(107 days)
This glove is intended to be worn by operating room personnel to protect a surgical wound from contamination. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05(Reapproved 2019).
Sterile Polyisoprene Powder Free Surgical Glove, tested for Use with Chemotherapy Drugs is a disposable singleuse, sterile, Cream-colored and powder-free surgical glove made from synthetic polyisoprene latex.
This document describes the premarket notification (510(k)) for a medical device – "Sterile Polyisoprene Powder Free Surgical Glove, Tested for Use with Chemotherapy Drugs." This device is a Class I, reserved product, meaning it's subject to general controls but does not require extensive clinical data for approval if it demonstrates substantial equivalence to a legally marketed predicate device.
The provided text focuses on the device's technical specifications and non-clinical testing to demonstrate substantial equivalence to a predicate device, not on proving an AI algorithm's performance in a diagnostic context. Therefore, many of the requested elements for describing an AI acceptance criteria study (e.g., sample size for test set, data provenance, expert ground truth, MRMC study, effect size, standalone performance, training set details) are not applicable to this submission.
The "acceptance criteria" here refer to the product's physical, chemical, and performance standards as determined by established industry and regulatory test methods, not diagnostic performance metrics of an AI.
Here's an interpretation of the "acceptance criteria" and "study" based on the provided document:
Acceptance Criteria and Reported Device Performance
The device's performance is demonstrated through adherence to various ASTM and ISO standards. The acceptance criteria are the minimum or maximum values specified by these standards, and the reported device performance indicates whether the tested product met these thresholds.
| Characteristic | Acceptance Criteria (Standard/Guidance) | Reported Device Performance | Conclusion |
|---|---|---|---|
| Dimensions | ASTM D3577-19 | Meets ASTM D3577 requirements for length, width, and thickness | Pass |
| Length | Minimum 265mm | 280-305mm | Pass |
| Palm Width (size) | Various (70±6mm to 114±6mm) | Average values within range (e.g., 73mm for size 5.5, 114mm for size 9.0) | Pass |
| Thickness (Finger, Palm, Cuff) | Minimum 0.10 mm | Finger: 0.22-0.24 mm, Palm: 0.22 mm, Cuff: 0.17-0.18 mm | Pass |
| Physical Properties | ASTM D3577-19 | Meets ASTM D3577-19 | Pass |
| Tensile Strength, Before Aging | ≥ 17 MPa | Average 20-21 MPa | Pass |
| Ultimate Elongation, Before Aging | ≥ 650 % | Average 780-823 % | Pass |
| Stress at 500% Elongation | 7.0 MPa, max | Average 2.5-3.1 MPa | Pass |
| Tensile Strength, After Accelerated Aging | ≥ 12 MPa | Average 18-20 MPa | Pass |
| Ultimate Elongation, After Accelerated Aging | ≥ 490 % | Average 747-809 % | Pass |
| Freedom from holes | ASTM D3577-19, ASTM D 5151-19 (AQL 1.5) | Meets AQL 1.5 | Pass |
| Powder-Free | ASTM D3577-19, ASTM D 6124-06(2022) (≤ 2 mg per glove) | 0.10-0.27 mg per glove | Pass |
| Aqueous Extractable Protein Content | ASTM D3577-19, ASTM D5712-15 (≤ 200 ug/dm2) | ≤ 50 ug/dm2 | Pass |
| Sterility | 10-6 SAL | 10-6 SAL | Pass |
| Biocompatibility | ISO 10993 standards (10, 23, 5, 11) | Results indicate compliance or acceptable levels | Pass |
| Skin Sensitization Test | No significant evidence of causing skin sensitization | No significant evidence of causing skin sensitization | Pass |
| Intracutaneous Reactivity Test | Score < 1.0 (requirements met) | Score < 1.0, requirements met | Pass |
| Cytotoxicity Test | (Acceptance criteria implied by predicate comparison) | Potential toxicity to L929 cells (Similar to predicate) | Pass |
| Acute Systemic Toxicity Test | No evidence of Acute systemic toxicity | No evidence of Acute systemic toxicity | Pass |
| Pyrogen Test | No rabbit shows individual rise in temperature of 0.5°C or more | Meets requirements of pyrogen test | Pass |
| Chemotherapy Drug Permeation | ASTM D6978-05 (Reapproved 2019) (Minimum Breakthrough Detection Time) | Varies per drug, compared to predicate | Similar |
Study Proving Device Meets Acceptance Criteria
The "study" refers to a series of non-clinical tests conducted according to recognized international and industry standards.
