(253 days)
A Sterile Nitrile Surgical Gloves Powder Free is a device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
The proposed device, Sterile Nitrile Surgical Gloves Powder Free is a sterile and disposable medical glove intended to be worn by operating room personnel to protect a surgical wound from contamination. The proposed device is made of synthetic rubber latex, as per standard ASTM D3577-2019, Standard Specification for Rubber Surgical Gloves. The classification is: Type II - gloves compounded from synthetic rubber latex. The proposed device is Sterile Nitrile Surgical Gloves Powder Free, and is produced in sizes 6, 6 ½, 7, 7 ½, 8, 8 ½, and 9. All sizes share the same White color. The proposed device is sterilized using Gamma Radiation method to achieve the Sterility Assurance Level (SAL) of 10-6 while packaged to maintain sterility. The shelf life is 3 years.
The provided text describes the acceptance criteria and the results from non-clinical performance testing for a medical device, "Sterile Nitrile Surgical Gloves Powder Free." It does not contain information about studies involving human readers or AI assistance. Therefore, I will focus on the non-clinical performance testing detailed.
Here's the information extracted and organized as requested, with "N/A" for sections not applicable to this type of submission:
1. A table of acceptance criteria and the reported device performance
| Test Method | Purpose | Acceptance Criteria (AC) | Reported Device Performance (Result) | Met AC |
|---|---|---|---|---|
| ASTM D5151-2019 | Freedom from holes (Before aging) | AQL 1.5 (3 non-consecutive lots) | Pass | Yes |
| ASTM D5151-2019 | Freedom from holes (After accelerated aging: 70 ± 2°C for 166 ± 2 h) | AQL 1.5 (3 non-consecutive lots) | Pass | Yes |
| ASTM D5151-2019 | Freedom from holes (After accelerated aging: 50 ± 2°C for 90 ± 1 days) | AQL 1.5 (3 non-consecutive lots) | Pass | Yes |
| ASTM D3577-19, Standard Specification for Rubber Surgical Gloves | Tensile strength (Before aging) | Minimum 17MPa for all sizes (AQL 4%, 3 non-consecutive lots) | Pass | Yes |
| ASTM D3577-19, Standard Specification for Rubber Surgical Gloves | Tensile strength (After accelerated aging: 70 ± 2°C for 166 ± 2 h) | Minimum 12MPa for all sizes (AQL 4%, 3 non-consecutive lots) | Pass | Yes |
| ASTM D3577-19, Standard Specification for Rubber Surgical Gloves | Tensile strength (After accelerated aging: 50 ± 2°C for 90 ± 1 days) | Minimum 12MPa for all sizes (AQL 4%, 3 non-consecutive lots) | Pass | Yes |
| ASTM D3577-19, Standard Specification for Rubber Surgical Gloves | Ultimate Elongation (Before aging) | Minimum 650% for all sizes (AQL 4%, 3 non-consecutive lots) | Pass | Yes |
| ASTM D3577-19, Standard Specification for Rubber Surgical Gloves | Ultimate elongation (After accelerated aging: 70 ± 2°C for 166 ± 2 h) | Minimum 490% for all sizes (AQL 4%, 3 non-consecutive lots) | Pass | Yes |
| ASTM D3577-19, Standard Specification for Rubber Surgical Gloves | Ultimate elongation (After accelerated aging: 50 ± 2°C for 90 ± 1 days) | Minimum 490% for all sizes (AQL 4%, 3 non-consecutive lots) | Pass | Yes |
| ASTM D3577-19, Standard Specification for Rubber Surgical Gloves | Stress at 500% elongation (Before accelerated aging) | Maximum 7.0MPa for all sizes (AQL 4%, 3 non-consecutive lots) | Pass | Yes |
| ASTM D3577-19, Standard Specification for Rubber Surgical Gloves | Stress at 500% elongation (After accelerated aging: 70 ± 2°C for 166 ± 2 h) | Maximum 7.0MPa for all sizes (AQL 4%, 3 non-consecutive lots) | Pass | Yes |
| ASTM D3577-19, Standard Specification for Rubber Surgical Gloves | Stress at 500% elongation (After accelerated aging: 50 ± 2°C for 90 ± 1 days) | Maximum 7.0MPa for all sizes (AQL 4%, 3 non-consecutive lots) | Pass | Yes |
| ASTM F1929, Test Method for detecting seal leaks in porous medical packaging by dye penetration | Package integrity (After accelerated aging: 70 ± 2°C for 166 ± 2 h) | No penetration (AQL 0.65%, 3 non-consecutive lots) | Pass | Yes |
| ASTM F1929, Test Method for detecting seal leaks in porous medical packaging by dye penetration | Package integrity (After accelerated aging: 50 ± 2°C for 90 ± 1 days) | No penetration (AQL 0.65%, 3 non-consecutive lots) | Pass | Yes |
