(86 days)
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs.
The subject device is single use, disposable gloves intended for medical purposes to be worn on the examiner's hands to prevent contamination between patient and examiner. The gloves are powder-free, ambidextrous with beaded cuff, blue colored, nitrile, and tested for use with chemotherapy drugs. The gloves are offered in four sizes: extra-small, small, medium, large, and extra-large.
The provided document describes the FDA 510(k) premarket notification for "Disposable Nitrile Powder-Free Examination Gloves (Tested for Use with Chemotherapy Drugs)". This document is for a medical device (gloves), not an AI/Software as a Medical Device (SaMD). Therefore, the concepts of acceptance criteria for AI performance, training/test sets, ground truth establishment by experts, MRMC studies, standalone algorithm performance, or a sample size for training data are not applicable to this submission.
The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the physical and chemical performance standards for the gloves, particularly their resistance to chemotherapy drugs and biocompatibility.
Here's the information extracted from the provided text, tailored to the context of a physical medical device:
Acceptance Criteria and Device Performance for Disposable Nitrile Powder-Free Examination Gloves
The acceptance criteria for the Disposable Nitrile Powder-Free Examination Gloves are based on compliance with established international and national standards for medical gloves, particularly regarding their physical properties, freedom from holes, residual powder content, and resistance to permeation by chemotherapy drugs.
1. Table of Acceptance Criteria and Reported Device Performance
| No. | Test Methodology / Standard | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|---|
| 1 | ISO 10993-10:2010 (Irritation & Skin Sensitization) | Assess possible contact hazards from chemicals released from medical devices (skin/mucosal irritation, eye irritation, skin sensitization). | Skin Sensitization Test: Grades less than 1, otherwise sensitization.Skin Irritation Test: Primary irritation index 0-0.4 (Negligible). | Skin Sensitization Test: All grades are 0. All animals survived with no abnormal signs.Skin Irritation Test: Primary irritation index is 0. Response categorized as negligible. |
| 2 | ISO 10993-5:2009 (In Vitro Cytotoxicity) | Assess in vitro cytotoxicity of medical devices. | Viability reduced to <70% of the blank indicates cytotoxic potential. | Viability of 100% test article extract is 17.1%. This means the device has potential toxicity to L-929 in the MTT method. (See further analysis in section below). |
| 3 | ISO 10993-11: 2017 (Systemic Toxicity) | Evaluate potential for medical device materials to cause adverse systemic reactions. | Within 72 h, if the toxicosis response of testing group is not greater than control group, sample is acceptable. | No evidence of systemic toxicity from the extract. |
| 4 | ASTM D6124-06 (Reapproved 2017) (Residual Powder) | Determine amount of residual powder on medical gloves. | Powder residue limit of 2.0 mg. | 0.15-0.19 mg /glove. |
| 5 | ASTM D5151-19 (Holes in Medical Gloves) | Cover the detection of holes in medical gloves. | Samples: 125 gloves, AQL: 2.5 (ISO 2859), Criterion ≤7 gloves for water leakage. | No glove water leakage found. |
| 6 | ASTM D6319-19 (Nitrile Examination Gloves) | Covers certain requirements for nitrile rubber gloves used in medical examinations. (Includes dimensions, physical properties, etc.) | Dimensions: S: width 80±10mm, Length ≥220mm; M: width 95±10mm, Length ≥230mm; L: width 110±10mm, Length ≥230mm; XL: width 120±10mm, Length ≥230mm. Thickness: Finger ≥0.05mm, Palm ≥0.05mm.Physical Properties (Before Aging): Tensile Strength ≥14MPa, Ultimate Elongation ≥500%.Physical Properties (After Aging): Tensile Strength ≥14MPa, Ultimate Elongation ≥400%. | Dimensions (Examples from 3 lots): S: width 84-87mm, Length 244-257mm; M: width 88-96mm, Length 237-266mm; L: width 90-110mm, Length 240-263mm; XL: width 110-119mm, Length 245-262mm.Thickness: Finger 0.09-0.21mm, Palm 0.06-0.15mm. (All reported values meet or exceed the minima/ranges).Physical Properties (Before Aging): Tensile Strength 14.1-29.8 MPa, Ultimate Elongation 500.492% - 670.613%.Physical Properties (After Accelerated Aging): Tensile Strength 14.1-23.9 MPa, Ultimate Elongation 411.403% - 599.996%. (All reported values meet or exceed the minima). |