-
Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated for each specific test, but the standards (e.g., ASTM D3577, ASTM D5151) would dictate the minimum sample sizes required for statistically valid testing (e.g., AQL levels for freedom from holes).
- Data Provenance: The tests were performed to verify that the subject device meets the acceptance criteria. The location of the testing laboratories is not specified, but the manufacturing company is based in China. The data would be considered prospective as it was generated specifically for this 510(k) submission to demonstrate compliance.
-
Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not Applicable. This is a physical product testing scenario, not an AI diagnostic study. "Ground truth" is established by the standardized test methods themselves and the precise measurement of physical properties (e.g., length, thickness, tensile strength) or chemical properties (e.g., breakdown time, residual powder). The "experts" are the technicians and scientists performing these standardized tests in accredited laboratories. Their qualifications would involve training and expertise in material science, chemistry, and quality control relative to medical device testing.
-
Adjudication Method for the Test Set:
- Not Applicable. As this is not an AI diagnostic study, there is no human "adjudication" in the sense of reconciling expert opinions. The test results are typically quantitative measurements, and compliance is determined by whether these measurements fall within the specified acceptance criteria. Any discrepancies in test results would be handled through laboratory quality control procedures and repeat testing.
-
If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. This type of study is relevant for diagnostic AI algorithms where human readers interpret medical images or data. It is not applicable to the testing of surgical gloves.
-
If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This product is a physical medical device, not an AI algorithm.
-
The Type of Ground Truth Used:
- Standardized Test Results and Established Benchmarks: The "ground truth" for the performance claims are the outcomes of tests conducted in accordance with well-established ASTM and ISO standards (e.g., ASTM D3577-19 for physical properties, ASTM D6978-05 for chemotherapy drug permeation, ISO 10993 series for biocompatibility). These standards define the methodologies and the "correct" or "acceptable" results for the device's characteristics.
-
The Sample Size for the Training Set:
- Not Applicable. There is no "training set" in the context of a physical product's performance validation as described here. This is not an AI/machine learning development.
-
How the Ground Truth for the Training Set Was Established:
- Not Applicable. (See point 7)
In summary, the provided document details a non-clinical performance evaluation of a medical device against established industry standards and regulatory requirements, not a study of an AI algorithm's diagnostic performance. The "acceptance criteria" are the thresholds defined by these standards, and the "study" is the battery of tests conducted to demonstrate compliance.
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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: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
May 13, 2023
Grand Work Plastic Products Co., Ltd % Kathy Liu Project Manager Hongray USA Medical Products Inc. 3973 Schaefer Avenue Chino, California 91710
Re: K230217
Trade/Device Name: Sterile Polyisoprene Powder Free Surgical Glove, Tested for Use with Chemotherapy Drugs Regulation Number: 21 CFR 878.4460 Regulation Name: Non-Powdered Surgeon's Glove Regulatory Class: Class I, reserved Product Code: KGO, LZC Dated: April 11, 2023 Received: April 12, 2023
Dear Kathy Liu:
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.
Bifeng Qian -S
Bifeng Qian, M.D., 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) K230217
Device Name
Sterile Polyisoprene Powder Free Surgical Glove, Tested for Use with Chemotherapy Drugs
Indications for Use (Describe)
This glove is intended to be worn by operating room personnel to protect a surgical wound from contamination. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05(Reapproved 2019).
| Chemotherapy Drug | Minimum Breakthrough Detection Time (BDT) in Minutes |
|---|---|
| Carmustine (3.3mg/ml) | 25.4 |
| Cisplatin (1mg/ml) | >240 |
| Cyclophosphamide (20mg/ml) | >240 |
| Doxorubicin HCL (2 mg/ml) | >240 |
| Etoposide (20mg/ml) | >240 |
| Fluorouracil (50mg/ml) | >240 |
| Methotrexate (25mg/ml) | >240 |
| Mitomycin C (0.5 mg/ml) | >240 |
| Paclitaxel (6mg/ml) | >240 |
| Thiotepa (10mg/ml) | 23.3 |
| Vincristine Sulfate (1mg/ml) | >240 |
Please note that the following drugs have low permeation times: Carmustine (BCNU): 25.4 minutes, Thiotepa: 23.3 minutes Warning: 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
This summary of 510(K) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR §807.92.
