(253 days)
Not Found
No
The device description and performance studies focus solely on the physical and material properties of surgical gloves, with no mention of AI or ML technologies.
No.
Explanation: A therapeutic device is designed to treat, cure, mitigate, or prevent disease. Surgical gloves, while protective, do not perform these therapeutic functions directly on the patient. They serve as a barrier to prevent contamination.
No
This device is a surgical glove, intended to protect a surgical wound from contamination, not to diagnose a condition or disease.
No
The device is a physical product (surgical gloves made of synthetic rubber) and does not involve any software components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to protect a surgical wound from contamination by being worn by operating room personnel. This is a barrier function for infection control during surgery.
- Device Description: The description focuses on the physical properties of the glove (material, size, sterility, etc.) and its function as a protective barrier.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment. IVDs are used in vitro (outside the body) to analyze biological samples.
The device described is a medical device, specifically a surgical glove, but it falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
KGO
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
operating room personnel
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Testing: The device underwent various tests based on ASTM and ISO standards. Key tests include:
- ASTM D5151-2019: Freedom from holes (AQL 1.5, 3 non-consecutive lots) - Pass for both before and after accelerated aging.
- ASTM D3577-19: Tensile strength (Minimum 17MPa unaged, Minimum 12MPa aged, AQL 4%, 3 non-consecutive lots) - Pass.
- ASTM D3577-19: Ultimate Elongation (Minimum 650% unaged, Minimum 490% aged, AQL 4%, 3 non-consecutive lots) - Pass.
- ASTM D3577-19: Stress at 500% elongation (Maximum 7.0MPa, AQL 4%, 3 non-consecutive lots) - Pass.
- ASTM F1929: Package integrity (No penetration, AQL 0.65%, 3 non-consecutive lots) - Pass.
- ASTM D3577-19: Length (Min 265mm) - Pass for all sizes.
- ASTM D3577-19: Width (e.g., Size 6: 76±6mm) - Pass for all sizes.
- ASTM D3577-19: Finger, Palm, and Cuff Thickness (Minimum 0.10mm, AQL 4%) - Pass for all sizes.
- ASTM D6124-06R17: Residual Powder on Medical Gloves (Less than 2mg/glove) - Pass.
- ISO 10993-10: Irritation and Skin Sensitization - Pass (not an irritant, not a sensitizer).
- ISO 10993-5: Cytotoxicity - Pass (not cytotoxic).
- ISO 10993-11: Acute Systemic Toxicity - Pass (no acute systemic toxicity).
- USP 41 : Pyrogen Test (Material mediated pyrogenicity) - Pass (non-pyrogenic).
- USP 42 : Bacterial Endotoxin Test (Less than 20EU/glove) - Pass.
Clinical Performance Testing: No clinical performance testing was performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath. The logo is simple and professional, and it is easily recognizable.
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.
1
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, Pusat | |
| Perindustrian 2, 44200 Rasa, Hulu | ||
| Selangor, 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 or | ||
| Trade 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 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 powder-free nitrile surgical | ||
| Gloves, is a sterile and single use | |||
| devise made of synthetic rubber | |||
| intended to be worn by operation | |||
| room personnel to protect a surgical | |||
| wound from contamination. The | |||
| gloves do not contain lubricating or | |||
| dusting powder | Similar | ||
| Powdered or Powder free | Powder free | Powder free | Same |
| Material | Synthetic Rubber | Synthetic Rubber | Same |
| Color | White | White | Same |
| Classification as per | |||
| ASTMD3577-19, | |||
| Standard Specification | |||
| for Rubber Surgical | |||
| Gloves | Type II - gloves compounded | ||
| from Synthetic rubber latex | Type II - gloves compounded from | ||
| Synthetic 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 Tip | |||
| Thickness | |||
| Min 0.10mm | Cuff- 0.12mm | ||
| Palm- 0.18mm | |||
| Finger Tip- 0.21mm | Cuff, Palm & Finger has a min | ||
| 0.10mm thickness | Similar | ||
| Tensile Strength | |||
| Unaged | |||
| 17MPa minimum | 24.20MPa | 17MPa min | Similar |
| Ultimate Elongation | |||
| Unaged | |||
| 650% minimum | 871% | 650% min | Similar |
| Stress at 500% | |||
| Unaged | |||
| 7.0 MPa Max | 6.1MPa | 7.0MPa max | Similar |
| Tensile Strength | |||
| Aged | |||
| 12MPa minimum | 18.53MPa | 12 MPa min | Similar |
| Ultimate Elongation | |||
| Aged | |||
| 490% minimum | 653% | 490% min | Similar |
| Freedom from Holes | AQL 1.5 | AQL 2.5 | Similar |
| Powder residue for | |||
| powder free glove | |||
| Powder content | |||
| Pyrogen Test | Material mediated | ||
| pyrogenicity | Under the conditions of | ||
| the testing, non-pyrogenic | Pass | ||
| USP 42 | |||
| Bacterial Endotoxin | |||
| Test | 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).