| 7 | ASTM D6978-05 (Reapproved 2019) (Chemotherapy Drug Permeation) | Assessment of resistance of medical gloves to permeation by chemotherapy drugs, determining minimum breakthrough times. | Specified Breakthrough Detection Times for Various Drugs: - Carmustine (BCNU) 3.3 mg/ml: 22.8 Minutes (min.)- Cisplatin 1.0 mg/ml: > 240 Minutes- Cyclophosphamide (Cytoxan) 20.0 mg/ml: > 240 Minutes- Dacarbazine 10 mg/ml: > 240 Minutes- Doxorubicin 2.0 mg/ml: > 240 Minutes- Etoposide 20.0 mg/ml: > 240 Minutes- Fluorouracil 50.0 mg/ml: >240 Minutes- Paclitaxel 6.0 mg/ml: >240 Minutes- Thio Tepa 10.0 mg/ml: 46.8Minutes (min.) | Reported Breakthrough Detection Times: (Matches acceptance criteria values exactly, indicating compliance).- Carmustine (BCNU) 3.3 mg/ml: 22.8(23.7, 22.8, 23.1) Minutes- Cisplatin 1.0 mg/ml: > 240 Minutes- Cyclophosphamide (Cytoxan) 20.0 mg/ml: > 240 Minutes- Dacarbazine 10 mg/ml: > 240 Minutes- Doxorubicin 2.0 mg/ml: > 240 Minutes- Etoposide 20.0 mg/ml: > 240 Minutes- Fluorouracil 50.0 mg/ml: >240 Minutes- Paclitaxel 6.0 mg/ml: >240 Minutes- Thio Tepa 10.0 mg/ml: 46.8(48.2, 48.6, 46.8) Minutes.Warning: Low permeation times for Carmustine (BCNU) and Thio Tepa are noted, with a warning not to use with these specific drugs given their breakthrough times. |
2. Sample Size Used for the Test Set and Data Provenance
The document describes material and performance testing, not a "test set" in the sense of an AI model's dataset. The "samples" refer to physical gloves selected for testing.
The provenance of the data is from laboratory testing conducted on the manufactured gloves. The specific country of origin for the testing itself is not explicitly stated, but the manufacturer is Shandong Maida Medical Technology Co.,Ltd. in China. The testing is prospective in the sense that newly manufactured gloves are tested to ensure they meet the standards.
- ASTM D5151 (Detection of Holes): Sample size for water leakage test: 125 gloves.
- ASTM D6319 (Dimensions & Physical Properties): Results are shown for multiple lots (e.g., Lot no.: 210515, 210518, 210520), indicating multiple samples were tested across different manufacturing batches. The exact number of gloves per lot for each physical test (e.g., tensile strength, elongation) is not specified but would be defined by the ASTM standard.
- ASTM D6978 (Chemotherapy Permeation): The results provide triplet values for Carmustine and Thio Tepa (e.g., 22.8(23.7, 22.8, 23.1)), suggesting three independent measurements were taken for these drugs. The standard itself specifies the number of replicates.
- Biocompatibility Testing: The number of animal subjects used for the animal irritation, sensitization, and systemic toxicity tests is not specified in the summary but would conform to the respective ISO standards.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This section is not applicable as the evaluation involves standardized laboratory testing against defined physical and chemical properties, not human expert interpretation of subjective data or images. The "ground truth" is defined by the objective measurement results according to the specified ASTM and ISO standards.
4. Adjudication Method for the Test Set
This is not applicable. Adjudication methods (like 2+1, 3+1) are for resolving discrepancies in human expert assessments (e.g., in medical image interpretation). Here, numerical test results from standardized methods are directly compared against established quantitative or qualitative acceptance criteria.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This is not applicable. MRMC studies are used to evaluate diagnostic imaging systems or AI tools where human readers are involved. This submission is for a physical medical glove.