The assigned 510(K) number is: K230217 Date Prepared: March 25, 2023
1. Owner's Identification:
Mrs. Wu Yuli Grand Work Plastic Products Co., Ltd. Donggao Industrial Zone, Zanhuang, Hebei, 050000, China Tel: 86-311-66179668
Contact: Ms. Kathy Liu, Project Manager Grand Work Plastic Products Co., Ltd Address: 3973 Schaefer Ave., Chino, CA 91710 Tel: 909-590-1611
2. Name of the Device:
Trade Name: Sterile Polyisoprene Powder Free Surgical Glove, Tested for Use with Chemotherapy Drugs Common Name: Surgeon's Glove Classification Name: Surgeon's Glove Classification Regulation: 21 CFR 878.4460 Product Code: KGO, LZC Device Class: Class I
3. Predicate Device Information:
Hartalega NGC SDN BHD Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs (Natural) (K221718)
4. Device Description:
Sterile Polyisoprene Powder Free Surgical Glove, tested for Use with Chemotherapy Drugs is a disposable singleuse, sterile, Cream-colored and powder-free surgical glove made from synthetic polyisoprene latex.
5. Indications for Use:
This glove is intended to be worn by operating room personnel to protect a surgical wound from contamination. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 (Reapproved 2019).
| Chemotherapy Drug | Minimum BDT (Minutes) |
|---|---|
| Carmustine (3.3mg/ml) | 25.4 |
| Cisplatin (1mg/ml) | >240 |
| Cyclophosphamide (20mg/ml) | >240 |
| Doxorubicin HCL (2 mg/ml) | >240 |
| Etoposide (20mg/ml) | >240 |
| Fluorouracil (50mg/ml) | >240 |
| Methotrexate (25mg/ml) | >240 |
| Mitomycin C (0.5 mg/ml) | >240 |
| Paclitaxel (6mg/ml) | >240 |
| Thiotepa (10mg/ml) | 23.3 |
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Vincristine Sulfate (1 mg/ml)
240
Please note that the following drugs have low permeation times: Carmustine (BCNU): 25.4 minutes, Thiotepa: 23.3 minutes Warning: Do not use with Carmustine and Thiotepa
6. Comparison table of Subject Device and Predicate Device:
| Items | Subject DeviceK230217 | Predicate DeviceK221718 | Remark |
|---|---|---|---|
| Trade Name | Sterile Polyisoprene PowderFree Surgical Glove, Tested forUse with Chemotherapy Drugs | Polyisoprene Powder Free Surgical GloveTested for Use with Chemotherapy Drugs(Natural) | Similar |
| Product Code | KGO, LZC | KGO, LZC | Same |
| Regulation Number | 21 CFR 878.4460 | 21 CFR 878.4460 | Same |
| Classification | I | I | Same |
| Regulation Name | Surgeon's Glove | Surgeon's Glove | Same |
| Indications for Use | This glove is intended to beworn by operating roompersonnel to protect a surgicalwound from contamination. Inaddition, these gloves weretested for use withchemotherapy drugs inaccordance with ASTMD6978-05 (Reapproved 2019). | Polyisoprene Powder Free Surgical GloveTested for Use with Chemotherapy Drugsis intended to be worn by operating roompersonnel to protect surgical wound fromcontamination. It is also tested for useagainst Chemotherapy Drugs.The gloves were tested for use withchemotherapy drugs as per ASTM D6978-05 (Reapproved 2019) Standard Practicefor Assessment of Resistance of MedicalGloves to Permeation by ChemotherapyDrugs. | Similar |
| Type of use | Over the counter use | Over the counter use | Same |
| Materials | Polyisoprene | Polyisoprene | Same |
| Color | Cream | Natural | Different |
| Design | · Single Use· Sterile• Powder-Free· Hand Specific• Beaded cuff | · Single Use· Sterile• Powder-Free· Hand Specific• Beaded cuff | Same |
| Sterility | Sterile | Sterile | Same |
| Sterilization | Radiation 10-6 SAL | Radiation 10-6 SAL | Same |
| Freedom fromholes | Meets ASTM D3577-19requirements of AQL 1.5 | Meets ASTM D3577-19 requirements ofAQL 1.5 | Similar |
| Length | Length (mm): ≥ 265 mm | Length (mm): ≥ 265 mm | Similar |