| ASTM D3577-19, Standard Specification for Rubber Surgical Gloves | To determine the length of the gloves | Min 265mm for all sizes | Pass for all sizes listed | Yes |
| ASTM D3577-19, Standard Specification for Rubber Surgical Gloves | To determine the width of the gloves | Specific width ranges for each size (e.g., 76±6mm for Size 6) | Pass for all sizes listed | Yes |
| ASTM D3577-19, Standard Specification for Rubber Surgical Gloves | To determine finger thickness | Minimum 0.10mm for all sizes (AQL 4%) | Pass for all sizes listed | Yes |
| ASTM D3577-19, Standard Specification for Rubber Surgical Gloves | To determine palm thickness | Minimum 0.10mm for all sizes (AQL 4%) | Pass for all sizes listed | Yes |
| ASTM D3577-19, Standard Specification for Rubber Surgical Gloves | To determine cuff thickness | Minimum 0.10mm for all sizes (AQL 4%) | Pass for all sizes listed | Yes |
| ASTM D6124-06R17, Standard Test Method for Residual Powder on Medical Gloves | Less than 2mg/glove | Maximum 2mg/glove for all sizes | Pass | Yes |
| ISO 10993-10: 2010, Biological evaluation of medical devices - Part 10- Tests for irritation and skin sensitization | Irritation | Under the conditions of the testing, not an irritant | Pass | Yes |
| ISO 10993-10: 2010, Biological evaluation of medical devices - Part 10- Tests for irritation and skin sensitization | Sensitization | Under the conditions of the testing, not a sensitizer | Pass | Yes |
| ISO 10993-5:2009(E) Biological Evaluation of Medical Devices - Part 5-Tests for in-vitro Cytotoxicity | Cytotoxicity | Under the conditions of the testing, non-cytotoxic | Pass | Yes |
| ISO 10993-11:2017(E) Biological Evaluation of Medical Devices - Part 11- Tests for Systemic Toxicity and Biological Tests | Acute systemic toxicity | Under the conditions of the testing, no acute systemic toxicity | Pass | Yes |
| USP 41 <151>Pyrogen Test | Material mediated pyrogenicity | Under the conditions of the testing, non-pyrogenic | Pass | Yes |
| USP 42 <85>Bacterial Endotoxin Test | Bacterial endotoxin limits | Less than 20EU/glove | Pass | Yes |
2. Sample size used for the test set and the data provenance
The document refers to "3 non-consecutive lots" for AQL (Acceptable Quality Limit) testing in several instances. However, the specific number of gloves sampled from each lot for each test is not explicitly stated.
Data provenance: Not specified (origin of the gloves/materials for testing). This is a non-clinical device performance test, not a study on patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
N/A - This submission concerns non-clinical performance testing of a physical medical device (gloves), not a diagnostic algorithm requiring expert "ground truth." The "ground truth" here is established by standardized test methods and their defined pass/fail criteria.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
N/A - See point 3.
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
N/A - This is not an AI/algorithm-assisted diagnostic device. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
N/A - This is not an AI/algorithm device. Standalone performance is demonstrated by the physical and biological testing results.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" or reference standard for these tests is defined by the technical specifications and methodologies outlined in the referenced ASTM and ISO standards (e.g., ASTM D3577-19 for surgical gloves, ISO 10993 for biological evaluation). These standards prescribe the testing procedures and define acceptable limits for various physical, chemical, and biological properties.
8. The sample size for the training set
N/A - This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
N/A - See point 8.
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April 13, 2023
JR Engineering & Medical Technologies (M) SDN. BHD. % Manoj Zacharias Consultant Liberty Management Group Ltd. 75 Executive Dr. STE 114 Aurora, Illinois 60504
Re: K222350
Trade/Device Name: Sterile Nitrile Surgical Gloves Powder Free Regulation Number: 21 CFR 878.4460 Regulation Name: Non-Powdered Surgeon's Glove Regulatory Class: Class I, reserved Product Code: KGO Dated: March 13, 2023 Received: March 13, 2023
Dear Manoj Zacharias:
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.