6. Standalone (Algorithm Only) Performance
This is not applicable. This concept applies to AI/software performance. The device is a physical glove, not an algorithm.
7. Type of Ground Truth Used
The ground truth used is based on objective, quantitative measurements derived from standardized laboratory tests (bench testing) and biological responses observed in validated biocompatibility assays according to international standards (ASTM and ISO). This includes:
- Quantitative Thresholds: e.g., minimum tensile strength, maximum residual powder, minimum breakthrough time for chemotherapy drugs.
- Qualitative Observations (Biological): e.g., absence of irritation or sensitization, absence of systemic toxicity.
- Conformity to Standards: The device's performance is compared directly to the specified requirements within each standard (e.g., ASTM D6319-19 dimensions, physical properties).
One point of note is the cytotoxicity result (17.1% viability) which is below the 70% threshold, indicating cytotoxicity. The document addresses this by stating: "Analysis3: The proposed device is potentially cytotoxic, but all proposed devices are conducted the systemic toxicity test." And the systemic toxicity test showed "no evidence of systemic toxicity." This implies that despite the in vitro cytotoxicity, the manufacturer argues that in vivo systemic toxicity (which is generally considered a more critical endpoint for patient safety) was not observed, suggesting the findings are acceptable for the device's intended use according to the biocompatibility evaluation framework.
8. Sample Size for the Training Set
This is not applicable. There is no "training set" in the context of a physical device. The manufacturing process is controlled to produce gloves consistently, and batch testing ensures quality.
9. How the Ground Truth for the Training Set Was Established
This is not applicable. As there is no training set, the establishment of ground truth for it is irrelevant. The manufacturing process is designed and verified to produce products meeting the specified design and performance criteria.
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July 27, 2022
Shandong Maida Medical Technology Co.,Ltd. % Boyle Wang General Manager Shanghai Truthful Information Technology Co., Ltd. Room608,No.738,Shangcheng Rd.,Pudong Shanghai, Shanghai 200120 China
Re: K221271
Trade/Device Name: Disposable 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: April 18, 2022 Received: May 2, 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 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, 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) K221271
Device Name
Disposable 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 |
|---|---|---|
| Carmustine (BCNU) | 3.3 mg/ml (3,300 ppm) | 22.8(23.7, 22.8, 23.1) Minutes |
| Cisplatin | 1.0 mg/ml(1,000 ppm) | > 240 Minutes |
| Cyclophosphamide (Cytoxan) | 20.0 mg/ml(20,000 ppm) | > 240 Minutes |
| Dacarbazine | 10 mg/ml (10,000 ppm) | > 240 Minutes |
| Doxorubicin | 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) | 46.8(48.2, 48.6, 46.8) Minutes |
Please note that the following drugs have low permeation times: Carmustine (BCNU) 3.3 mg/ml 22.8 Minutes (min.); Thio Tepa 10.0 mg/ml 46.8 Minutes (min.). 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) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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K221271 510(k) Summary
This summary of 510(k) is being submitted in accordance with 21 CFR 807.92.
1.0 Submitter's Information
Name: Shandong Maida Medical Technology Co.,Ltd. Address: Room 102, Eastern building, No.166, South 1st Road, Development zone, Dongying, Shandong, China Room 102, Eastern building, No.166, South 1st Road, Development Contact: zone, Dongying, Shandong, China Date of Preparation: 2022.04.25
Designated Submission Correspondent
Mr. Boyle Wanq 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: 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.
Disposable Powder Free Nitrile Examination Glove, Tested For Device: Use With Chemotherapy Drugs, Disposable Powder Free Nitrile Examination Glove. Tested For Use With Chemotherapy Drugs, Orange Color
510(k) number: K190860
5.0 Device Description
The subject device is single use, disposable gloves intended for medical
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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: extra-small, 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(minutes) |
|---|---|---|
| Carmustine (BCNU) | 3.3 mg/ml (3,300 ppm) | 22.8(23.7, 22.8, 23.1) |
| Cisplatin | 1.0 mg/ml(1,000 ppm) | > 240 |
| Cyclophosphamide(Cytoxan) | 20.0 mg/ml(20,000 ppm) | > 240 |
| Dacarbazine | 10 mg/ml (10,000 ppm) | > 240 |
| Doxorubicin | 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) | 46.8(48.2, 48.6, 46.8) |
Please note that the following drugs have low permeation times:
Carmustine (BCNU) 3.3 mg/ml 22.8 Minutes (min.);
Thio Tepa 10.0 mg/ml 46.8 Minutes (min.).