| Dimensions | 5.5:70 ± 6 (mm)6.0: 76 ± 6 (mm)6.5: 83 ± 6 (mm)7.0: 89 ± 6 (mm)7.5: 95 ± 6 (mm)8.0: 102 ± 6 (mm)8.5: 108 ± 6 (mm)9.0: 114 ± 6 (mm) | 5.5:70 ± 6 (mm)6.0: 76 ± 6 (mm)6.5: 83 ± 6 (mm)7.0: 89 ± 6 (mm)7.5: 95 ± 6 (mm)8.0: 102 ± 6 (mm)8.5: 108 ± 6 (mm)9.0: 114 ± 6 (mm) | Similar |
| Thickness | Cuff Thickness: ≥ 0.10 mmPalm Thickness: ≥ 0.10 mm | Cuff Thickness: ≥ 0.10 mmPalm Thickness: ≥ 0.10 mm | Similar |
| Finger Thickness: ≥ 0.10 mm | Finger Thickness: ≥ 0.10 mm | ||
| PhysicalProperties | Tensile Strength Before Aging:≥ 17 MPaTensile Strength After Aging: ≥12 MPaUltimate Elongation BeforeAging: ≥ 650 %Ultimate Elongation AfterAging: ≥ 490 % | Tensile Strength Before Aging: ≥ 17 MPaTensile Strength After Aging: ≥ 12 MPaUltimate Elongation Before Aging: ≥650 %Ultimate Elongation After Aging: ≥ 490 % | Similar |
| Powder residual | Residual Powder: ≤ 2 mg perglove | Residual Powder: ≤ 2 mg per glove | Similar |
| In Vitro Cytotoxicity | Under the conditions of thisstudy, the test article extractshowed potential toxicity toL929 cells. | Under the conditions of the study, thedevice was found to be cytotoxic | Similar |
| Primary SkinIrritation | The test result showed that thepolar and non-polar extract ofthe final test sample score is less1.0, the requirements of the testare met. | Under the conditions of the study, thedevice is not an irritant | Similar |
| Dermal Sensitization | Under the conditions of thisstudy, the test article extractshowed no significant evidenceof causing skin sensitization | Under the conditions of the study, thedevice is not a sensitizer | Similar |
| Acute SystemicToxicity | Under the conditions of thisstudy, there was no evidenceof Acute systemic toxicityfrom the extract.The test article extract met therequirements of this study. | Under the conditions of the study, therewas no evidence of systemic toxicity | Similar |
| Pyrogenicity Test | Under the conditions of thisstudy, no rabbit shows anindividual rise in temperature of0.5℃ or more, the test articleSterile Polyisoprene PowderFree Surgical Gloves, Tested forUse with Chemotherapy Drugsmeets the requirements ofpyrogen test. | Under the conditions of the study, the testarticle was non-pyrogenic | Similar |
| Endotoxin Test | ≤0.5 units/pair of gloves | Not Performed | Different |
| Chemotherapy DrugPermeation Claim | See below comparison table | See below comparison table | Similar |
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Chemotherapy Permeation Comparison Claim:
| Tested Chemotherapy Drug and | Minimum BDT (Minutes) | Remark | |
|---|---|---|---|
| Concentration | Subject DeviceK230217 | Predicate DeviceK221718 | |
| Carmustine (3.3mg/ml) | 25.4 | 12.3 | Similar |
| Cisplatin (1mg/ml) | >240 | >240 | Same |
| Cyclophosphamide (20mg/ml) | >240 | >240 | Same |
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| Dacarbazine (10.0 mg/ml) | Not performed | >240 | Different* |
|---|---|---|---|
| Doxorubicin HCL (2 mg/ml) | >240 | >240 | Same |
| Etoposide (20mg/ml) | >240 | >240 | Same |
| Fluorouracil (50mg/ml) | >240 | >240 | Same |
| Methotrexate (25mg/ml) | >240 | >240 | Same |
| Mitomycin C (0.5 mg/ml) | >240 | >240 | Same |
| Paclitaxel (6mg/ml) | >240 | >240 | Same |
| Thiotepa (10mg/ml) | 23.3 | 17.4 | Similar |
| Vincristine Sulfate (1 mg/ml) | >240 | >240 | Same |
- Chemotherapy drugs and the minimum breakthrough time of subject device will be listed on labeling, so this difference does not raise questions of safetv and effectiveness.
7 Summary of Non-Clinical Testing
Non-clinical testing was performed to verify that the subject device meets the acceptance criteria of the performance test and all design specifications. The test results demonstrated that the subject device complies with the following standards as shown below.