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) K22350
Device Name
Sterile Nitrile Surgical Gloves Powder Free
Indications for Use (Describe)
A Sterile Nitrile Surgical Gloves Powder Free is a device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
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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510K SUMMARY
K22350
Date of Preparation: April 10, 2023 As required by: 21CFR § 807.92
A. APPLICANT INFORMATION
| Submitter Name | JR Engineering & Medical Technologies (M) SDN. BHD | |
|---|---|---|
| Address | Lot 8 &10, Jalan Zurah 3 & Lot 1&3, Jalan Zurah 3A/1, PusatPerindustrian 2, 44200 Rasa, HuluSelangor, Selangor Darul Ehsan, Malaysia. | |
| Phone | +603-60572081 | |
| Fax | +603-60572181 | |
| ganeshjrmt@gmail.com | ||
| Contact Person | Mr. Ganesan Subramaniam | |
| Designation | Managing Director | |
| Contact Number | +6012 224 6677 | |
| Contact Email | ganeshjrmt@gmail.com | |
| US Agent | Manoj Zacharias | |
| US Agent Address | Liberty Management Group Ltd.75 Executive Dr. Ste 114 Aurora, IL 60504 USA | |
| US Agent Telephone | 1 (630) 270-2921 | |
| US Agent Fax | 1 (815) 986-2632 | |
| US Agent Email | manoj@libertymanagement.us | |
| B. | Device Identification | |
| Common Name | Surgical Gloves | |
| Device Name | Sterile Nitrile Surgical Gloves Powder Free | |
| Product Proprietary orTrade Name | JR MEDIC | |
| Classification Name | Surgeon's Gloves |
1 KGO 21 CFR 878.4460
C. Predicate Device
Product Code
Device Classification
Regulation Number
510k Number Common Name Device Name Classification name Device Classification Product Code Regulation Number
K170515 Surgical Gloves Sterile Nitrile Surgical Gloves, Powder Free Surgeon's Gloves 1 KGO 21 CFR 878.4460
D. Description of the Device
The proposed device, Sterile Nitrile Surgical Gloves Powder Free is a sterile and disposable medical glove intended to be worn by operating room personnel to protect a surgical wound from contamination.
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The proposed device is made of synthetic rubber latex, as per standard ASTM D3577-2019, Standard Specification for Rubber Surgical Gloves.
The classification is: Type II - gloves compounded from synthetic rubber latex.
The proposed device is Sterile Nitrile Surgical Gloves Powder Free, and is produced in sizes 6, 6 ½, 7, 7 ½, 8, 8 ½, and 9. All sizes share the same White color.
The proposed device is sterilized using Gamma Radiation method to achieve the Sterility Assurance Level (SAL) of 10 6 while packaged to maintain sterility. The shelf life is 3 years.
E. Technological Characteristics
| Characteristic | Subject device K222350 | Predicate device K170515 | Remarks |
|---|---|---|---|
| Product Code | KGO | KGO | Same |
| Regulation No. | 21 CFR 878.4460 | 21 CFR 878.4460 | Same |
| Class | 1 | 1 | Same |
| Intended Use | A Sterile Nitrile Surgical GlovesPowder Free is a device made ofsynthetic rubber intended to beworn by operating roompersonnel to protect a surgicalwound from contamination. | The powder-free nitrile surgicalGloves, is a sterile and single usedevise made of synthetic rubberintended to be worn by operationroom personnel to protect a surgicalwound from contamination. Thegloves do not contain lubricating ordusting powder | Similar |
| Powdered or Powder free | Powder free | Powder free | Same |
| Material | Synthetic Rubber | Synthetic Rubber | Same |
| Color | White | White | Same |
| Classification as perASTMD3577-19,Standard Specificationfor Rubber SurgicalGloves | Type II - gloves compoundedfrom Synthetic rubber latex | Type II - gloves compounded fromSynthetic rubber latex | Same |
| Sterilization | Radiation, SAL-10-6 | ETO/as well as Radiation, SAL- 10-6 | Similar |
| Label and Labeling | Meet FDA's label Requirements | Meet FDA's label Requirements | Same |
| Type of use | Over the counter use | Over the counter use | Same |
| Dimensions Length:-Min 265mm | 307mm | 265mm min | Similar |