Warning: Please do not use with Carmustine (BCNU) and Thiotepa.
7.0 Technological Characteristic Comparison Table
| Item | Subject DevicePending | Predicate Device(K190860) | Comparison |
|---|---|---|---|
| Product Code | LZA,LZC | LZA,LZC | Same |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 | Same |
| Class | I | I | Same |
Table1-General Comparison
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| Intended Use | A patient examinationgloves is a disposabledevice intended for medicalpurpose that is worn on theexaminer's hand orfingers to preventcontamination betweenpatient and examiner. Inaddition, these gloves weretested for use withchemotherapy drugs inaccordance with ASTMD6978-05 StandardPractice for Assessment of | A patient examination glovesis a disposable deviceintended for medical purposethat is worn on theexaminer's hand orfingers to preventcontamination betweenpatient and examiner. Inaddition, these gloves weretested for use withchemotherapy drugs inaccordance with ASTMD6978-05 Standard Practicefor Assessment of Medical | Same |
|---|---|---|---|
| Medical gloves toPermeationbyChemotherapy Drugs. | Medical gloves toPermeationbyChemotherapy Drugs. | ||
| Powdered orPowered free | Powdered free | Powdered free | Same |
| Design Feature | Ambidextrous | Ambidextrous | Same |
| Sterility | Non-Sterile | Non-Sterile | Same |
| Labeling Information | Single-useindication,powder free, device color,device name, glove size andquantity, Non-Sterile,a statement of standardASTM D6978-05compliance and asummary of the testingresults. | Single-useindication,powder free, device color,device name, glove size andquantity, Non-Sterile, astatement of standardASTM D6978-05compliance and a summaryof the testing results. | Similar |
Table2 Device Dimensions Comparison
| PredicateDevice(K190860) | Designation | Size | Tolerance | ||||
|---|---|---|---|---|---|---|---|
| XS | S | M | L | XL | |||
| 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 | Designation | Size | Tolerance | ||||
| S | M | L | XL | ||||
| Length, mm | 220 | 230 | 230 | 230 | min | ||
| Width, mm | 80 | 95 | 110 | 120 | ±10 |
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| Thickness, mm: | |||
|---|---|---|---|
| Finger | 0.05 | min | |
| Palm | 0.05 | min | |
| Remark | Different |
Analysis: The physical dimensions are different with that of the predicate, but they all meet the requirements of ASTM D6319-19.
| Item | Subject device | Predicate device(K190860) | Comparison | |
|---|---|---|---|---|
| Colorant | Blue | White, Orange | Different 1 | |
| PhysicalProperties | Before AgingTensile Strength | 14MPa, min | 14MPa, min | Same |
| Before AgingUltimate Elongation | 500% min | 500% min | Same | |
| After AgingTensile Strength | 14MPa, min | 14MPa, min | Same | |
| After AgingUltimate 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 | 0.15-0.19 mg per glove, Meet the requirements of ASTM D6124 | Meet the requirements of ASTM D6124 | Same | |
| Chemotherapy DrugsTested with MinimumBreakthroughDetection Time asTested per ASTM D6978 | Carmustine (BCNU) 3.3 mg/ml:22.8 Minutes (min.) | 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 10 mg/ml:> 240 Minutes | Dacarbazine (DTIC)10.0 mg/ml:>240 Minutes | Same |
Table3 Performance Comparison
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| Doxorubicin 2.0 mg/ml: >240 Minutes | DoxorubicinHydrochloride 2.0mg/ml: >240 Minutes | Similar | |
|---|---|---|---|
| Etoposide 20.0 mg/ml: > 240Minutes | Etoposide (Toposar)20.0mg/ml: >240 Minutes | Similar | |
| Fluorouracil 50.0 mg/ml: >240 Minutes | Fluorouracil 50.0mg/ml: >240Minutes | Same | |
| Paclitaxel 6.0 mg/ml: >240Minutes | Paclitaxel (Taxol) 6.0mg/ml:>240 Minutes | Same | |
| Thio Tepa 10.0 mg/ml:46.8Minutes (min.) | Thio-Tepa 10.0 mg/ml:White:16.9 Minutes;Orange: 72.5 Minutes | Similar |
Analysis:
Different 1: The color of the subject device is different of that of the predicate. Biocompatibility testing was successfully completed for the subject device.