- · ASTM D3577-19 Standard Specification for Rubber Surgical Gloves
- · ASTM D5151-19 Standard Test Method for Detection of Holes in Medical Gloves
- · ASTM D6124-06 (Reapproved 2022) Standard Test Method for Residual Powder on Medical Gloves
- · ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to
- Permeation by Chemotherapy Drugs
- ISO 10993-5 In Vitro Cytotoxicity
- ISO 10993-23 Primary Skin Irritation
- ISO 10993-10 Dermal Sensitization
- · ISO 10993-11 Acute Systemic Toxicity
- ISO 10993-11 Pyrogen Test
- · U.S. Pharmacopeia Sterility Test
- · U.S. Pharmacopeia endotoxin test
8. Specification for subject Gloves:
| TechnologicalCharacteristics | Standard/Test/FDA Guidance | Result Summary | Conclusion |
|---|---|---|---|
| Dimensions | ASTM D3577-19 | Meets ASTM D3577requirements for length, widthand thickness | Same |
| --Length | Minimum 265mm | 280-305mm | Pass |
| --Palm Width (size) | (mm) | Average value in mm | |
| 5.5 | 70±6 | 73 | Pass |
| 6.0 | 76±6 | 79 | Pass |
| 6.5 | 83±6 | 84 | Pass |
| 7.0 | 89±6 | 90 | Pass |
| 7.5 | 95±6 | 96 | Pass |
| 8.0 | 102±6 | 101 | Pass |
| 8.5 | 108±6 | 108 | Pass |
| 9.0 | 114±6 | 114 | Pass |
| --Thickness | Average value in mm | ||
| Finger | Minimum 0.10 | 0.22-0.24 | Pass |
| Palm | Minimum 0.10 | 0.22 | Pass |
| Cuff | Minimum 0.10 | 0.17-0.18 | Pass |
| Physical Properties | ASTM D3577-19 | Meets ASTM D3577-19 | |
| Tensile Strength, Before | 17MPa, min | Average 20-21MPa | Pass |
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| Aging | |||
|---|---|---|---|
| Ultimate Elongation,Before Aging | 650%, min | Average 780-823% | Pass |
| Stress at 500% Elongation | 7.0 MPa, max | Average 2.5-3.1MPa | Pass |
| Tensile Strength, AfterAccelerated Aging | 12 MPa, min | Average 18-20MPa | Pass |
| Ultimate Elongation, AfterAccelerated Aging | 490%, min | Average 747-809 % | Pass |
| Freedom from holes | ASTM D3577-19ASTM D 5151-19requirements of AQL1.5 | Meets AQL1.5 | Pass |
| Powder-Free | ASTM D3577-19ASTM D 6124-06(2022)$\leq$ 2 mg per glove | 0.10-0.27 mg per glove | Pass |
| Aqueous ExtractableProtein Content | ASTM D3577-19ASTM D5712-15$\leq$ 200ug/dm2 | $\leq$ =50ug/dm2 | Pass |
| Sterility | 10-6 SAL | 10-6 SAL | Pass |
9. Biocompatibility
| Test | Result Summary |
|---|---|
| Skin Sensitization TestISO 10993-10 | Under the conditions of this study, the test article extract showed no significantevidence of causing skin sensitization |
| Intracutaneous Reactivity TestISO 10993-23 | The test result showed that the polar and non-polar extract of the final testsample score is less 1.0, the requirements of the test are met. |
| Cytotoxicity TestISO 10993-5 | Under the conditions of this study, the test article extract showed potentialtoxicity to L929 cells. |
| Acute Systemic Toxicity Test10993-11 | Under the conditions of this study, there was no evidence of Acute systemictoxicity from the extract.The test article extract met the requirements of this study. |
| Pyrogen Test10993-11 | Under the conditions of this study, no rabbit shows an individual rise intemperature of 0.5°C or more, the test article Sterile Polyisoprene Powder FreeSurgical Gloves, Tested for Use with Chemotherapy Drugs meets therequirements of pyrogen test. |
10. Clinical Performance Data:
Not applicable. There was no clinical data required to support the subject device as the indication for use is equivalent to the predicate device.
11. Conclusion:
The conclusions drawn from the non-clinical tests demonstrate that the Subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device.
§ 878.4460 Non-powdered surgeon's glove.
(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's 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).