mg/ml | > 240 Minutes |
| Etoposide | 20.0 mg/ml | > 240 Minutes |
| Fluorouracil | 50.0 mg/ml | > 240 Minutes |
| Methotrexate | 25.0 mg/ml | > 240 Minutes |
| Mitomycin C | 0.5 mg/ml | > 240 Minutes |
| Paclitaxel | 6.0 mg/ml | > 240 Minutes |
| ThioTepa | 10.0 mg/ml | 77.8 Minutes |
| Vincristine Sulfate | 1.0 mg/ml | > 240 Minutes |
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Please note that the following drugs have low permeation times: Carmustine 3.3 mg/ml 27.3 Minutes ThioTepa 10.0 mg/ml 77.8 Minutes Warning: Please do not use with Carmustine and ThioTepa.
- The following is the resistance to permeation by chemotherapy drugs for the purple gloves.
| Chemotherapy Drug | Concentration | Breakthrough Detection Time in Minutes |
|---|---|---|
| Carmustine | 3.3 mg/ml | 23.5 Minutes |
| Cisplatin | 1.0 mg/ml | > 240 Minutes |
| Cyclophosphamide | 20.0 mg/ml | > 240 Minutes |
| Dacarbazine | 10.0 mg/ml | > 240 Minutes |
| Doxorubicin HCI | 2.0 mg/ml | > 240 Minutes |
| Etoposide | 20.0 mg/ml | > 240 Minutes |
| Fluorouracil | 50.0 mg/ml | > 240 Minutes |
| Methotrexate | 25.0 mg/ml | > 240 Minutes |
| Mitomycin C | 0.5 mg/ml | > 240 Minutes |
| Paclitaxel | 6.0 mg/ml | > 240 Minutes |
| ThioTepa | 10.0 mg/ml | 56.1 Minutes |
| Vincristine Sulfate | 1.0 mg/ml | > 240 Minutes |
Please note that the following drugs have low permeation times: Carmustine 3.3 mg/ml 23.5 Minutes ThioTepa 10.0 mg/ml 56.1 Minutes Warning: Please do not use with Carmustine 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 K220382
This summary of 510(k) is being submitted in accordance with 21 CFR 807.92.
1.0 Submitter's Information
Jiangsu Bytech Medical Supplies Co.,Ltd. Name: Address: NO.88 Junshi Road, Petroleum Equipment Industrial Park, Jianyang Town, Jianhu County, Yancheng City, Jiangsu Province, China Contact: Shen Hongxing Date of Preparation: Jan.28, 2022
Designated Submission Correspondent
Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 1801, No. 161 Lujiazui East Rd., Pudong Shanghai, 200120 China Tel: +86-21-50313932 Email: Info@truthful.com.cn
2.0 Device Information
Trade name: Disposable Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) - Blue/Black/Purple Patient Examination Gloves Common name: Classification name: Non-powdered patient examination glove Model(s): S, M, L, XL
3.0 Classification
Production code: LZA, LZC Requlation 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
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Drugs, Orange Color 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/black/purple colored, nitrile, and tested for use with chemotherapy drugs. The gloves are offered in six sizes: S, M, L, XL. The subject device is non-sterile.
6.0 Indication for Use
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs
| Chemotherapy Drug | Concentration | Breakthrough DetectionTime in Minutes |
|---|---|---|
| Carmustine | 3.3 mg/ml | 26.6 |
| Cisplatin | 1.0 mg/ml | > 240 |
| Cyclophosphamide | 20.0 mg/ml | > 240 |
| Dacarbazine | 10.0 mg/ml | > 240 |
| Doxorubicin HCI | 2.0 mg/ml | > 240 |
| Etoposide | 20.0 mg/ml | > 240 |
| Fluorouracil | 50.0 mg/ml | > 240 |
| Methotrexate | 25.0 mg/ml | > 240 |
| Mitomycin C | 0.5 mg/ml | > 240 |
| Paclitaxel | 6.0 mg/ml | > 240 |
| ThioTepa | 10.0 mg/ml | 58.8 |
| Vincristine Sulfate | 1.0 mg/ml | > 240 |
6.1 The following is the resistance to permeation by chemotherapy drugs for the blue gloves.
Please note that the following drugs have low permeation times:
Carmustine (BCNU) 3.3 mg/ml 26.6 Minutes;
Thio Tepa 10.0 mg/ml 58.8 Minutes.
Warning: Please do not use with Carmustine and ThioTepa.