Table4 Safety Comparison
| Item | Proposed device | Predicated device | Comparison | |
|---|---|---|---|---|
| Material | Nitrile | Nitrile | SAME | |
| Biocompatibility | Irritation | Under the conditions of the study, not an irritant | Comply withISO10993-10 | SAME |
| Sensitization | Under conditions of the study, not a sensitizer. | |||
| Cytotoxicity | Under the conditions of the study, the device is potentially cytotoxic | Comply withISO10993-5 | Analysis3 | |
| Systemictoxicity | Under the conditions of the study, the device does not elicit a systemic toxicity response in the model animal. | Complies with ISO10993-11 Third edition2017-09 | ||
| Label and Labeling | Meet FDA's Requirement | Meet FDA'sRequirement | SAME |
Analysis3: The proposed device is potentially cytotoxic, but all proposed devices are conducted the systemic toxicity test.
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8.0 Summary of Non-Clinical Testing
Biocompatibility Testing
biocompatibility evaluation for Disposable Nitrile Powder-Free The 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 Third edition 2017-09 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 Disposable Nitrile Powder-Free 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 Disposable Nitrile -Powder-Free 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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| No. | Name of the TestMethodology / Standard | Purpose | Acceptance Criteria | Results |
|---|---|---|---|---|
| 1 | ISO 10993-10:2010Biological Evaluation OfMedical Devices - Part10: Tests For IrritationAnd Skin Sensitization. | This part of ISO10993 assessespossible contacthazards fromchemicalsreleased frommedical devices, | Skin SensitizationTest:providedgrades less than 1,otherwisesensitization. | All grades are 0.All animals were survived and noabnormal signs were observedduring the study. |
| 2 | which mayproduce skin andmucosal irritation,eye irritation orskin sensitization. | Skin Irritation Test:If the primary irritationindex is 0-0,4, theresponse category isNegligible.0,5-1,9 means slight2-4,9 means moderate5-8 means severe | The primary irritation index is 0.The response of the proposeddevice was categorized asnegligible under the testcondition | |
| 3 | ISO 10993-5:2009Biological Evaluation OfMedical Devices - Part5: Tests For In VitroCytotoxicity | This part of ISO10993 describestest methods toassess the in vitrocytotoxicity ofmedical devices. | The viab.% of the100% extract of thetest article is the finalresult, and if viability isreduced to <70% ofthe blank, it hascytotoxic potential. | Viab.% of 100% test articleextract is 17.1%It means the proposed devicehave potential toxicity to L-929 inthe MTT method |
| 4 | ISO 10993-11: 2017Biological evaluation ofmedical devices — Part11: Tests for systemictoxicity | To evaluate thepotential formedical devicematerials to causeadverse systemicreactions. | Within the monitoringperiod (72 h), if thetoxicosis response oftesting group is notgreater than that ofcontrol group, thetesting sample isregarded asacceptable. | There was no evidence ofsystemic toxicity from the extract. |
| 5 | ASTM D6124-06(Reapproved 2017),Standard Test Methodfor Residual Powder onMedical Gloves | This standard isdesigned todetermine theamount ofresidualpowder (orfilter-retainedmass) foundon medical gloves | powder residue limit of2.0 mg | 0.15-0.19 mg /glove |