| Size: Width | |||
| 6.0 (76±6mm) | 78mm | 76±6mm | |
| 6.5 (83±6mm) | 85mm | 83±6mm | Similar |
| 7.0 (89±6mm) | 88mm | 89±6mm | |
| 7.5 (95±6mm) | 97mm | 95±6mm | |
| 8.0 (102±6mm) | 103mm | 102±6mm | |
| 8.5 (108±6mm) | 110mm | 108±6mm | |
| 9.0 (114±6mm) | 116mm | 114±6mm | |
| Cuff, Palm, Finger TipThicknessMin 0.10mm | Cuff- 0.12mmPalm- 0.18mmFinger Tip- 0.21mm | Cuff, Palm & Finger has a min0.10mm thickness | Similar |
| Tensile StrengthUnaged17MPa minimum | 24.20MPa | 17MPa min | Similar |
| Ultimate ElongationUnaged650% minimum | 871% | 650% min | Similar |
| Stress at 500% | |||
| Unaged7.0 MPa Max | 6.1MPa | 7.0MPa max | Similar |
| Tensile Strength | |||
| Aged12MPa minimum | 18.53MPa | 12 MPa min | Similar |
| Ultimate Elongation | |||
| Aged490% minimum | 653% | 490% min | Similar |
| Freedom from Holes | AQL 1.5 | AQL 2.5 | Similar |
| Powder residue forpowder free glovePowder content< 2 mg/Glove | 0.40mg/Glove | < 2mg/Glove | Similar |
| Skin Irritation | Under conditions of the testing, not an irritant | Under conditions of the testing, not an irritant | Similar |
| Skin Sensitization | Under the conditions of the testing, not a sensitizer | Under the conditions of the testing, not a sensitizer | Similar |
| In vitro cytotoxicity | Under the conditions of the testing, not cytotoxic | Under the conditions of the testing, not cytotoxic | Similar |
| Material Mediatedpyrogenicity | Under the conditions of the testing, non-pyrogenic | No data available | Different |
| Bacterial Endotoxin Test | < 20 EU/glove | No data available | Different |
| Systemic Toxicity | Under the conditions of the testing, no acute systemictoxicity | No data available | Different |
| Sterilization Modality | Radiation | Radiation/EtO | Similar |
| Sterility Assurance Level | 10-6 | 10-6 | Same |
| Shelf Life | 3 years | Unknown | Different |
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F. Summary of Non-Clinical Performance Testing
| Test Method | Purpose | Acceptance Criteria | Result | ||
|---|---|---|---|---|---|
| ASTM D5151-2019 | Freedom from holesBefore aging | AQL 1.53 non-consecutive lots | Pass | ||
| ASTM D5151-2019 | Freedom from holesAfter accelerated aging70 $\pm$ 2°C for 166 $\pm$ 2 h | AQL 1.53 non-consecutive lots | Pass | ||
| ASTM D5151-2019 | Freedom from holesAfter accelerated aging50 $\pm$ 2°C for 90 $\pm$ 1 days | AQL 1.53 non-consecutive lots | Pass | ||
| ASTM D3577-19,StandardSpecification forRubber SurgicalGloves | Tensile strengthBefore aging | Minimum 17MPa for allsizesAQL 4%3 non-consecutive lots | Pass | ||
| ASTM D3577-19,StandardSpecification forRubber Surgical | Tensile strengthAfter accelerated aging70 $\pm$ 2°C for 166 $\pm$ 2 h | Minimum 12MPa for allsizesAQL 4%3 non-consecutive lots | Pass | ||
| Gloves | |||||
| ASTM D3577-19,StandardSpecification forRubber SurgicalGloves | Tensile strengthAfter accelerated aging$50\pm2$ °C for $90\pm1$ days | Minimum 12MPa for allsizesAQL 4%3 non-consecutive lots | Pass | ||
| ASTM D3577-19,StandardSpecification forRubber SurgicalGloves | Ultimate ElongationBefore aging | Minimum 650% for allsizesAQL 4%3 non-consecutive lots | Pass | ||
| ASTM D3577-19,StandardSpecification forRubber SurgicalGloves | Ultimate elongationAfter accelerated aging$70\pm2$ °C for $166\pm2$ h | Minimum 490% for allsizesAQL 4%3 non-consecutive lots | Pass | ||
| ASTM D3577-19,StandardSpecification forRubber SurgicalGloves | Ultimate elongationAfter accelerated aging$50\pm2$ °C for $90\pm1$ days | Minimum 490% for allsizesAQL 4%3 non-consecutive lots | Pass | ||
| ASTM D3577-19,StandardSpecification forRubber SurgicalGloves | Stress at 500% elongationBefore accelerated aging | Maximum 7.0MPa for allsizesAQL 4%3 non-consecutive lots | Pass | ||
| ASTM D3577-19,StandardSpecification forRubber SurgicalGloves | Stress at 500% elongationAfter accelerated aging$70\pm2$ °C for $166\pm2$ h | Maximum 7.0MPa for allsizesAQL 4%3 non-consecutive lots | Pass | ||