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6.2 The following is the resistance to permeation by chemotherapy drugs for the black gloves.
| Chemotherapy Drug | Concentration | Breakthrough DetectionTime in Minutes |
|---|---|---|
| Carmustine | 3.3 mg/ml | 27.3 |
| Cisplatin | 1.0 mg/ml | > 240 |
| Cyclophosphamide | 20.0 mg/ml | > 240 |
| Dacarbazine | 10.0 mg/ml | > 240 |
| Doxorubicin HCI | 2.0 mg/ml | > 240 |
| Etoposide | 20.0 mg/ml | > 240 |
| Fluorouracil | 50.0 mg/ml | > 240 |
| Methotrexate | 25.0 mg/ml | > 240 |
| Mitomycin C | 0.5 mg/ml | > 240 |
| Paclitaxel | 6.0 mg/ml | > 240 |
| Thio Tepa | 10.0 mg/ml | 77.8 |
| Vincristine Sulfate | 1.0 mg/ml | > 240 |
Please note that the following drugs have low permeation times:
Carmustine (BCNU) 3.3 mg/ml 27.3 Minutes;
Thio Tepa 10.0 mg/ml 77.8 Minutes.
Warning: Please do not use with Carmustine (BCNU) and ThioTepa.
6.3 The following is the resistance to permeation by chemotherapy drugs for the purple gloves.
| Chemotherapy Drug | Concentration | Breakthrough DetectionTime in Minutes |
|---|---|---|
| Carmustine | 3.3 mg/ml | 23.5 |
| Cisplatin | 1.0 mg/ml | > 240 |
| Cyclophosphamide | 20.0 mg/ml | > 240 |
| Dacarbazine | 10.0 mg/ml | > 240 |
| Doxorubicin HCI | 2.0 mg/ml | > 240 |
| Etoposide | 20.0 mg/ml | > 240 |
| Fluorouracil | 50.0 mg/ml | > 240 |
| Methotrexate | 25.0 mg/ml | > 240 |
| Mitomycin C | 0.5 mg/ml | > 240 |
| Paclitaxel | 6.0 mg/ml | > 240 |
| Thio Tepa | 10.0 mg/ml | 56.1 |
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| Vincristine Sulfate | 1.0 mg/ml | > 240 |
|---|---|---|
| --------------------- | ----------- | ------- |
Please note that the following drugs have low permeation times:
Carmustine (BCNU) 3.3 mg/ml 23.5 Minutes;
Thio Tepa 10.0 mg/ml 56.1 Minutes.
Warning: Please do not use with Carmustine (BCNU) and ThioTepa.
7.0Technological Characteristic Comparison Table
| Table1-General Comparison | |||
|---|---|---|---|
| Item | Subject Device(K220382) | Predicate Device(K190860) | Remark |
| Product Code | LZA,LZC | LZA,LZC | Same |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 | Same |
| Class | I | I | Same |
| Intended Use | A patient 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 chemotherapydrugs 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 chemotherapydrugs 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 | Single-use indication, powder free, device color, device name, glove size and quantity, Non-Sterile, a statement of standard ASTM D6978-05 | Same |
Table1-General Comparison
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| complianceandasummary of the testingresults. | complianceandasummary of the testingresults. | ||||
|---|---|---|---|---|---|
| Length:XS/S:≥220;M/L/XL/XXL: ≥230;Width:S: 80±10;M: 95±10;L: 110±10;XL: 120±10. | Length:XS/S/M/L/XL: ≥230;Width:XS:70±10;S: 80±10;M: 95±10;L: 110±10;XL: 120±10 | Similar | |||
| Thickness(mm) | Finger: ≥0.05;Palm: ≥0.05 | Finger: ≥0.05;Palm: ≥0.05 | Same | ||
| Colorant | Blue, Black, Purple | White, Orange | Different | ||
| PhysicalProperties | BeforeAging | Tensile Strength 14MPa, minUltimate Elongation 500% min | Tensile Strength 14MPa, minUltimate Elongation 500% min | Same | |
| After Aging | Tensile Strength 14MPa, minUltimate Elongation 400%min | Tensile Strength 14MPa, minUltimate Elongation 400%min | Same | ||
| Freedom from Holes | Be free from holes when tested in accordance with ASTMD5151AQL=2.5 | Be free from holes when tested in accordance with ASTMD5151AQL=2.5 | Same | ||
| Powder Content | 0.11~0.16 mg per glove,Meet the requirements of ASTM D6124 | Meet the requirements of ASTM D6124 | Similar | ||
| Biocompatibility | ISO 10993-10;Under the conditions of the study, not an irritant or a sensitizer | ISO 10993-10;Under the conditions of the study, not an irritant or a sensitizer | Same | ||
| ISO 10993-5Under conditions of the study, device extract is cytotoxic | ISO 10993-5Under conditions of the study, device extract is not cytotoxic | / | |||
| ISO 10993-11;Under the condition of acute systemic toxicity test,the test article did not show acute systemic toxicity in vivo | / | / |
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| ChemotherapyDrugs Testedwith MinimumBreakthroughDetection Timeas Tested perASTM D 6978 | Carmustine3.3 mg/ml | Blue: 26.6 MinutesBlack: 27.3 MinutesPurple: 23.5 Minutes | White:11.8 Minutes;Orange:31.6Minutes | Similar |