| 6 | ASTMD5151-06(Reapproved2015), Standard TestMethod for Detection ofHoles in Medical Gloves. | This test methodcovers thedetection of holesinmedical gloves. | Samples number: 125glovesAQL: 2.5 (ISO 2859)Criterion ≤7 glovesfor water leakage | no glove water leakage found |
| 7 | ASTMD6319-10(Reapproved2015), StandardSpecification For NitrileExamination Gloves ForMedical Application. | This specificationcovers certainrequirements fornitrile rubbergloves used inconductingmedicalexaminations anddiagnostic andtherapeuticprocedures. | Sterility: no needFreedom from holes:pl. Refer to No. 5 intable 5Dimensions:S: width 80±10mmLength ≥220 mmM: width 95±10mmLength ≥230 mmL: width 110±10mmLength ≥230 mmXL: width 120±10mmLength ≥230 mmThickness:Finger ≥0.05 mmPalm ≥0.05 mm | N.A.Please refer to No. 5 in table 5Lot no.:210515Dimensions:S: width: 85-87 mmLength 247-253 mmM: width 88-96 mmLength 242-257 mmL: width 90-99 mmLength 240-254 mmXL: width 110-115 mmLength 245-253 mmThickness:Finger 0.09-0.21 mmPalm 0.06-0.15 mmPhysical properties:Before agingTensile strength 14.1-22.5 MPaUltimate Elongation 503.274% -670.613%After Accelerated AgingTensile strength 14.6-20.8 MPaUltimate Elongation 411.403% -592.683%Powder-free Residue:pl. Refer to No. 4 in table 5Lot no.:210518Dimensions:S: width: 84-86 mmLength 248-256 mmM: width 95-96 mmLength 237-266 mmL: width 105-108 mm |
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| Length 257-262 mm | ||
|---|---|---|
| XL: width 114-117 mm | ||
| Length 252-262 mm | ||
| Thickness: | ||
| Finger 0.10-0.12mm | ||
| Palm 0.07-0.08mm | ||
| Physical properties: | ||
| Before aging | ||
| Tensile strength 15.2-29.8 MPa | ||
| Ultimate Elongation 500.492% - | ||
| 593.853% | ||
| AfterAging | ||
| Tensile strength 14.1-23.8MPa | ||
| Ultimate Elongation 451.751% - | ||
| 597.368% | ||
| Powder-free Residue: | ||
| pl. Refer to No. 4 in table 5 | ||
| Lot no.:210520 | ||
| Dimensions: | ||
| S: width: 84-87 mm | ||
| Length 244-257 mm | ||
| M: width 93-98 mm | ||
| Length 245-260 mm | ||
| L: width 104-110mm | ||
| Length 250-263 mm | ||
| XL: width 114-119 mm | ||
| Length 252-260 mm | ||
| Thickness: | ||
| Finger 0.10-0.12 mm | ||
| Palm 0.06-0.08 mm | ||
| Physical properties: | ||
| Before aging | ||
| Tensile strength 14.4-23.9MPa | ||
| Ultimate Elongation 501.484% - | ||
| 547.660% | ||
| After Accelerated Aging | ||
| Tensile strength 14.2-23.9 MPa | ||
| Ultimate Elongation 492.901% - | ||
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| 599.996%Powder-free Residue:pl. Refer to No. 4 in table 5 | ||||
|---|---|---|---|---|
| 8 | ASTM D6978 | ChemotherapyDrugsTested withMinimumBreakthroughDetection Time | Carmustine (BCNU) 3.3 mg/ml: 22.8 Minutes (min.) | |
| Cisplatin 1.0 mg/ml: > 240 Minutes | ||||
| Cyclophosphamide (Cytoxan) 20.0 mg/ml: > 240 Minutes | ||||
| Dacarbazine 10 mg/ml:> 240 Minutes | ||||
| Doxorubicin 2.0 mg/ml: > 240 Minutes | ||||
| Etoposide 20.0 mg/ml: > 240 Minutes | ||||
| Fluorouracil 50.0 mg/ml: >240 Minutes | ||||
| Paclitaxel 6.0 mg/ml: >240 Minutes | ||||
| Thio Tepa 10.0 mg/ml: 46.8Minutes (min.) |
9.0 _Summary of Clinical Testing
Clinical testing is not needed for this device.
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10.0 Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the subject device, Disposable Nitrile Powder-Free Examination Gloves (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 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.