| ASTM D3577-19,StandardSpecification forRubber SurgicalGloves | Stress at 500% elongationAfter accelerated aging$50\pm2$ °C for $90\pm1$ days | Maximum 7.0MPa for allsizesAQL 4%3 non-consecutive lots | Pass | ||
| ASTM F1929,Test Method fordetecting seal leaks inporous medicalpackaging by dyepenetration | Package integrityAfter accelerated aging$70\pm2$ °C for $166\pm2$ h | No penetrationAQL 0.65%3 non-consecutive lots | Pass | ||
| ASTM F1929,Test Method fordetecting seal leaks inporous medicalpackaging by dyepenetration | Package integrityAfter accelerated aging$50\pm2$ °C for $90\pm1$ days | No penetrationAQL 0.65%3 non-consecutive lots | Pass | ||
| ASTM D3577-19,StandardSpecification forRubber Surgical | To determine the length ofthe gloves | Min 265mm for all sizes | Size 6 | Pass | |
| Size 6 ½ | Pass | ||||
| Size 7 | Pass | ||||
| Gloves | Size 7 ½ | Pass | |||
| Size 8 | Pass | ||||
| Size 8½ | Pass | ||||
| Size 9 | Pass | ||||
| ASTM D3577-19, Standard Specification for Rubber Surgical Gloves | To determine the width of the gloves | Size 6 | 76±6mm | Size 6 | Pass |
| Size 6 ½ | 83±6mm | Size 6 ½ | Pass | ||
| Size 7 | 89±6mm | Size 7 | Pass | ||
| Size 7 ½ | 95±6mm | Size 7 ½ | Pass | ||
| Size 8 | 102±6mm | Size 8 | Pass | ||
| Size 8 ½ | 108±6mm | Size 8 ½ | Pass | ||
| Size 9 | 114±6mm | Size 9 | Pass | ||
| ASTM D3577-19, Standard Specification for Rubber Surgical Gloves | To determine finger thickness | Minimum 0.10mm for all sizesAQL 4% | Size 6 | Pass | |
| Size 6 ½ | Pass | ||||
| Size 7 | Pass | ||||
| Size 7 ½ | Pass | ||||
| Size 8 | Pass | ||||
| Size 8 ½ | Pass | ||||
| Size 9 | Pass | ||||
| ASTM D3577-19, Standard Specification for Rubber Surgical Gloves | To determine palm thickness | Minimum 0.10mm for all sizesAQL 4% | Size 6 | Pass | |
| Size 6 ½ | Pass | ||||
| Size 7 | Pass | ||||
| Size 7 ½ | Pass | ||||
| Size 8 | Pass | ||||
| Size 8 ½ | Pass | ||||
| Size 9 | Pass | ||||
| ASTM D3577-19, Standard Specification for Rubber Surgical Gloves | To determine cuff thickness | Minimum 0.10mm for all sizesAQL 4% | Size 6 | Pass | |
| Size 6 ½ | Pass | ||||
| Size 7 | Pass | ||||
| Size 7 ½ | Pass | ||||
| Size 8 | Pass | ||||
| Size 8 ½ | Pass | ||||
| Size 9 | Pass | ||||
| ASTM D6124-06R17, Standard Test Method for Residual Powder on Medical Gloves | Less than 2mg/glove | Maximum 2mg/glove for all sizes | Pass | ||
| ISO 10993-10: 2010, Biological evaluation of medical devices - Part 10- Tests for irritation and skin sensitization | Irritation | Under the conditions of the testing, not an irritant | Pass | ||
| ISO 10993-10: 2010, Biological evaluation of medical devices - Part 10- Tests for irritation and skin sensitization | Sensitization | Under the conditions of the testing, not a sensitizer | Pass | ||
| ISO 10993-5:2009(E) Cytotoxicity | Under the conditions of | Pass |
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| Biological Evaluationof Medical Devices -Part 5-Tests forin-vitro Cytotoxicity | the testing, non-cytotoxic | ||
|---|---|---|---|
| ISO 10993-11:2017(E)Biological Evaluationof Medical Devices -Part 11- Tests forSystemicToxicity andBiological Tests | Acute systemic toxicity | Under the conditions ofthe testing, no acutesystemic toxicity | Pass |
| USP 41<151>Pyrogen Test | Material mediatedpyrogenicity | Under the conditions ofthe testing, non-pyrogenic | Pass |
| USP 42 <85>Bacterial EndotoxinTest | Bacterial endotoxin limits | Less than 20EU/glove | Pass |
G. Summary of Clinical Performance Testing
No clinical performance testing was performed in support of this submission.
H. Conclusion
The conclusion drawn from the nonclinical tests demonstrates that the subject device Sterile Nitrile Surgical Gloves Powder Free is as safe, as effective and performs as well or better than the legally marketed predicate device "PRIMUS NITRILE GLOVES" Sterile Nitrile Surgical Gloves Powder Free (K170515).
§ 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).