|---|---|---|---|---|
| Cisplatin1.0 mg/ml | >240 Minutes | >240 Minutes | Different | |
| Cyclophosph-amide20.0 mg/ml | >240 Minutes | >240 Minutes | Same | |
| Dacarbazine10.0 mg/ml | >240 Minutes | >240 Minutes | Same | |
| DoxorubicinHCI2.0 mg/ml | >240 Minutes | >240 Minutes | Same | |
| Etoposide20.0 mg/ml | >240 Minutes | >240 Minutes | Same | |
| Fluorouracil50.0 mg/ml | >240 Minutes | >240 Minutes | Same | |
| Methotrexate25.0 mg/ml | >240 Minutes | / | Different | |
| Mitomycin C0.5 mg/ml | >240 Minutes | / | Different | |
| Paclitaxel6.0 mg/ml | >240 Minutes | >240 Minutes | Same | |
| Thio Tepa10.0 mg/ml | Blue: 58.8 MinutesBlack: 77.8 MinutesPurple: 56.1 Minutes | White:16.9 Minutes;Orange: 72.5 Minutes | Different | |
| VincristineSulfate1.0 mg/ml | >240 Minutes | / | Different |
Analysis 1:
The physical dimensions are different with that of the predicate.
Analysis 2:
The color of the subject device is different with that of the predicate.
Analysis 3: Powder Content of subject device is similar with that of the predicate.
Analysis 4:
And Breakthrough detection times of Carmustine and Thio Tepa of subject device are different with those of the predicate.
8.0 Summary of Non-Clinical Testing
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Biocompatibility Testing
The biocompatibility evaluation for Nitrile Patient Examination Gloves (Tested for Use with Chemotherapy Drugs) 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
- ISO 10993-11:2017, Biological evaluation of medical devices Part 11: Tests for systemic toxicity.
Performance Testing (Bench)
Physical performance qualities of the proposed device were evaluated per ASTM D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application.
Permeation testing was conducted to support the addition of the labeling claim: Tested for use with chemotherapy drugs. In addition, the proposed device was tested according to ASTM D6978-05 (Reapproved 2019), Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs, in which minimum breakthrough times were determined for a wide range of chemotherapy drugs.
In summary, the performance testing of the subject device was conducted to adequately demonstrate the effectiveness of the device in accordance with the relevant test methods cited below:
- ASTM D6124-06 (Reapproved 2017), Standard Test Method for -Residual Powder on Medical Gloves
- ASTM D5151-19, Standard Test Method for Detection of Holes in -Medical Gloves.
- ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application.
- ASTM D6978-05 (Reapproved 2019), Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
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| Test Method | Purpose | Acceptance Criteria | Results | |
|---|---|---|---|---|
| ASTM D6319 | Physical Dimensions Test | Length(mm):S: ≥220;M/L/XL: ≥230. | Length(mm):S: ≥220;M/L/XL: ≥230. | |
| Width(mm):S: 80±10;M: 95±10;L: 110±10;XL: 120±10. | Width(mm):S: 84-87/PassM: 95-98/ PassL: 105-109/ PassXL:113-117/ Pass | |||
| Finger: ≥0.05;Palm: ≥0.05 | Thickness (mm):Finger:0.10-0.12/PassPalm:0.07-0.09/Pass | |||
| ASTM D5151 | Watertightness Test for Detection of Holes | Meet the requirements of ASTM D5151AQL 2.5 | 0/125/Pass | |
| ASTM D6124 | Powder Content | Meet the requirements of ASTM D6124 <2.0mg | 0.11-0.16mg/Pass | |
| ASTM D412 | Physical properties | Before Aging | Tensile Strength ≥14MPa | 15.5-35.6MPa/Pass |
| Ultimate Elongation ≥500% | 513-599%/Pass | |||
| After Aging | Tensile Strength ≥14MPa | 14.3-25.3MPa/Pass | ||
| Ultimate Elongation ≥400% | 484-576%/Pass | |||
| ISO | Cytotoxicity | Non- In Vitro Cytotoxicity | Under conditions of | |
| 10993-5 | the study, device extract is cytotoxic. | |||
| ISO10993-11 | Cytotoxicity | Non- acute systemic toxicity | Under conditions of the study, did not show acute systemic toxicity in vivo / Pass | |
| ISO10993-10 | Irritation | Non-irritating | Under conditions of the study, not an irritant. / Pass | |
| ISO10993-10 | Sensitization | Non-sensitizing | Under conditions of the study, not a sensitizer. / Pass |
Table 2 - Summary of non-clinical performance 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, Disposable Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) - Blue/Black/Purple 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.